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<hr />
<div>[[Wiki section]]<br />
<br />
==Process to Identify Possible Acquisition Targets==<br />
<br />
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.<br />
<br />
===Advantage of Mergers and Acquisitions===<br />
<br />
The most common motives and advantages of mergers and acquisitions are:-<br />
<br />
*Accelerating a company's growth, particularly when its internal growth is constrained due to paucity of resources. Internal growth requires that a company should develop its operating facilities- manufacturing, research, marketing, etc. But, lack or inadequacy of resources and time needed for internal development may constrain a company's pace of growth. Hence, a company can acquire production facilities as well as other resources from outside through mergers and acquisitions. Specially, for entering in new products/markets, the company may lack technical skills and may require special marketing skills and a wide distribution network to access different segments of markets. The company can acquire existing company or companies with requisite infrastructure and skills and grow quickly.<br />
<br />
*Enhancing profitability because a combination of two or more companies may result in more than average profitability due to cost reduction and efficient utilization of resources. This may happen because of:-<br />
**Economies of scale:- arise when increase in the volume of production leads to a reduction in the cost of production per unit. This is because, with merger, fixed costs are distributed over a large volume of production causing the unit cost of production to decline. Economies of scale may also arise from other indivisibilities such as production facilities, management functions and management resources and systems. This is because a given function, facility or resource is utilized for a large scale of operations by the combined firm.<br />
**Operating economies:- arise because, a combination of two or more firms may result in cost reduction due to operating economies. In other words, a combined firm may avoid or reduce over-lapping functions and consolidate its management functions such as manufacturing, marketing, R&D and thus reduce operating costs. For example, a combined firm may eliminate duplicate channels of distribution, or crate a centralized training center, or introduce an integrated planning and control system.<br />
**Synergy:- implies a situation where the combined firm is more valuable than the sum of the individual combining firms. It refers to benefits other than those related to economies of scale. Operating economies are one form of synergy benefits. But apart from operating economies, synergy may also arise from enhanced managerial capabilities, creativity, innovativeness, R&D and market coverage capacity due to the complementarity of resources and skills and a widened horizon of opportunities.<br />
<br />
*Diversifying the risks of the company, particularly when it acquires those businesses whose income streams are not correlated. Diversification implies growth through the combination of firms in unrelated businesses. It results in reduction of total risks through substantial reduction of cyclicality of operations. The combination of management and other systems strengthen the capacity of the combined firm to withstand the severity of the unforeseen economic factors which could otherwise endanger the survival of the individual companies.<br />
<br />
*A merger may result in financial synergy and benefits for the firm in many ways:-<br />
**By eliminating financial constraints<br />
**By enhancing debt capacity. This is because a merger of two companies can bring stability of cash flows which in turn reduces the risk of insolvency and enhances the capacity of the new entity to service a larger amount of debt<br />
**By lowering the financial costs. This is because due to financial stability, the merged firm is able to borrow at a lower rate of interest.<br />
<br />
*Limiting the severity of competition by increasing the company's market power. A merger can increase the market share of the merged firm. This improves the profitability of the firm due to economies of scale. The bargaining power of the firm vis-à-vis labour, suppliers and buyers is also enhanced. The merged firm can exploit technological breakthroughs against obsolescence and price wars.<br />
<br />
'''Note:''' In this research report, researcher considered two following objective of merger and acquisition:<br />
<br />
#To Enter in emerging markets<br />
#To improve product portfolio<br />
<br />
===Methodology===<br />
<br />
* '''Step 1''': First, list all the players present in Ureteral Stent Market were identified.(The list of companies was retrieved from the FDA site from Registration & Listing database)<br />
** Number of companies that were identified in this step: 20 <br />
<br />
* '''Step 2''': The second step involved identifying and eliminating companies that are large, and established players or the subsidiaries of the big players in the industry. <br />
**Number of companies eliminated in this step: 14<br />
**Number of (small) companies of interest left: 6<br />
<br />
* '''Step 3''': Once the large, and established players were eliminated, companies were compared based on various parameters and rated on the scale of 5 to identify the best target. Please check the following table and dashboard:<br />
**Number of potential target companies: 6<br />
<br />
<br/><br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="80%" align="center"<br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Company'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Headquartered'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Stent Details'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Company Type'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''2010 Revenue (Mn)'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''No of Employees'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Geographical Revenue Share'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''R&D investment (Mn)'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''No. of Patent'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Technology Focus'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|Applied Medical Resources Corp.<br />
|bgcolor = "#DBE5F1"|USA<br />
|bgcolor = "#DBE5F1"|Mesh ureteral stent<br>C-flex ureteral stent<br>Silicone ureteral stent<br>Tethered ureteral stent<br>C-flex ureteral stent<br>Ureteral stent<br>Silhouette pediatric stent<br />
|bgcolor = "#DBE5F1"|Manufacturer<br />
|align = "center" bgcolor = "#DBE5F1"|$282<br />
|align = "center" bgcolor = "#DBE5F1"|1900<br />
|bgcolor = "#DBE5F1"|USA: 62%<br>Asia: 32%<br>Rest of World: 6%<br />
|bgcolor = "#DBE5F1"|$38.3 (13%)<br />
|align = "center" bgcolor = "#DBE5F1"|212<br />
|bgcolor = "#DBE5F1"|High<br />
|-<br />
|Bioteque Corp.<br />
|Taiwan<br />
|Bioteque Double Pigta<br />
|Contract Manufacturer; Contract Sterilizer; Manufacturer<br />
|align = "center"|$27.85<br />
|align = "center"|350<br />
|Taiwan: 100%<br />
|$1.4 (5%)<br />
|align = "center"|16<br />
|Medium<br />
|-<br />
|bgcolor = "#DBE5F1"|Hobbs Medical, Inc.<br />
|bgcolor = "#DBE5F1"|USA<br />
|bgcolor = "#DBE5F1"|HM Ureteral Double Pigtail Stent<br />
|bgcolor = "#DBE5F1"|Manufacturer<br />
|align = "center" bgcolor = "#DBE5F1"|$2.30<br />
|align = "center" bgcolor = "#DBE5F1"|22<br />
|bgcolor = "#DBE5F1"|USA: 97.2%<br>Japan: 2.3%<br>Others: 0.5%<br />
|bgcolor = "#DBE5F1"|$0.06 (2.87%)<br />
|align = "center" bgcolor = "#DBE5F1"|1<br />
|bgcolor = "#DBE5F1"|Low<br />
|-<br />
|Lake Region Medical Limited<br />
|Ireland<br />
|M-Wires<br />
|Contract Manufacturer<br />
|align = "center"|$84.86<br />
|align = "center"|611<br />
|Europe: 68%<br>USA: 21%<br>Others: 11%<br />
|$8.48 (3.85%)<br />
|align = "center"|8<br />
|Medium<br />
|-<br />
|bgcolor = "#DBE5F1"|Martech Medical Products<br />
|bgcolor = "#DBE5F1"|USA<br />
|bgcolor = "#DBE5F1"|Ureteral Stent<br />
|bgcolor = "#DBE5F1"|Contract Manufacturer<br />
|align = "center" bgcolor = "#DBE5F1"|$23.00<br />
|align = "center" bgcolor = "#DBE5F1"|180<br />
|bgcolor = "#DBE5F1"|USA: 78.3%<br>Europe: 12.7%<br>Others: 9%<br />
|bgcolor = "#DBE5F1"|$1.1 (4.79%)<br />
|align = "center" bgcolor = "#DBE5F1"|0<br />
|bgcolor = "#DBE5F1"|Low<br />
|-<br />
|Allium Medical<br />
|Israel<br />
|URS - Ureteral Stent<br>TPS - Triangular Prostatic Stent<br>BUS - Bulbar Urethral Stent<br>RPS - Round Posterior Urethral Stent<br>BIS - Biliary Stent<br />
|Manufaturer<br />
|align = "center"|$2.04<br />
|align = "center"|20<br />
|Domestic: 88.6%<br>International: 11.4%<br />
|$0.082 (4%)<br />
|align = "center"|2<br />
|Low<br />
|-<br />
|}<br clear="all"><br />
<br />
'''Note:''' Data for Geographical segment, R&D expenditure and Technology focus has been masked.<br />
<br />
{|align="center"<br />
|<gflash>1000 750 http://dolcera.com/upload/files/ranking1.swf</gflash><br />
|-<br />
|}<br />
<br/><br />
<br />
<br />
* '''Step 4''': Finally, after an in-depth analysis of the potential target companies’ on various parameters, following companies identified to be best possible target companies.<br />
**To improve Product Portfolio : '''Applied Medical Resources Corp.'''<br />
**To enter in Emerging Markets : '''Bioteque Corp.'''<br />
<br />
===Company Profile===<br />
====Applied Medical Resources Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''APPLIED MEDICAL RESOURCES CORP.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $280 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $ 38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|1900<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1987<br />
|-<br />
|'''Headquarters'''<br />
|USA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"|CEO: Said S. Hilal<br />
|-<br />
|'''Products & Technology'''<br />
|Specialty Areas:Cardiac/Vascular, Colorectal, GYN, Urology <br>New Products:Epix (Laparoscopic Intrumentation), GelPOINT (Advanced Access Platform), Kii Fios (First EntrySystem)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|USA: $182.70 million (65%)<br>Others: $99.47 million (35%)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Applied Medical Resources Corporation is a new generation medical device company founded in 1987 and headquartered in Southern California. It is involved in developing, manufacturing and marketing of innovative products for Minimally Invasive Surgery, Cardiac, Vascular, Urological, Colorectal, Bariatric, Obstetric, Gynecologic and General Surgery. The product portfolio covers 25 technologies and more than 700 products. The company has spread its business globally across 75 countries including Africa, Middle East,Americas, Caribbean, Asia, Australia and Europe through its network of international distributors.<br />
|-<br />
|}<br />
<br />
====Bioteque Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''Bioteque Corp.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $27.85 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|350<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1991<br />
|-<br />
|'''Headquarters'''<br />
|Taiwan<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"| <br />
|-<br />
|'''Products & Technology'''<br />
|<br> NEPHROLOGY, UROLOGY, RADIOLOGY, CARDIOLOGY, RESPIRATORY CARE<br> CRITICAL CARE, IV ADMINISTRATION THERAPY, MOLDING PARTS<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|NA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Bioteque Corporation manufactures and sells medical devices in Taiwan. It offers medical disposables for use in hemodialysis access, endovascular treatment, and other fields. It offers blood tubing lines, AVF needles, transducer protectors, and on line HDF with check valves or without check valves; IV infusion bags, precision IV infusion sets, drainage bags, insufflation tubing sets/filters, and various surgical drainage tubes; a range of medical components, which comprise blood tubing line components, percutaneous drainage components, infusion bag components, AVF needle components, precision IV infusion set components, and IV infusion bag components; a range of thermoplastic polyurethane catheters, including pigtail drainage catheter sets, double pigtail ureteral stent sets, biliary drainage catheters, percutaneous nephrostomy kits, and dialysis catheters; and other medical disposable products, such as closed suction catheters and artificial nose. The company also provides endovascular products, which consist of percutaneous transluminal coronary angioplasty, percutaneous transluminal angioplasty, angiography catheters, guiding catheters, sheath introducers, MRI/CT/angiography syringes, micro catheters, and hydrophilic coated guidewires. Bioteque Corporation was founded in 1991 and is based in Taipei, Taiwan.<br />
|-<br />
|}<br />
<br />
==M&A Due Diligence Process==<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
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'''Dolcera can provide a comprehensive report customized to your needs'''</p><br />
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<br />
==Contact Dolcera==<br />
<br />
{| style="border:1px solid #AAA; background:#E9E9E9" align="center"<br />
|-<br />
! style="background:lightgrey" | Samir Raiyani<br />
|-<br />
| '''Email''': [mailto:info@dolcera.com info@dolcera.com]<br />
|-<br />
| '''Phone''': +1-650-269-7952<br />
|}<br />
<br />
= Addition =<br />
=== Patent Categorization: Interactive mind map linked to Dolcera Dashboard ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
=== Product-Patent-Clinical Trials Mapping ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=== Product to Patent Mapping ===<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''here ''']]to download the excel file.<br />
* Mapped Patent vs Not Mapped Patents<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Backup&diff=10392
Backup
2012-02-16T13:45:55Z
<p>Shweta.mittal@dolcera.com: /* Methodology */</p>
<hr />
<div>[[Wiki section]]<br />
<br />
==Process to Identify Possible Acquisition Targets==<br />
<br />
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.<br />
<br />
===Advantage of Mergers and Acquisitions===<br />
<br />
The most common motives and advantages of mergers and acquisitions are:-<br />
<br />
*Accelerating a company's growth, particularly when its internal growth is constrained due to paucity of resources. Internal growth requires that a company should develop its operating facilities- manufacturing, research, marketing, etc. But, lack or inadequacy of resources and time needed for internal development may constrain a company's pace of growth. Hence, a company can acquire production facilities as well as other resources from outside through mergers and acquisitions. Specially, for entering in new products/markets, the company may lack technical skills and may require special marketing skills and a wide distribution network to access different segments of markets. The company can acquire existing company or companies with requisite infrastructure and skills and grow quickly.<br />
<br />
*Enhancing profitability because a combination of two or more companies may result in more than average profitability due to cost reduction and efficient utilization of resources. This may happen because of:-<br />
**Economies of scale:- arise when increase in the volume of production leads to a reduction in the cost of production per unit. This is because, with merger, fixed costs are distributed over a large volume of production causing the unit cost of production to decline. Economies of scale may also arise from other indivisibilities such as production facilities, management functions and management resources and systems. This is because a given function, facility or resource is utilized for a large scale of operations by the combined firm.<br />
**Operating economies:- arise because, a combination of two or more firms may result in cost reduction due to operating economies. In other words, a combined firm may avoid or reduce over-lapping functions and consolidate its management functions such as manufacturing, marketing, R&D and thus reduce operating costs. For example, a combined firm may eliminate duplicate channels of distribution, or crate a centralized training center, or introduce an integrated planning and control system.<br />
**Synergy:- implies a situation where the combined firm is more valuable than the sum of the individual combining firms. It refers to benefits other than those related to economies of scale. Operating economies are one form of synergy benefits. But apart from operating economies, synergy may also arise from enhanced managerial capabilities, creativity, innovativeness, R&D and market coverage capacity due to the complementarity of resources and skills and a widened horizon of opportunities.<br />
<br />
*Diversifying the risks of the company, particularly when it acquires those businesses whose income streams are not correlated. Diversification implies growth through the combination of firms in unrelated businesses. It results in reduction of total risks through substantial reduction of cyclicality of operations. The combination of management and other systems strengthen the capacity of the combined firm to withstand the severity of the unforeseen economic factors which could otherwise endanger the survival of the individual companies.<br />
<br />
*A merger may result in financial synergy and benefits for the firm in many ways:-<br />
**By eliminating financial constraints<br />
**By enhancing debt capacity. This is because a merger of two companies can bring stability of cash flows which in turn reduces the risk of insolvency and enhances the capacity of the new entity to service a larger amount of debt<br />
**By lowering the financial costs. This is because due to financial stability, the merged firm is able to borrow at a lower rate of interest.<br />
<br />
*Limiting the severity of competition by increasing the company's market power. A merger can increase the market share of the merged firm. This improves the profitability of the firm due to economies of scale. The bargaining power of the firm vis-à-vis labour, suppliers and buyers is also enhanced. The merged firm can exploit technological breakthroughs against obsolescence and price wars.<br />
<br />
'''Note:''' In this research report, researcher considered two following objective of merger and acquisition:<br />
<br />
#To Enter in emerging markets<br />
#To improve product portfolio<br />
<br />
===Methodology===<br />
<br />
* '''Step 1''': First, list all the players present in Ureteral Stent Market were identified.(The list of companies was retrieved from the FDA site from Registration & Listing database)<br />
** Number of companies that were identified in this step: 20 <br />
<br />
* '''Step 2''': The second step involved identifying and eliminating companies that are large, and established players or the subsidiaries of the big players in the industry. <br />
**Number of companies eliminated in this step: 14<br />
**Number of (small) companies of interest left: 6<br />
<br />
* '''Step 3''': Once the large, and established players were eliminated, companies were compared based on various parameters and rated on the scale of 5 to identify the best target. Please check the following table and dashboard:<br />
**Number of potential target companies: 6<br />
<br />
<br/><br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="80%" align="center"<br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Company'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Headquartered'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Stent Details'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Company Type'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''2010 Revenue (Mn)'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''No of Employees'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Geographical Revenue Share'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''R&D investment (Mn)'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''No. of Patent'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Technology Focus'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|Applied Medical Resources Corp.<br />
|bgcolor = "#DBE5F1"|USA<br />
|bgcolor = "#DBE5F1"|Mesh ureteral stent<br>C-flex ureteral stent<br>Silicone ureteral stent<br>Tethered ureteral stent<br>C-flex ureteral stent<br>Ureteral stent<br>Silhouette pediatric stent<br />
|bgcolor = "#DBE5F1"|Manufacturer<br />
|align = "center" bgcolor = "#DBE5F1"|$282<br />
|align = "center" bgcolor = "#DBE5F1"|1900<br />
|bgcolor = "#DBE5F1"|USA: 62%<br>Asia: 32%<br>Rest of World: 6%<br />
|bgcolor = "#DBE5F1"|$38.3 (13%)<br />
|align = "center" bgcolor = "#DBE5F1"|212<br />
|bgcolor = "#DBE5F1"|High<br />
|-<br />
|Bioteque Corp.<br />
|Taiwan<br />
|Bioteque Double Pigta<br />
|Contract Manufacturer; Contract Sterilizer; Manufacturer<br />
|align = "center"|$27.85<br />
|align = "center"|350<br />
|Taiwan: 100%<br />
|$1.4 (5%)<br />
|align = "center"|16<br />
|Medium<br />
|-<br />
|bgcolor = "#DBE5F1"|Hobbs Medical, Inc.<br />
|bgcolor = "#DBE5F1"|USA<br />
|bgcolor = "#DBE5F1"|HM Ureteral Double Pigtail Stent<br />
|bgcolor = "#DBE5F1"|Manufacturer<br />
|align = "center" bgcolor = "#DBE5F1"|$2.30<br />
|align = "center" bgcolor = "#DBE5F1"|22<br />
|bgcolor = "#DBE5F1"|USA: 97.2%<br>Japan: 2.3%<br>Others: 0.5%<br />
|bgcolor = "#DBE5F1"|$0.06 (2.87%)<br />
|align = "center" bgcolor = "#DBE5F1"|1<br />
|bgcolor = "#DBE5F1"|Low<br />
|-<br />
|Lake Region Medical Limited<br />
|Ireland<br />
|M-Wires<br />
|Contract Manufacturer<br />
|align = "center"|$84.86<br />
|align = "center"|611<br />
|Europe: 68%<br>USA: 21%<br>Others: 11%<br />
|$8.48 (3.85%)<br />
|align = "center"|8<br />
|Medium<br />
|-<br />
|bgcolor = "#DBE5F1"|Martech Medical Products<br />
|bgcolor = "#DBE5F1"|USA<br />
|bgcolor = "#DBE5F1"|Ureteral Stent<br />
|bgcolor = "#DBE5F1"|Contract Manufacturer<br />
|align = "center" bgcolor = "#DBE5F1"|$23.00<br />
|align = "center" bgcolor = "#DBE5F1"|180<br />
|bgcolor = "#DBE5F1"|USA: 78.3%<br>Europe: 12.7%<br>Others: 9%<br />
|bgcolor = "#DBE5F1"|$1.1 (4.79%)<br />
|align = "center" bgcolor = "#DBE5F1"|0<br />
|bgcolor = "#DBE5F1"|Low<br />
|-<br />
|Allium Medical<br />
|Israel<br />
|URS - Ureteral Stent<br>TPS - Triangular Prostatic Stent<br>BUS - Bulbar Urethral Stent<br>RPS - Round Posterior Urethral Stent<br>BIS - Biliary Stent<br />
|Manufaturer<br />
|align = "center"|$2.04<br />
|align = "center"|20<br />
|Domestic: 88.6%<br>International: 11.4%<br />
|$0.082 (4%)<br />
|align = "center"|2<br />
|Low<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
<br />
{|align="center"<br />
|<gflash>1000 750 http://dolcera.com/upload/files/ranking1.swf</gflash><br />
|-<br />
|}<br />
<br/><br />
<br />
<br />
* '''Step 4''': Finally, after an in-depth analysis of the potential target companies’ on various parameters, following companies identified to be best possible target companies.<br />
**To improve Product Portfolio : '''Applied Medical Resources Corp.'''<br />
**To enter in Emerging Markets : '''Bioteque Corp.'''<br />
<br />
===Company Profile===<br />
====Applied Medical Resources Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''APPLIED MEDICAL RESOURCES CORP.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $280 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $ 38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|1900<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1987<br />
|-<br />
|'''Headquarters'''<br />
|USA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"|CEO: Said S. Hilal<br />
|-<br />
|'''Products & Technology'''<br />
|Specialty Areas:Cardiac/Vascular, Colorectal, GYN, Urology <br>New Products:Epix (Laparoscopic Intrumentation), GelPOINT (Advanced Access Platform), Kii Fios (First EntrySystem)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|USA: $182.70 million (65%)<br>Others: $99.47 million (35%)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Applied Medical Resources Corporation is a new generation medical device company founded in 1987 and headquartered in Southern California. It is involved in developing, manufacturing and marketing of innovative products for Minimally Invasive Surgery, Cardiac, Vascular, Urological, Colorectal, Bariatric, Obstetric, Gynecologic and General Surgery. The product portfolio covers 25 technologies and more than 700 products. The company has spread its business globally across 75 countries including Africa, Middle East,Americas, Caribbean, Asia, Australia and Europe through its network of international distributors.<br />
|-<br />
|}<br />
<br />
====Bioteque Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''Bioteque Corp.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $27.85 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|350<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1991<br />
|-<br />
|'''Headquarters'''<br />
|Taiwan<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"| <br />
|-<br />
|'''Products & Technology'''<br />
|<br> NEPHROLOGY, UROLOGY, RADIOLOGY, CARDIOLOGY, RESPIRATORY CARE<br> CRITICAL CARE, IV ADMINISTRATION THERAPY, MOLDING PARTS<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|NA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Bioteque Corporation manufactures and sells medical devices in Taiwan. It offers medical disposables for use in hemodialysis access, endovascular treatment, and other fields. It offers blood tubing lines, AVF needles, transducer protectors, and on line HDF with check valves or without check valves; IV infusion bags, precision IV infusion sets, drainage bags, insufflation tubing sets/filters, and various surgical drainage tubes; a range of medical components, which comprise blood tubing line components, percutaneous drainage components, infusion bag components, AVF needle components, precision IV infusion set components, and IV infusion bag components; a range of thermoplastic polyurethane catheters, including pigtail drainage catheter sets, double pigtail ureteral stent sets, biliary drainage catheters, percutaneous nephrostomy kits, and dialysis catheters; and other medical disposable products, such as closed suction catheters and artificial nose. The company also provides endovascular products, which consist of percutaneous transluminal coronary angioplasty, percutaneous transluminal angioplasty, angiography catheters, guiding catheters, sheath introducers, MRI/CT/angiography syringes, micro catheters, and hydrophilic coated guidewires. Bioteque Corporation was founded in 1991 and is based in Taipei, Taiwan.<br />
|-<br />
|}<br />
<br />
==M&A Due Diligence Process==<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
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{| style="border:1px solid #AAA; background:#E9E9E9" align="center"<br />
|-<br />
! style="background:lightgrey" | Samir Raiyani<br />
|-<br />
| '''Email''': [mailto:info@dolcera.com info@dolcera.com]<br />
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*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
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=== Product-Patent-Clinical Trials Mapping ===<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=== Product to Patent Mapping ===<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''here ''']]to download the excel file.<br />
* Mapped Patent vs Not Mapped Patents<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
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'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
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* [[Company Profile - Flash]]<br />
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=Removed Sections=<br />
[[Removed Sections]]</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Backup&diff=10391
Backup
2012-02-16T13:45:25Z
<p>Shweta.mittal@dolcera.com: /* Methodology */</p>
<hr />
<div>[[Wiki section]]<br />
<br />
==Process to Identify Possible Acquisition Targets==<br />
<br />
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.<br />
<br />
===Advantage of Mergers and Acquisitions===<br />
<br />
The most common motives and advantages of mergers and acquisitions are:-<br />
<br />
*Accelerating a company's growth, particularly when its internal growth is constrained due to paucity of resources. Internal growth requires that a company should develop its operating facilities- manufacturing, research, marketing, etc. But, lack or inadequacy of resources and time needed for internal development may constrain a company's pace of growth. Hence, a company can acquire production facilities as well as other resources from outside through mergers and acquisitions. Specially, for entering in new products/markets, the company may lack technical skills and may require special marketing skills and a wide distribution network to access different segments of markets. The company can acquire existing company or companies with requisite infrastructure and skills and grow quickly.<br />
<br />
*Enhancing profitability because a combination of two or more companies may result in more than average profitability due to cost reduction and efficient utilization of resources. This may happen because of:-<br />
**Economies of scale:- arise when increase in the volume of production leads to a reduction in the cost of production per unit. This is because, with merger, fixed costs are distributed over a large volume of production causing the unit cost of production to decline. Economies of scale may also arise from other indivisibilities such as production facilities, management functions and management resources and systems. This is because a given function, facility or resource is utilized for a large scale of operations by the combined firm.<br />
**Operating economies:- arise because, a combination of two or more firms may result in cost reduction due to operating economies. In other words, a combined firm may avoid or reduce over-lapping functions and consolidate its management functions such as manufacturing, marketing, R&D and thus reduce operating costs. For example, a combined firm may eliminate duplicate channels of distribution, or crate a centralized training center, or introduce an integrated planning and control system.<br />
**Synergy:- implies a situation where the combined firm is more valuable than the sum of the individual combining firms. It refers to benefits other than those related to economies of scale. Operating economies are one form of synergy benefits. But apart from operating economies, synergy may also arise from enhanced managerial capabilities, creativity, innovativeness, R&D and market coverage capacity due to the complementarity of resources and skills and a widened horizon of opportunities.<br />
<br />
*Diversifying the risks of the company, particularly when it acquires those businesses whose income streams are not correlated. Diversification implies growth through the combination of firms in unrelated businesses. It results in reduction of total risks through substantial reduction of cyclicality of operations. The combination of management and other systems strengthen the capacity of the combined firm to withstand the severity of the unforeseen economic factors which could otherwise endanger the survival of the individual companies.<br />
<br />
*A merger may result in financial synergy and benefits for the firm in many ways:-<br />
**By eliminating financial constraints<br />
**By enhancing debt capacity. This is because a merger of two companies can bring stability of cash flows which in turn reduces the risk of insolvency and enhances the capacity of the new entity to service a larger amount of debt<br />
**By lowering the financial costs. This is because due to financial stability, the merged firm is able to borrow at a lower rate of interest.<br />
<br />
*Limiting the severity of competition by increasing the company's market power. A merger can increase the market share of the merged firm. This improves the profitability of the firm due to economies of scale. The bargaining power of the firm vis-à-vis labour, suppliers and buyers is also enhanced. The merged firm can exploit technological breakthroughs against obsolescence and price wars.<br />
<br />
'''Note:''' In this research report, researcher considered two following objective of merger and acquisition:<br />
<br />
#To Enter in emerging markets<br />
#To improve product portfolio<br />
<br />
===Methodology===<br />
<br />
* '''Step 1''': First, list all the players present in Ureteral Stent Market were identified.(The list of companies was retrieved from the FDA site from Registration & Listing database)<br />
** Number of companies that were identified in this step: 20 <br />
<br />
* '''Step 2''': The second step involved identifying and eliminating companies that are large, and established players or the subsidiaries of the big players in the industry. <br />
**Number of companies eliminated in this step: 14<br />
**Number of (small) companies of interest left: 6<br />
<br />
* '''Step 3''': Once the large, and established players were eliminated, companies were compared based on various parameters and rated on the scale of 5 to identify the best target. Please check the following table and dashboard:<br />
**Number of potential target companies: 6<br />
<br />
<br/><br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%" align="center"<br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Company'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Headquartered'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Stent Details'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Company Type'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''2010 Revenue (Mn)'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''No of Employees'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Geographical Revenue Share'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''R&D investment (Mn)'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''No. of Patent'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Technology Focus'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|Applied Medical Resources Corp.<br />
|bgcolor = "#DBE5F1"|USA<br />
|bgcolor = "#DBE5F1"|Mesh ureteral stent<br>C-flex ureteral stent<br>Silicone ureteral stent<br>Tethered ureteral stent<br>C-flex ureteral stent<br>Ureteral stent<br>Silhouette pediatric stent<br />
|bgcolor = "#DBE5F1"|Manufacturer<br />
|align = "center" bgcolor = "#DBE5F1"|$282<br />
|align = "center" bgcolor = "#DBE5F1"|1900<br />
|bgcolor = "#DBE5F1"|USA: 62%<br>Asia: 32%<br>Rest of World: 6%<br />
|bgcolor = "#DBE5F1"|$38.3 (13%)<br />
|align = "center" bgcolor = "#DBE5F1"|212<br />
|bgcolor = "#DBE5F1"|High<br />
|-<br />
|Bioteque Corp.<br />
|Taiwan<br />
|Bioteque Double Pigta<br />
|Contract Manufacturer; Contract Sterilizer; Manufacturer<br />
|align = "center"|$27.85<br />
|align = "center"|350<br />
|Taiwan: 100%<br />
|$1.4 (5%)<br />
|align = "center"|16<br />
|Medium<br />
|-<br />
|bgcolor = "#DBE5F1"|Hobbs Medical, Inc.<br />
|bgcolor = "#DBE5F1"|USA<br />
|bgcolor = "#DBE5F1"|HM Ureteral Double Pigtail Stent<br />
|bgcolor = "#DBE5F1"|Manufacturer<br />
|align = "center" bgcolor = "#DBE5F1"|$2.30<br />
|align = "center" bgcolor = "#DBE5F1"|22<br />
|bgcolor = "#DBE5F1"|USA: 97.2%<br>Japan: 2.3%<br>Others: 0.5%<br />
|bgcolor = "#DBE5F1"|$0.06 (2.87%)<br />
|align = "center" bgcolor = "#DBE5F1"|1<br />
|bgcolor = "#DBE5F1"|Low<br />
|-<br />
|Lake Region Medical Limited<br />
|Ireland<br />
|M-Wires<br />
|Contract Manufacturer<br />
|align = "center"|$84.86<br />
|align = "center"|611<br />
|Europe: 68%<br>USA: 21%<br>Others: 11%<br />
|$8.48 (3.85%)<br />
|align = "center"|8<br />
|Medium<br />
|-<br />
|bgcolor = "#DBE5F1"|Martech Medical Products<br />
|bgcolor = "#DBE5F1"|USA<br />
|bgcolor = "#DBE5F1"|Ureteral Stent<br />
|bgcolor = "#DBE5F1"|Contract Manufacturer<br />
|align = "center" bgcolor = "#DBE5F1"|$23.00<br />
|align = "center" bgcolor = "#DBE5F1"|180<br />
|bgcolor = "#DBE5F1"|USA: 78.3%<br>Europe: 12.7%<br>Others: 9%<br />
|bgcolor = "#DBE5F1"|$1.1 (4.79%)<br />
|align = "center" bgcolor = "#DBE5F1"|0<br />
|bgcolor = "#DBE5F1"|Low<br />
|-<br />
|Allium Medical<br />
|Israel<br />
|URS - Ureteral Stent<br>TPS - Triangular Prostatic Stent<br>BUS - Bulbar Urethral Stent<br>RPS - Round Posterior Urethral Stent<br>BIS - Biliary Stent<br />
|Manufaturer<br />
|align = "center"|$2.04<br />
|align = "center"|20<br />
|Domestic: 88.6%<br>International: 11.4%<br />
|$0.082 (4%)<br />
|align = "center"|2<br />
|Low<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
<br />
{|align="center"<br />
|<gflash>1000 750 http://dolcera.com/upload/files/ranking1.swf</gflash><br />
|-<br />
|}<br />
<br/><br />
<br />
<br />
* '''Step 4''': Finally, after an in-depth analysis of the potential target companies’ on various parameters, following companies identified to be best possible target companies.<br />
**To improve Product Portfolio : '''Applied Medical Resources Corp.'''<br />
**To enter in Emerging Markets : '''Bioteque Corp.'''<br />
<br />
===Company Profile===<br />
====Applied Medical Resources Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''APPLIED MEDICAL RESOURCES CORP.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $280 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $ 38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|1900<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1987<br />
|-<br />
|'''Headquarters'''<br />
|USA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"|CEO: Said S. Hilal<br />
|-<br />
|'''Products & Technology'''<br />
|Specialty Areas:Cardiac/Vascular, Colorectal, GYN, Urology <br>New Products:Epix (Laparoscopic Intrumentation), GelPOINT (Advanced Access Platform), Kii Fios (First EntrySystem)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|USA: $182.70 million (65%)<br>Others: $99.47 million (35%)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Applied Medical Resources Corporation is a new generation medical device company founded in 1987 and headquartered in Southern California. It is involved in developing, manufacturing and marketing of innovative products for Minimally Invasive Surgery, Cardiac, Vascular, Urological, Colorectal, Bariatric, Obstetric, Gynecologic and General Surgery. The product portfolio covers 25 technologies and more than 700 products. The company has spread its business globally across 75 countries including Africa, Middle East,Americas, Caribbean, Asia, Australia and Europe through its network of international distributors.<br />
|-<br />
|}<br />
<br />
====Bioteque Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''Bioteque Corp.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $27.85 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|350<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1991<br />
|-<br />
|'''Headquarters'''<br />
|Taiwan<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"| <br />
|-<br />
|'''Products & Technology'''<br />
|<br> NEPHROLOGY, UROLOGY, RADIOLOGY, CARDIOLOGY, RESPIRATORY CARE<br> CRITICAL CARE, IV ADMINISTRATION THERAPY, MOLDING PARTS<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|NA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Bioteque Corporation manufactures and sells medical devices in Taiwan. It offers medical disposables for use in hemodialysis access, endovascular treatment, and other fields. It offers blood tubing lines, AVF needles, transducer protectors, and on line HDF with check valves or without check valves; IV infusion bags, precision IV infusion sets, drainage bags, insufflation tubing sets/filters, and various surgical drainage tubes; a range of medical components, which comprise blood tubing line components, percutaneous drainage components, infusion bag components, AVF needle components, precision IV infusion set components, and IV infusion bag components; a range of thermoplastic polyurethane catheters, including pigtail drainage catheter sets, double pigtail ureteral stent sets, biliary drainage catheters, percutaneous nephrostomy kits, and dialysis catheters; and other medical disposable products, such as closed suction catheters and artificial nose. The company also provides endovascular products, which consist of percutaneous transluminal coronary angioplasty, percutaneous transluminal angioplasty, angiography catheters, guiding catheters, sheath introducers, MRI/CT/angiography syringes, micro catheters, and hydrophilic coated guidewires. Bioteque Corporation was founded in 1991 and is based in Taipei, Taiwan.<br />
|-<br />
|}<br />
<br />
==M&A Due Diligence Process==<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
==<span style="color:#C41E3A">Like this report?</span>==<br />
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{|border="2" cellspacing="0" cellpadding="4" align="center" "<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
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{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Backup&diff=10390
Backup
2012-02-16T13:44:27Z
<p>Shweta.mittal@dolcera.com: /* Methodology */</p>
<hr />
<div>[[Wiki section]]<br />
<br />
==Process to Identify Possible Acquisition Targets==<br />
<br />
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.<br />
<br />
===Advantage of Mergers and Acquisitions===<br />
<br />
The most common motives and advantages of mergers and acquisitions are:-<br />
<br />
*Accelerating a company's growth, particularly when its internal growth is constrained due to paucity of resources. Internal growth requires that a company should develop its operating facilities- manufacturing, research, marketing, etc. But, lack or inadequacy of resources and time needed for internal development may constrain a company's pace of growth. Hence, a company can acquire production facilities as well as other resources from outside through mergers and acquisitions. Specially, for entering in new products/markets, the company may lack technical skills and may require special marketing skills and a wide distribution network to access different segments of markets. The company can acquire existing company or companies with requisite infrastructure and skills and grow quickly.<br />
<br />
*Enhancing profitability because a combination of two or more companies may result in more than average profitability due to cost reduction and efficient utilization of resources. This may happen because of:-<br />
**Economies of scale:- arise when increase in the volume of production leads to a reduction in the cost of production per unit. This is because, with merger, fixed costs are distributed over a large volume of production causing the unit cost of production to decline. Economies of scale may also arise from other indivisibilities such as production facilities, management functions and management resources and systems. This is because a given function, facility or resource is utilized for a large scale of operations by the combined firm.<br />
**Operating economies:- arise because, a combination of two or more firms may result in cost reduction due to operating economies. In other words, a combined firm may avoid or reduce over-lapping functions and consolidate its management functions such as manufacturing, marketing, R&D and thus reduce operating costs. For example, a combined firm may eliminate duplicate channels of distribution, or crate a centralized training center, or introduce an integrated planning and control system.<br />
**Synergy:- implies a situation where the combined firm is more valuable than the sum of the individual combining firms. It refers to benefits other than those related to economies of scale. Operating economies are one form of synergy benefits. But apart from operating economies, synergy may also arise from enhanced managerial capabilities, creativity, innovativeness, R&D and market coverage capacity due to the complementarity of resources and skills and a widened horizon of opportunities.<br />
<br />
*Diversifying the risks of the company, particularly when it acquires those businesses whose income streams are not correlated. Diversification implies growth through the combination of firms in unrelated businesses. It results in reduction of total risks through substantial reduction of cyclicality of operations. The combination of management and other systems strengthen the capacity of the combined firm to withstand the severity of the unforeseen economic factors which could otherwise endanger the survival of the individual companies.<br />
<br />
*A merger may result in financial synergy and benefits for the firm in many ways:-<br />
**By eliminating financial constraints<br />
**By enhancing debt capacity. This is because a merger of two companies can bring stability of cash flows which in turn reduces the risk of insolvency and enhances the capacity of the new entity to service a larger amount of debt<br />
**By lowering the financial costs. This is because due to financial stability, the merged firm is able to borrow at a lower rate of interest.<br />
<br />
*Limiting the severity of competition by increasing the company's market power. A merger can increase the market share of the merged firm. This improves the profitability of the firm due to economies of scale. The bargaining power of the firm vis-à-vis labour, suppliers and buyers is also enhanced. The merged firm can exploit technological breakthroughs against obsolescence and price wars.<br />
<br />
'''Note:''' In this research report, researcher considered two following objective of merger and acquisition:<br />
<br />
#To Enter in emerging markets<br />
#To improve product portfolio<br />
<br />
===Methodology===<br />
<br />
* '''Step 1''': First, list all the players present in Ureteral Stent Market were identified.(The list of companies was retrieved from the FDA site from Registration & Listing database)<br />
** Number of companies that were identified in this step: 20 <br />
<br />
* '''Step 2''': The second step involved identifying and eliminating companies that are large, and established players or the subsidiaries of the big players in the industry. <br />
**Number of companies eliminated in this step: 14<br />
**Number of (small) companies of interest left: 6<br />
<br />
* '''Step 3''': Once the large, and established players were eliminated, companies were compared based on various parameters and rated on the scale of 5 to identify the best target. Please check the following table and dashboard:<br />
**Number of potential target companies: 6<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%" align="center"<br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Company'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Headquartered'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Stent Details'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Company Type'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''2010 Revenue (Mn)'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''No of Employees'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Geographical Revenue Share'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''R&D investment (Mn)'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''No. of Patent'''</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Technology Focus'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|Applied Medical Resources Corp.<br />
|bgcolor = "#DBE5F1"|USA<br />
|bgcolor = "#DBE5F1"|Mesh ureteral stent<br>C-flex ureteral stent<br>Silicone ureteral stent<br>Tethered ureteral stent<br>C-flex ureteral stent<br>Ureteral stent<br>Silhouette pediatric stent<br />
|bgcolor = "#DBE5F1"|Manufacturer<br />
|align = "center" bgcolor = "#DBE5F1"|$282<br />
|align = "center" bgcolor = "#DBE5F1"|1900<br />
|bgcolor = "#DBE5F1"|USA: 62%<br>Asia: 32%<br>Rest of World: 6%<br />
|bgcolor = "#DBE5F1"|$38.3 (13%)<br />
|align = "center" bgcolor = "#DBE5F1"|212<br />
|bgcolor = "#DBE5F1"|High<br />
|-<br />
|Bioteque Corp.<br />
|Taiwan<br />
|Bioteque Double Pigta<br />
|Contract Manufacturer; Contract Sterilizer; Manufacturer<br />
|align = "center"|$27.85<br />
|align = "center"|350<br />
|Taiwan: 100%<br />
|$1.4 (5%)<br />
|align = "center"|16<br />
|Medium<br />
|-<br />
|bgcolor = "#DBE5F1"|Hobbs Medical, Inc.<br />
|bgcolor = "#DBE5F1"|USA<br />
|bgcolor = "#DBE5F1"|HM Ureteral Double Pigtail Stent<br />
|bgcolor = "#DBE5F1"|Manufacturer<br />
|align = "center" bgcolor = "#DBE5F1"|$2.30<br />
|align = "center" bgcolor = "#DBE5F1"|22<br />
|bgcolor = "#DBE5F1"|USA: 97.2%<br>Japan: 2.3%<br>Others: 0.5%<br />
|bgcolor = "#DBE5F1"|$0.06 (2.87%)<br />
|align = "center" bgcolor = "#DBE5F1"|1<br />
|bgcolor = "#DBE5F1"|Low<br />
|-<br />
|Lake Region Medical Limited<br />
|Ireland<br />
|M-Wires<br />
|Contract Manufacturer<br />
|align = "center"|$84.86<br />
|align = "center"|611<br />
|Europe: 68%<br>USA: 21%<br>Others: 11%<br />
|$8.48 (3.85%)<br />
|align = "center"|8<br />
|Medium<br />
|-<br />
|bgcolor = "#DBE5F1"|Martech Medical Products<br />
|bgcolor = "#DBE5F1"|USA<br />
|bgcolor = "#DBE5F1"|Ureteral Stent<br />
|bgcolor = "#DBE5F1"|Contract Manufacturer<br />
|align = "center" bgcolor = "#DBE5F1"|$23.00<br />
|align = "center" bgcolor = "#DBE5F1"|180<br />
|bgcolor = "#DBE5F1"|USA: 78.3%<br>Europe: 12.7%<br>Others: 9%<br />
|bgcolor = "#DBE5F1"|$1.1 (4.79%)<br />
|align = "center" bgcolor = "#DBE5F1"|0<br />
|bgcolor = "#DBE5F1"|Low<br />
|-<br />
|Allium Medical<br />
|Israel<br />
|URS - Ureteral Stent<br>TPS - Triangular Prostatic Stent<br>BUS - Bulbar Urethral Stent<br>RPS - Round Posterior Urethral Stent<br>BIS - Biliary Stent<br />
|Manufaturer<br />
|align = "center"|$2.04<br />
|align = "center"|20<br />
|Domestic: 88.6%<br>International: 11.4%<br />
|$0.082 (4%)<br />
|align = "center"|2<br />
|Low<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
<br />
{|align="center"<br />
|<gflash>1000 750 http://dolcera.com/upload/files/ranking1.swf</gflash><br />
|-<br />
|}<br />
<br/><br />
<br />
<br />
* '''Step 4''': Finally, after an in-depth analysis of the potential target companies’ on various parameters, following companies identified to be best possible target companies.<br />
**To improve Product Portfolio : '''Applied Medical Resources Corp.'''<br />
**To enter in Emerging Markets : '''Bioteque Corp.'''<br />
<br />
===Company Profile===<br />
====Applied Medical Resources Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''APPLIED MEDICAL RESOURCES CORP.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $280 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $ 38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|1900<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1987<br />
|-<br />
|'''Headquarters'''<br />
|USA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"|CEO: Said S. Hilal<br />
|-<br />
|'''Products & Technology'''<br />
|Specialty Areas:Cardiac/Vascular, Colorectal, GYN, Urology <br>New Products:Epix (Laparoscopic Intrumentation), GelPOINT (Advanced Access Platform), Kii Fios (First EntrySystem)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|USA: $182.70 million (65%)<br>Others: $99.47 million (35%)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Applied Medical Resources Corporation is a new generation medical device company founded in 1987 and headquartered in Southern California. It is involved in developing, manufacturing and marketing of innovative products for Minimally Invasive Surgery, Cardiac, Vascular, Urological, Colorectal, Bariatric, Obstetric, Gynecologic and General Surgery. The product portfolio covers 25 technologies and more than 700 products. The company has spread its business globally across 75 countries including Africa, Middle East,Americas, Caribbean, Asia, Australia and Europe through its network of international distributors.<br />
|-<br />
|}<br />
<br />
====Bioteque Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''Bioteque Corp.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $27.85 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|350<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1991<br />
|-<br />
|'''Headquarters'''<br />
|Taiwan<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"| <br />
|-<br />
|'''Products & Technology'''<br />
|<br> NEPHROLOGY, UROLOGY, RADIOLOGY, CARDIOLOGY, RESPIRATORY CARE<br> CRITICAL CARE, IV ADMINISTRATION THERAPY, MOLDING PARTS<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|NA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Bioteque Corporation manufactures and sells medical devices in Taiwan. It offers medical disposables for use in hemodialysis access, endovascular treatment, and other fields. It offers blood tubing lines, AVF needles, transducer protectors, and on line HDF with check valves or without check valves; IV infusion bags, precision IV infusion sets, drainage bags, insufflation tubing sets/filters, and various surgical drainage tubes; a range of medical components, which comprise blood tubing line components, percutaneous drainage components, infusion bag components, AVF needle components, precision IV infusion set components, and IV infusion bag components; a range of thermoplastic polyurethane catheters, including pigtail drainage catheter sets, double pigtail ureteral stent sets, biliary drainage catheters, percutaneous nephrostomy kits, and dialysis catheters; and other medical disposable products, such as closed suction catheters and artificial nose. The company also provides endovascular products, which consist of percutaneous transluminal coronary angioplasty, percutaneous transluminal angioplasty, angiography catheters, guiding catheters, sheath introducers, MRI/CT/angiography syringes, micro catheters, and hydrophilic coated guidewires. Bioteque Corporation was founded in 1991 and is based in Taipei, Taiwan.<br />
|-<br />
|}<br />
<br />
==M&A Due Diligence Process==<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Backup&diff=10389
Backup
2012-02-16T13:38:29Z
<p>Shweta.mittal@dolcera.com: /* Methodology */</p>
<hr />
<div>[[Wiki section]]<br />
<br />
==Process to Identify Possible Acquisition Targets==<br />
<br />
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.<br />
<br />
===Advantage of Mergers and Acquisitions===<br />
<br />
The most common motives and advantages of mergers and acquisitions are:-<br />
<br />
*Accelerating a company's growth, particularly when its internal growth is constrained due to paucity of resources. Internal growth requires that a company should develop its operating facilities- manufacturing, research, marketing, etc. But, lack or inadequacy of resources and time needed for internal development may constrain a company's pace of growth. Hence, a company can acquire production facilities as well as other resources from outside through mergers and acquisitions. Specially, for entering in new products/markets, the company may lack technical skills and may require special marketing skills and a wide distribution network to access different segments of markets. The company can acquire existing company or companies with requisite infrastructure and skills and grow quickly.<br />
<br />
*Enhancing profitability because a combination of two or more companies may result in more than average profitability due to cost reduction and efficient utilization of resources. This may happen because of:-<br />
**Economies of scale:- arise when increase in the volume of production leads to a reduction in the cost of production per unit. This is because, with merger, fixed costs are distributed over a large volume of production causing the unit cost of production to decline. Economies of scale may also arise from other indivisibilities such as production facilities, management functions and management resources and systems. This is because a given function, facility or resource is utilized for a large scale of operations by the combined firm.<br />
**Operating economies:- arise because, a combination of two or more firms may result in cost reduction due to operating economies. In other words, a combined firm may avoid or reduce over-lapping functions and consolidate its management functions such as manufacturing, marketing, R&D and thus reduce operating costs. For example, a combined firm may eliminate duplicate channels of distribution, or crate a centralized training center, or introduce an integrated planning and control system.<br />
**Synergy:- implies a situation where the combined firm is more valuable than the sum of the individual combining firms. It refers to benefits other than those related to economies of scale. Operating economies are one form of synergy benefits. But apart from operating economies, synergy may also arise from enhanced managerial capabilities, creativity, innovativeness, R&D and market coverage capacity due to the complementarity of resources and skills and a widened horizon of opportunities.<br />
<br />
*Diversifying the risks of the company, particularly when it acquires those businesses whose income streams are not correlated. Diversification implies growth through the combination of firms in unrelated businesses. It results in reduction of total risks through substantial reduction of cyclicality of operations. The combination of management and other systems strengthen the capacity of the combined firm to withstand the severity of the unforeseen economic factors which could otherwise endanger the survival of the individual companies.<br />
<br />
*A merger may result in financial synergy and benefits for the firm in many ways:-<br />
**By eliminating financial constraints<br />
**By enhancing debt capacity. This is because a merger of two companies can bring stability of cash flows which in turn reduces the risk of insolvency and enhances the capacity of the new entity to service a larger amount of debt<br />
**By lowering the financial costs. This is because due to financial stability, the merged firm is able to borrow at a lower rate of interest.<br />
<br />
*Limiting the severity of competition by increasing the company's market power. A merger can increase the market share of the merged firm. This improves the profitability of the firm due to economies of scale. The bargaining power of the firm vis-à-vis labour, suppliers and buyers is also enhanced. The merged firm can exploit technological breakthroughs against obsolescence and price wars.<br />
<br />
'''Note:''' In this research report, researcher considered two following objective of merger and acquisition:<br />
<br />
#To Enter in emerging markets<br />
#To improve product portfolio<br />
<br />
===Methodology===<br />
<br />
* '''Step 1''': First, list all the players present in Ureteral Stent Market were identified.(The list of companies was retrieved from the FDA site from Registration & Listing database)<br />
** Number of companies that were identified in this step: 20 <br />
<br />
* '''Step 2''': The second step involved identifying and eliminating companies that are large, and established players or the subsidiaries of the big players in the industry. <br />
**Number of companies eliminated in this step: 14<br />
**Number of (small) companies of interest left: 6<br />
<br />
* '''Step 3''': Once the large, and established players were eliminated, companies were compared based on various parameters and rated on the scale of 5 to identify the best target. Please check the following dashboard:<br />
**Number of potential target companies: 6<br />
<br />
{|align="center"<br />
|<gflash>1000 750 http://dolcera.com/upload/files/ranking1.swf</gflash><br />
|-<br />
|}<br />
<br/><br />
<br />
<br />
* '''Step 4''': Finally, after an in-depth analysis of the potential target companies’ on various parameters, following companies identified to be best possible target companies.<br />
**To improve Product Portfolio : '''Applied Medical Resources Corp.'''<br />
**To enter in Emerging Markets : '''Bioteque Corp.'''<br />
<br />
===Company Profile===<br />
====Applied Medical Resources Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''APPLIED MEDICAL RESOURCES CORP.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $280 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $ 38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|1900<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1987<br />
|-<br />
|'''Headquarters'''<br />
|USA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"|CEO: Said S. Hilal<br />
|-<br />
|'''Products & Technology'''<br />
|Specialty Areas:Cardiac/Vascular, Colorectal, GYN, Urology <br>New Products:Epix (Laparoscopic Intrumentation), GelPOINT (Advanced Access Platform), Kii Fios (First EntrySystem)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|USA: $182.70 million (65%)<br>Others: $99.47 million (35%)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Applied Medical Resources Corporation is a new generation medical device company founded in 1987 and headquartered in Southern California. It is involved in developing, manufacturing and marketing of innovative products for Minimally Invasive Surgery, Cardiac, Vascular, Urological, Colorectal, Bariatric, Obstetric, Gynecologic and General Surgery. The product portfolio covers 25 technologies and more than 700 products. The company has spread its business globally across 75 countries including Africa, Middle East,Americas, Caribbean, Asia, Australia and Europe through its network of international distributors.<br />
|-<br />
|}<br />
<br />
====Bioteque Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''Bioteque Corp.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $27.85 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|350<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1991<br />
|-<br />
|'''Headquarters'''<br />
|Taiwan<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"| <br />
|-<br />
|'''Products & Technology'''<br />
|<br> NEPHROLOGY, UROLOGY, RADIOLOGY, CARDIOLOGY, RESPIRATORY CARE<br> CRITICAL CARE, IV ADMINISTRATION THERAPY, MOLDING PARTS<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|NA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Bioteque Corporation manufactures and sells medical devices in Taiwan. It offers medical disposables for use in hemodialysis access, endovascular treatment, and other fields. It offers blood tubing lines, AVF needles, transducer protectors, and on line HDF with check valves or without check valves; IV infusion bags, precision IV infusion sets, drainage bags, insufflation tubing sets/filters, and various surgical drainage tubes; a range of medical components, which comprise blood tubing line components, percutaneous drainage components, infusion bag components, AVF needle components, precision IV infusion set components, and IV infusion bag components; a range of thermoplastic polyurethane catheters, including pigtail drainage catheter sets, double pigtail ureteral stent sets, biliary drainage catheters, percutaneous nephrostomy kits, and dialysis catheters; and other medical disposable products, such as closed suction catheters and artificial nose. The company also provides endovascular products, which consist of percutaneous transluminal coronary angioplasty, percutaneous transluminal angioplasty, angiography catheters, guiding catheters, sheath introducers, MRI/CT/angiography syringes, micro catheters, and hydrophilic coated guidewires. Bioteque Corporation was founded in 1991 and is based in Taipei, Taiwan.<br />
|-<br />
|}<br />
<br />
==M&A Due Diligence Process==<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
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{| style="border:1px solid #AAA; background:#E9E9E9" align="center"<br />
|-<br />
! style="background:lightgrey" | Samir Raiyani<br />
|-<br />
| '''Email''': [mailto:info@dolcera.com info@dolcera.com]<br />
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{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Backup&diff=10388
Backup
2012-02-16T13:37:43Z
<p>Shweta.mittal@dolcera.com: /* Advantage of Mergers and Acquisitions */</p>
<hr />
<div>[[Wiki section]]<br />
<br />
==Process to Identify Possible Acquisition Targets==<br />
<br />
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.<br />
<br />
===Advantage of Mergers and Acquisitions===<br />
<br />
The most common motives and advantages of mergers and acquisitions are:-<br />
<br />
*Accelerating a company's growth, particularly when its internal growth is constrained due to paucity of resources. Internal growth requires that a company should develop its operating facilities- manufacturing, research, marketing, etc. But, lack or inadequacy of resources and time needed for internal development may constrain a company's pace of growth. Hence, a company can acquire production facilities as well as other resources from outside through mergers and acquisitions. Specially, for entering in new products/markets, the company may lack technical skills and may require special marketing skills and a wide distribution network to access different segments of markets. The company can acquire existing company or companies with requisite infrastructure and skills and grow quickly.<br />
<br />
*Enhancing profitability because a combination of two or more companies may result in more than average profitability due to cost reduction and efficient utilization of resources. This may happen because of:-<br />
**Economies of scale:- arise when increase in the volume of production leads to a reduction in the cost of production per unit. This is because, with merger, fixed costs are distributed over a large volume of production causing the unit cost of production to decline. Economies of scale may also arise from other indivisibilities such as production facilities, management functions and management resources and systems. This is because a given function, facility or resource is utilized for a large scale of operations by the combined firm.<br />
**Operating economies:- arise because, a combination of two or more firms may result in cost reduction due to operating economies. In other words, a combined firm may avoid or reduce over-lapping functions and consolidate its management functions such as manufacturing, marketing, R&D and thus reduce operating costs. For example, a combined firm may eliminate duplicate channels of distribution, or crate a centralized training center, or introduce an integrated planning and control system.<br />
**Synergy:- implies a situation where the combined firm is more valuable than the sum of the individual combining firms. It refers to benefits other than those related to economies of scale. Operating economies are one form of synergy benefits. But apart from operating economies, synergy may also arise from enhanced managerial capabilities, creativity, innovativeness, R&D and market coverage capacity due to the complementarity of resources and skills and a widened horizon of opportunities.<br />
<br />
*Diversifying the risks of the company, particularly when it acquires those businesses whose income streams are not correlated. Diversification implies growth through the combination of firms in unrelated businesses. It results in reduction of total risks through substantial reduction of cyclicality of operations. The combination of management and other systems strengthen the capacity of the combined firm to withstand the severity of the unforeseen economic factors which could otherwise endanger the survival of the individual companies.<br />
<br />
*A merger may result in financial synergy and benefits for the firm in many ways:-<br />
**By eliminating financial constraints<br />
**By enhancing debt capacity. This is because a merger of two companies can bring stability of cash flows which in turn reduces the risk of insolvency and enhances the capacity of the new entity to service a larger amount of debt<br />
**By lowering the financial costs. This is because due to financial stability, the merged firm is able to borrow at a lower rate of interest.<br />
<br />
*Limiting the severity of competition by increasing the company's market power. A merger can increase the market share of the merged firm. This improves the profitability of the firm due to economies of scale. The bargaining power of the firm vis-à-vis labour, suppliers and buyers is also enhanced. The merged firm can exploit technological breakthroughs against obsolescence and price wars.<br />
<br />
'''Note:''' In this research report, researcher considered two following objective of merger and acquisition:<br />
<br />
#To Enter in emerging markets<br />
#To improve product portfolio<br />
<br />
===Methodology===<br />
<br />
* Step 1: First, list all the players present in Ureteral Stent Market were identified.(The list of companies was retrieved from the FDA site from Registration & Listing database)<br />
** Number of companies that were identified in this step: 20 <br />
<br />
* Step 2: The second step involved identifying and eliminating companies that are large, and established players or the subsidiaries of the big players in the industry. <br />
**Number of companies eliminated in this step: 14<br />
**Number of (small) companies of interest left: 6<br />
<br />
* Step 3: Once the large, and established players were eliminated, companies were compared based on various parameters and rated on the scale of 5 to identify the best target. Please check the following dashboard:<br />
**Number of potential target companies: 6<br />
<br />
{|align="center"<br />
|<gflash>1000 750 http://dolcera.com/upload/files/ranking1.swf</gflash><br />
|-<br />
|}<br />
<br/><br />
<br />
<br />
* Step 4: Finally, after an in-depth analysis of the potential target companies’ on various parameters, following companies identified to be best possible target companies.<br />
**To improve Product Portfolio : Applied Medical Resources Corp.<br />
**To enter in Emerging Markets : Bioteque Corp.<br />
<br />
===Company Profile===<br />
====Applied Medical Resources Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''APPLIED MEDICAL RESOURCES CORP.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $280 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $ 38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|1900<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1987<br />
|-<br />
|'''Headquarters'''<br />
|USA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"|CEO: Said S. Hilal<br />
|-<br />
|'''Products & Technology'''<br />
|Specialty Areas:Cardiac/Vascular, Colorectal, GYN, Urology <br>New Products:Epix (Laparoscopic Intrumentation), GelPOINT (Advanced Access Platform), Kii Fios (First EntrySystem)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|USA: $182.70 million (65%)<br>Others: $99.47 million (35%)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Applied Medical Resources Corporation is a new generation medical device company founded in 1987 and headquartered in Southern California. It is involved in developing, manufacturing and marketing of innovative products for Minimally Invasive Surgery, Cardiac, Vascular, Urological, Colorectal, Bariatric, Obstetric, Gynecologic and General Surgery. The product portfolio covers 25 technologies and more than 700 products. The company has spread its business globally across 75 countries including Africa, Middle East,Americas, Caribbean, Asia, Australia and Europe through its network of international distributors.<br />
|-<br />
|}<br />
<br />
====Bioteque Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''Bioteque Corp.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $27.85 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|350<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1991<br />
|-<br />
|'''Headquarters'''<br />
|Taiwan<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"| <br />
|-<br />
|'''Products & Technology'''<br />
|<br> NEPHROLOGY, UROLOGY, RADIOLOGY, CARDIOLOGY, RESPIRATORY CARE<br> CRITICAL CARE, IV ADMINISTRATION THERAPY, MOLDING PARTS<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|NA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Bioteque Corporation manufactures and sells medical devices in Taiwan. It offers medical disposables for use in hemodialysis access, endovascular treatment, and other fields. It offers blood tubing lines, AVF needles, transducer protectors, and on line HDF with check valves or without check valves; IV infusion bags, precision IV infusion sets, drainage bags, insufflation tubing sets/filters, and various surgical drainage tubes; a range of medical components, which comprise blood tubing line components, percutaneous drainage components, infusion bag components, AVF needle components, precision IV infusion set components, and IV infusion bag components; a range of thermoplastic polyurethane catheters, including pigtail drainage catheter sets, double pigtail ureteral stent sets, biliary drainage catheters, percutaneous nephrostomy kits, and dialysis catheters; and other medical disposable products, such as closed suction catheters and artificial nose. The company also provides endovascular products, which consist of percutaneous transluminal coronary angioplasty, percutaneous transluminal angioplasty, angiography catheters, guiding catheters, sheath introducers, MRI/CT/angiography syringes, micro catheters, and hydrophilic coated guidewires. Bioteque Corporation was founded in 1991 and is based in Taipei, Taiwan.<br />
|-<br />
|}<br />
<br />
==M&A Due Diligence Process==<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
==<span style="color:#C41E3A">Like this report?</span>==<br />
<p align="center"> '''This is only a sample report with brief analysis''' <br><br />
'''Dolcera can provide a comprehensive report customized to your needs'''</p><br />
{|border="2" cellspacing="0" cellpadding="4" align="center" "<br />
|style="background:lightgrey" align = "center" colspan = "3"|'''[mailto:info@dolcera.com <span style="color:#0047AB">Buy the customized report from Dolcera</span>]''' <br />
|-<br />
| align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services Patent Analytics Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/business-research-services Market Research Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/tools/patent-dashboard Purchase Patent Dashboard]<br />
|-<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Landscape Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/research-processes Dolcera Processes]<br />
|align = "center"| [http://www.dolcera.com/website_prod/industries Industry Focus]<br />
|-<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Search Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/alerts-and-updates Patent Alerting Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/tools Dolcera Tools]<br />
|-<br />
|}<br />
<br><br />
<br />
==Contact Dolcera==<br />
<br />
{| style="border:1px solid #AAA; background:#E9E9E9" align="center"<br />
|-<br />
! style="background:lightgrey" | Samir Raiyani<br />
|-<br />
| '''Email''': [mailto:info@dolcera.com info@dolcera.com]<br />
|-<br />
| '''Phone''': +1-650-269-7952<br />
|}<br />
<br />
= Addition =<br />
=== Patent Categorization: Interactive mind map linked to Dolcera Dashboard ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
=== Product-Patent-Clinical Trials Mapping ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=== Product to Patent Mapping ===<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''here ''']]to download the excel file.<br />
* Mapped Patent vs Not Mapped Patents<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=== Dolcera Dashboard ===<br />
[[Image:dashboard_features.png|center|750px|]]<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
|-<br />
|}<br />
*Flash Player is essential to view the Dolcera Dashboard<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
<br />
= Key Artifacts =<br />
* [[Investment Heat Map ]]<br />
* [[Revenue Heat Map ]]<br />
* [[Patent Heat Map]]<br />
* [http://www.dolcera.com/website/demos/dental/main.html Dynamic Patent Dashboard]<br />
* [http://www.dolcera.com/ipmapdemo/stent_model.swf Stent Landscape-Flash]<br />
* [[Company Profile - Flash]]<br />
<br />
=Removed Sections=<br />
[[Removed Sections]]</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Backup&diff=10387
Backup
2012-02-16T13:34:06Z
<p>Shweta.mittal@dolcera.com: /* Methodology */</p>
<hr />
<div>[[Wiki section]]<br />
<br />
==Process to Identify Possible Acquisition Targets==<br />
<br />
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.<br />
<br />
===Advantage of Mergers and Acquisitions===<br />
<br />
The most common motives and advantages of mergers and acquisitions are:-<br />
<br />
*Accelerating a company's growth, particularly when its internal growth is constrained due to paucity of resources. Internal growth requires that a company should develop its operating facilities- manufacturing, research, marketing, etc. But, lack or inadequacy of resources and time needed for internal development may constrain a company's pace of growth. Hence, a company can acquire production facilities as well as other resources from outside through mergers and acquisitions. Specially, for entering in new products/markets, the company may lack technical skills and may require special marketing skills and a wide distribution network to access different segments of markets. The company can acquire existing company or companies with requisite infrastructure and skills and grow quickly.<br />
<br />
*Enhancing profitability because a combination of two or more companies may result in more than average profitability due to cost reduction and efficient utilization of resources. This may happen because of:-<br />
**Economies of scale:- arise when increase in the volume of production leads to a reduction in the cost of production per unit. This is because, with merger, fixed costs are distributed over a large volume of production causing the unit cost of production to decline. Economies of scale may also arise from other indivisibilities such as production facilities, management functions and management resources and systems. This is because a given function, facility or resource is utilized for a large scale of operations by the combined firm.<br />
**Operating economies:- arise because, a combination of two or more firms may result in cost reduction due to operating economies. In other words, a combined firm may avoid or reduce over-lapping functions and consolidate its management functions such as manufacturing, marketing, R&D and thus reduce operating costs. For example, a combined firm may eliminate duplicate channels of distribution, or crate a centralized training center, or introduce an integrated planning and control system.<br />
**Synergy:- implies a situation where the combined firm is more valuable than the sum of the individual combining firms. It refers to benefits other than those related to economies of scale. Operating economies are one form of synergy benefits. But apart from operating economies, synergy may also arise from enhanced managerial capabilities, creativity, innovativeness, R&D and market coverage capacity due to the complementarity of resources and skills and a widened horizon of opportunities.<br />
<br />
*Diversifying the risks of the company, particularly when it acquires those businesses whose income streams are not correlated. Diversification implies growth through the combination of firms in unrelated businesses. It results in reduction of total risks through substantial reduction of cyclicality of operations. The combination of management and other systems strengthen the capacity of the combined firm to withstand the severity of the unforeseen economic factors which could otherwise endanger the survival of the individual companies.<br />
<br />
*A merger may result in financial synergy and benefits for the firm in many ways:-<br />
**By eliminating financial constraints<br />
**By enhancing debt capacity. This is because a merger of two companies can bring stability of cash flows which in turn reduces the risk of insolvency and enhances the capacity of the new entity to service a larger amount of debt<br />
**By lowering the financial costs. This is because due to financial stability, the merged firm is able to borrow at a lower rate of interest.<br />
<br />
*Limiting the severity of competition by increasing the company's market power. A merger can increase the market share of the merged firm. This improves the profitability of the firm due to economies of scale. The bargaining power of the firm vis-à-vis labour, suppliers and buyers is also enhanced. The merged firm can exploit technological breakthroughs against obsolescence and price wars.<br />
<br />
In this research report, researcher considered two following objective of merger and acquisition:<br />
<br />
#To Enter in emerging markets<br />
#To improve product portfolio<br />
<br />
===Methodology===<br />
<br />
* Step 1: First, list all the players present in Ureteral Stent Market were identified.(The list of companies was retrieved from the FDA site from Registration & Listing database)<br />
** Number of companies that were identified in this step: 20 <br />
<br />
* Step 2: The second step involved identifying and eliminating companies that are large, and established players or the subsidiaries of the big players in the industry. <br />
**Number of companies eliminated in this step: 14<br />
**Number of (small) companies of interest left: 6<br />
<br />
* Step 3: Once the large, and established players were eliminated, companies were compared based on various parameters and rated on the scale of 5 to identify the best target. Please check the following dashboard:<br />
**Number of potential target companies: 6<br />
<br />
{|align="center"<br />
|<gflash>1000 750 http://dolcera.com/upload/files/ranking1.swf</gflash><br />
|-<br />
|}<br />
<br/><br />
<br />
<br />
* Step 4: Finally, after an in-depth analysis of the potential target companies’ on various parameters, following companies identified to be best possible target companies.<br />
**To improve Product Portfolio : Applied Medical Resources Corp.<br />
**To enter in Emerging Markets : Bioteque Corp.<br />
<br />
===Company Profile===<br />
====Applied Medical Resources Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''APPLIED MEDICAL RESOURCES CORP.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $280 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $ 38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|1900<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1987<br />
|-<br />
|'''Headquarters'''<br />
|USA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"|CEO: Said S. Hilal<br />
|-<br />
|'''Products & Technology'''<br />
|Specialty Areas:Cardiac/Vascular, Colorectal, GYN, Urology <br>New Products:Epix (Laparoscopic Intrumentation), GelPOINT (Advanced Access Platform), Kii Fios (First EntrySystem)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|USA: $182.70 million (65%)<br>Others: $99.47 million (35%)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Applied Medical Resources Corporation is a new generation medical device company founded in 1987 and headquartered in Southern California. It is involved in developing, manufacturing and marketing of innovative products for Minimally Invasive Surgery, Cardiac, Vascular, Urological, Colorectal, Bariatric, Obstetric, Gynecologic and General Surgery. The product portfolio covers 25 technologies and more than 700 products. The company has spread its business globally across 75 countries including Africa, Middle East,Americas, Caribbean, Asia, Australia and Europe through its network of international distributors.<br />
|-<br />
|}<br />
<br />
====Bioteque Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''Bioteque Corp.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $27.85 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|350<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1991<br />
|-<br />
|'''Headquarters'''<br />
|Taiwan<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"| <br />
|-<br />
|'''Products & Technology'''<br />
|<br> NEPHROLOGY, UROLOGY, RADIOLOGY, CARDIOLOGY, RESPIRATORY CARE<br> CRITICAL CARE, IV ADMINISTRATION THERAPY, MOLDING PARTS<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|NA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Bioteque Corporation manufactures and sells medical devices in Taiwan. It offers medical disposables for use in hemodialysis access, endovascular treatment, and other fields. It offers blood tubing lines, AVF needles, transducer protectors, and on line HDF with check valves or without check valves; IV infusion bags, precision IV infusion sets, drainage bags, insufflation tubing sets/filters, and various surgical drainage tubes; a range of medical components, which comprise blood tubing line components, percutaneous drainage components, infusion bag components, AVF needle components, precision IV infusion set components, and IV infusion bag components; a range of thermoplastic polyurethane catheters, including pigtail drainage catheter sets, double pigtail ureteral stent sets, biliary drainage catheters, percutaneous nephrostomy kits, and dialysis catheters; and other medical disposable products, such as closed suction catheters and artificial nose. The company also provides endovascular products, which consist of percutaneous transluminal coronary angioplasty, percutaneous transluminal angioplasty, angiography catheters, guiding catheters, sheath introducers, MRI/CT/angiography syringes, micro catheters, and hydrophilic coated guidewires. Bioteque Corporation was founded in 1991 and is based in Taipei, Taiwan.<br />
|-<br />
|}<br />
<br />
==M&A Due Diligence Process==<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
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'''Dolcera can provide a comprehensive report customized to your needs'''</p><br />
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<br><br />
<br />
==Contact Dolcera==<br />
<br />
{| style="border:1px solid #AAA; background:#E9E9E9" align="center"<br />
|-<br />
! style="background:lightgrey" | Samir Raiyani<br />
|-<br />
| '''Email''': [mailto:info@dolcera.com info@dolcera.com]<br />
|-<br />
| '''Phone''': +1-650-269-7952<br />
|}<br />
<br />
= Addition =<br />
=== Patent Categorization: Interactive mind map linked to Dolcera Dashboard ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
=== Product-Patent-Clinical Trials Mapping ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=== Product to Patent Mapping ===<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''here ''']]to download the excel file.<br />
* Mapped Patent vs Not Mapped Patents<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=== Dolcera Dashboard ===<br />
[[Image:dashboard_features.png|center|750px|]]<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
|-<br />
|}<br />
*Flash Player is essential to view the Dolcera Dashboard<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
<br />
= Key Artifacts =<br />
* [[Investment Heat Map ]]<br />
* [[Revenue Heat Map ]]<br />
* [[Patent Heat Map]]<br />
* [http://www.dolcera.com/website/demos/dental/main.html Dynamic Patent Dashboard]<br />
* [http://www.dolcera.com/ipmapdemo/stent_model.swf Stent Landscape-Flash]<br />
* [[Company Profile - Flash]]<br />
<br />
=Removed Sections=<br />
[[Removed Sections]]</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Backup&diff=10386
Backup
2012-02-16T13:33:22Z
<p>Shweta.mittal@dolcera.com: /* Methodology */</p>
<hr />
<div>[[Wiki section]]<br />
<br />
==Process to Identify Possible Acquisition Targets==<br />
<br />
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.<br />
<br />
===Advantage of Mergers and Acquisitions===<br />
<br />
The most common motives and advantages of mergers and acquisitions are:-<br />
<br />
*Accelerating a company's growth, particularly when its internal growth is constrained due to paucity of resources. Internal growth requires that a company should develop its operating facilities- manufacturing, research, marketing, etc. But, lack or inadequacy of resources and time needed for internal development may constrain a company's pace of growth. Hence, a company can acquire production facilities as well as other resources from outside through mergers and acquisitions. Specially, for entering in new products/markets, the company may lack technical skills and may require special marketing skills and a wide distribution network to access different segments of markets. The company can acquire existing company or companies with requisite infrastructure and skills and grow quickly.<br />
<br />
*Enhancing profitability because a combination of two or more companies may result in more than average profitability due to cost reduction and efficient utilization of resources. This may happen because of:-<br />
**Economies of scale:- arise when increase in the volume of production leads to a reduction in the cost of production per unit. This is because, with merger, fixed costs are distributed over a large volume of production causing the unit cost of production to decline. Economies of scale may also arise from other indivisibilities such as production facilities, management functions and management resources and systems. This is because a given function, facility or resource is utilized for a large scale of operations by the combined firm.<br />
**Operating economies:- arise because, a combination of two or more firms may result in cost reduction due to operating economies. In other words, a combined firm may avoid or reduce over-lapping functions and consolidate its management functions such as manufacturing, marketing, R&D and thus reduce operating costs. For example, a combined firm may eliminate duplicate channels of distribution, or crate a centralized training center, or introduce an integrated planning and control system.<br />
**Synergy:- implies a situation where the combined firm is more valuable than the sum of the individual combining firms. It refers to benefits other than those related to economies of scale. Operating economies are one form of synergy benefits. But apart from operating economies, synergy may also arise from enhanced managerial capabilities, creativity, innovativeness, R&D and market coverage capacity due to the complementarity of resources and skills and a widened horizon of opportunities.<br />
<br />
*Diversifying the risks of the company, particularly when it acquires those businesses whose income streams are not correlated. Diversification implies growth through the combination of firms in unrelated businesses. It results in reduction of total risks through substantial reduction of cyclicality of operations. The combination of management and other systems strengthen the capacity of the combined firm to withstand the severity of the unforeseen economic factors which could otherwise endanger the survival of the individual companies.<br />
<br />
*A merger may result in financial synergy and benefits for the firm in many ways:-<br />
**By eliminating financial constraints<br />
**By enhancing debt capacity. This is because a merger of two companies can bring stability of cash flows which in turn reduces the risk of insolvency and enhances the capacity of the new entity to service a larger amount of debt<br />
**By lowering the financial costs. This is because due to financial stability, the merged firm is able to borrow at a lower rate of interest.<br />
<br />
*Limiting the severity of competition by increasing the company's market power. A merger can increase the market share of the merged firm. This improves the profitability of the firm due to economies of scale. The bargaining power of the firm vis-à-vis labour, suppliers and buyers is also enhanced. The merged firm can exploit technological breakthroughs against obsolescence and price wars.<br />
<br />
In this research report, researcher considered two following objective of merger and acquisition:<br />
<br />
#To Enter in emerging markets<br />
#To improve product portfolio<br />
<br />
===Methodology===<br />
<br />
* Step 1: First, list all the players present in Ureteral Stent Market were identified.(The list of companies was retrieved from the FDA site from Registration & Listing database)<br />
** Number of companies that were identified in this step: 20 <br />
<br />
* Step 2: The second step involved identifying and eliminating companies that are large, and established players or the subsidiaries of the big players in the industry. <br />
**Number of companies eliminated in this step: 14<br />
**Number of (small) companies of interest left: 6<br />
<br />
* Step 3: Once the large, and established players were eliminated, companies were compared based on various parameters and rated on the scale of 5 to identify the best target. Please check the following dashboard:<br />
**Number of potential target companies: 6<br />
<br />
{|align="center"<br />
|<gflash>1200 900 http://dolcera.com/upload/files/ranking1.swf</gflash><br />
|-<br />
|}<br />
<br/><br />
<br />
<br />
* Step 4: Finally, after an in-depth analysis of the potential target companies’ on various parameters, following companies identified to be best possible target companies.<br />
**To improve Product Portfolio : Applied Medical Resources Corp.<br />
**To enter in Emerging Markets : Bioteque Corp.<br />
<br />
===Company Profile===<br />
====Applied Medical Resources Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''APPLIED MEDICAL RESOURCES CORP.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $280 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $ 38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|1900<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1987<br />
|-<br />
|'''Headquarters'''<br />
|USA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"|CEO: Said S. Hilal<br />
|-<br />
|'''Products & Technology'''<br />
|Specialty Areas:Cardiac/Vascular, Colorectal, GYN, Urology <br>New Products:Epix (Laparoscopic Intrumentation), GelPOINT (Advanced Access Platform), Kii Fios (First EntrySystem)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|USA: $182.70 million (65%)<br>Others: $99.47 million (35%)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Applied Medical Resources Corporation is a new generation medical device company founded in 1987 and headquartered in Southern California. It is involved in developing, manufacturing and marketing of innovative products for Minimally Invasive Surgery, Cardiac, Vascular, Urological, Colorectal, Bariatric, Obstetric, Gynecologic and General Surgery. The product portfolio covers 25 technologies and more than 700 products. The company has spread its business globally across 75 countries including Africa, Middle East,Americas, Caribbean, Asia, Australia and Europe through its network of international distributors.<br />
|-<br />
|}<br />
<br />
====Bioteque Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''Bioteque Corp.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $27.85 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|350<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1991<br />
|-<br />
|'''Headquarters'''<br />
|Taiwan<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"| <br />
|-<br />
|'''Products & Technology'''<br />
|<br> NEPHROLOGY, UROLOGY, RADIOLOGY, CARDIOLOGY, RESPIRATORY CARE<br> CRITICAL CARE, IV ADMINISTRATION THERAPY, MOLDING PARTS<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|NA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Bioteque Corporation manufactures and sells medical devices in Taiwan. It offers medical disposables for use in hemodialysis access, endovascular treatment, and other fields. It offers blood tubing lines, AVF needles, transducer protectors, and on line HDF with check valves or without check valves; IV infusion bags, precision IV infusion sets, drainage bags, insufflation tubing sets/filters, and various surgical drainage tubes; a range of medical components, which comprise blood tubing line components, percutaneous drainage components, infusion bag components, AVF needle components, precision IV infusion set components, and IV infusion bag components; a range of thermoplastic polyurethane catheters, including pigtail drainage catheter sets, double pigtail ureteral stent sets, biliary drainage catheters, percutaneous nephrostomy kits, and dialysis catheters; and other medical disposable products, such as closed suction catheters and artificial nose. The company also provides endovascular products, which consist of percutaneous transluminal coronary angioplasty, percutaneous transluminal angioplasty, angiography catheters, guiding catheters, sheath introducers, MRI/CT/angiography syringes, micro catheters, and hydrophilic coated guidewires. Bioteque Corporation was founded in 1991 and is based in Taipei, Taiwan.<br />
|-<br />
|}<br />
<br />
==M&A Due Diligence Process==<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
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'''Dolcera can provide a comprehensive report customized to your needs'''</p><br />
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<br><br />
<br />
==Contact Dolcera==<br />
<br />
{| style="border:1px solid #AAA; background:#E9E9E9" align="center"<br />
|-<br />
! style="background:lightgrey" | Samir Raiyani<br />
|-<br />
| '''Email''': [mailto:info@dolcera.com info@dolcera.com]<br />
|-<br />
| '''Phone''': +1-650-269-7952<br />
|}<br />
<br />
= Addition =<br />
=== Patent Categorization: Interactive mind map linked to Dolcera Dashboard ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
=== Product-Patent-Clinical Trials Mapping ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=== Product to Patent Mapping ===<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''here ''']]to download the excel file.<br />
* Mapped Patent vs Not Mapped Patents<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=== Dolcera Dashboard ===<br />
[[Image:dashboard_features.png|center|750px|]]<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
|-<br />
|}<br />
*Flash Player is essential to view the Dolcera Dashboard<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
<br />
= Key Artifacts =<br />
* [[Investment Heat Map ]]<br />
* [[Revenue Heat Map ]]<br />
* [[Patent Heat Map]]<br />
* [http://www.dolcera.com/website/demos/dental/main.html Dynamic Patent Dashboard]<br />
* [http://www.dolcera.com/ipmapdemo/stent_model.swf Stent Landscape-Flash]<br />
* [[Company Profile - Flash]]<br />
<br />
=Removed Sections=<br />
[[Removed Sections]]</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Backup&diff=10385
Backup
2012-02-16T13:31:48Z
<p>Shweta.mittal@dolcera.com: /* Methodology */</p>
<hr />
<div>[[Wiki section]]<br />
<br />
==Process to Identify Possible Acquisition Targets==<br />
<br />
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.<br />
<br />
===Advantage of Mergers and Acquisitions===<br />
<br />
The most common motives and advantages of mergers and acquisitions are:-<br />
<br />
*Accelerating a company's growth, particularly when its internal growth is constrained due to paucity of resources. Internal growth requires that a company should develop its operating facilities- manufacturing, research, marketing, etc. But, lack or inadequacy of resources and time needed for internal development may constrain a company's pace of growth. Hence, a company can acquire production facilities as well as other resources from outside through mergers and acquisitions. Specially, for entering in new products/markets, the company may lack technical skills and may require special marketing skills and a wide distribution network to access different segments of markets. The company can acquire existing company or companies with requisite infrastructure and skills and grow quickly.<br />
<br />
*Enhancing profitability because a combination of two or more companies may result in more than average profitability due to cost reduction and efficient utilization of resources. This may happen because of:-<br />
**Economies of scale:- arise when increase in the volume of production leads to a reduction in the cost of production per unit. This is because, with merger, fixed costs are distributed over a large volume of production causing the unit cost of production to decline. Economies of scale may also arise from other indivisibilities such as production facilities, management functions and management resources and systems. This is because a given function, facility or resource is utilized for a large scale of operations by the combined firm.<br />
**Operating economies:- arise because, a combination of two or more firms may result in cost reduction due to operating economies. In other words, a combined firm may avoid or reduce over-lapping functions and consolidate its management functions such as manufacturing, marketing, R&D and thus reduce operating costs. For example, a combined firm may eliminate duplicate channels of distribution, or crate a centralized training center, or introduce an integrated planning and control system.<br />
**Synergy:- implies a situation where the combined firm is more valuable than the sum of the individual combining firms. It refers to benefits other than those related to economies of scale. Operating economies are one form of synergy benefits. But apart from operating economies, synergy may also arise from enhanced managerial capabilities, creativity, innovativeness, R&D and market coverage capacity due to the complementarity of resources and skills and a widened horizon of opportunities.<br />
<br />
*Diversifying the risks of the company, particularly when it acquires those businesses whose income streams are not correlated. Diversification implies growth through the combination of firms in unrelated businesses. It results in reduction of total risks through substantial reduction of cyclicality of operations. The combination of management and other systems strengthen the capacity of the combined firm to withstand the severity of the unforeseen economic factors which could otherwise endanger the survival of the individual companies.<br />
<br />
*A merger may result in financial synergy and benefits for the firm in many ways:-<br />
**By eliminating financial constraints<br />
**By enhancing debt capacity. This is because a merger of two companies can bring stability of cash flows which in turn reduces the risk of insolvency and enhances the capacity of the new entity to service a larger amount of debt<br />
**By lowering the financial costs. This is because due to financial stability, the merged firm is able to borrow at a lower rate of interest.<br />
<br />
*Limiting the severity of competition by increasing the company's market power. A merger can increase the market share of the merged firm. This improves the profitability of the firm due to economies of scale. The bargaining power of the firm vis-à-vis labour, suppliers and buyers is also enhanced. The merged firm can exploit technological breakthroughs against obsolescence and price wars.<br />
<br />
In this research report, researcher considered two following objective of merger and acquisition:<br />
<br />
#To Enter in emerging markets<br />
#To improve product portfolio<br />
<br />
===Methodology===<br />
<br />
* Step 1: First, list all the players present in Ureteral Stent Market were identified.(The list of companies was retrieved from the FDA site from Registration & Listing database)<br />
** Number of companies that were identified in this step: 20 <br />
<br />
* Step 2: The second step involved identifying and eliminating companies that are large, and established players or the subsidiaries of the big players in the industry. <br />
**Number of companies eliminated in this step: 14<br />
**Number of (small) companies of interest left: 6<br />
<br />
* Step 3: Once the large, and established players were eliminated, companies were compared based on various parameters and rated on the scale of 5 to identify the best target. Please check the following dashboard:<br />
**Number of potential target companies: 6<br />
<br />
{|align="center"<br />
|<gflash>1200 900 http://dolcera.com/upload/files/Ranking.swf</gflash><br />
|-<br />
|}<br />
<br/><br />
<br />
<br />
* Step 4: Finally, after an in-depth analysis of the potential target companies’ on various parameters, following companies identified to be best possible target companies.<br />
**To improve Product Portfolio : Applied Medical Resources Corp.<br />
**To enter in Emerging Markets : Bioteque Corp.<br />
<br />
===Company Profile===<br />
====Applied Medical Resources Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''APPLIED MEDICAL RESOURCES CORP.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $280 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $ 38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|1900<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1987<br />
|-<br />
|'''Headquarters'''<br />
|USA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"|CEO: Said S. Hilal<br />
|-<br />
|'''Products & Technology'''<br />
|Specialty Areas:Cardiac/Vascular, Colorectal, GYN, Urology <br>New Products:Epix (Laparoscopic Intrumentation), GelPOINT (Advanced Access Platform), Kii Fios (First EntrySystem)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|USA: $182.70 million (65%)<br>Others: $99.47 million (35%)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Applied Medical Resources Corporation is a new generation medical device company founded in 1987 and headquartered in Southern California. It is involved in developing, manufacturing and marketing of innovative products for Minimally Invasive Surgery, Cardiac, Vascular, Urological, Colorectal, Bariatric, Obstetric, Gynecologic and General Surgery. The product portfolio covers 25 technologies and more than 700 products. The company has spread its business globally across 75 countries including Africa, Middle East,Americas, Caribbean, Asia, Australia and Europe through its network of international distributors.<br />
|-<br />
|}<br />
<br />
====Bioteque Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''Bioteque Corp.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $27.85 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|350<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1991<br />
|-<br />
|'''Headquarters'''<br />
|Taiwan<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"| <br />
|-<br />
|'''Products & Technology'''<br />
|<br> NEPHROLOGY, UROLOGY, RADIOLOGY, CARDIOLOGY, RESPIRATORY CARE<br> CRITICAL CARE, IV ADMINISTRATION THERAPY, MOLDING PARTS<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|NA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Bioteque Corporation manufactures and sells medical devices in Taiwan. It offers medical disposables for use in hemodialysis access, endovascular treatment, and other fields. It offers blood tubing lines, AVF needles, transducer protectors, and on line HDF with check valves or without check valves; IV infusion bags, precision IV infusion sets, drainage bags, insufflation tubing sets/filters, and various surgical drainage tubes; a range of medical components, which comprise blood tubing line components, percutaneous drainage components, infusion bag components, AVF needle components, precision IV infusion set components, and IV infusion bag components; a range of thermoplastic polyurethane catheters, including pigtail drainage catheter sets, double pigtail ureteral stent sets, biliary drainage catheters, percutaneous nephrostomy kits, and dialysis catheters; and other medical disposable products, such as closed suction catheters and artificial nose. The company also provides endovascular products, which consist of percutaneous transluminal coronary angioplasty, percutaneous transluminal angioplasty, angiography catheters, guiding catheters, sheath introducers, MRI/CT/angiography syringes, micro catheters, and hydrophilic coated guidewires. Bioteque Corporation was founded in 1991 and is based in Taipei, Taiwan.<br />
|-<br />
|}<br />
<br />
==M&A Due Diligence Process==<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
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<br />
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* Mapped Patent vs Not Mapped Patents<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
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=Removed Sections=<br />
[[Removed Sections]]</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Backup&diff=10384
Backup
2012-02-16T13:26:06Z
<p>Shweta.mittal@dolcera.com: /* Bioteque Corp. */</p>
<hr />
<div>[[Wiki section]]<br />
<br />
==Process to Identify Possible Acquisition Targets==<br />
<br />
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.<br />
<br />
===Advantage of Mergers and Acquisitions===<br />
<br />
The most common motives and advantages of mergers and acquisitions are:-<br />
<br />
*Accelerating a company's growth, particularly when its internal growth is constrained due to paucity of resources. Internal growth requires that a company should develop its operating facilities- manufacturing, research, marketing, etc. But, lack or inadequacy of resources and time needed for internal development may constrain a company's pace of growth. Hence, a company can acquire production facilities as well as other resources from outside through mergers and acquisitions. Specially, for entering in new products/markets, the company may lack technical skills and may require special marketing skills and a wide distribution network to access different segments of markets. The company can acquire existing company or companies with requisite infrastructure and skills and grow quickly.<br />
<br />
*Enhancing profitability because a combination of two or more companies may result in more than average profitability due to cost reduction and efficient utilization of resources. This may happen because of:-<br />
**Economies of scale:- arise when increase in the volume of production leads to a reduction in the cost of production per unit. This is because, with merger, fixed costs are distributed over a large volume of production causing the unit cost of production to decline. Economies of scale may also arise from other indivisibilities such as production facilities, management functions and management resources and systems. This is because a given function, facility or resource is utilized for a large scale of operations by the combined firm.<br />
**Operating economies:- arise because, a combination of two or more firms may result in cost reduction due to operating economies. In other words, a combined firm may avoid or reduce over-lapping functions and consolidate its management functions such as manufacturing, marketing, R&D and thus reduce operating costs. For example, a combined firm may eliminate duplicate channels of distribution, or crate a centralized training center, or introduce an integrated planning and control system.<br />
**Synergy:- implies a situation where the combined firm is more valuable than the sum of the individual combining firms. It refers to benefits other than those related to economies of scale. Operating economies are one form of synergy benefits. But apart from operating economies, synergy may also arise from enhanced managerial capabilities, creativity, innovativeness, R&D and market coverage capacity due to the complementarity of resources and skills and a widened horizon of opportunities.<br />
<br />
*Diversifying the risks of the company, particularly when it acquires those businesses whose income streams are not correlated. Diversification implies growth through the combination of firms in unrelated businesses. It results in reduction of total risks through substantial reduction of cyclicality of operations. The combination of management and other systems strengthen the capacity of the combined firm to withstand the severity of the unforeseen economic factors which could otherwise endanger the survival of the individual companies.<br />
<br />
*A merger may result in financial synergy and benefits for the firm in many ways:-<br />
**By eliminating financial constraints<br />
**By enhancing debt capacity. This is because a merger of two companies can bring stability of cash flows which in turn reduces the risk of insolvency and enhances the capacity of the new entity to service a larger amount of debt<br />
**By lowering the financial costs. This is because due to financial stability, the merged firm is able to borrow at a lower rate of interest.<br />
<br />
*Limiting the severity of competition by increasing the company's market power. A merger can increase the market share of the merged firm. This improves the profitability of the firm due to economies of scale. The bargaining power of the firm vis-à-vis labour, suppliers and buyers is also enhanced. The merged firm can exploit technological breakthroughs against obsolescence and price wars.<br />
<br />
In this research report, researcher considered two following objective of merger and acquisition:<br />
<br />
#To Enter in emerging markets<br />
#To improve product portfolio<br />
<br />
===Methodology===<br />
<br />
* Step 1: First, list all the players present in Ureteral Stent Market were identified.(The list of companies was retrieved from the FDA site from Registration & Listing database)<br />
** Number of companies that were identified in this step: 20 <br />
<br />
* Step 2: The second step involved identifying and eliminating companies that are large, and established players or the subsidiaries of the big players in the industry. <br />
**Number of companies eliminated in this step: 14<br />
**Number of (small) companies of interest left: 6<br />
<br />
* Step 3: Once the large, and established players were eliminated, companies were compared based on various parameters and rated on the scale of 5 to identify the best target. Please check the following dashboard:<br />
**Number of potential target companies: 6<br />
<br />
<br />
<br />
<br />
* Step 4: Finally, after an in-depth analysis of the potential target companies’ on various parameters, following companies identified to be best possible target companies.<br />
**To improve Product Portfolio : Applied Medical Resources Corp.<br />
**To enter in Emerging Markets : Bioteque Corp.<br />
<br />
===Company Profile===<br />
====Applied Medical Resources Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''APPLIED MEDICAL RESOURCES CORP.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $280 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $ 38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|1900<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1987<br />
|-<br />
|'''Headquarters'''<br />
|USA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"|CEO: Said S. Hilal<br />
|-<br />
|'''Products & Technology'''<br />
|Specialty Areas:Cardiac/Vascular, Colorectal, GYN, Urology <br>New Products:Epix (Laparoscopic Intrumentation), GelPOINT (Advanced Access Platform), Kii Fios (First EntrySystem)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|USA: $182.70 million (65%)<br>Others: $99.47 million (35%)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Applied Medical Resources Corporation is a new generation medical device company founded in 1987 and headquartered in Southern California. It is involved in developing, manufacturing and marketing of innovative products for Minimally Invasive Surgery, Cardiac, Vascular, Urological, Colorectal, Bariatric, Obstetric, Gynecologic and General Surgery. The product portfolio covers 25 technologies and more than 700 products. The company has spread its business globally across 75 countries including Africa, Middle East,Americas, Caribbean, Asia, Australia and Europe through its network of international distributors.<br />
|-<br />
|}<br />
<br />
====Bioteque Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''Bioteque Corp.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $27.85 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|350<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1991<br />
|-<br />
|'''Headquarters'''<br />
|Taiwan<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"| <br />
|-<br />
|'''Products & Technology'''<br />
|<br> NEPHROLOGY, UROLOGY, RADIOLOGY, CARDIOLOGY, RESPIRATORY CARE<br> CRITICAL CARE, IV ADMINISTRATION THERAPY, MOLDING PARTS<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|NA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Bioteque Corporation manufactures and sells medical devices in Taiwan. It offers medical disposables for use in hemodialysis access, endovascular treatment, and other fields. It offers blood tubing lines, AVF needles, transducer protectors, and on line HDF with check valves or without check valves; IV infusion bags, precision IV infusion sets, drainage bags, insufflation tubing sets/filters, and various surgical drainage tubes; a range of medical components, which comprise blood tubing line components, percutaneous drainage components, infusion bag components, AVF needle components, precision IV infusion set components, and IV infusion bag components; a range of thermoplastic polyurethane catheters, including pigtail drainage catheter sets, double pigtail ureteral stent sets, biliary drainage catheters, percutaneous nephrostomy kits, and dialysis catheters; and other medical disposable products, such as closed suction catheters and artificial nose. The company also provides endovascular products, which consist of percutaneous transluminal coronary angioplasty, percutaneous transluminal angioplasty, angiography catheters, guiding catheters, sheath introducers, MRI/CT/angiography syringes, micro catheters, and hydrophilic coated guidewires. Bioteque Corporation was founded in 1991 and is based in Taipei, Taiwan.<br />
|-<br />
|}<br />
<br />
==M&A Due Diligence Process==<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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|align = "center"| [http://www.dolcera.com/website_prod/industries Industry Focus]<br />
|-<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Search Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/alerts-and-updates Patent Alerting Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/tools Dolcera Tools]<br />
|-<br />
|}<br />
<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
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{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Backup&diff=10383
Backup
2012-02-16T13:25:47Z
<p>Shweta.mittal@dolcera.com: /* Applied Medical Resources Corp. */</p>
<hr />
<div>[[Wiki section]]<br />
<br />
==Process to Identify Possible Acquisition Targets==<br />
<br />
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.<br />
<br />
===Advantage of Mergers and Acquisitions===<br />
<br />
The most common motives and advantages of mergers and acquisitions are:-<br />
<br />
*Accelerating a company's growth, particularly when its internal growth is constrained due to paucity of resources. Internal growth requires that a company should develop its operating facilities- manufacturing, research, marketing, etc. But, lack or inadequacy of resources and time needed for internal development may constrain a company's pace of growth. Hence, a company can acquire production facilities as well as other resources from outside through mergers and acquisitions. Specially, for entering in new products/markets, the company may lack technical skills and may require special marketing skills and a wide distribution network to access different segments of markets. The company can acquire existing company or companies with requisite infrastructure and skills and grow quickly.<br />
<br />
*Enhancing profitability because a combination of two or more companies may result in more than average profitability due to cost reduction and efficient utilization of resources. This may happen because of:-<br />
**Economies of scale:- arise when increase in the volume of production leads to a reduction in the cost of production per unit. This is because, with merger, fixed costs are distributed over a large volume of production causing the unit cost of production to decline. Economies of scale may also arise from other indivisibilities such as production facilities, management functions and management resources and systems. This is because a given function, facility or resource is utilized for a large scale of operations by the combined firm.<br />
**Operating economies:- arise because, a combination of two or more firms may result in cost reduction due to operating economies. In other words, a combined firm may avoid or reduce over-lapping functions and consolidate its management functions such as manufacturing, marketing, R&D and thus reduce operating costs. For example, a combined firm may eliminate duplicate channels of distribution, or crate a centralized training center, or introduce an integrated planning and control system.<br />
**Synergy:- implies a situation where the combined firm is more valuable than the sum of the individual combining firms. It refers to benefits other than those related to economies of scale. Operating economies are one form of synergy benefits. But apart from operating economies, synergy may also arise from enhanced managerial capabilities, creativity, innovativeness, R&D and market coverage capacity due to the complementarity of resources and skills and a widened horizon of opportunities.<br />
<br />
*Diversifying the risks of the company, particularly when it acquires those businesses whose income streams are not correlated. Diversification implies growth through the combination of firms in unrelated businesses. It results in reduction of total risks through substantial reduction of cyclicality of operations. The combination of management and other systems strengthen the capacity of the combined firm to withstand the severity of the unforeseen economic factors which could otherwise endanger the survival of the individual companies.<br />
<br />
*A merger may result in financial synergy and benefits for the firm in many ways:-<br />
**By eliminating financial constraints<br />
**By enhancing debt capacity. This is because a merger of two companies can bring stability of cash flows which in turn reduces the risk of insolvency and enhances the capacity of the new entity to service a larger amount of debt<br />
**By lowering the financial costs. This is because due to financial stability, the merged firm is able to borrow at a lower rate of interest.<br />
<br />
*Limiting the severity of competition by increasing the company's market power. A merger can increase the market share of the merged firm. This improves the profitability of the firm due to economies of scale. The bargaining power of the firm vis-à-vis labour, suppliers and buyers is also enhanced. The merged firm can exploit technological breakthroughs against obsolescence and price wars.<br />
<br />
In this research report, researcher considered two following objective of merger and acquisition:<br />
<br />
#To Enter in emerging markets<br />
#To improve product portfolio<br />
<br />
===Methodology===<br />
<br />
* Step 1: First, list all the players present in Ureteral Stent Market were identified.(The list of companies was retrieved from the FDA site from Registration & Listing database)<br />
** Number of companies that were identified in this step: 20 <br />
<br />
* Step 2: The second step involved identifying and eliminating companies that are large, and established players or the subsidiaries of the big players in the industry. <br />
**Number of companies eliminated in this step: 14<br />
**Number of (small) companies of interest left: 6<br />
<br />
* Step 3: Once the large, and established players were eliminated, companies were compared based on various parameters and rated on the scale of 5 to identify the best target. Please check the following dashboard:<br />
**Number of potential target companies: 6<br />
<br />
<br />
<br />
<br />
* Step 4: Finally, after an in-depth analysis of the potential target companies’ on various parameters, following companies identified to be best possible target companies.<br />
**To improve Product Portfolio : Applied Medical Resources Corp.<br />
**To enter in Emerging Markets : Bioteque Corp.<br />
<br />
===Company Profile===<br />
====Applied Medical Resources Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''APPLIED MEDICAL RESOURCES CORP.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $280 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $ 38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|1900<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1987<br />
|-<br />
|'''Headquarters'''<br />
|USA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"|CEO: Said S. Hilal<br />
|-<br />
|'''Products & Technology'''<br />
|Specialty Areas:Cardiac/Vascular, Colorectal, GYN, Urology <br>New Products:Epix (Laparoscopic Intrumentation), GelPOINT (Advanced Access Platform), Kii Fios (First EntrySystem)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|USA: $182.70 million (65%)<br>Others: $99.47 million (35%)<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Applied Medical Resources Corporation is a new generation medical device company founded in 1987 and headquartered in Southern California. It is involved in developing, manufacturing and marketing of innovative products for Minimally Invasive Surgery, Cardiac, Vascular, Urological, Colorectal, Bariatric, Obstetric, Gynecologic and General Surgery. The product portfolio covers 25 technologies and more than 700 products. The company has spread its business globally across 75 countries including Africa, Middle East,Americas, Caribbean, Asia, Australia and Europe through its network of international distributors.<br />
|-<br />
|}<br />
<br />
====Bioteque Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="80%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''Bioteque Corp.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $27.85 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|350<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1991<br />
|-<br />
|'''Headquarters'''<br />
|Taiwan<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"| <br />
|-<br />
|'''Products & Technology'''<br />
|<br> NEPHROLOGY, UROLOGY, RADIOLOGY, CARDIOLOGY, RESPIRATORY CARE<br> CRITICAL CARE, IV ADMINISTRATION THERAPY, MOLDING PARTS<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|NA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Bioteque Corporation manufactures and sells medical devices in Taiwan. It offers medical disposables for use in hemodialysis access, endovascular treatment, and other fields. It offers blood tubing lines, AVF needles, transducer protectors, and on line HDF with check valves or without check valves; IV infusion bags, precision IV infusion sets, drainage bags, insufflation tubing sets/filters, and various surgical drainage tubes; a range of medical components, which comprise blood tubing line components, percutaneous drainage components, infusion bag components, AVF needle components, precision IV infusion set components, and IV infusion bag components; a range of thermoplastic polyurethane catheters, including pigtail drainage catheter sets, double pigtail ureteral stent sets, biliary drainage catheters, percutaneous nephrostomy kits, and dialysis catheters; and other medical disposable products, such as closed suction catheters and artificial nose. The company also provides endovascular products, which consist of percutaneous transluminal coronary angioplasty, percutaneous transluminal angioplasty, angiography catheters, guiding catheters, sheath introducers, MRI/CT/angiography syringes, micro catheters, and hydrophilic coated guidewires. Bioteque Corporation was founded in 1991 and is based in Taipei, Taiwan.<br />
|-<br />
|}<br />
<br />
==M&A Due Diligence Process==<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Backup&diff=10382
Backup
2012-02-16T13:24:59Z
<p>Shweta.mittal@dolcera.com: /* Bioteque Corp. */</p>
<hr />
<div>[[Wiki section]]<br />
<br />
==Process to Identify Possible Acquisition Targets==<br />
<br />
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.<br />
<br />
===Advantage of Mergers and Acquisitions===<br />
<br />
The most common motives and advantages of mergers and acquisitions are:-<br />
<br />
*Accelerating a company's growth, particularly when its internal growth is constrained due to paucity of resources. Internal growth requires that a company should develop its operating facilities- manufacturing, research, marketing, etc. But, lack or inadequacy of resources and time needed for internal development may constrain a company's pace of growth. Hence, a company can acquire production facilities as well as other resources from outside through mergers and acquisitions. Specially, for entering in new products/markets, the company may lack technical skills and may require special marketing skills and a wide distribution network to access different segments of markets. The company can acquire existing company or companies with requisite infrastructure and skills and grow quickly.<br />
<br />
*Enhancing profitability because a combination of two or more companies may result in more than average profitability due to cost reduction and efficient utilization of resources. This may happen because of:-<br />
**Economies of scale:- arise when increase in the volume of production leads to a reduction in the cost of production per unit. This is because, with merger, fixed costs are distributed over a large volume of production causing the unit cost of production to decline. Economies of scale may also arise from other indivisibilities such as production facilities, management functions and management resources and systems. This is because a given function, facility or resource is utilized for a large scale of operations by the combined firm.<br />
**Operating economies:- arise because, a combination of two or more firms may result in cost reduction due to operating economies. In other words, a combined firm may avoid or reduce over-lapping functions and consolidate its management functions such as manufacturing, marketing, R&D and thus reduce operating costs. For example, a combined firm may eliminate duplicate channels of distribution, or crate a centralized training center, or introduce an integrated planning and control system.<br />
**Synergy:- implies a situation where the combined firm is more valuable than the sum of the individual combining firms. It refers to benefits other than those related to economies of scale. Operating economies are one form of synergy benefits. But apart from operating economies, synergy may also arise from enhanced managerial capabilities, creativity, innovativeness, R&D and market coverage capacity due to the complementarity of resources and skills and a widened horizon of opportunities.<br />
<br />
*Diversifying the risks of the company, particularly when it acquires those businesses whose income streams are not correlated. Diversification implies growth through the combination of firms in unrelated businesses. It results in reduction of total risks through substantial reduction of cyclicality of operations. The combination of management and other systems strengthen the capacity of the combined firm to withstand the severity of the unforeseen economic factors which could otherwise endanger the survival of the individual companies.<br />
<br />
*A merger may result in financial synergy and benefits for the firm in many ways:-<br />
**By eliminating financial constraints<br />
**By enhancing debt capacity. This is because a merger of two companies can bring stability of cash flows which in turn reduces the risk of insolvency and enhances the capacity of the new entity to service a larger amount of debt<br />
**By lowering the financial costs. This is because due to financial stability, the merged firm is able to borrow at a lower rate of interest.<br />
<br />
*Limiting the severity of competition by increasing the company's market power. A merger can increase the market share of the merged firm. This improves the profitability of the firm due to economies of scale. The bargaining power of the firm vis-à-vis labour, suppliers and buyers is also enhanced. The merged firm can exploit technological breakthroughs against obsolescence and price wars.<br />
<br />
In this research report, researcher considered two following objective of merger and acquisition:<br />
<br />
#To Enter in emerging markets<br />
#To improve product portfolio<br />
<br />
===Methodology===<br />
<br />
* Step 1: First, list all the players present in Ureteral Stent Market were identified.(The list of companies was retrieved from the FDA site from Registration & Listing database)<br />
** Number of companies that were identified in this step: 20 <br />
<br />
* Step 2: The second step involved identifying and eliminating companies that are large, and established players or the subsidiaries of the big players in the industry. <br />
**Number of companies eliminated in this step: 14<br />
**Number of (small) companies of interest left: 6<br />
<br />
* Step 3: Once the large, and established players were eliminated, companies were compared based on various parameters and rated on the scale of 5 to identify the best target. Please check the following dashboard:<br />
**Number of potential target companies: 6<br />
<br />
<br />
<br />
<br />
* Step 4: Finally, after an in-depth analysis of the potential target companies’ on various parameters, following companies identified to be best possible target companies.<br />
**To improve Product Portfolio : Applied Medical Resources Corp.<br />
**To enter in Emerging Markets : Bioteque Corp.<br />
<br />
===Company Profile===<br />
====Applied Medical Resources Corp.====<br />
<br />
<br />
<br />
====Bioteque Corp.====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="80%" align="center"<br />
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''Bioteque Corp.'''</font><br />
|-<br />
|bgcolor = "#C5D9F1"|'''Revenues'''<br />
|bgcolor = "#C5D9F1"|2010: $27.85 million<br />
|-<br />
|'''Net profit (2010)'''<br />
|$20.89 million<br />
|-<br />
|bgcolor = "#C5D9F1"|'''R&D Investment'''<br />
|bgcolor = "#C5D9F1"|2010: $38.3 million (13% of revenues)<br />
|-<br />
|'''Number of employees'''<br />
|350<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Year Established'''<br />
|bgcolor = "#C5D9F1"|1991<br />
|-<br />
|'''Headquarters'''<br />
|Taiwan<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Key People'''<br />
|bgcolor = "#C5D9F1"| <br />
|-<br />
|'''Products & Technology'''<br />
|<br> NEPHROLOGY, UROLOGY, RADIOLOGY, CARDIOLOGY, RESPIRATORY CARE<br> CRITICAL CARE, IV ADMINISTRATION THERAPY, MOLDING PARTS<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''<br />
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent<br />
|-<br />
|'''Geographical revenue breakdown (2010)'''<br />
|NA<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Company Overview'''<br />
|bgcolor = "#C5D9F1"|Bioteque Corporation manufactures and sells medical devices in Taiwan. It offers medical disposables for use in hemodialysis access, endovascular treatment, and other fields. It offers blood tubing lines, AVF needles, transducer protectors, and on line HDF with check valves or without check valves; IV infusion bags, precision IV infusion sets, drainage bags, insufflation tubing sets/filters, and various surgical drainage tubes; a range of medical components, which comprise blood tubing line components, percutaneous drainage components, infusion bag components, AVF needle components, precision IV infusion set components, and IV infusion bag components; a range of thermoplastic polyurethane catheters, including pigtail drainage catheter sets, double pigtail ureteral stent sets, biliary drainage catheters, percutaneous nephrostomy kits, and dialysis catheters; and other medical disposable products, such as closed suction catheters and artificial nose. The company also provides endovascular products, which consist of percutaneous transluminal coronary angioplasty, percutaneous transluminal angioplasty, angiography catheters, guiding catheters, sheath introducers, MRI/CT/angiography syringes, micro catheters, and hydrophilic coated guidewires. Bioteque Corporation was founded in 1991 and is based in Taipei, Taiwan.<br />
|-<br />
|}<br />
<br />
==M&A Due Diligence Process==<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
==<span style="color:#C41E3A">Like this report?</span>==<br />
<p align="center"> '''This is only a sample report with brief analysis''' <br><br />
'''Dolcera can provide a comprehensive report customized to your needs'''</p><br />
{|border="2" cellspacing="0" cellpadding="4" align="center" "<br />
|style="background:lightgrey" align = "center" colspan = "3"|'''[mailto:info@dolcera.com <span style="color:#0047AB">Buy the customized report from Dolcera</span>]''' <br />
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|align = "center"| [http://www.dolcera.com/website_prod/tools/patent-dashboard Purchase Patent Dashboard]<br />
|-<br />
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<br><br />
<br />
==Contact Dolcera==<br />
<br />
{| style="border:1px solid #AAA; background:#E9E9E9" align="center"<br />
|-<br />
! style="background:lightgrey" | Samir Raiyani<br />
|-<br />
| '''Email''': [mailto:info@dolcera.com info@dolcera.com]<br />
|-<br />
| '''Phone''': +1-650-269-7952<br />
|}<br />
<br />
= Addition =<br />
=== Patent Categorization: Interactive mind map linked to Dolcera Dashboard ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
=== Product-Patent-Clinical Trials Mapping ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=== Product to Patent Mapping ===<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''here ''']]to download the excel file.<br />
* Mapped Patent vs Not Mapped Patents<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=== Dolcera Dashboard ===<br />
[[Image:dashboard_features.png|center|750px|]]<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
|-<br />
|}<br />
*Flash Player is essential to view the Dolcera Dashboard<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
<br />
= Key Artifacts =<br />
* [[Investment Heat Map ]]<br />
* [[Revenue Heat Map ]]<br />
* [[Patent Heat Map]]<br />
* [http://www.dolcera.com/website/demos/dental/main.html Dynamic Patent Dashboard]<br />
* [http://www.dolcera.com/ipmapdemo/stent_model.swf Stent Landscape-Flash]<br />
* [[Company Profile - Flash]]<br />
<br />
=Removed Sections=<br />
[[Removed Sections]]</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Backup&diff=10381
Backup
2012-02-16T13:24:17Z
<p>Shweta.mittal@dolcera.com: /* Methodology */</p>
<hr />
<div>[[Wiki section]]<br />
<br />
==Process to Identify Possible Acquisition Targets==<br />
<br />
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.<br />
<br />
===Advantage of Mergers and Acquisitions===<br />
<br />
The most common motives and advantages of mergers and acquisitions are:-<br />
<br />
*Accelerating a company's growth, particularly when its internal growth is constrained due to paucity of resources. Internal growth requires that a company should develop its operating facilities- manufacturing, research, marketing, etc. But, lack or inadequacy of resources and time needed for internal development may constrain a company's pace of growth. Hence, a company can acquire production facilities as well as other resources from outside through mergers and acquisitions. Specially, for entering in new products/markets, the company may lack technical skills and may require special marketing skills and a wide distribution network to access different segments of markets. The company can acquire existing company or companies with requisite infrastructure and skills and grow quickly.<br />
<br />
*Enhancing profitability because a combination of two or more companies may result in more than average profitability due to cost reduction and efficient utilization of resources. This may happen because of:-<br />
**Economies of scale:- arise when increase in the volume of production leads to a reduction in the cost of production per unit. This is because, with merger, fixed costs are distributed over a large volume of production causing the unit cost of production to decline. Economies of scale may also arise from other indivisibilities such as production facilities, management functions and management resources and systems. This is because a given function, facility or resource is utilized for a large scale of operations by the combined firm.<br />
**Operating economies:- arise because, a combination of two or more firms may result in cost reduction due to operating economies. In other words, a combined firm may avoid or reduce over-lapping functions and consolidate its management functions such as manufacturing, marketing, R&D and thus reduce operating costs. For example, a combined firm may eliminate duplicate channels of distribution, or crate a centralized training center, or introduce an integrated planning and control system.<br />
**Synergy:- implies a situation where the combined firm is more valuable than the sum of the individual combining firms. It refers to benefits other than those related to economies of scale. Operating economies are one form of synergy benefits. But apart from operating economies, synergy may also arise from enhanced managerial capabilities, creativity, innovativeness, R&D and market coverage capacity due to the complementarity of resources and skills and a widened horizon of opportunities.<br />
<br />
*Diversifying the risks of the company, particularly when it acquires those businesses whose income streams are not correlated. Diversification implies growth through the combination of firms in unrelated businesses. It results in reduction of total risks through substantial reduction of cyclicality of operations. The combination of management and other systems strengthen the capacity of the combined firm to withstand the severity of the unforeseen economic factors which could otherwise endanger the survival of the individual companies.<br />
<br />
*A merger may result in financial synergy and benefits for the firm in many ways:-<br />
**By eliminating financial constraints<br />
**By enhancing debt capacity. This is because a merger of two companies can bring stability of cash flows which in turn reduces the risk of insolvency and enhances the capacity of the new entity to service a larger amount of debt<br />
**By lowering the financial costs. This is because due to financial stability, the merged firm is able to borrow at a lower rate of interest.<br />
<br />
*Limiting the severity of competition by increasing the company's market power. A merger can increase the market share of the merged firm. This improves the profitability of the firm due to economies of scale. The bargaining power of the firm vis-à-vis labour, suppliers and buyers is also enhanced. The merged firm can exploit technological breakthroughs against obsolescence and price wars.<br />
<br />
In this research report, researcher considered two following objective of merger and acquisition:<br />
<br />
#To Enter in emerging markets<br />
#To improve product portfolio<br />
<br />
===Methodology===<br />
<br />
* Step 1: First, list all the players present in Ureteral Stent Market were identified.(The list of companies was retrieved from the FDA site from Registration & Listing database)<br />
** Number of companies that were identified in this step: 20 <br />
<br />
* Step 2: The second step involved identifying and eliminating companies that are large, and established players or the subsidiaries of the big players in the industry. <br />
**Number of companies eliminated in this step: 14<br />
**Number of (small) companies of interest left: 6<br />
<br />
* Step 3: Once the large, and established players were eliminated, companies were compared based on various parameters and rated on the scale of 5 to identify the best target. Please check the following dashboard:<br />
**Number of potential target companies: 6<br />
<br />
<br />
<br />
<br />
* Step 4: Finally, after an in-depth analysis of the potential target companies’ on various parameters, following companies identified to be best possible target companies.<br />
**To improve Product Portfolio : Applied Medical Resources Corp.<br />
**To enter in Emerging Markets : Bioteque Corp.<br />
<br />
===Company Profile===<br />
====Applied Medical Resources Corp.====<br />
<br />
<br />
<br />
====Bioteque Corp.====<br />
<br />
==M&A Due Diligence Process==<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
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* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
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<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=== Product to Patent Mapping ===<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''here ''']]to download the excel file.<br />
* Mapped Patent vs Not Mapped Patents<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
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=Removed Sections=<br />
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Backup&diff=10380
Backup
2012-02-16T13:23:50Z
<p>Shweta.mittal@dolcera.com: /* Advantage of Mergers and Acquisitions */</p>
<hr />
<div>[[Wiki section]]<br />
<br />
==Process to Identify Possible Acquisition Targets==<br />
<br />
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.<br />
<br />
===Advantage of Mergers and Acquisitions===<br />
<br />
The most common motives and advantages of mergers and acquisitions are:-<br />
<br />
*Accelerating a company's growth, particularly when its internal growth is constrained due to paucity of resources. Internal growth requires that a company should develop its operating facilities- manufacturing, research, marketing, etc. But, lack or inadequacy of resources and time needed for internal development may constrain a company's pace of growth. Hence, a company can acquire production facilities as well as other resources from outside through mergers and acquisitions. Specially, for entering in new products/markets, the company may lack technical skills and may require special marketing skills and a wide distribution network to access different segments of markets. The company can acquire existing company or companies with requisite infrastructure and skills and grow quickly.<br />
<br />
*Enhancing profitability because a combination of two or more companies may result in more than average profitability due to cost reduction and efficient utilization of resources. This may happen because of:-<br />
**Economies of scale:- arise when increase in the volume of production leads to a reduction in the cost of production per unit. This is because, with merger, fixed costs are distributed over a large volume of production causing the unit cost of production to decline. Economies of scale may also arise from other indivisibilities such as production facilities, management functions and management resources and systems. This is because a given function, facility or resource is utilized for a large scale of operations by the combined firm.<br />
**Operating economies:- arise because, a combination of two or more firms may result in cost reduction due to operating economies. In other words, a combined firm may avoid or reduce over-lapping functions and consolidate its management functions such as manufacturing, marketing, R&D and thus reduce operating costs. For example, a combined firm may eliminate duplicate channels of distribution, or crate a centralized training center, or introduce an integrated planning and control system.<br />
**Synergy:- implies a situation where the combined firm is more valuable than the sum of the individual combining firms. It refers to benefits other than those related to economies of scale. Operating economies are one form of synergy benefits. But apart from operating economies, synergy may also arise from enhanced managerial capabilities, creativity, innovativeness, R&D and market coverage capacity due to the complementarity of resources and skills and a widened horizon of opportunities.<br />
<br />
*Diversifying the risks of the company, particularly when it acquires those businesses whose income streams are not correlated. Diversification implies growth through the combination of firms in unrelated businesses. It results in reduction of total risks through substantial reduction of cyclicality of operations. The combination of management and other systems strengthen the capacity of the combined firm to withstand the severity of the unforeseen economic factors which could otherwise endanger the survival of the individual companies.<br />
<br />
*A merger may result in financial synergy and benefits for the firm in many ways:-<br />
**By eliminating financial constraints<br />
**By enhancing debt capacity. This is because a merger of two companies can bring stability of cash flows which in turn reduces the risk of insolvency and enhances the capacity of the new entity to service a larger amount of debt<br />
**By lowering the financial costs. This is because due to financial stability, the merged firm is able to borrow at a lower rate of interest.<br />
<br />
*Limiting the severity of competition by increasing the company's market power. A merger can increase the market share of the merged firm. This improves the profitability of the firm due to economies of scale. The bargaining power of the firm vis-à-vis labour, suppliers and buyers is also enhanced. The merged firm can exploit technological breakthroughs against obsolescence and price wars.<br />
<br />
In this research report, researcher considered two following objective of merger and acquisition:<br />
<br />
#To Enter in emerging markets<br />
#To improve product portfolio<br />
<br />
===Methodology===<br />
<br />
* Step 1: First, list all the players present in Ureteral Stent Market were identified.(The list of companies was retrieved from the FDA site from Registration & Listing database)<br />
<br />
** Number of companies that were identified in this step: 20 <br />
<br />
* Step 2: The second step involved identifying and eliminating companies that are large, and established players or the subsidiaries of the big players in the industry. <br />
<br />
**Number of companies eliminated in this step: 14<br />
**Number of (small) companies of interest left: 6<br />
<br />
* Step 3: Once the large, and established players were eliminated, companies were compared based on various parameters and rated on the scale of 5 to identify the best target. Please check the following dashboard:<br />
<br />
**Number of potential target companies: 6<br />
<br />
<br />
<br />
<br />
* Step 4: Finally, after an in-depth analysis of the potential target companies’ on various parameters, following companies identified to be best possible target companies.<br />
<br />
**To improve Product Portfolio : Applied Medical Resources Corp.<br />
**To enter in Emerging Markets : Bioteque Corp.<br />
<br />
===Company Profile===<br />
====Applied Medical Resources Corp.====<br />
<br />
<br />
<br />
====Bioteque Corp.====<br />
<br />
==M&A Due Diligence Process==<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
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{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Backup&diff=10379
Backup
2012-02-16T13:23:10Z
<p>Shweta.mittal@dolcera.com: /* Methodology */</p>
<hr />
<div>[[Wiki section]]<br />
<br />
==Process to Identify Possible Acquisition Targets==<br />
<br />
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.<br />
<br />
===Advantage of Mergers and Acquisitions===<br />
<br />
The most common motives and advantages of mergers and acquisitions are:-<br />
<br />
*Accelerating a company's growth, particularly when its internal growth is constrained due to paucity of resources. Internal growth requires that a company should develop its operating facilities- manufacturing, research, marketing, etc. But, lack or inadequacy of resources and time needed for internal development may constrain a company's pace of growth. Hence, a company can acquire production facilities as well as other resources from outside through mergers and acquisitions. Specially, for entering in new products/markets, the company may lack technical skills and may require special marketing skills and a wide distribution network to access different segments of markets. The company can acquire existing company or companies with requisite infrastructure and skills and grow quickly.<br />
<br />
*Enhancing profitability because a combination of two or more companies may result in more than average profitability due to cost reduction and efficient utilization of resources. This may happen because of:-<br />
**Economies of scale:- arise when increase in the volume of production leads to a reduction in the cost of production per unit. This is because, with merger, fixed costs are distributed over a large volume of production causing the unit cost of production to decline. Economies of scale may also arise from other indivisibilities such as production facilities, management functions and management resources and systems. This is because a given function, facility or resource is utilized for a large scale of operations by the combined firm.<br />
**Operating economies:- arise because, a combination of two or more firms may result in cost reduction due to operating economies. In other words, a combined firm may avoid or reduce over-lapping functions and consolidate its management functions such as manufacturing, marketing, R&D and thus reduce operating costs. For example, a combined firm may eliminate duplicate channels of distribution, or crate a centralized training center, or introduce an integrated planning and control system.<br />
**Synergy:- implies a situation where the combined firm is more valuable than the sum of the individual combining firms. It refers to benefits other than those related to economies of scale. Operating economies are one form of synergy benefits. But apart from operating economies, synergy may also arise from enhanced managerial capabilities, creativity, innovativeness, R&D and market coverage capacity due to the complementarity of resources and skills and a widened horizon of opportunities.<br />
<br />
*Diversifying the risks of the company, particularly when it acquires those businesses whose income streams are not correlated. Diversification implies growth through the combination of firms in unrelated businesses. It results in reduction of total risks through substantial reduction of cyclicality of operations. The combination of management and other systems strengthen the capacity of the combined firm to withstand the severity of the unforeseen economic factors which could otherwise endanger the survival of the individual companies.<br />
<br />
*A merger may result in financial synergy and benefits for the firm in many ways:-<br />
<br />
**By eliminating financial constraints<br />
**By enhancing debt capacity. This is because a merger of two companies can bring stability of cash flows which in turn reduces the risk of insolvency and enhances the capacity of the new entity to service a larger amount of debt<br />
**By lowering the financial costs. This is because due to financial stability, the merged firm is able to borrow at a lower rate of interest.<br />
<br />
*Limiting the severity of competition by increasing the company's market power. A merger can increase the market share of the merged firm. This improves the profitability of the firm due to economies of scale. The bargaining power of the firm vis-à-vis labour, suppliers and buyers is also enhanced. The merged firm can exploit technological breakthroughs against obsolescence and price wars.<br />
<br />
In this research report, researcher considered two following objective of merger and acquisition:<br />
<br />
#To Enter in emerging markets<br />
#To improve product portfolio<br />
<br />
===Methodology===<br />
<br />
* Step 1: First, list all the players present in Ureteral Stent Market were identified.(The list of companies was retrieved from the FDA site from Registration & Listing database)<br />
<br />
** Number of companies that were identified in this step: 20 <br />
<br />
* Step 2: The second step involved identifying and eliminating companies that are large, and established players or the subsidiaries of the big players in the industry. <br />
<br />
**Number of companies eliminated in this step: 14<br />
**Number of (small) companies of interest left: 6<br />
<br />
* Step 3: Once the large, and established players were eliminated, companies were compared based on various parameters and rated on the scale of 5 to identify the best target. Please check the following dashboard:<br />
<br />
**Number of potential target companies: 6<br />
<br />
<br />
<br />
<br />
* Step 4: Finally, after an in-depth analysis of the potential target companies’ on various parameters, following companies identified to be best possible target companies.<br />
<br />
**To improve Product Portfolio : Applied Medical Resources Corp.<br />
**To enter in Emerging Markets : Bioteque Corp.<br />
<br />
===Company Profile===<br />
====Applied Medical Resources Corp.====<br />
<br />
<br />
<br />
====Bioteque Corp.====<br />
<br />
==M&A Due Diligence Process==<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
==<span style="color:#C41E3A">Like this report?</span>==<br />
<p align="center"> '''This is only a sample report with brief analysis''' <br><br />
'''Dolcera can provide a comprehensive report customized to your needs'''</p><br />
{|border="2" cellspacing="0" cellpadding="4" align="center" "<br />
|style="background:lightgrey" align = "center" colspan = "3"|'''[mailto:info@dolcera.com <span style="color:#0047AB">Buy the customized report from Dolcera</span>]''' <br />
|-<br />
| align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services Patent Analytics Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/business-research-services Market Research Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/tools/patent-dashboard Purchase Patent Dashboard]<br />
|-<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Landscape Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/research-processes Dolcera Processes]<br />
|align = "center"| [http://www.dolcera.com/website_prod/industries Industry Focus]<br />
|-<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Search Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/alerts-and-updates Patent Alerting Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/tools Dolcera Tools]<br />
|-<br />
|}<br />
<br><br />
<br />
==Contact Dolcera==<br />
<br />
{| style="border:1px solid #AAA; background:#E9E9E9" align="center"<br />
|-<br />
! style="background:lightgrey" | Samir Raiyani<br />
|-<br />
| '''Email''': [mailto:info@dolcera.com info@dolcera.com]<br />
|-<br />
| '''Phone''': +1-650-269-7952<br />
|}<br />
<br />
= Addition =<br />
=== Patent Categorization: Interactive mind map linked to Dolcera Dashboard ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
=== Product-Patent-Clinical Trials Mapping ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=== Product to Patent Mapping ===<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''here ''']]to download the excel file.<br />
* Mapped Patent vs Not Mapped Patents<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=== Dolcera Dashboard ===<br />
[[Image:dashboard_features.png|center|750px|]]<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
|-<br />
|}<br />
*Flash Player is essential to view the Dolcera Dashboard<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
<br />
= Key Artifacts =<br />
* [[Investment Heat Map ]]<br />
* [[Revenue Heat Map ]]<br />
* [[Patent Heat Map]]<br />
* [http://www.dolcera.com/website/demos/dental/main.html Dynamic Patent Dashboard]<br />
* [http://www.dolcera.com/ipmapdemo/stent_model.swf Stent Landscape-Flash]<br />
* [[Company Profile - Flash]]<br />
<br />
=Removed Sections=<br />
[[Removed Sections]]</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Backup&diff=10378
Backup
2012-02-16T13:19:08Z
<p>Shweta.mittal@dolcera.com: </p>
<hr />
<div>[[Wiki section]]<br />
<br />
==Process to Identify Possible Acquisition Targets==<br />
<br />
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.<br />
<br />
===Advantage of Mergers and Acquisitions===<br />
<br />
The most common motives and advantages of mergers and acquisitions are:-<br />
<br />
*Accelerating a company's growth, particularly when its internal growth is constrained due to paucity of resources. Internal growth requires that a company should develop its operating facilities- manufacturing, research, marketing, etc. But, lack or inadequacy of resources and time needed for internal development may constrain a company's pace of growth. Hence, a company can acquire production facilities as well as other resources from outside through mergers and acquisitions. Specially, for entering in new products/markets, the company may lack technical skills and may require special marketing skills and a wide distribution network to access different segments of markets. The company can acquire existing company or companies with requisite infrastructure and skills and grow quickly.<br />
<br />
*Enhancing profitability because a combination of two or more companies may result in more than average profitability due to cost reduction and efficient utilization of resources. This may happen because of:-<br />
**Economies of scale:- arise when increase in the volume of production leads to a reduction in the cost of production per unit. This is because, with merger, fixed costs are distributed over a large volume of production causing the unit cost of production to decline. Economies of scale may also arise from other indivisibilities such as production facilities, management functions and management resources and systems. This is because a given function, facility or resource is utilized for a large scale of operations by the combined firm.<br />
**Operating economies:- arise because, a combination of two or more firms may result in cost reduction due to operating economies. In other words, a combined firm may avoid or reduce over-lapping functions and consolidate its management functions such as manufacturing, marketing, R&D and thus reduce operating costs. For example, a combined firm may eliminate duplicate channels of distribution, or crate a centralized training center, or introduce an integrated planning and control system.<br />
**Synergy:- implies a situation where the combined firm is more valuable than the sum of the individual combining firms. It refers to benefits other than those related to economies of scale. Operating economies are one form of synergy benefits. But apart from operating economies, synergy may also arise from enhanced managerial capabilities, creativity, innovativeness, R&D and market coverage capacity due to the complementarity of resources and skills and a widened horizon of opportunities.<br />
<br />
*Diversifying the risks of the company, particularly when it acquires those businesses whose income streams are not correlated. Diversification implies growth through the combination of firms in unrelated businesses. It results in reduction of total risks through substantial reduction of cyclicality of operations. The combination of management and other systems strengthen the capacity of the combined firm to withstand the severity of the unforeseen economic factors which could otherwise endanger the survival of the individual companies.<br />
<br />
*A merger may result in financial synergy and benefits for the firm in many ways:-<br />
<br />
**By eliminating financial constraints<br />
**By enhancing debt capacity. This is because a merger of two companies can bring stability of cash flows which in turn reduces the risk of insolvency and enhances the capacity of the new entity to service a larger amount of debt<br />
**By lowering the financial costs. This is because due to financial stability, the merged firm is able to borrow at a lower rate of interest.<br />
<br />
*Limiting the severity of competition by increasing the company's market power. A merger can increase the market share of the merged firm. This improves the profitability of the firm due to economies of scale. The bargaining power of the firm vis-à-vis labour, suppliers and buyers is also enhanced. The merged firm can exploit technological breakthroughs against obsolescence and price wars.<br />
<br />
In this research report, researcher considered two following objective of merger and acquisition:<br />
<br />
#To Enter in emerging markets<br />
#To improve product portfolio<br />
<br />
===Methodology===<br />
<br />
# Step 1: First, list all the players present in Ureteral Stent Market were identified.(The list of companies was retrieved from the FDA site from Registration & Listing database)<br />
<br />
*Number of companies that were identified in this step: 20 <br />
<br />
# Step 2: The second step involved identifying and eliminating companies that are large, and established players or the subsidiaries of the big players in the industry. <br />
<br />
*Number of companies eliminated in this step: 14<br />
*Number of (small) companies of interest left: 6<br />
<br />
# Step 3: Once the large, and established players were eliminated, companies were compared based on various parameters and rated on the scale of 5 to identify the best target. Please check the following dashboard:<br />
<br />
*Number of potential target companies: 6<br />
<br />
<br />
<br />
<br />
# Step 4: Finally, after an in-depth analysis of the potential target companies’ on various parameters, following companies identified to be best possible target companies.<br />
<br />
* To improve Product Portfolio : Applied Medical Resources Corp.<br />
* To enter in Emerging Markets : Bioteque Corp.<br />
<br />
<br />
<br />
===Company Profile===<br />
====Applied Medical Resources Corp.====<br />
<br />
<br />
<br />
====Bioteque Corp.====<br />
<br />
==M&A Due Diligence Process==<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
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'''Dolcera can provide a comprehensive report customized to your needs'''</p><br />
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<br />
==Contact Dolcera==<br />
<br />
{| style="border:1px solid #AAA; background:#E9E9E9" align="center"<br />
|-<br />
! style="background:lightgrey" | Samir Raiyani<br />
|-<br />
| '''Email''': [mailto:info@dolcera.com info@dolcera.com]<br />
|-<br />
| '''Phone''': +1-650-269-7952<br />
|}<br />
<br />
= Addition =<br />
=== Patent Categorization: Interactive mind map linked to Dolcera Dashboard ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
=== Product-Patent-Clinical Trials Mapping ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
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*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=== Product to Patent Mapping ===<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''here ''']]to download the excel file.<br />
* Mapped Patent vs Not Mapped Patents<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=== Dolcera Dashboard ===<br />
[[Image:dashboard_features.png|center|750px|]]<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
|-<br />
|}<br />
*Flash Player is essential to view the Dolcera Dashboard<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
<br />
= Key Artifacts =<br />
* [[Investment Heat Map ]]<br />
* [[Revenue Heat Map ]]<br />
* [[Patent Heat Map]]<br />
* [http://www.dolcera.com/website/demos/dental/main.html Dynamic Patent Dashboard]<br />
* [http://www.dolcera.com/ipmapdemo/stent_model.swf Stent Landscape-Flash]<br />
* [[Company Profile - Flash]]<br />
<br />
=Removed Sections=<br />
[[Removed Sections]]</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=OLED_Mobile_Phones_Market_Research_and_Analysis_Report&diff=9800
OLED Mobile Phones Market Research and Analysis Report
2011-10-04T11:54:06Z
<p>Shweta.mittal@dolcera.com: /* OLED Market: Revenue Overview */</p>
<hr />
<div>==Executive Summary==<br />
<br />
* The '''OLED''' (Organic Light-Emitting Diode) technology is rapidly evolving, and these improvements are changing the dynamics display screens in mobile phones, TVs, camera, etc. The report provides a technological overview of OLEDS and includes comparisons with the rival technology of LCDs. <br />
* This report analyses the '''Market for OLED display mobile phones''' in terms of products, applications, market size and structure, competitive environment and technology, and determines its future prospects.<br />
* The statistical tools of '''Cluster Analysis''' and '''Regression''' are used to determine the segments of smart-phones likely to adopt OLED displays<br />
* '''Bass Diffusion Model''' for adoption of new technologies is applied to forecast sales of OLED display based mobile phones. This forecast is arrived at by modeling the sales on the historical sales data of certain proxy products and is graphically presented in the report.<br />
* The study reveals that by 2012 cumulative sale of OLED based mobile phone is expected to reach '''183 million units''' and details the trend of these sales over the years<br />
<br />
<br />
==Research Objective==<br />
<br />
* To provide a '''Technology Overview''' for OLED Mobile Phones<br />
* To provide a '''Market Overview''' for OLED Mobile Phones<br />
* To provide a '''Market Estimate''' for OLED Mobile Phones<br />
* To forecast the '''Adoption Rate''' of OLED Mobile Phones<br />
<br />
<br />
==Research Methodology==<br />
<br />
A '''four stage analysis''' was conducted:<br />
<br />
[[Image:4stageanalysis.jpg|center|500px]]<br />
<br />
===Technology Overview===<br />
<br />
A brief understanding of the Technology behind the OLED displays forms the introduction to this report.<br />
<br />
===Market Overview===<br />
<br />
A detailed overview of the OLED Technology forms the basis of the Analysis performed using Base Diffusion Model.<br />
<br />
===Cluster Analysis===<br />
<br />
Cluster Analysis was used to determine a class of mobile handsets that is most likely to use OLED displays. Cluster analysis is a technique used to assign objects to groups (called clusters), such that objects from the same cluster are ''more similar'' to each other than objects from different clusters. To determine the cluster, certain attributes of a handset like input mode, display size, camera resolution, etc. were considered.<br />
<br />
===Bass Diffusion Model===<br />
<br />
The Bass Diffusion Model was used to forecast the adoption of the OLED display mobile phones by consumers. The Bass Diffusion model is a quantitative tool that describes the process of how new products get adopted as an interaction between users and potential users. In this analysis, the model was employed to forecast the sales of a new product by utilizing historical sales data of analogous products from the same product category as well as from a diverse product category. The market penetration for mobiles with OLED displays is arrived at with result for both the proxies.<br />
<br />
== Mobile Phone Display: Technology Overview ==<br />
<br />
'''OLED (Organic Light Emitting Diodes)''' is a flat display technology, made by placing a series of organic thin films between two conductors. On applying an electric current, a bright light is emitted. OLEDs use organic semiconductor material instead of inorganic semiconductor material used in conventional Light Emitting Diodes (LEDs). Through a process called electrophosphorescence, OLEDs emit light in the presence of an electric current. Like any other diode, OLEDs permit electric current to pass only in one direction. Unlike diodes made from inorganic semiconductors, OLEDs are very flexible because they are only '''100 to 500 nanometers''' thick - the human hair is 200 times thicker than it. As a result, OLED screens are very flexible and can be made in very large sheets. OLEDs use lesser energy than LEDs as well.<br />
<br />
The easiest way to understand OLEDs is to compare them to LCDs. LCDs are made by placing a color filter over a white backlight source – filtering out the colors that are not wanted for each pixel. If you want to display blue, you'll have to filter out green and red. OLEDs, on the other hand, are emissive, which means that you simply need to display the colors you need for each pixel, which is made from three color (RGB) OLED “pixels.”<br />
<br />
<br />
=== Mobile Phone Display Types ===<br />
There are two types of display technologies which are used in mobile phones:<br />
# Liquid Crystal Display (LCD)<br />
# Organic Light-Emitting Diode (OLED)<br />
<br />
Recent developments in LCD are Super LCD (S-LCD) and IPS (In-Plane Switching technology) Panel. IPS technology is used in Apple’s Retina display and LG’s NOVA display. OLED technology includes developments such as Super AMOLED, Super AMOLED Plus and ClearBlack.<br />
<br />
<br />
=== Difference between LCD and OLED ===<br />
The LCD uses light modulating properties of liquid crystals (LCs). The liquid crystals do not emit light directly. So, a light source is needed for proper viewing. The OLED uses organic compounds that illuminate when exposed to electric currents. Hence, a backlight is not required for OLEDs. This makes OLED displays thinner than LCD displays.<br />
<br />
==== Difference between AMOLED and AMLCD ====<br />
{|border="2" cellspacing="0" cellpadding="2" width="90%" align="center"<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Properties'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''AM OLED'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''AM LCD'''</font><br />
|-<br />
|'''Thickness/Weight'''<br />
|Thinner, best is 0.05 mm; lighter<br />
|Thicker, best is 0.8 mm; heavier<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Diagonal Size'''<br />
|bgcolor = "#C5D9F1"|Limited to small and medium sizes; largest demo is around 40"<br />
|bgcolor = "#C5D9F1"|Can be manufactured larger; largest demo is <nowiki>~</nowiki>100"<br />
|-<br />
|'''Viewing Angle'''<br />
|Up to 180 degrees<br />
|Narrower, depends on liquid crystal type<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Color Gamut'''<br />
|bgcolor = "#C5D9F1"|<nowiki>></nowiki>100% NTSC (top emission), around 70% NTSC (bottom); high at all gray levels<br />
|bgcolor = "#C5D9F1"|Around 70%, up to 100% NTSC (LED backlight and new color filter); falls at low gray levels<br />
|-<br />
|'''Color Reproduction'''<br />
|Better; gamut independent of view angle<br />
|Good; gamut changes with viewing angle<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Resolution'''<br />
|bgcolor = "#C5D9F1"|Lower; 308 dpi (SM), 202 dpi (polymer)<br />
|bgcolor = "#C5D9F1"|Higher; best is 498 dpi<br />
|-<br />
|'''Response Time'''<br />
|Faster, nanoseconds. No motion blur, good for 3D<br />
|Slower, milliseconds<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Contrast Ratio'''<br />
|bgcolor = "#C5D9F1"|Higher<br />
|bgcolor = "#C5D9F1"|Lower<br />
|-<br />
|'''Sunlight Readability'''<br />
|Better than transmissive LCD, worse than transflective LCD<br />
|Ok if transflective<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Operating Temperature'''<br />
|bgcolor = "#C5D9F1"|Range is larger, can operate at low temps like -40°C<br />
|bgcolor = "#C5D9F1"|Range is smaller, lowest temp is -10°C<br />
|-<br />
|'''Power Consumption'''<br />
|Lower at typical video content, when around 30% of pixels are on<br />
|Higher at typical video content<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Lifetime'''<br />
|bgcolor = "#C5D9F1"|Shorter, 5K to 30K hour, but improving<br />
|bgcolor = "#C5D9F1"|Much longer, above 50K hour<br />
|-<br />
|'''Manufacturing Investment'''<br />
|Lower, but lack of standards keeps the investment only slightly lower<br />
|Higher<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Production Cost'''<br />
|bgcolor = "#C5D9F1"|Expensive; low yield and complex structure, potential to be low cost<br />
|bgcolor = "#C5D9F1"|Cheaper than AMOLED<br />
|-<br />
|align = "center" colspan = "3"|'''[http://www.displaysearch.com/ Source: DisplaySearch]'''<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
==== OLED Construction ====<br />
An OLED can be made of a single layer of organic material but multiple layers increase efficiency and effectiveness. A typical OLED is comprised of five layers of material:<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Layer'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|'''Substrate layer'''<br />
|bgcolor = "#DBE5F1"|This layer supports the OLED and is made of clear plastic, glass, foil or other materials.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Anode layer'''<br />
|bgcolor = "#B8CCE4"|The anode layer is transparent and is positively charged. When an electric current is applied, this layer attracts electrons as they flow through the OLED. As with a LED, the anode forms "holes" onto which electrons fall.<br />
|-<br />
|bgcolor = "#DBE5F1"|'''Conducting layer'''<br />
|bgcolor = "#DBE5F1"|This layer is made of organic plastic material and transports the "holes" from the anode layer.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Emissive layer'''<br />
|bgcolor = "#B8CCE4"|This layer transports electrons from the cathode. It is also made of organic plastic molecules but there are different from those in the conducting layer. This is the layer that determines the color of the light emitted.<br />
|-<br />
|bgcolor = "#DBE5F1"|'''Cathode layer'''<br />
|bgcolor = "#DBE5F1"|This layer injects electrons into the OLED when an electric current is applied. Depending on the OLED and the color effect desired, this layer may or may not be transparent.<br />
|-<br />
|}<br />
<br />
<br />
[[image:oledstructure.jpg|center|406*365px|thumb|Source: [http://electronics.howstuffworks.com/oled1.htm How Stuff Works]]]<br />
<br />
==== Types of OLED Construction ====<br />
OLEDs can be constructed in a variety of ways to serve a variety of functions. While each type of construction uses the layers described previously, the manner in which each layer is built alters the way the OLED functions. The six most common types of OLEDs are as follows:<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Passive-Matrix OLED'''<br />
|bgcolor = "#DBE5F1"|Anode and cathode laid perpendicular to each other<br />
|-<br />
|bgcolor = "#DBE5F1"|PM OLEDs are easy to make and display text and icons very effectively, particularly in small 2-inch to 3-inch screens<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''Active-Matrix OLED'''<br />
|bgcolor = "#B8CCE4"|AM OLEDs are constructed with continuous film materials<br />
|-<br />
|bgcolor = "#B8CCE4"|AM OLEDs use less energy than PM OLEDs and have faster refresh rates<br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Transparent OLED'''<br />
|bgcolor = "#DBE5F1"|Constructed with transparent materials for all five layers, a transparent OLED can be made as either a PM OLED or an AM OLED<br />
|-<br />
|bgcolor = "#DBE5F1"|Useful for heads-up display applications<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''Top-Emitting OLED'''<br />
|bgcolor = "#B8CCE4"|These types of OLEDs use an opaque or reflective substrate that is useful for smart card applications<br />
|-<br />
|bgcolor = "#B8CCE4"|Best suited for an active-matrix design<br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Foldable OLED'''<br />
|bgcolor = "#DBE5F1"|The substrate of this type of OLED is very flexible, allowing the OLED to be folded or rolled up<br />
|-<br />
|bgcolor = "#DBE5F1"|Because of their flexibility, foldable OLEDs could be attached to fabrics with a variety of applications<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''White OLED'''<br />
|bgcolor = "#B8CCE4"|These OLEDs emit white light that is brighter, more uniform and more energy efficient than that emitted by fluorescent lights<br />
|-<br />
|bgcolor = "#B8CCE4"|Potential to replace incandescent and fluorescent lighting in commercial industrial, and residential applications<br />
|-<br />
|}<br />
<br />
<br />
==== Advantages and Disadvantages ====<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|align = "center" bgcolor = "#DBE5F1" rowspan = "3"|'''Advantages of OLED over LCD'''<br />
|bgcolor = "#DBE5F1"|As there is no backlighting, OLED displays offer deeper black levels than LCD displays<br />
|-<br />
|bgcolor = "#DBE5F1"|OLED displays have better contrast ratios<br />
|-<br />
|bgcolor = "#DBE5F1"|Viewing angles offered by OLEDs is more than that offered by LCDs<br />
|-<br />
|align = "center" bgcolor = "#B8CCE4" rowspan = "3"|'''Disadvantages of OLED over LCD'''<br />
|bgcolor = "#B8CCE4"|Brightness levels of OLED display is less than that of LCD<br />
|-<br />
|bgcolor = "#B8CCE4"|Color in OLED displays are often oversaturated<br />
|-<br />
|bgcolor = "#B8CCE4"|The red, green and blue sub-pixels deteriorate and lose efficiency at different rates, thus color consistency worsens over time<br />
|-<br />
|}<br />
<br />
<br />
=== OLED Screen Types in Mobile Phones ===<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|align = "justify" bgcolor = "#DBE5F1"|'''AMOLED'''<br />
|align = "justify" bgcolor = "#DBE5F1"|AMOLED relies on a TFT backplane to switch individual pixels on and off. Active-matrix displays consume significantly less power than passive-matrix counterparts. This makes them well-suited for mobile devices. AMOLED displays are manufactured by printing electroluminescent materials onto a substrate. The relatively simplistic process suggests that OLEDs will ultimately become cheaper and easier to manufacture than LCDs. The creation of the substrate is the most difficult and expensive part of the process. Currently, AMOLED screens are limited in supply. Coupled with high demand, their availability is restricted and they are found in high-end smartphones.<br />
|-<br />
|align = "justify" bgcolor = "#B8CCE4"|'''Super AMOLED'''<br />
|align = "justify" bgcolor = "#B8CCE4"|Super-AMOLED displays are AMOLED displays with an integrated touch function. The original AMOLED screens had reduced visibility in direct sunlight. The thickness of the touch sensor is less than 0.001mm in Super AMOLED displays. This allows the screen to provide better images and to have great visibility even in direct sunlight.<br />
|-<br />
|align = "justify" bgcolor = "#DBE5F1"|'''ClearBlack'''<br />
|align = "justify" bgcolor = "#DBE5F1"|Nokia introduced a display similar to Samsung<nowiki>’</nowiki>s Super AMOLED known as the ClearBlack display. The ClearBlack display makes the screen more visible in direct sunlight. A polarized filter is added to the display. This allows the viewer to see through the screen<nowiki>’</nowiki>s reflection and view the images as they would appear under more ideal conditions.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Super AMOLED Plus'''<br />
|align = "justify" bgcolor = "#B8CCE4"|The Super AMOLED Plus features a traditional three sub-pixels of equal proportion within one pixel. It has an increased sub-pixel count and density. As a result, the display is much crisper, especially when it comes to text. The tighter spacing between pixels also results in better visibility under direct sunlight. The displays are also thinner, brighter and more efficient (by 18%) than the old Super AMOLED displays.<br />
|-<br />
|}<br />
<br />
<br />
=== Future OLED Mobile Screen Variations ===<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|'''Transparent Displays'''<br />
|align = "justify" bgcolor = "#DBE5F1"|Transparent OLEDs have only transparent components (substrate, cathode and anode) and, when turned off, are up to 85 percent as transparent as their substrate. When a transparent OLED display is turned on, it allows light to pass in both directions. A transparent OLED display can be either active- or passive-matrix. TDK began production of a see-through OLED earlier this year.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Flexible Displays'''<br />
|align = "justify" bgcolor = "#B8CCE4"|Flexible OLEDs have substrates made of very flexible metallic foils or plastics. Flexible OLEDs are very lightweight and durable. Their use in devices such as cell phones and PDAs can reduce breakage, a major cause for return or repair. Samsung is readying flexible AMOLED displays for production next year.<br />
|-<br />
|}<br />
<br />
<br />
==OLED Market Overview==<br />
<br />
<br />
===OLED Market: Revenue Overview===<br />
* The Global OLED Display Market was estimated at '''$1,800 million''' for the year 2010.<br />
* The market stood at '''$1,102 million''' in the year 2009, and showed a growth of '''63.3%''' for 2010.<br />
* The market is estimated to reach '''$6,934 million''' by the year 2014. <br />
<br />
[[Image:Global_OLED_revenue.JPG|center|760*401px|thumb|Global OLED Display Market: Revenue Forecasts 2004-2014 (in $million), Source: [http://www.pira-international.com/Sustained-Development-Efforts-to-Spur-Ten-Fold-Growth-of-OLEDs-Lighting-and-Displays-Market-by-2014.aspx pira-international ]]]<br />
<br />
===OLED Market: Volume Overview===<br />
<br />
* The shipments of Organic Light-Emitting Diode (OLED) screens was estimated at '''100 million''' units in 2010<br />
* The shipments of Organic Light-Emitting Diode (OLED) screens are set to rise to '''326.8 million''' units in 2015<br />
* The market is going to be driven by booming demand for Active-Matrix (AM) displays for mobile handsets<br />
* AM-OLED segment, which will boom to '''261.5 million''' units in 2015, up more than twelve fold from '''21.1 million''' in 2009<br />
<br />
[[Image:Global_OLED_Volume.JPG|center|659*383px|thumb|Global OLED Display Shipment 2007-2015 <br />
(Millions of Unit), Source: [http://www.isuppli.com/Display-Materials-and-Systems/News/Pages/iSuppli-Issues-Fast-Facts-on-the-Display-Industry-for-SID-2010.aspx iSuppli ]]]<br />
<br />
===Market Potential by Geography===<br />
<br />
====OLED Market Potential by Geography====<br />
The following chart illustrates the OLED Market Potential by Geography over the period 2004-2014:<br />
{|align = "center"<br />
|<gflash>1050 625 http://dolcera.com/upload/files/OLED_Geography.swf</gflash><br />
|-<br />
|}<br />
<br />
Source: [http://www.icongrouponline.com/ ICON Group International]<br />
<br />
<br />
====AMOLED Market Potential by Geography====<br />
The following chart illustrates the AMOLED Market Potential by Geography over the period 2004-2014:<br />
{|align = "center"<br />
|<gflash>1050 625 http://dolcera.com/upload/files/AMOLED_Geography_01.swf</gflash><br />
|-<br />
|}<br />
<br><br />
Source: [http://www.icongrouponline.com/ ICON Group International]<br />
<br />
<br />
===OLED Market Share===<br />
* '''Samsung Mobile''' leads the OLED Display Market with a market share of 43.2% as reported in 2010<br />
* '''TDK''' is a distant 2nd with a market share of 17.5% and is closely followed by '''RiT Display''' with a share of 16.0%<br />
<br />
The following chart illustrates the Global OLED Display Unit Shipment: Market Share, for the year 2010:<br />
[[Image:Global_OLED_Market_Share.JPG|center|760*401px|thumb|Global OLED Display Unit Shipment: Market Share 2010<br />
, Source: [http://www.displaysearch.com/cps/rde/xchg/displaysearch/hs.xsl/quarterly_oled_shipment_and_forecast_report.asp Quarterly OLED Shipment and Forecast Report, DisplaySearch ]]]<br />
<br />
===OLED Market Share by Application===<br />
* '''Mobile Handset application''' forecast to account for 84%, followed by NBPC at 6% and tablet PC at 4% of 2011E total revenue.<br />
<br />
<br />
The following chart illustrates the Global OLED Display total revenue: Market Share, for the year 2011E:<br />
[[Image:OLED_app_revenue.jpg|center|760*401px|thumb|OLED Display Revenue: Market Share 20111E<br />
, Source: [http://7economy.com/archives/6051 7economy]]]<br />
<br />
==OLED Eco-System==<br />
The following dashboard illustrates all the Companies in the OLED Eco-System:<br />
{|align = "center"<br />
|<gflash>900 425 http://dolcera.com/upload/files/OLED_Ecosystem.swf</gflash><br />
|-<br />
|}<br />
Source: [http://www.oled-info.com/ OLED-info.com]<br />
<br />
<br />
==OLED Market Drivers & Restraints==<br />
<br />
The following figure illustrates a '''Forcefield Analysis of Market Drivers and Restraint'''s for OLED Market (2011-2017):<br />
[[Image:OLED_Drivers_Restraints.JPG|center|900*533px|thumb|Forcefield Analysis of Market Drivers and Restraints for OLED Market (2011-2017)<br />
, Source: [http://www.frost.com Frost & Sullivan]]]<br />
<br />
<br />
===OLED Market Drivers===<br />
The following table illustrates the '''Impact Analysis of OLED Market Drivers''' over a period of time:<br />
{|border="2" cellspacing="0" cellpadding="2" width="60%" align="center"<br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Rank'''</font><br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Driver'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''1-2 years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''3-4 Years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''5-7 years'''</font><br />
|-<br />
|align = "center"|1<br />
|Inherent Advantages of OLED Technology<br />
|align = "center"|Medium<br />
|align = "center"|High<br />
|align = "center"|Very High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|2<br />
|bgcolor = "#C5D9F1"|Increasing Demand for Green Products<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|-<br />
|align = "center"|3<br />
|Increasing demand for OLED Display in Mobile Phones and Signage<br />
|align = "center"|Medium<br />
|align = "center"|Medium<br />
|align = "center"|High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|4<br />
|bgcolor = "#C5D9F1"|Rising Potential of OLED TV<nowiki>’</nowiki>s<br />
|align = "center" bgcolor = "#C5D9F1"|Low<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
'''Inherent Advantages of OLED Technology'''<br />
<br />
* OLED display offer sharper images and better contrast ratios, crisp colors and faster refresh rates compared to any existing display technology.<br />
* OLED Technology also offers consumers better energy management as the whole system functions at optimal power and is of organic substrate.<br />
* OLED displays are created by inserting thin organic films between two conductors and require no backlight; therefore, the displays are more compact and thinner.<br />
* OLED displays, especially or television, are capable of offering viewers a viewing angle of 180 degrees<br />
* As the benefits of OLED displays become more prominent, the demand for OLED manufacturing equipment is expected to increase in the next three to seven years.<br />
<br />
<br />
'''Increasing Demand for Green Products'''<br />
<br />
* The demand for lower power consumption , reduced material usage, and simplicity is expected to propel the OLED demand in the coming years<br />
* The OLED manufacturing equipment market, however, is facing challenges due to its premium and manufacturing challenges. As Manufacturers realize the economies of scale, average selling price is expected to decline, further spurring demand.<br />
* OLED TV market continues to evolve technologically and benefit from increasing demands for energy efficiency from consumers.<br />
<br />
<br />
'''Increasing demand for OLED Displays in Mobile Phones and Signage'''<br />
<br />
* Technology innovations, better functionalities and falling prices are expected to keep up the demand for OLED displays in mobile phones<br />
* Mobile Phones accounted for over 82.0% of the Total OLED display market. With the success of mobile phones, such as the Galaxy, the demand for OLED displays for mobile applications is expected to increase<br />
* The market is also expected to benefit from increasing demand for OLED displays used for signage<br />
* These factors are expected to propel the sales of OLED during the medium and later part of the forecast period.<br />
<br />
<br />
'''Rising Potential of OLED TVs'''<br />
<br />
* The OLED market is yet to observe strong demand for TVs. High premium price and smaller display sizes are key restraints for customers. However, with increasing collaboration within the entire supply chain of the OLED market, the market is expected to experience gradual increase in attractive solutions. According to DisplaySearch, the OLED TV market is expected to generate revenue of $28 billion by 2017.<br />
* The increasing momentum is expected to help commercialize the technology in the next five to seven years. Many display manufacturers have already set up dedicated manufacturing lines from Gen 3.5 to Gen 5.5.<br />
* This is expected to propel OLED manufacturing equipment sales during the latter part of the forecasted period.<br />
<br />
Source: [http://www.frost.com Frost & Sullivan]<br />
<br />
<br />
===OLED Market Restraints===<br />
The following table illustrates the '''Impact Analysis of OLED Market Restraints''' over a period of time:<br />
{|border="2" cellspacing="0" cellpadding="2" width="60%" align="center"<br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Rank'''</font><br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Restraint'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''1-2 years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''3-4 Years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''5-7 years'''</font><br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|1<br />
|bgcolor = "#C5D9F1"|Slow Adoption Rate of New Technology<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|-<br />
|align = "center"|2<br />
|Declining Prices of competing technologies<br />
|align = "center"|High<br />
|align = "center"|High<br />
|align = "center"|High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|3<br />
|bgcolor = "#C5D9F1"|High cost of products<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
'''Slow Adoption Rate of New Technology'''<br />
<br />
* The adoption rate of OLED Technology is comparatively slower than the initial launch of LCD technology. Consumers are complacent with the current technologies it offers then a myriad o advantages and benefits.<br />
* The largest issues foreseen are consumer perception, cost effectiveness of the product, ease of implementation and the ability of the service to provide true blended services<br />
* As a result, there is a significant and vital gap between new product design to volume manufacturing in the OLED market<br />
* Increasing costs and manufacturing complexity has hindered the adoption rate of OLED manufacturing equipment, especially for larger substrate sizes<br />
* The growth of the OLED display market and, in turn equipment sales, will rely on increasing collaboration between material suppliers, technology enablers and equipment providers. Decreased time to market and focus on R&D will be the key to attaining the desired growth trajectory.<br />
<br />
<br />
'''High Cost of Products'''<br />
<br />
* The high cost of OLED display has hindered adoption rates. For Example, customers, while willing to pay a premium price for quality products, hedge until the product has reached mass adoption level. A manufacturing facility typically requires an investment of $ 1 Billion to 3 Billion.<br />
* This has restrained the demand for OLED equipment. Equipment providers are still caught in a dilemma of balancing the high cost of technology development with affordable pricing for consumers.<br />
* Careful adjustment of prices can help minimize the impact of this restraint. Pricing strategy is crucial for success for the overall OLED market.<br />
<br />
<br />
'''Declining Prices of Competing Technologies'''<br />
<br />
* The LCD market is continuing to witness strong demand despite the emergence of new products in the market.<br />
* LCD Technology is transitioning t meet increasing demands for higher switching speeds, becoming more environmentally friendly by using LED backlighting, becoming sleeker and more compact, and having better resolution.<br />
* The LCD and other existing technologies also offer consumers the ability to buy large screen displays. This had created major barriers for increasing the adoption rate for OLED manufacturing equipment.<br />
<br />
Source: [http://www.frost.com Frost & Sullivan]<br />
<br />
<br />
==Transaction Landscape==<br />
The Transaction Landscape in the OLED Market is illustrated in the following links:<br />
# [[Mergers & Acquisitions Landscape]]<br />
# [[Partnerships Landscape]]<br />
# [[Investment Landscape]]<br />
<br />
<br />
==Cluster Analysis for TFT Display Mobile Phones==<br />
The table here summarizes the objective, methodology, procedure and result of the cluster analysis <br />
[[Image:Cluster Analysis.jpg|thumb|center|1000px|[http://faculty.chass.ncsu.edu/garson/PA765/cluster.htm Source: Statnotes, North Carolina State University]]]<br><br />
<br />
===Selection of model===<br />
Using the analysis, one cluster of smart-phones likely to move to OLED technology was identified for each of the two categories. For the next stage of the research - that of forecasting sales - would need the historical sales data of one particular model. For this purpose, '''Apple iPhone''' from the 2nd cluster of candy-bar phones was selected because of constraint of availability of sales data for other models like Blackberry, Nokia N96, HTC Dreamers etc.<br />
<br />
<br />
==='''A Comparison of LCD and OLED technologies'''===<br />
<br />
<br />
The ''radar graph'' here shows the comparison between OLED and TFT LCD.<br />
<br />
[[Image:Comparison.jpg|500px|thumb|center|Comparison[http://digidelve.com/oled/problems Source]]]<br />
<br />
<br />
<br />
The graph depicts the following things:<br />
<br />
# OLEDs are ''thinner'' than LCDs.<br />
# OLEDs are ''lighter'' in weight.<br />
# OLEDs consume ''more power'' than LCDs but OLEDs have an inherent advantage in that they only consume power when they emit light while an LCD backlight consumes constant power regardless of the image being displayed.<br />
# OLEDs ''cost more'': The Cost of an AM-LCD is currently about half that of a comparable AM-OLED display. This is due to the maturity of LCD manufacturing processes and facilities. OLED manufacturing facilities suffer from low yields, currently at 60%-70%.<br />
# OLEDs have a ''shorter lifespan'' as compared to LCDs.<br />
# OLEDs have a ''faster response time'' of .01ms while LCDs have a response time about 8-12ms.<br />
# OLEDs have a ''superior viewing angle'' of 180 degree while LCDs have a lower viewing angle.<br />
<br />
==='''Cluster Analysis'''===<br />
<br />
<br />
====Methodology====<br />
<br />
'''Sample Definition:''' The sample space consists of moblie phones by leading players in the smart-phone mobile category. These models were identified from Gartner reports. The models of smart-phones launched in the last three years in North America were considered. <br />
<br />
'''Sample Space:'''After defining the sample, the various key attributes of smart-phones like camera, display, etc. were defined. The data for these attributes for all the models was collected from the company websites as well as the following websites:<br />
<br />
* www.phonearena.com<br />
* www.phonegg.com<br />
* www.mobile.am<br />
<br />
<br />
The pricing information was obtained from<br />
* www.fonearena.com<br />
* www.india-cellular.com<br />
* www.naaptaol.com<br />
* www.mobilestore.com<br />
* www.indiatimes.com.<br />
<br />
<br />
After aggregating the data we used the '''k-clustering''' method to identify the different clusters for the samples. This technique aims to partition ''n'' observations into ''k'' clusters in which each observation belongs to the cluster with the nearest mean. Hence clusters of phones with similar attributes is achieved.<br />
<br />
Samples were segregated into two broad categories - candy-bar phones and clamshell or sliding phones - with thickness being the differentiating parameter. This was done in order to mitigate any error due to the design of the phone(i.e. candybar,clamshell,slider), since the thicknes of the mobile could be a cause for erroneous results.<br />
<br />
====Cluster analysis results====<br />
<br />
The sheet below shows the clusters formed for the candy-bar phones.<br />
<br />
[[Image:Candy_bar_excels.jpg|Candy bar|1500px|center|thumb]]<br />
<br />
The sheet below shows the cluster formed for the clamshell/sliding phones.<br />
<br />
[[Image:clamshellexcel.jpg|Clamshell_slider|650px|center|thumb]]<br />
<br />
'''Definition of Attributes:'''<br />
*'''Camera''' : resolution in Megapixels<br />
*'''Input method''': two types of input methods - touchscreen and keyboard<br />
*'''Display size''': diagonal length of the displeay screen<br />
*'''Resolution''': display resolutions<br />
*'''Color''': display color<br />
*'''Thickness''': total thickness of the phone<br />
<br />
<br />
The cluster analysis results and subsequent profiling of those clusters are summarized below:<br />
<br />
<br />
''' Candy - Bar Phones'''<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center"|<font color="#262626">'''Clusters'''</font><br />
|align = "center"|<font color="#262626">'''Cell phones'''</font><br />
|align = "center"|<font color="#262626">'''Profile'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''1'''<br />
|align = "center" bgcolor = "#D3DFEE"|Apple iPhone, Samsung i910<br />
|align = "justify" bgcolor = "#D3DFEE"|* Cluster 1 consists of high end cell phones<br>* Cell phones falling in this cluster are touch screen phones with large display size<br>* This is mainly targeting the premium market which is not price sensitive as the mobile phones in this cluster are priced high<br />
|-<br />
|align = "center"|'''2'''<br />
|align = "center"|HTC P3470, HTC touch cruise, HTC touch diamond, HTC touch viva, HTC X7510, i780<br />
|align = "justify"|* This cluster includes cell phones with moderate display size and having touch screen facility<br>* Cell phones in this cluster are in the price range of medium to high, so it is targeting the upper middle to high class.<br>* Almost all the mobile phones falling in this cluster are having WLAN facility indicating that this cluster target trendy class people and people who prefer online games and downloads on mobile phones<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''3'''<br />
|align = "center" bgcolor = "#D3DFEE"|Nokia 5320 express music, Nokia 5800 express music, Nokia 6124 classic, Nokia 6220 classic, Nokia E63, i200, i450, N6120, N78, N79, Pearl 8100<br />
|align = "justify" bgcolor = "#D3DFEE"|* Mobile phones in this cluster are targeted at the middle class as these phones are of moderate price and normal input<br>* They have small display size and moderate camera resolution, which is in sync with their target market<br>* Average thickness<br />
|-<br />
|align = "center"|'''4'''<br />
|align = "center"|E71, i550W, N5700, N73, N82, Blackberry 7130c/7130g<br />
|align = "justify"|* This cluster consists of mobile phones having high camera resolution and normal input indicating that this cluster is for people who give high preference to clicking photographs on mobile phones<br>* They have small display size with most of them not having the WLAN facility, so this is for people who low on using the browsing facilities<br>* The target segment for this cluster is the middle class segment as the mobile phones are also moderately priced<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''5'''<br />
|align = "center" bgcolor = "#D3DFEE"|Curve 8310, Blackberry 8820, Curve 8300, Blackberry 8800, Blackberry bold 9000, Blackberry curve 8330<br />
|align = "justify" bgcolor = "#D3DFEE"|* It includes mobile phones having input through qwerty and with average display size<br>* Target market is Business class people who prefer using email facility on mobiles<br>* The mobile phones are low on camera resolution<br>* All the mobiles in this cluster are high priced indicating that the targeted segment for this cluster is not price sensitive<br />
|-<br />
|}<br />
<br />
<br />
<br />
'''Clamshell Phones'''<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center"|'''Clusters'''<br />
|align = "center"|'''Cell phones'''<br />
|align = "center"|'''Profile'''<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''1'''<br />
|align = "center" bgcolor = "#D3DFEE"|N6650, N95 8GB, E66, 6210 navi, N85<br />
|bgcolor = "#D3DFEE"|* This cluster consists of medium to high priced mobile phones and is targeted at upper middle class<br>* These mobile phones have high camera resolution and normal keypad input<br>* All the mobiles in this cluster have average display size having 16M colors<br />
|-<br />
|align = "center"|'''2'''<br />
|align = "center"|N96, N97<br />
|* It includes mobile phones which are high priced and targeted at affluent people who are not price sensitive<br>* The mobile phones in this cluster are characterized by high camera resolution, big display size and moderate thickness<br>* WLAN facility and high graphic resolution in these mobile phones will attract people who prefer downloading and playing online games<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''3'''<br />
|align = "center" bgcolor = "#D3DFEE"|HTC dream<br />
|bgcolor = "#D3DFEE"|* Mobile phones in this cluster are moderately priced and, targeted at the middle class and the upper middle class segment<br>* These phones have high thickness and high camera resolution<br>* These phones are WLAN enabled and have both qwerty keypad and touch screen input<br />
|-<br />
|align = "center"|'''4'''<br />
|align = "center"|N76, N6290, N75, HTC shadow, E65, i620, N6110<br />
|* This cluster consists of mobile phones with low camera resolution and mainly has normal keypad for input<br>* These phones have medium display size and medium to high thickness<br>* These are low to moderately priced phones targeted at the middle class segment<br />
|-<br />
|}<br />
<br />
=== Prices for AMOLED screens===<br />
<br />
Market data was collected for the prices of OLED screens by various manufacturers<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#FFFF00"|Company Name<br />
|bgcolor = "#FFFF00"|Model Number<br />
|bgcolor = "#FFFF00"|Size<br />
|bgcolor = "#FFFF00"|Resolution<br />
|bgcolor = "#FFFF00"|Colors<br />
|align = "center" bgcolor = "#FFFF00" colspan = "3"|Price/unit(in USD)<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|0-99<br />
|100-999<br />
|1000 <nowiki>++</nowiki><br />
<br />
|-<br />
|Chung Yuan Technology Co., Ltd<br />
|align = "right"|&nbsp;<br />
|2.2"<br />
|220x176<br />
|align = "right"|&nbsp;<br />
|20.00<br />
|16.5<br />
|align = "right"|&nbsp;<br />
<br />
|-<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
<br />
|-<br />
|Digiprotek Markcom India P Ltd.(Densitron)<br />
|C0201QILK-C<br />
|2<br />
|176xRGBx220<br />
|262K<br />
|25.69<br />
|24.92<br />
|20.67<br />
<br />
|-<br />
|&nbsp;<br />
|C0240QGLA-T&nbsp;<br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|35.97<br />
|34.9<br />
|27.83<br />
<br />
|-<br />
|&nbsp;<br />
|P0340WQLC-T&nbsp;<br />
|3.45<br />
|480xRGBx272<br />
|16M<br />
|85.65<br />
|83.1<br />
|47.72<br />
<br />
|-<br />
|&nbsp;<br />
|P0430WQLC-T&nbsp;<br />
|4.3<br />
|480xRGBx272<br />
|16M<br />
|119.90<br />
|116.32<br />
|85.84<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|GLYN GmbH & Co. KG(CMEL)<br />
|C0201QILKC&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2<br />
|176x220<br />
|262K<br />
|25.00<br />
|&nbsp;<br />
|15<br />
<br />
|-<br />
|&nbsp;<br />
|C0240QGLAT&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|30.00<br />
|&nbsp;<br />
|20<br />
<br />
|-<br />
|&nbsp;<br />
|C0283QGLDT&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2.83<br />
|240xRGBx320<br />
|262K<br />
|38&nbsp;<br />
|&nbsp;<br />
|26<br />
<br />
|-<br />
|&nbsp;<br />
|P0340WQLCT&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br />
|3.4<br />
|480xRGBx272&nbsp;<br />
|16M<br />
|60.00<br />
|&nbsp;<br />
|35<br />
<br />
|-<br />
|&nbsp;<br />
|P0430WQLCT&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br />
|4.3<br />
|480xRGBx272<br />
|16M<br />
|90&nbsp;&nbsp;<br />
|&nbsp;<br />
|63<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|A4G Technologies(OSD)<br />
|OSD020AMQCIF<br />
|2<br />
|176x220<br />
|262K<br />
|22.50<br />
|20.98 <br />
|19.10 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD024AMQV <br />
|2.4<br />
|240x320<br />
|262K<br />
|30.20<br />
|28.57 <br />
|25.40 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0283AMQV<br />
|2.83<br />
|240x320<br />
|262K<br />
|38.30<br />
|36.16 <br />
|33.63 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0340WQLC <br />
|3.4<br />
|480x272<br />
|16M<br />
|69.50<br />
|67.25 <br />
|42.48 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0430WQLC-T <br />
|4.3<br />
|480x272<br />
|16M<br />
|109.00<br />
|87.00 <br />
|72.00 <br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|Blaze Technology<br />
|BDO-0240QGLA-T<br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|20.8<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0283QGLD-T<br />
|2.83<br />
|240xRGBx320<br />
|262K<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|26.85<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0340WQLA-T<br />
|3.4<br />
|480x272<br />
|16M<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|39.5<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0430WQLA-T<br />
|4.3<br />
|480x272<br />
|16M<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|90.6<br />
<br />
|}<br />
<br />
==Bass Diffusion Analysis==<br />
<br />
One of the most important functions during the launch of a new product is to forecast the demand for that product, as it guides many other critical decisions faced by the company. Companies can schedule their production activities once they have an idea about the demand in the coming months or years. At a high level, Bass Diffusion Model is used to determine the shape of the curve representing the cumulative adoption of the new product. Bass describes the individuals who decide to adopt an innovation independently of the actions of others as ''innovators''. Those who respond to the influences of the social system and obtain information about a new product from those who have already adopted the product are termed as ''imitators''.<br />
<br />
===Proxies for analysis===<br />
<br />
The use of the model has been made by using the historical sales data of ''proxy'' products to forecast sales for OLED display mobile phones with an assumption that OLED display mobile phones would mimic the diffusion patterns of the proxies. Hence it was important to select the proxies carefully. We used the following for this forecast:<br />
* iPhone - since this was the latest revolution in mobile phone devices and consumers would show a similar adoption behavior for a new mobile phone technology even though it comes at a price premium<br />
* LCD/Plasma TVs & Monitors - consumers spent more money to purchase screens with superior quality by significantly increasing their budget<br />
** LCD and Plasma TVs and LCD monitors were treated as a single analogous product(by ascribing different weights to these) for the forecast<br />
<br />
===Forecasting OLED display phone sales using Analogous Products===<br />
<br />
<br />
<br />
'''The following products from different product categories were considered:'''<br><br />
:# LCD TV <br />
:# Plasma Display TV<br />
:# LCD Monitor<br />
<br />
They were considered to be befitting analogies because of the following similarities:<br><br />
[[Image:Similarities.jpg|center|600px]]<br><br />
<br />
'''Weighted average for the analogous products:'''<br />
Weights for modeling co-efficients for the analogous products such as LCD TV, Plasma Display TV and LCD monitor had been assigned.<br><br />
To judge the similarity of analogous products to OLED, we examined two criteria.<br><br />
::a. Market Structure<br><br />
::b. Product Characteristics<br><br />
[[Image:Criterion.jpg|center|600px]]<br><br />
<br />
The '''S-Graph''' for the cumulative projected sale of OLED display mobiles modeled on analogous products<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart1.swf</gflash></center><br />
<br />
:* In 2009 and 2010 OLED Mobile Phone market would grow slowly driven by ''innovators''<br />
:* From 2011 to 2015, market will grow rapidly due to the ''early adopters''<br />
:* In 2016 and 2017, market will growth will dwindle as ''late adopters'' take to the phones<br />
:* 2018 onwards growth will peter, as the laggards pick up the last few models and the market will saturate<br />
:* From 2016 the technology will near obsolescence and a new technology would replace it<br><br />
<br />
<br />
'''Comparison of Adoption rate of Innovators with those of Imitators'''<br><br />
The model helps to determine sales to innovators and imitators for each year:<br><br><br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart2.swf</gflash></center><br />
<br />
<br />
This graph shows that a small number of innovators will kick-start the sales. OLED display mobile Phones will get off to a slow start in first 2 years. Once a '''''critical mass''''' is reached by the end of the second year, strong imitative effects will take over as the innovators decrease.<br />
<br />
===Detailed Analysis===<br />
<br />
The detailed modeling with a description of parameters and mathematical equations can be viewed here:<br><br />
[[Bass Diffusion Analysis for OLED display phones]]<br />
<br />
==OLED Mobile Phone Projections Based on I-Phone==<br />
<br />
The '''S-Graph''' for the cumulative projected sale of OLED display mobiles modeled on analogous products<br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart3.swf</gflash></center><br />
<br />
:* From Q1,'09 to Q3,'09, the OLED display mobile phone market would grow slowly, driven by ''innovators''<br />
:* From Q4,'09 to Q4,'10 market will grow rapidly due to the ''early adopters''<br />
:* From Q1,'11 and Q3,'11 market growth will dwindle as ''late adopters'' take to the phones<br />
:* Q4,'11 onwards growth will peter, as the laggards pick up the last few models and the market will saturate<br />
:* From Q4, the technology will near obsolescence and a new technology would substitute it<br><br><br />
<br />
'''Comparison of Adoption rate of Innovators with those of Imitators'''<br><br />
The model helps to determine sales to innovators and imitators for each year:<br><br><br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart4.swf</gflash></center><br />
<br />
<br />
This graph shows that a small number of innovators will kick-start the sales. OLED display mobile Phones will get off to a slow start in first three quarters. Once a '''''critical mass''''' is reached by the end of the Q3, strong imitative effects will take over as the innovators decrease.<br />
<br />
===Detailed Analysis===<br />
<br />
The detailed modeling with a description of parameters and mathematical equations can be viewed here:<br><br />
[[Bass Diffusion Analysis for OLED display phones]]<br />
<br />
==Comparing projections==<br />
Since disparate product categories had been used for the two forecasts, the two were compared to cross validate the results [[media:Bass-Model_OLED_comparison.xls|''<<excel sheet with calculations>>'']]<br><br />
<br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart5.swf</gflash></center><br />
<br />
:* Looking at the forecast for OLED display mobile phones based on analogous products and on iPhone, both are seen to be ''convergent''<br />
:* This validates the forecast<br />
<br />
<br />
<br />
==Sneak Preview of some models using OLED technology==<br />
{| class="wikitable" style="font-size:100%" border="1" cellpadding="5" cellspacing="0" width=80%<br />
|-<br />
| width=40% valign=top | [[Image:Apple.jpg|thumb|center|200px|[http://www.appleiphoneapps.com/2009/03/next-iphone-to-have-oled-display-why-should-you-care/ Source: appleiphoneapps.com]]]<br />
| width=60% valign=top | '''1. Apple iPhone''' - It’s nothing official at the moment, but word on the street is that Apple might have chosen a series of OLED displays for its next round of handsets. Such a move would certainly be in the best interests of battery life, as the iPhone isn’t noted for its battery capabilities. Considering the amount of new features that were announced in the iPhone 3.0 firmware update, it would be fairly practical to have a capacitive OLED display in the future.<br />
|-<br />
| width=40% valign=top | [[Image:Nokia.jpg|thumb|center|200px|[http://www.mobilephonereviews.org/category/nokia/ Source: Mobile Phone Reviews]]]<br />
<br />
| width=60% valign=top | '''2. Nokia''' - '''Nokia 6600''' Slide Mobile Phone is a 3G device with large OLED display and 3.2 megapixel camera. It has curved edges and with a weight of 110g is a bit heavy to hold. The 2.2” screen supports 16 million colors and comes with QVGA resolution. The dimensions of the phone are 90 x 45 x 14mm.<br />
<br />
|-<br />
| width=40% valign=top | [[Image:Samsung.jpg|thumb|center|200px|[http://www.att-phones.org/att-samsung-a877-phone-will-be-available.html Source: ATT Phones]]]<br />
<br />
| width=60% valign=top | '''3. Samsung''' - '''Samsung A877''' features include a 3.2-inch WQVGA AMOLED touchscreen, a 3 megapixel camera, GPS, HSDPA and Bluetooth. And as well at it supports AT&T’s 3G service.<br />
|-<br />
<br />
| width=40% valign=top | [[Image:Sony.jpg|thumb|center|200px|[http://www.itechnews.net/2008/01/08/sony-ericsson-z555-stylish-phone/ Source: Itechnews]]]<br />
| width=60% valign=top | '''4. Sony''' - '''Sony Ericsson Z555''' features a 1.9-inch LCD display, an OLED 128×36 external display, a 1.3 Megapixel camera with 4x digital zoom.<br />
|-<br />
| width=40% valign=top | [[Image:LG Mobile.jpg|thumb|center|200px|[http://www.unwiredview.com/2008/02/20/lg-sh150a-gets-am-oled-display-with-26-million-colors-and-hd-support/ Source: Unwiredview]]]<br />
| width=60% valign=top | '''5. LG''' - One of the first handsets to get the new AM OLED, is already advanced '''LG SH150''' DMB TV phone. <br />
|-<br />
| width=40% valign=top | [[Image:Motorola.jpg|thumb|center|200px|[http://www.itechnews.net/2007/10/12/motorola-u9-mobile-phone/ Source: Itechnews]]]<br />
| width=60% valign=top | '''6. Motorola''' - The '''MOTO U9''' is a Quad-band phone with a 2-inch QVGA LCD display, a 1.45-inch secondary OLED display, integrated music player, Bluetooth, 25MB internal memory and a microSD card slot.<br />
<br />
|-<br />
|}<br />
<br />
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=OLED_Mobile_Phones_Market_Research_and_Analysis_Report&diff=9799
OLED Mobile Phones Market Research and Analysis Report
2011-10-04T11:53:39Z
<p>Shweta.mittal@dolcera.com: /* OLED Market: Revenue Overview */</p>
<hr />
<div>==Executive Summary==<br />
<br />
* The '''OLED''' (Organic Light-Emitting Diode) technology is rapidly evolving, and these improvements are changing the dynamics display screens in mobile phones, TVs, camera, etc. The report provides a technological overview of OLEDS and includes comparisons with the rival technology of LCDs. <br />
* This report analyses the '''Market for OLED display mobile phones''' in terms of products, applications, market size and structure, competitive environment and technology, and determines its future prospects.<br />
* The statistical tools of '''Cluster Analysis''' and '''Regression''' are used to determine the segments of smart-phones likely to adopt OLED displays<br />
* '''Bass Diffusion Model''' for adoption of new technologies is applied to forecast sales of OLED display based mobile phones. This forecast is arrived at by modeling the sales on the historical sales data of certain proxy products and is graphically presented in the report.<br />
* The study reveals that by 2012 cumulative sale of OLED based mobile phone is expected to reach '''183 million units''' and details the trend of these sales over the years<br />
<br />
<br />
==Research Objective==<br />
<br />
* To provide a '''Technology Overview''' for OLED Mobile Phones<br />
* To provide a '''Market Overview''' for OLED Mobile Phones<br />
* To provide a '''Market Estimate''' for OLED Mobile Phones<br />
* To forecast the '''Adoption Rate''' of OLED Mobile Phones<br />
<br />
<br />
==Research Methodology==<br />
<br />
A '''four stage analysis''' was conducted:<br />
<br />
[[Image:4stageanalysis.jpg|center|500px]]<br />
<br />
===Technology Overview===<br />
<br />
A brief understanding of the Technology behind the OLED displays forms the introduction to this report.<br />
<br />
===Market Overview===<br />
<br />
A detailed overview of the OLED Technology forms the basis of the Analysis performed using Base Diffusion Model.<br />
<br />
===Cluster Analysis===<br />
<br />
Cluster Analysis was used to determine a class of mobile handsets that is most likely to use OLED displays. Cluster analysis is a technique used to assign objects to groups (called clusters), such that objects from the same cluster are ''more similar'' to each other than objects from different clusters. To determine the cluster, certain attributes of a handset like input mode, display size, camera resolution, etc. were considered.<br />
<br />
===Bass Diffusion Model===<br />
<br />
The Bass Diffusion Model was used to forecast the adoption of the OLED display mobile phones by consumers. The Bass Diffusion model is a quantitative tool that describes the process of how new products get adopted as an interaction between users and potential users. In this analysis, the model was employed to forecast the sales of a new product by utilizing historical sales data of analogous products from the same product category as well as from a diverse product category. The market penetration for mobiles with OLED displays is arrived at with result for both the proxies.<br />
<br />
== Mobile Phone Display: Technology Overview ==<br />
<br />
'''OLED (Organic Light Emitting Diodes)''' is a flat display technology, made by placing a series of organic thin films between two conductors. On applying an electric current, a bright light is emitted. OLEDs use organic semiconductor material instead of inorganic semiconductor material used in conventional Light Emitting Diodes (LEDs). Through a process called electrophosphorescence, OLEDs emit light in the presence of an electric current. Like any other diode, OLEDs permit electric current to pass only in one direction. Unlike diodes made from inorganic semiconductors, OLEDs are very flexible because they are only '''100 to 500 nanometers''' thick - the human hair is 200 times thicker than it. As a result, OLED screens are very flexible and can be made in very large sheets. OLEDs use lesser energy than LEDs as well.<br />
<br />
The easiest way to understand OLEDs is to compare them to LCDs. LCDs are made by placing a color filter over a white backlight source – filtering out the colors that are not wanted for each pixel. If you want to display blue, you'll have to filter out green and red. OLEDs, on the other hand, are emissive, which means that you simply need to display the colors you need for each pixel, which is made from three color (RGB) OLED “pixels.”<br />
<br />
<br />
=== Mobile Phone Display Types ===<br />
There are two types of display technologies which are used in mobile phones:<br />
# Liquid Crystal Display (LCD)<br />
# Organic Light-Emitting Diode (OLED)<br />
<br />
Recent developments in LCD are Super LCD (S-LCD) and IPS (In-Plane Switching technology) Panel. IPS technology is used in Apple’s Retina display and LG’s NOVA display. OLED technology includes developments such as Super AMOLED, Super AMOLED Plus and ClearBlack.<br />
<br />
<br />
=== Difference between LCD and OLED ===<br />
The LCD uses light modulating properties of liquid crystals (LCs). The liquid crystals do not emit light directly. So, a light source is needed for proper viewing. The OLED uses organic compounds that illuminate when exposed to electric currents. Hence, a backlight is not required for OLEDs. This makes OLED displays thinner than LCD displays.<br />
<br />
==== Difference between AMOLED and AMLCD ====<br />
{|border="2" cellspacing="0" cellpadding="2" width="90%" align="center"<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Properties'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''AM OLED'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''AM LCD'''</font><br />
|-<br />
|'''Thickness/Weight'''<br />
|Thinner, best is 0.05 mm; lighter<br />
|Thicker, best is 0.8 mm; heavier<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Diagonal Size'''<br />
|bgcolor = "#C5D9F1"|Limited to small and medium sizes; largest demo is around 40"<br />
|bgcolor = "#C5D9F1"|Can be manufactured larger; largest demo is <nowiki>~</nowiki>100"<br />
|-<br />
|'''Viewing Angle'''<br />
|Up to 180 degrees<br />
|Narrower, depends on liquid crystal type<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Color Gamut'''<br />
|bgcolor = "#C5D9F1"|<nowiki>></nowiki>100% NTSC (top emission), around 70% NTSC (bottom); high at all gray levels<br />
|bgcolor = "#C5D9F1"|Around 70%, up to 100% NTSC (LED backlight and new color filter); falls at low gray levels<br />
|-<br />
|'''Color Reproduction'''<br />
|Better; gamut independent of view angle<br />
|Good; gamut changes with viewing angle<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Resolution'''<br />
|bgcolor = "#C5D9F1"|Lower; 308 dpi (SM), 202 dpi (polymer)<br />
|bgcolor = "#C5D9F1"|Higher; best is 498 dpi<br />
|-<br />
|'''Response Time'''<br />
|Faster, nanoseconds. No motion blur, good for 3D<br />
|Slower, milliseconds<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Contrast Ratio'''<br />
|bgcolor = "#C5D9F1"|Higher<br />
|bgcolor = "#C5D9F1"|Lower<br />
|-<br />
|'''Sunlight Readability'''<br />
|Better than transmissive LCD, worse than transflective LCD<br />
|Ok if transflective<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Operating Temperature'''<br />
|bgcolor = "#C5D9F1"|Range is larger, can operate at low temps like -40°C<br />
|bgcolor = "#C5D9F1"|Range is smaller, lowest temp is -10°C<br />
|-<br />
|'''Power Consumption'''<br />
|Lower at typical video content, when around 30% of pixels are on<br />
|Higher at typical video content<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Lifetime'''<br />
|bgcolor = "#C5D9F1"|Shorter, 5K to 30K hour, but improving<br />
|bgcolor = "#C5D9F1"|Much longer, above 50K hour<br />
|-<br />
|'''Manufacturing Investment'''<br />
|Lower, but lack of standards keeps the investment only slightly lower<br />
|Higher<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Production Cost'''<br />
|bgcolor = "#C5D9F1"|Expensive; low yield and complex structure, potential to be low cost<br />
|bgcolor = "#C5D9F1"|Cheaper than AMOLED<br />
|-<br />
|align = "center" colspan = "3"|'''[http://www.displaysearch.com/ Source: DisplaySearch]'''<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
==== OLED Construction ====<br />
An OLED can be made of a single layer of organic material but multiple layers increase efficiency and effectiveness. A typical OLED is comprised of five layers of material:<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Layer'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|'''Substrate layer'''<br />
|bgcolor = "#DBE5F1"|This layer supports the OLED and is made of clear plastic, glass, foil or other materials.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Anode layer'''<br />
|bgcolor = "#B8CCE4"|The anode layer is transparent and is positively charged. When an electric current is applied, this layer attracts electrons as they flow through the OLED. As with a LED, the anode forms "holes" onto which electrons fall.<br />
|-<br />
|bgcolor = "#DBE5F1"|'''Conducting layer'''<br />
|bgcolor = "#DBE5F1"|This layer is made of organic plastic material and transports the "holes" from the anode layer.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Emissive layer'''<br />
|bgcolor = "#B8CCE4"|This layer transports electrons from the cathode. It is also made of organic plastic molecules but there are different from those in the conducting layer. This is the layer that determines the color of the light emitted.<br />
|-<br />
|bgcolor = "#DBE5F1"|'''Cathode layer'''<br />
|bgcolor = "#DBE5F1"|This layer injects electrons into the OLED when an electric current is applied. Depending on the OLED and the color effect desired, this layer may or may not be transparent.<br />
|-<br />
|}<br />
<br />
<br />
[[image:oledstructure.jpg|center|406*365px|thumb|Source: [http://electronics.howstuffworks.com/oled1.htm How Stuff Works]]]<br />
<br />
==== Types of OLED Construction ====<br />
OLEDs can be constructed in a variety of ways to serve a variety of functions. While each type of construction uses the layers described previously, the manner in which each layer is built alters the way the OLED functions. The six most common types of OLEDs are as follows:<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Passive-Matrix OLED'''<br />
|bgcolor = "#DBE5F1"|Anode and cathode laid perpendicular to each other<br />
|-<br />
|bgcolor = "#DBE5F1"|PM OLEDs are easy to make and display text and icons very effectively, particularly in small 2-inch to 3-inch screens<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''Active-Matrix OLED'''<br />
|bgcolor = "#B8CCE4"|AM OLEDs are constructed with continuous film materials<br />
|-<br />
|bgcolor = "#B8CCE4"|AM OLEDs use less energy than PM OLEDs and have faster refresh rates<br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Transparent OLED'''<br />
|bgcolor = "#DBE5F1"|Constructed with transparent materials for all five layers, a transparent OLED can be made as either a PM OLED or an AM OLED<br />
|-<br />
|bgcolor = "#DBE5F1"|Useful for heads-up display applications<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''Top-Emitting OLED'''<br />
|bgcolor = "#B8CCE4"|These types of OLEDs use an opaque or reflective substrate that is useful for smart card applications<br />
|-<br />
|bgcolor = "#B8CCE4"|Best suited for an active-matrix design<br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Foldable OLED'''<br />
|bgcolor = "#DBE5F1"|The substrate of this type of OLED is very flexible, allowing the OLED to be folded or rolled up<br />
|-<br />
|bgcolor = "#DBE5F1"|Because of their flexibility, foldable OLEDs could be attached to fabrics with a variety of applications<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''White OLED'''<br />
|bgcolor = "#B8CCE4"|These OLEDs emit white light that is brighter, more uniform and more energy efficient than that emitted by fluorescent lights<br />
|-<br />
|bgcolor = "#B8CCE4"|Potential to replace incandescent and fluorescent lighting in commercial industrial, and residential applications<br />
|-<br />
|}<br />
<br />
<br />
==== Advantages and Disadvantages ====<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|align = "center" bgcolor = "#DBE5F1" rowspan = "3"|'''Advantages of OLED over LCD'''<br />
|bgcolor = "#DBE5F1"|As there is no backlighting, OLED displays offer deeper black levels than LCD displays<br />
|-<br />
|bgcolor = "#DBE5F1"|OLED displays have better contrast ratios<br />
|-<br />
|bgcolor = "#DBE5F1"|Viewing angles offered by OLEDs is more than that offered by LCDs<br />
|-<br />
|align = "center" bgcolor = "#B8CCE4" rowspan = "3"|'''Disadvantages of OLED over LCD'''<br />
|bgcolor = "#B8CCE4"|Brightness levels of OLED display is less than that of LCD<br />
|-<br />
|bgcolor = "#B8CCE4"|Color in OLED displays are often oversaturated<br />
|-<br />
|bgcolor = "#B8CCE4"|The red, green and blue sub-pixels deteriorate and lose efficiency at different rates, thus color consistency worsens over time<br />
|-<br />
|}<br />
<br />
<br />
=== OLED Screen Types in Mobile Phones ===<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|align = "justify" bgcolor = "#DBE5F1"|'''AMOLED'''<br />
|align = "justify" bgcolor = "#DBE5F1"|AMOLED relies on a TFT backplane to switch individual pixels on and off. Active-matrix displays consume significantly less power than passive-matrix counterparts. This makes them well-suited for mobile devices. AMOLED displays are manufactured by printing electroluminescent materials onto a substrate. The relatively simplistic process suggests that OLEDs will ultimately become cheaper and easier to manufacture than LCDs. The creation of the substrate is the most difficult and expensive part of the process. Currently, AMOLED screens are limited in supply. Coupled with high demand, their availability is restricted and they are found in high-end smartphones.<br />
|-<br />
|align = "justify" bgcolor = "#B8CCE4"|'''Super AMOLED'''<br />
|align = "justify" bgcolor = "#B8CCE4"|Super-AMOLED displays are AMOLED displays with an integrated touch function. The original AMOLED screens had reduced visibility in direct sunlight. The thickness of the touch sensor is less than 0.001mm in Super AMOLED displays. This allows the screen to provide better images and to have great visibility even in direct sunlight.<br />
|-<br />
|align = "justify" bgcolor = "#DBE5F1"|'''ClearBlack'''<br />
|align = "justify" bgcolor = "#DBE5F1"|Nokia introduced a display similar to Samsung<nowiki>’</nowiki>s Super AMOLED known as the ClearBlack display. The ClearBlack display makes the screen more visible in direct sunlight. A polarized filter is added to the display. This allows the viewer to see through the screen<nowiki>’</nowiki>s reflection and view the images as they would appear under more ideal conditions.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Super AMOLED Plus'''<br />
|align = "justify" bgcolor = "#B8CCE4"|The Super AMOLED Plus features a traditional three sub-pixels of equal proportion within one pixel. It has an increased sub-pixel count and density. As a result, the display is much crisper, especially when it comes to text. The tighter spacing between pixels also results in better visibility under direct sunlight. The displays are also thinner, brighter and more efficient (by 18%) than the old Super AMOLED displays.<br />
|-<br />
|}<br />
<br />
<br />
=== Future OLED Mobile Screen Variations ===<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|'''Transparent Displays'''<br />
|align = "justify" bgcolor = "#DBE5F1"|Transparent OLEDs have only transparent components (substrate, cathode and anode) and, when turned off, are up to 85 percent as transparent as their substrate. When a transparent OLED display is turned on, it allows light to pass in both directions. A transparent OLED display can be either active- or passive-matrix. TDK began production of a see-through OLED earlier this year.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Flexible Displays'''<br />
|align = "justify" bgcolor = "#B8CCE4"|Flexible OLEDs have substrates made of very flexible metallic foils or plastics. Flexible OLEDs are very lightweight and durable. Their use in devices such as cell phones and PDAs can reduce breakage, a major cause for return or repair. Samsung is readying flexible AMOLED displays for production next year.<br />
|-<br />
|}<br />
<br />
<br />
==OLED Market Overview==<br />
<br />
<br />
===OLED Market: Revenue Overview===<br />
* The Global OLED Display Market was estimated at '''$1800 million''' for the year 2010.<br />
* The market stood at '''$1102 million''' in the year 2009, and showed a growth of '''63.3%''' for 2010.<br />
* The market is estimated to reach '''$6.934 million''' by the year 2014. <br />
<br />
[[Image:Global_OLED_revenue.JPG|center|760*401px|thumb|Global OLED Display Market: Revenue Forecasts 2004-2014 (in $million), Source: [http://www.pira-international.com/Sustained-Development-Efforts-to-Spur-Ten-Fold-Growth-of-OLEDs-Lighting-and-Displays-Market-by-2014.aspx pira-international ]]]<br />
<br />
===OLED Market: Volume Overview===<br />
<br />
* The shipments of Organic Light-Emitting Diode (OLED) screens was estimated at '''100 million''' units in 2010<br />
* The shipments of Organic Light-Emitting Diode (OLED) screens are set to rise to '''326.8 million''' units in 2015<br />
* The market is going to be driven by booming demand for Active-Matrix (AM) displays for mobile handsets<br />
* AM-OLED segment, which will boom to '''261.5 million''' units in 2015, up more than twelve fold from '''21.1 million''' in 2009<br />
<br />
[[Image:Global_OLED_Volume.JPG|center|659*383px|thumb|Global OLED Display Shipment 2007-2015 <br />
(Millions of Unit), Source: [http://www.isuppli.com/Display-Materials-and-Systems/News/Pages/iSuppli-Issues-Fast-Facts-on-the-Display-Industry-for-SID-2010.aspx iSuppli ]]]<br />
<br />
===Market Potential by Geography===<br />
<br />
====OLED Market Potential by Geography====<br />
The following chart illustrates the OLED Market Potential by Geography over the period 2004-2014:<br />
{|align = "center"<br />
|<gflash>1050 625 http://dolcera.com/upload/files/OLED_Geography.swf</gflash><br />
|-<br />
|}<br />
<br />
Source: [http://www.icongrouponline.com/ ICON Group International]<br />
<br />
<br />
====AMOLED Market Potential by Geography====<br />
The following chart illustrates the AMOLED Market Potential by Geography over the period 2004-2014:<br />
{|align = "center"<br />
|<gflash>1050 625 http://dolcera.com/upload/files/AMOLED_Geography_01.swf</gflash><br />
|-<br />
|}<br />
<br><br />
Source: [http://www.icongrouponline.com/ ICON Group International]<br />
<br />
<br />
===OLED Market Share===<br />
* '''Samsung Mobile''' leads the OLED Display Market with a market share of 43.2% as reported in 2010<br />
* '''TDK''' is a distant 2nd with a market share of 17.5% and is closely followed by '''RiT Display''' with a share of 16.0%<br />
<br />
The following chart illustrates the Global OLED Display Unit Shipment: Market Share, for the year 2010:<br />
[[Image:Global_OLED_Market_Share.JPG|center|760*401px|thumb|Global OLED Display Unit Shipment: Market Share 2010<br />
, Source: [http://www.displaysearch.com/cps/rde/xchg/displaysearch/hs.xsl/quarterly_oled_shipment_and_forecast_report.asp Quarterly OLED Shipment and Forecast Report, DisplaySearch ]]]<br />
<br />
===OLED Market Share by Application===<br />
* '''Mobile Handset application''' forecast to account for 84%, followed by NBPC at 6% and tablet PC at 4% of 2011E total revenue.<br />
<br />
<br />
The following chart illustrates the Global OLED Display total revenue: Market Share, for the year 2011E:<br />
[[Image:OLED_app_revenue.jpg|center|760*401px|thumb|OLED Display Revenue: Market Share 20111E<br />
, Source: [http://7economy.com/archives/6051 7economy]]]<br />
<br />
==OLED Eco-System==<br />
The following dashboard illustrates all the Companies in the OLED Eco-System:<br />
{|align = "center"<br />
|<gflash>900 425 http://dolcera.com/upload/files/OLED_Ecosystem.swf</gflash><br />
|-<br />
|}<br />
Source: [http://www.oled-info.com/ OLED-info.com]<br />
<br />
<br />
==OLED Market Drivers & Restraints==<br />
<br />
The following figure illustrates a '''Forcefield Analysis of Market Drivers and Restraint'''s for OLED Market (2011-2017):<br />
[[Image:OLED_Drivers_Restraints.JPG|center|900*533px|thumb|Forcefield Analysis of Market Drivers and Restraints for OLED Market (2011-2017)<br />
, Source: [http://www.frost.com Frost & Sullivan]]]<br />
<br />
<br />
===OLED Market Drivers===<br />
The following table illustrates the '''Impact Analysis of OLED Market Drivers''' over a period of time:<br />
{|border="2" cellspacing="0" cellpadding="2" width="60%" align="center"<br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Rank'''</font><br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Driver'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''1-2 years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''3-4 Years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''5-7 years'''</font><br />
|-<br />
|align = "center"|1<br />
|Inherent Advantages of OLED Technology<br />
|align = "center"|Medium<br />
|align = "center"|High<br />
|align = "center"|Very High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|2<br />
|bgcolor = "#C5D9F1"|Increasing Demand for Green Products<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|-<br />
|align = "center"|3<br />
|Increasing demand for OLED Display in Mobile Phones and Signage<br />
|align = "center"|Medium<br />
|align = "center"|Medium<br />
|align = "center"|High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|4<br />
|bgcolor = "#C5D9F1"|Rising Potential of OLED TV<nowiki>’</nowiki>s<br />
|align = "center" bgcolor = "#C5D9F1"|Low<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
'''Inherent Advantages of OLED Technology'''<br />
<br />
* OLED display offer sharper images and better contrast ratios, crisp colors and faster refresh rates compared to any existing display technology.<br />
* OLED Technology also offers consumers better energy management as the whole system functions at optimal power and is of organic substrate.<br />
* OLED displays are created by inserting thin organic films between two conductors and require no backlight; therefore, the displays are more compact and thinner.<br />
* OLED displays, especially or television, are capable of offering viewers a viewing angle of 180 degrees<br />
* As the benefits of OLED displays become more prominent, the demand for OLED manufacturing equipment is expected to increase in the next three to seven years.<br />
<br />
<br />
'''Increasing Demand for Green Products'''<br />
<br />
* The demand for lower power consumption , reduced material usage, and simplicity is expected to propel the OLED demand in the coming years<br />
* The OLED manufacturing equipment market, however, is facing challenges due to its premium and manufacturing challenges. As Manufacturers realize the economies of scale, average selling price is expected to decline, further spurring demand.<br />
* OLED TV market continues to evolve technologically and benefit from increasing demands for energy efficiency from consumers.<br />
<br />
<br />
'''Increasing demand for OLED Displays in Mobile Phones and Signage'''<br />
<br />
* Technology innovations, better functionalities and falling prices are expected to keep up the demand for OLED displays in mobile phones<br />
* Mobile Phones accounted for over 82.0% of the Total OLED display market. With the success of mobile phones, such as the Galaxy, the demand for OLED displays for mobile applications is expected to increase<br />
* The market is also expected to benefit from increasing demand for OLED displays used for signage<br />
* These factors are expected to propel the sales of OLED during the medium and later part of the forecast period.<br />
<br />
<br />
'''Rising Potential of OLED TVs'''<br />
<br />
* The OLED market is yet to observe strong demand for TVs. High premium price and smaller display sizes are key restraints for customers. However, with increasing collaboration within the entire supply chain of the OLED market, the market is expected to experience gradual increase in attractive solutions. According to DisplaySearch, the OLED TV market is expected to generate revenue of $28 billion by 2017.<br />
* The increasing momentum is expected to help commercialize the technology in the next five to seven years. Many display manufacturers have already set up dedicated manufacturing lines from Gen 3.5 to Gen 5.5.<br />
* This is expected to propel OLED manufacturing equipment sales during the latter part of the forecasted period.<br />
<br />
Source: [http://www.frost.com Frost & Sullivan]<br />
<br />
<br />
===OLED Market Restraints===<br />
The following table illustrates the '''Impact Analysis of OLED Market Restraints''' over a period of time:<br />
{|border="2" cellspacing="0" cellpadding="2" width="60%" align="center"<br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Rank'''</font><br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Restraint'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''1-2 years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''3-4 Years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''5-7 years'''</font><br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|1<br />
|bgcolor = "#C5D9F1"|Slow Adoption Rate of New Technology<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|-<br />
|align = "center"|2<br />
|Declining Prices of competing technologies<br />
|align = "center"|High<br />
|align = "center"|High<br />
|align = "center"|High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|3<br />
|bgcolor = "#C5D9F1"|High cost of products<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
'''Slow Adoption Rate of New Technology'''<br />
<br />
* The adoption rate of OLED Technology is comparatively slower than the initial launch of LCD technology. Consumers are complacent with the current technologies it offers then a myriad o advantages and benefits.<br />
* The largest issues foreseen are consumer perception, cost effectiveness of the product, ease of implementation and the ability of the service to provide true blended services<br />
* As a result, there is a significant and vital gap between new product design to volume manufacturing in the OLED market<br />
* Increasing costs and manufacturing complexity has hindered the adoption rate of OLED manufacturing equipment, especially for larger substrate sizes<br />
* The growth of the OLED display market and, in turn equipment sales, will rely on increasing collaboration between material suppliers, technology enablers and equipment providers. Decreased time to market and focus on R&D will be the key to attaining the desired growth trajectory.<br />
<br />
<br />
'''High Cost of Products'''<br />
<br />
* The high cost of OLED display has hindered adoption rates. For Example, customers, while willing to pay a premium price for quality products, hedge until the product has reached mass adoption level. A manufacturing facility typically requires an investment of $ 1 Billion to 3 Billion.<br />
* This has restrained the demand for OLED equipment. Equipment providers are still caught in a dilemma of balancing the high cost of technology development with affordable pricing for consumers.<br />
* Careful adjustment of prices can help minimize the impact of this restraint. Pricing strategy is crucial for success for the overall OLED market.<br />
<br />
<br />
'''Declining Prices of Competing Technologies'''<br />
<br />
* The LCD market is continuing to witness strong demand despite the emergence of new products in the market.<br />
* LCD Technology is transitioning t meet increasing demands for higher switching speeds, becoming more environmentally friendly by using LED backlighting, becoming sleeker and more compact, and having better resolution.<br />
* The LCD and other existing technologies also offer consumers the ability to buy large screen displays. This had created major barriers for increasing the adoption rate for OLED manufacturing equipment.<br />
<br />
Source: [http://www.frost.com Frost & Sullivan]<br />
<br />
<br />
==Transaction Landscape==<br />
The Transaction Landscape in the OLED Market is illustrated in the following links:<br />
# [[Mergers & Acquisitions Landscape]]<br />
# [[Partnerships Landscape]]<br />
# [[Investment Landscape]]<br />
<br />
<br />
==Cluster Analysis for TFT Display Mobile Phones==<br />
The table here summarizes the objective, methodology, procedure and result of the cluster analysis <br />
[[Image:Cluster Analysis.jpg|thumb|center|1000px|[http://faculty.chass.ncsu.edu/garson/PA765/cluster.htm Source: Statnotes, North Carolina State University]]]<br><br />
<br />
===Selection of model===<br />
Using the analysis, one cluster of smart-phones likely to move to OLED technology was identified for each of the two categories. For the next stage of the research - that of forecasting sales - would need the historical sales data of one particular model. For this purpose, '''Apple iPhone''' from the 2nd cluster of candy-bar phones was selected because of constraint of availability of sales data for other models like Blackberry, Nokia N96, HTC Dreamers etc.<br />
<br />
<br />
==='''A Comparison of LCD and OLED technologies'''===<br />
<br />
<br />
The ''radar graph'' here shows the comparison between OLED and TFT LCD.<br />
<br />
[[Image:Comparison.jpg|500px|thumb|center|Comparison[http://digidelve.com/oled/problems Source]]]<br />
<br />
<br />
<br />
The graph depicts the following things:<br />
<br />
# OLEDs are ''thinner'' than LCDs.<br />
# OLEDs are ''lighter'' in weight.<br />
# OLEDs consume ''more power'' than LCDs but OLEDs have an inherent advantage in that they only consume power when they emit light while an LCD backlight consumes constant power regardless of the image being displayed.<br />
# OLEDs ''cost more'': The Cost of an AM-LCD is currently about half that of a comparable AM-OLED display. This is due to the maturity of LCD manufacturing processes and facilities. OLED manufacturing facilities suffer from low yields, currently at 60%-70%.<br />
# OLEDs have a ''shorter lifespan'' as compared to LCDs.<br />
# OLEDs have a ''faster response time'' of .01ms while LCDs have a response time about 8-12ms.<br />
# OLEDs have a ''superior viewing angle'' of 180 degree while LCDs have a lower viewing angle.<br />
<br />
==='''Cluster Analysis'''===<br />
<br />
<br />
====Methodology====<br />
<br />
'''Sample Definition:''' The sample space consists of moblie phones by leading players in the smart-phone mobile category. These models were identified from Gartner reports. The models of smart-phones launched in the last three years in North America were considered. <br />
<br />
'''Sample Space:'''After defining the sample, the various key attributes of smart-phones like camera, display, etc. were defined. The data for these attributes for all the models was collected from the company websites as well as the following websites:<br />
<br />
* www.phonearena.com<br />
* www.phonegg.com<br />
* www.mobile.am<br />
<br />
<br />
The pricing information was obtained from<br />
* www.fonearena.com<br />
* www.india-cellular.com<br />
* www.naaptaol.com<br />
* www.mobilestore.com<br />
* www.indiatimes.com.<br />
<br />
<br />
After aggregating the data we used the '''k-clustering''' method to identify the different clusters for the samples. This technique aims to partition ''n'' observations into ''k'' clusters in which each observation belongs to the cluster with the nearest mean. Hence clusters of phones with similar attributes is achieved.<br />
<br />
Samples were segregated into two broad categories - candy-bar phones and clamshell or sliding phones - with thickness being the differentiating parameter. This was done in order to mitigate any error due to the design of the phone(i.e. candybar,clamshell,slider), since the thicknes of the mobile could be a cause for erroneous results.<br />
<br />
====Cluster analysis results====<br />
<br />
The sheet below shows the clusters formed for the candy-bar phones.<br />
<br />
[[Image:Candy_bar_excels.jpg|Candy bar|1500px|center|thumb]]<br />
<br />
The sheet below shows the cluster formed for the clamshell/sliding phones.<br />
<br />
[[Image:clamshellexcel.jpg|Clamshell_slider|650px|center|thumb]]<br />
<br />
'''Definition of Attributes:'''<br />
*'''Camera''' : resolution in Megapixels<br />
*'''Input method''': two types of input methods - touchscreen and keyboard<br />
*'''Display size''': diagonal length of the displeay screen<br />
*'''Resolution''': display resolutions<br />
*'''Color''': display color<br />
*'''Thickness''': total thickness of the phone<br />
<br />
<br />
The cluster analysis results and subsequent profiling of those clusters are summarized below:<br />
<br />
<br />
''' Candy - Bar Phones'''<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center"|<font color="#262626">'''Clusters'''</font><br />
|align = "center"|<font color="#262626">'''Cell phones'''</font><br />
|align = "center"|<font color="#262626">'''Profile'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''1'''<br />
|align = "center" bgcolor = "#D3DFEE"|Apple iPhone, Samsung i910<br />
|align = "justify" bgcolor = "#D3DFEE"|* Cluster 1 consists of high end cell phones<br>* Cell phones falling in this cluster are touch screen phones with large display size<br>* This is mainly targeting the premium market which is not price sensitive as the mobile phones in this cluster are priced high<br />
|-<br />
|align = "center"|'''2'''<br />
|align = "center"|HTC P3470, HTC touch cruise, HTC touch diamond, HTC touch viva, HTC X7510, i780<br />
|align = "justify"|* This cluster includes cell phones with moderate display size and having touch screen facility<br>* Cell phones in this cluster are in the price range of medium to high, so it is targeting the upper middle to high class.<br>* Almost all the mobile phones falling in this cluster are having WLAN facility indicating that this cluster target trendy class people and people who prefer online games and downloads on mobile phones<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''3'''<br />
|align = "center" bgcolor = "#D3DFEE"|Nokia 5320 express music, Nokia 5800 express music, Nokia 6124 classic, Nokia 6220 classic, Nokia E63, i200, i450, N6120, N78, N79, Pearl 8100<br />
|align = "justify" bgcolor = "#D3DFEE"|* Mobile phones in this cluster are targeted at the middle class as these phones are of moderate price and normal input<br>* They have small display size and moderate camera resolution, which is in sync with their target market<br>* Average thickness<br />
|-<br />
|align = "center"|'''4'''<br />
|align = "center"|E71, i550W, N5700, N73, N82, Blackberry 7130c/7130g<br />
|align = "justify"|* This cluster consists of mobile phones having high camera resolution and normal input indicating that this cluster is for people who give high preference to clicking photographs on mobile phones<br>* They have small display size with most of them not having the WLAN facility, so this is for people who low on using the browsing facilities<br>* The target segment for this cluster is the middle class segment as the mobile phones are also moderately priced<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''5'''<br />
|align = "center" bgcolor = "#D3DFEE"|Curve 8310, Blackberry 8820, Curve 8300, Blackberry 8800, Blackberry bold 9000, Blackberry curve 8330<br />
|align = "justify" bgcolor = "#D3DFEE"|* It includes mobile phones having input through qwerty and with average display size<br>* Target market is Business class people who prefer using email facility on mobiles<br>* The mobile phones are low on camera resolution<br>* All the mobiles in this cluster are high priced indicating that the targeted segment for this cluster is not price sensitive<br />
|-<br />
|}<br />
<br />
<br />
<br />
'''Clamshell Phones'''<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center"|'''Clusters'''<br />
|align = "center"|'''Cell phones'''<br />
|align = "center"|'''Profile'''<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''1'''<br />
|align = "center" bgcolor = "#D3DFEE"|N6650, N95 8GB, E66, 6210 navi, N85<br />
|bgcolor = "#D3DFEE"|* This cluster consists of medium to high priced mobile phones and is targeted at upper middle class<br>* These mobile phones have high camera resolution and normal keypad input<br>* All the mobiles in this cluster have average display size having 16M colors<br />
|-<br />
|align = "center"|'''2'''<br />
|align = "center"|N96, N97<br />
|* It includes mobile phones which are high priced and targeted at affluent people who are not price sensitive<br>* The mobile phones in this cluster are characterized by high camera resolution, big display size and moderate thickness<br>* WLAN facility and high graphic resolution in these mobile phones will attract people who prefer downloading and playing online games<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''3'''<br />
|align = "center" bgcolor = "#D3DFEE"|HTC dream<br />
|bgcolor = "#D3DFEE"|* Mobile phones in this cluster are moderately priced and, targeted at the middle class and the upper middle class segment<br>* These phones have high thickness and high camera resolution<br>* These phones are WLAN enabled and have both qwerty keypad and touch screen input<br />
|-<br />
|align = "center"|'''4'''<br />
|align = "center"|N76, N6290, N75, HTC shadow, E65, i620, N6110<br />
|* This cluster consists of mobile phones with low camera resolution and mainly has normal keypad for input<br>* These phones have medium display size and medium to high thickness<br>* These are low to moderately priced phones targeted at the middle class segment<br />
|-<br />
|}<br />
<br />
=== Prices for AMOLED screens===<br />
<br />
Market data was collected for the prices of OLED screens by various manufacturers<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#FFFF00"|Company Name<br />
|bgcolor = "#FFFF00"|Model Number<br />
|bgcolor = "#FFFF00"|Size<br />
|bgcolor = "#FFFF00"|Resolution<br />
|bgcolor = "#FFFF00"|Colors<br />
|align = "center" bgcolor = "#FFFF00" colspan = "3"|Price/unit(in USD)<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|0-99<br />
|100-999<br />
|1000 <nowiki>++</nowiki><br />
<br />
|-<br />
|Chung Yuan Technology Co., Ltd<br />
|align = "right"|&nbsp;<br />
|2.2"<br />
|220x176<br />
|align = "right"|&nbsp;<br />
|20.00<br />
|16.5<br />
|align = "right"|&nbsp;<br />
<br />
|-<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
<br />
|-<br />
|Digiprotek Markcom India P Ltd.(Densitron)<br />
|C0201QILK-C<br />
|2<br />
|176xRGBx220<br />
|262K<br />
|25.69<br />
|24.92<br />
|20.67<br />
<br />
|-<br />
|&nbsp;<br />
|C0240QGLA-T&nbsp;<br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|35.97<br />
|34.9<br />
|27.83<br />
<br />
|-<br />
|&nbsp;<br />
|P0340WQLC-T&nbsp;<br />
|3.45<br />
|480xRGBx272<br />
|16M<br />
|85.65<br />
|83.1<br />
|47.72<br />
<br />
|-<br />
|&nbsp;<br />
|P0430WQLC-T&nbsp;<br />
|4.3<br />
|480xRGBx272<br />
|16M<br />
|119.90<br />
|116.32<br />
|85.84<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|GLYN GmbH & Co. KG(CMEL)<br />
|C0201QILKC&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2<br />
|176x220<br />
|262K<br />
|25.00<br />
|&nbsp;<br />
|15<br />
<br />
|-<br />
|&nbsp;<br />
|C0240QGLAT&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|30.00<br />
|&nbsp;<br />
|20<br />
<br />
|-<br />
|&nbsp;<br />
|C0283QGLDT&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2.83<br />
|240xRGBx320<br />
|262K<br />
|38&nbsp;<br />
|&nbsp;<br />
|26<br />
<br />
|-<br />
|&nbsp;<br />
|P0340WQLCT&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br />
|3.4<br />
|480xRGBx272&nbsp;<br />
|16M<br />
|60.00<br />
|&nbsp;<br />
|35<br />
<br />
|-<br />
|&nbsp;<br />
|P0430WQLCT&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br />
|4.3<br />
|480xRGBx272<br />
|16M<br />
|90&nbsp;&nbsp;<br />
|&nbsp;<br />
|63<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|A4G Technologies(OSD)<br />
|OSD020AMQCIF<br />
|2<br />
|176x220<br />
|262K<br />
|22.50<br />
|20.98 <br />
|19.10 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD024AMQV <br />
|2.4<br />
|240x320<br />
|262K<br />
|30.20<br />
|28.57 <br />
|25.40 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0283AMQV<br />
|2.83<br />
|240x320<br />
|262K<br />
|38.30<br />
|36.16 <br />
|33.63 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0340WQLC <br />
|3.4<br />
|480x272<br />
|16M<br />
|69.50<br />
|67.25 <br />
|42.48 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0430WQLC-T <br />
|4.3<br />
|480x272<br />
|16M<br />
|109.00<br />
|87.00 <br />
|72.00 <br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|Blaze Technology<br />
|BDO-0240QGLA-T<br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|20.8<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0283QGLD-T<br />
|2.83<br />
|240xRGBx320<br />
|262K<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|26.85<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0340WQLA-T<br />
|3.4<br />
|480x272<br />
|16M<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|39.5<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0430WQLA-T<br />
|4.3<br />
|480x272<br />
|16M<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|90.6<br />
<br />
|}<br />
<br />
==Bass Diffusion Analysis==<br />
<br />
One of the most important functions during the launch of a new product is to forecast the demand for that product, as it guides many other critical decisions faced by the company. Companies can schedule their production activities once they have an idea about the demand in the coming months or years. At a high level, Bass Diffusion Model is used to determine the shape of the curve representing the cumulative adoption of the new product. Bass describes the individuals who decide to adopt an innovation independently of the actions of others as ''innovators''. Those who respond to the influences of the social system and obtain information about a new product from those who have already adopted the product are termed as ''imitators''.<br />
<br />
===Proxies for analysis===<br />
<br />
The use of the model has been made by using the historical sales data of ''proxy'' products to forecast sales for OLED display mobile phones with an assumption that OLED display mobile phones would mimic the diffusion patterns of the proxies. Hence it was important to select the proxies carefully. We used the following for this forecast:<br />
* iPhone - since this was the latest revolution in mobile phone devices and consumers would show a similar adoption behavior for a new mobile phone technology even though it comes at a price premium<br />
* LCD/Plasma TVs & Monitors - consumers spent more money to purchase screens with superior quality by significantly increasing their budget<br />
** LCD and Plasma TVs and LCD monitors were treated as a single analogous product(by ascribing different weights to these) for the forecast<br />
<br />
===Forecasting OLED display phone sales using Analogous Products===<br />
<br />
<br />
<br />
'''The following products from different product categories were considered:'''<br><br />
:# LCD TV <br />
:# Plasma Display TV<br />
:# LCD Monitor<br />
<br />
They were considered to be befitting analogies because of the following similarities:<br><br />
[[Image:Similarities.jpg|center|600px]]<br><br />
<br />
'''Weighted average for the analogous products:'''<br />
Weights for modeling co-efficients for the analogous products such as LCD TV, Plasma Display TV and LCD monitor had been assigned.<br><br />
To judge the similarity of analogous products to OLED, we examined two criteria.<br><br />
::a. Market Structure<br><br />
::b. Product Characteristics<br><br />
[[Image:Criterion.jpg|center|600px]]<br><br />
<br />
The '''S-Graph''' for the cumulative projected sale of OLED display mobiles modeled on analogous products<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart1.swf</gflash></center><br />
<br />
:* In 2009 and 2010 OLED Mobile Phone market would grow slowly driven by ''innovators''<br />
:* From 2011 to 2015, market will grow rapidly due to the ''early adopters''<br />
:* In 2016 and 2017, market will growth will dwindle as ''late adopters'' take to the phones<br />
:* 2018 onwards growth will peter, as the laggards pick up the last few models and the market will saturate<br />
:* From 2016 the technology will near obsolescence and a new technology would replace it<br><br />
<br />
<br />
'''Comparison of Adoption rate of Innovators with those of Imitators'''<br><br />
The model helps to determine sales to innovators and imitators for each year:<br><br><br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart2.swf</gflash></center><br />
<br />
<br />
This graph shows that a small number of innovators will kick-start the sales. OLED display mobile Phones will get off to a slow start in first 2 years. Once a '''''critical mass''''' is reached by the end of the second year, strong imitative effects will take over as the innovators decrease.<br />
<br />
===Detailed Analysis===<br />
<br />
The detailed modeling with a description of parameters and mathematical equations can be viewed here:<br><br />
[[Bass Diffusion Analysis for OLED display phones]]<br />
<br />
==OLED Mobile Phone Projections Based on I-Phone==<br />
<br />
The '''S-Graph''' for the cumulative projected sale of OLED display mobiles modeled on analogous products<br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart3.swf</gflash></center><br />
<br />
:* From Q1,'09 to Q3,'09, the OLED display mobile phone market would grow slowly, driven by ''innovators''<br />
:* From Q4,'09 to Q4,'10 market will grow rapidly due to the ''early adopters''<br />
:* From Q1,'11 and Q3,'11 market growth will dwindle as ''late adopters'' take to the phones<br />
:* Q4,'11 onwards growth will peter, as the laggards pick up the last few models and the market will saturate<br />
:* From Q4, the technology will near obsolescence and a new technology would substitute it<br><br><br />
<br />
'''Comparison of Adoption rate of Innovators with those of Imitators'''<br><br />
The model helps to determine sales to innovators and imitators for each year:<br><br><br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart4.swf</gflash></center><br />
<br />
<br />
This graph shows that a small number of innovators will kick-start the sales. OLED display mobile Phones will get off to a slow start in first three quarters. Once a '''''critical mass''''' is reached by the end of the Q3, strong imitative effects will take over as the innovators decrease.<br />
<br />
===Detailed Analysis===<br />
<br />
The detailed modeling with a description of parameters and mathematical equations can be viewed here:<br><br />
[[Bass Diffusion Analysis for OLED display phones]]<br />
<br />
==Comparing projections==<br />
Since disparate product categories had been used for the two forecasts, the two were compared to cross validate the results [[media:Bass-Model_OLED_comparison.xls|''<<excel sheet with calculations>>'']]<br><br />
<br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart5.swf</gflash></center><br />
<br />
:* Looking at the forecast for OLED display mobile phones based on analogous products and on iPhone, both are seen to be ''convergent''<br />
:* This validates the forecast<br />
<br />
<br />
<br />
==Sneak Preview of some models using OLED technology==<br />
{| class="wikitable" style="font-size:100%" border="1" cellpadding="5" cellspacing="0" width=80%<br />
|-<br />
| width=40% valign=top | [[Image:Apple.jpg|thumb|center|200px|[http://www.appleiphoneapps.com/2009/03/next-iphone-to-have-oled-display-why-should-you-care/ Source: appleiphoneapps.com]]]<br />
| width=60% valign=top | '''1. Apple iPhone''' - It’s nothing official at the moment, but word on the street is that Apple might have chosen a series of OLED displays for its next round of handsets. Such a move would certainly be in the best interests of battery life, as the iPhone isn’t noted for its battery capabilities. Considering the amount of new features that were announced in the iPhone 3.0 firmware update, it would be fairly practical to have a capacitive OLED display in the future.<br />
|-<br />
| width=40% valign=top | [[Image:Nokia.jpg|thumb|center|200px|[http://www.mobilephonereviews.org/category/nokia/ Source: Mobile Phone Reviews]]]<br />
<br />
| width=60% valign=top | '''2. Nokia''' - '''Nokia 6600''' Slide Mobile Phone is a 3G device with large OLED display and 3.2 megapixel camera. It has curved edges and with a weight of 110g is a bit heavy to hold. The 2.2” screen supports 16 million colors and comes with QVGA resolution. The dimensions of the phone are 90 x 45 x 14mm.<br />
<br />
|-<br />
| width=40% valign=top | [[Image:Samsung.jpg|thumb|center|200px|[http://www.att-phones.org/att-samsung-a877-phone-will-be-available.html Source: ATT Phones]]]<br />
<br />
| width=60% valign=top | '''3. Samsung''' - '''Samsung A877''' features include a 3.2-inch WQVGA AMOLED touchscreen, a 3 megapixel camera, GPS, HSDPA and Bluetooth. And as well at it supports AT&T’s 3G service.<br />
|-<br />
<br />
| width=40% valign=top | [[Image:Sony.jpg|thumb|center|200px|[http://www.itechnews.net/2008/01/08/sony-ericsson-z555-stylish-phone/ Source: Itechnews]]]<br />
| width=60% valign=top | '''4. Sony''' - '''Sony Ericsson Z555''' features a 1.9-inch LCD display, an OLED 128×36 external display, a 1.3 Megapixel camera with 4x digital zoom.<br />
|-<br />
| width=40% valign=top | [[Image:LG Mobile.jpg|thumb|center|200px|[http://www.unwiredview.com/2008/02/20/lg-sh150a-gets-am-oled-display-with-26-million-colors-and-hd-support/ Source: Unwiredview]]]<br />
| width=60% valign=top | '''5. LG''' - One of the first handsets to get the new AM OLED, is already advanced '''LG SH150''' DMB TV phone. <br />
|-<br />
| width=40% valign=top | [[Image:Motorola.jpg|thumb|center|200px|[http://www.itechnews.net/2007/10/12/motorola-u9-mobile-phone/ Source: Itechnews]]]<br />
| width=60% valign=top | '''6. Motorola''' - The '''MOTO U9''' is a Quad-band phone with a 2-inch QVGA LCD display, a 1.45-inch secondary OLED display, integrated music player, Bluetooth, 25MB internal memory and a microSD card slot.<br />
<br />
|-<br />
|}<br />
<br />
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=File:Global_OLED_revenue.JPG&diff=9798
File:Global OLED revenue.JPG
2011-10-04T11:51:26Z
<p>Shweta.mittal@dolcera.com: </p>
<hr />
<div></div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=OLED_Mobile_Phones_Market_Research_and_Analysis_Report&diff=9797
OLED Mobile Phones Market Research and Analysis Report
2011-10-04T11:51:10Z
<p>Shweta.mittal@dolcera.com: /* OLED Market: Revenue Overview */</p>
<hr />
<div>==Executive Summary==<br />
<br />
* The '''OLED''' (Organic Light-Emitting Diode) technology is rapidly evolving, and these improvements are changing the dynamics display screens in mobile phones, TVs, camera, etc. The report provides a technological overview of OLEDS and includes comparisons with the rival technology of LCDs. <br />
* This report analyses the '''Market for OLED display mobile phones''' in terms of products, applications, market size and structure, competitive environment and technology, and determines its future prospects.<br />
* The statistical tools of '''Cluster Analysis''' and '''Regression''' are used to determine the segments of smart-phones likely to adopt OLED displays<br />
* '''Bass Diffusion Model''' for adoption of new technologies is applied to forecast sales of OLED display based mobile phones. This forecast is arrived at by modeling the sales on the historical sales data of certain proxy products and is graphically presented in the report.<br />
* The study reveals that by 2012 cumulative sale of OLED based mobile phone is expected to reach '''183 million units''' and details the trend of these sales over the years<br />
<br />
<br />
==Research Objective==<br />
<br />
* To provide a '''Technology Overview''' for OLED Mobile Phones<br />
* To provide a '''Market Overview''' for OLED Mobile Phones<br />
* To provide a '''Market Estimate''' for OLED Mobile Phones<br />
* To forecast the '''Adoption Rate''' of OLED Mobile Phones<br />
<br />
<br />
==Research Methodology==<br />
<br />
A '''four stage analysis''' was conducted:<br />
<br />
[[Image:4stageanalysis.jpg|center|500px]]<br />
<br />
===Technology Overview===<br />
<br />
A brief understanding of the Technology behind the OLED displays forms the introduction to this report.<br />
<br />
===Market Overview===<br />
<br />
A detailed overview of the OLED Technology forms the basis of the Analysis performed using Base Diffusion Model.<br />
<br />
===Cluster Analysis===<br />
<br />
Cluster Analysis was used to determine a class of mobile handsets that is most likely to use OLED displays. Cluster analysis is a technique used to assign objects to groups (called clusters), such that objects from the same cluster are ''more similar'' to each other than objects from different clusters. To determine the cluster, certain attributes of a handset like input mode, display size, camera resolution, etc. were considered.<br />
<br />
===Bass Diffusion Model===<br />
<br />
The Bass Diffusion Model was used to forecast the adoption of the OLED display mobile phones by consumers. The Bass Diffusion model is a quantitative tool that describes the process of how new products get adopted as an interaction between users and potential users. In this analysis, the model was employed to forecast the sales of a new product by utilizing historical sales data of analogous products from the same product category as well as from a diverse product category. The market penetration for mobiles with OLED displays is arrived at with result for both the proxies.<br />
<br />
== Mobile Phone Display: Technology Overview ==<br />
<br />
'''OLED (Organic Light Emitting Diodes)''' is a flat display technology, made by placing a series of organic thin films between two conductors. On applying an electric current, a bright light is emitted. OLEDs use organic semiconductor material instead of inorganic semiconductor material used in conventional Light Emitting Diodes (LEDs). Through a process called electrophosphorescence, OLEDs emit light in the presence of an electric current. Like any other diode, OLEDs permit electric current to pass only in one direction. Unlike diodes made from inorganic semiconductors, OLEDs are very flexible because they are only '''100 to 500 nanometers''' thick - the human hair is 200 times thicker than it. As a result, OLED screens are very flexible and can be made in very large sheets. OLEDs use lesser energy than LEDs as well.<br />
<br />
The easiest way to understand OLEDs is to compare them to LCDs. LCDs are made by placing a color filter over a white backlight source – filtering out the colors that are not wanted for each pixel. If you want to display blue, you'll have to filter out green and red. OLEDs, on the other hand, are emissive, which means that you simply need to display the colors you need for each pixel, which is made from three color (RGB) OLED “pixels.”<br />
<br />
<br />
=== Mobile Phone Display Types ===<br />
There are two types of display technologies which are used in mobile phones:<br />
# Liquid Crystal Display (LCD)<br />
# Organic Light-Emitting Diode (OLED)<br />
<br />
Recent developments in LCD are Super LCD (S-LCD) and IPS (In-Plane Switching technology) Panel. IPS technology is used in Apple’s Retina display and LG’s NOVA display. OLED technology includes developments such as Super AMOLED, Super AMOLED Plus and ClearBlack.<br />
<br />
<br />
=== Difference between LCD and OLED ===<br />
The LCD uses light modulating properties of liquid crystals (LCs). The liquid crystals do not emit light directly. So, a light source is needed for proper viewing. The OLED uses organic compounds that illuminate when exposed to electric currents. Hence, a backlight is not required for OLEDs. This makes OLED displays thinner than LCD displays.<br />
<br />
==== Difference between AMOLED and AMLCD ====<br />
{|border="2" cellspacing="0" cellpadding="2" width="90%" align="center"<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Properties'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''AM OLED'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''AM LCD'''</font><br />
|-<br />
|'''Thickness/Weight'''<br />
|Thinner, best is 0.05 mm; lighter<br />
|Thicker, best is 0.8 mm; heavier<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Diagonal Size'''<br />
|bgcolor = "#C5D9F1"|Limited to small and medium sizes; largest demo is around 40"<br />
|bgcolor = "#C5D9F1"|Can be manufactured larger; largest demo is <nowiki>~</nowiki>100"<br />
|-<br />
|'''Viewing Angle'''<br />
|Up to 180 degrees<br />
|Narrower, depends on liquid crystal type<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Color Gamut'''<br />
|bgcolor = "#C5D9F1"|<nowiki>></nowiki>100% NTSC (top emission), around 70% NTSC (bottom); high at all gray levels<br />
|bgcolor = "#C5D9F1"|Around 70%, up to 100% NTSC (LED backlight and new color filter); falls at low gray levels<br />
|-<br />
|'''Color Reproduction'''<br />
|Better; gamut independent of view angle<br />
|Good; gamut changes with viewing angle<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Resolution'''<br />
|bgcolor = "#C5D9F1"|Lower; 308 dpi (SM), 202 dpi (polymer)<br />
|bgcolor = "#C5D9F1"|Higher; best is 498 dpi<br />
|-<br />
|'''Response Time'''<br />
|Faster, nanoseconds. No motion blur, good for 3D<br />
|Slower, milliseconds<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Contrast Ratio'''<br />
|bgcolor = "#C5D9F1"|Higher<br />
|bgcolor = "#C5D9F1"|Lower<br />
|-<br />
|'''Sunlight Readability'''<br />
|Better than transmissive LCD, worse than transflective LCD<br />
|Ok if transflective<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Operating Temperature'''<br />
|bgcolor = "#C5D9F1"|Range is larger, can operate at low temps like -40°C<br />
|bgcolor = "#C5D9F1"|Range is smaller, lowest temp is -10°C<br />
|-<br />
|'''Power Consumption'''<br />
|Lower at typical video content, when around 30% of pixels are on<br />
|Higher at typical video content<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Lifetime'''<br />
|bgcolor = "#C5D9F1"|Shorter, 5K to 30K hour, but improving<br />
|bgcolor = "#C5D9F1"|Much longer, above 50K hour<br />
|-<br />
|'''Manufacturing Investment'''<br />
|Lower, but lack of standards keeps the investment only slightly lower<br />
|Higher<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Production Cost'''<br />
|bgcolor = "#C5D9F1"|Expensive; low yield and complex structure, potential to be low cost<br />
|bgcolor = "#C5D9F1"|Cheaper than AMOLED<br />
|-<br />
|align = "center" colspan = "3"|'''[http://www.displaysearch.com/ Source: DisplaySearch]'''<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
==== OLED Construction ====<br />
An OLED can be made of a single layer of organic material but multiple layers increase efficiency and effectiveness. A typical OLED is comprised of five layers of material:<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Layer'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|'''Substrate layer'''<br />
|bgcolor = "#DBE5F1"|This layer supports the OLED and is made of clear plastic, glass, foil or other materials.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Anode layer'''<br />
|bgcolor = "#B8CCE4"|The anode layer is transparent and is positively charged. When an electric current is applied, this layer attracts electrons as they flow through the OLED. As with a LED, the anode forms "holes" onto which electrons fall.<br />
|-<br />
|bgcolor = "#DBE5F1"|'''Conducting layer'''<br />
|bgcolor = "#DBE5F1"|This layer is made of organic plastic material and transports the "holes" from the anode layer.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Emissive layer'''<br />
|bgcolor = "#B8CCE4"|This layer transports electrons from the cathode. It is also made of organic plastic molecules but there are different from those in the conducting layer. This is the layer that determines the color of the light emitted.<br />
|-<br />
|bgcolor = "#DBE5F1"|'''Cathode layer'''<br />
|bgcolor = "#DBE5F1"|This layer injects electrons into the OLED when an electric current is applied. Depending on the OLED and the color effect desired, this layer may or may not be transparent.<br />
|-<br />
|}<br />
<br />
<br />
[[image:oledstructure.jpg|center|406*365px|thumb|Source: [http://electronics.howstuffworks.com/oled1.htm How Stuff Works]]]<br />
<br />
==== Types of OLED Construction ====<br />
OLEDs can be constructed in a variety of ways to serve a variety of functions. While each type of construction uses the layers described previously, the manner in which each layer is built alters the way the OLED functions. The six most common types of OLEDs are as follows:<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Passive-Matrix OLED'''<br />
|bgcolor = "#DBE5F1"|Anode and cathode laid perpendicular to each other<br />
|-<br />
|bgcolor = "#DBE5F1"|PM OLEDs are easy to make and display text and icons very effectively, particularly in small 2-inch to 3-inch screens<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''Active-Matrix OLED'''<br />
|bgcolor = "#B8CCE4"|AM OLEDs are constructed with continuous film materials<br />
|-<br />
|bgcolor = "#B8CCE4"|AM OLEDs use less energy than PM OLEDs and have faster refresh rates<br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Transparent OLED'''<br />
|bgcolor = "#DBE5F1"|Constructed with transparent materials for all five layers, a transparent OLED can be made as either a PM OLED or an AM OLED<br />
|-<br />
|bgcolor = "#DBE5F1"|Useful for heads-up display applications<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''Top-Emitting OLED'''<br />
|bgcolor = "#B8CCE4"|These types of OLEDs use an opaque or reflective substrate that is useful for smart card applications<br />
|-<br />
|bgcolor = "#B8CCE4"|Best suited for an active-matrix design<br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Foldable OLED'''<br />
|bgcolor = "#DBE5F1"|The substrate of this type of OLED is very flexible, allowing the OLED to be folded or rolled up<br />
|-<br />
|bgcolor = "#DBE5F1"|Because of their flexibility, foldable OLEDs could be attached to fabrics with a variety of applications<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''White OLED'''<br />
|bgcolor = "#B8CCE4"|These OLEDs emit white light that is brighter, more uniform and more energy efficient than that emitted by fluorescent lights<br />
|-<br />
|bgcolor = "#B8CCE4"|Potential to replace incandescent and fluorescent lighting in commercial industrial, and residential applications<br />
|-<br />
|}<br />
<br />
<br />
==== Advantages and Disadvantages ====<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|align = "center" bgcolor = "#DBE5F1" rowspan = "3"|'''Advantages of OLED over LCD'''<br />
|bgcolor = "#DBE5F1"|As there is no backlighting, OLED displays offer deeper black levels than LCD displays<br />
|-<br />
|bgcolor = "#DBE5F1"|OLED displays have better contrast ratios<br />
|-<br />
|bgcolor = "#DBE5F1"|Viewing angles offered by OLEDs is more than that offered by LCDs<br />
|-<br />
|align = "center" bgcolor = "#B8CCE4" rowspan = "3"|'''Disadvantages of OLED over LCD'''<br />
|bgcolor = "#B8CCE4"|Brightness levels of OLED display is less than that of LCD<br />
|-<br />
|bgcolor = "#B8CCE4"|Color in OLED displays are often oversaturated<br />
|-<br />
|bgcolor = "#B8CCE4"|The red, green and blue sub-pixels deteriorate and lose efficiency at different rates, thus color consistency worsens over time<br />
|-<br />
|}<br />
<br />
<br />
=== OLED Screen Types in Mobile Phones ===<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|align = "justify" bgcolor = "#DBE5F1"|'''AMOLED'''<br />
|align = "justify" bgcolor = "#DBE5F1"|AMOLED relies on a TFT backplane to switch individual pixels on and off. Active-matrix displays consume significantly less power than passive-matrix counterparts. This makes them well-suited for mobile devices. AMOLED displays are manufactured by printing electroluminescent materials onto a substrate. The relatively simplistic process suggests that OLEDs will ultimately become cheaper and easier to manufacture than LCDs. The creation of the substrate is the most difficult and expensive part of the process. Currently, AMOLED screens are limited in supply. Coupled with high demand, their availability is restricted and they are found in high-end smartphones.<br />
|-<br />
|align = "justify" bgcolor = "#B8CCE4"|'''Super AMOLED'''<br />
|align = "justify" bgcolor = "#B8CCE4"|Super-AMOLED displays are AMOLED displays with an integrated touch function. The original AMOLED screens had reduced visibility in direct sunlight. The thickness of the touch sensor is less than 0.001mm in Super AMOLED displays. This allows the screen to provide better images and to have great visibility even in direct sunlight.<br />
|-<br />
|align = "justify" bgcolor = "#DBE5F1"|'''ClearBlack'''<br />
|align = "justify" bgcolor = "#DBE5F1"|Nokia introduced a display similar to Samsung<nowiki>’</nowiki>s Super AMOLED known as the ClearBlack display. The ClearBlack display makes the screen more visible in direct sunlight. A polarized filter is added to the display. This allows the viewer to see through the screen<nowiki>’</nowiki>s reflection and view the images as they would appear under more ideal conditions.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Super AMOLED Plus'''<br />
|align = "justify" bgcolor = "#B8CCE4"|The Super AMOLED Plus features a traditional three sub-pixels of equal proportion within one pixel. It has an increased sub-pixel count and density. As a result, the display is much crisper, especially when it comes to text. The tighter spacing between pixels also results in better visibility under direct sunlight. The displays are also thinner, brighter and more efficient (by 18%) than the old Super AMOLED displays.<br />
|-<br />
|}<br />
<br />
<br />
=== Future OLED Mobile Screen Variations ===<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|'''Transparent Displays'''<br />
|align = "justify" bgcolor = "#DBE5F1"|Transparent OLEDs have only transparent components (substrate, cathode and anode) and, when turned off, are up to 85 percent as transparent as their substrate. When a transparent OLED display is turned on, it allows light to pass in both directions. A transparent OLED display can be either active- or passive-matrix. TDK began production of a see-through OLED earlier this year.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Flexible Displays'''<br />
|align = "justify" bgcolor = "#B8CCE4"|Flexible OLEDs have substrates made of very flexible metallic foils or plastics. Flexible OLEDs are very lightweight and durable. Their use in devices such as cell phones and PDAs can reduce breakage, a major cause for return or repair. Samsung is readying flexible AMOLED displays for production next year.<br />
|-<br />
|}<br />
<br />
<br />
==OLED Market Overview==<br />
<br />
<br />
===OLED Market: Revenue Overview===<br />
* The Global OLED Display Market was estimated at '''$964 million''' for the year 2010.<br />
* The market stood at '''$884 million''' in the year 2009, and showed a growth of '''11%''' for 2010.<br />
* The market is estimated to reach '''$1,428 million''' by the year 2013 <br />
<br />
[[Image:Global_OLED_revenue.JPG|center|760*401px|thumb|Global OLED Display Market: Revenue Forecasts 2004-2014 (in $million), Source: [http://www.pira-international.com/Sustained-Development-Efforts-to-Spur-Ten-Fold-Growth-of-OLEDs-Lighting-and-Displays-Market-by-2014.aspx pira-international ]]]<br />
<br />
===OLED Market: Volume Overview===<br />
<br />
* The shipments of Organic Light-Emitting Diode (OLED) screens was estimated at '''100 million''' units in 2010<br />
* The shipments of Organic Light-Emitting Diode (OLED) screens are set to rise to '''326.8 million''' units in 2015<br />
* The market is going to be driven by booming demand for Active-Matrix (AM) displays for mobile handsets<br />
* AM-OLED segment, which will boom to '''261.5 million''' units in 2015, up more than twelve fold from '''21.1 million''' in 2009<br />
<br />
[[Image:Global_OLED_Volume.JPG|center|659*383px|thumb|Global OLED Display Shipment 2007-2015 <br />
(Millions of Unit), Source: [http://www.isuppli.com/Display-Materials-and-Systems/News/Pages/iSuppli-Issues-Fast-Facts-on-the-Display-Industry-for-SID-2010.aspx iSuppli ]]]<br />
<br />
===Market Potential by Geography===<br />
<br />
====OLED Market Potential by Geography====<br />
The following chart illustrates the OLED Market Potential by Geography over the period 2004-2014:<br />
{|align = "center"<br />
|<gflash>1050 625 http://dolcera.com/upload/files/OLED_Geography.swf</gflash><br />
|-<br />
|}<br />
<br />
Source: [http://www.icongrouponline.com/ ICON Group International]<br />
<br />
<br />
====AMOLED Market Potential by Geography====<br />
The following chart illustrates the AMOLED Market Potential by Geography over the period 2004-2014:<br />
{|align = "center"<br />
|<gflash>1050 625 http://dolcera.com/upload/files/AMOLED_Geography_01.swf</gflash><br />
|-<br />
|}<br />
<br><br />
Source: [http://www.icongrouponline.com/ ICON Group International]<br />
<br />
<br />
===OLED Market Share===<br />
* '''Samsung Mobile''' leads the OLED Display Market with a market share of 43.2% as reported in 2010<br />
* '''TDK''' is a distant 2nd with a market share of 17.5% and is closely followed by '''RiT Display''' with a share of 16.0%<br />
<br />
The following chart illustrates the Global OLED Display Unit Shipment: Market Share, for the year 2010:<br />
[[Image:Global_OLED_Market_Share.JPG|center|760*401px|thumb|Global OLED Display Unit Shipment: Market Share 2010<br />
, Source: [http://www.displaysearch.com/cps/rde/xchg/displaysearch/hs.xsl/quarterly_oled_shipment_and_forecast_report.asp Quarterly OLED Shipment and Forecast Report, DisplaySearch ]]]<br />
<br />
===OLED Market Share by Application===<br />
* '''Mobile Handset application''' forecast to account for 84%, followed by NBPC at 6% and tablet PC at 4% of 2011E total revenue.<br />
<br />
<br />
The following chart illustrates the Global OLED Display total revenue: Market Share, for the year 2011E:<br />
[[Image:OLED_app_revenue.jpg|center|760*401px|thumb|OLED Display Revenue: Market Share 20111E<br />
, Source: [http://7economy.com/archives/6051 7economy]]]<br />
<br />
==OLED Eco-System==<br />
The following dashboard illustrates all the Companies in the OLED Eco-System:<br />
{|align = "center"<br />
|<gflash>900 425 http://dolcera.com/upload/files/OLED_Ecosystem.swf</gflash><br />
|-<br />
|}<br />
Source: [http://www.oled-info.com/ OLED-info.com]<br />
<br />
<br />
==OLED Market Drivers & Restraints==<br />
<br />
The following figure illustrates a '''Forcefield Analysis of Market Drivers and Restraint'''s for OLED Market (2011-2017):<br />
[[Image:OLED_Drivers_Restraints.JPG|center|900*533px|thumb|Forcefield Analysis of Market Drivers and Restraints for OLED Market (2011-2017)<br />
, Source: [http://www.frost.com Frost & Sullivan]]]<br />
<br />
<br />
===OLED Market Drivers===<br />
The following table illustrates the '''Impact Analysis of OLED Market Drivers''' over a period of time:<br />
{|border="2" cellspacing="0" cellpadding="2" width="60%" align="center"<br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Rank'''</font><br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Driver'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''1-2 years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''3-4 Years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''5-7 years'''</font><br />
|-<br />
|align = "center"|1<br />
|Inherent Advantages of OLED Technology<br />
|align = "center"|Medium<br />
|align = "center"|High<br />
|align = "center"|Very High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|2<br />
|bgcolor = "#C5D9F1"|Increasing Demand for Green Products<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|-<br />
|align = "center"|3<br />
|Increasing demand for OLED Display in Mobile Phones and Signage<br />
|align = "center"|Medium<br />
|align = "center"|Medium<br />
|align = "center"|High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|4<br />
|bgcolor = "#C5D9F1"|Rising Potential of OLED TV<nowiki>’</nowiki>s<br />
|align = "center" bgcolor = "#C5D9F1"|Low<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
'''Inherent Advantages of OLED Technology'''<br />
<br />
* OLED display offer sharper images and better contrast ratios, crisp colors and faster refresh rates compared to any existing display technology.<br />
* OLED Technology also offers consumers better energy management as the whole system functions at optimal power and is of organic substrate.<br />
* OLED displays are created by inserting thin organic films between two conductors and require no backlight; therefore, the displays are more compact and thinner.<br />
* OLED displays, especially or television, are capable of offering viewers a viewing angle of 180 degrees<br />
* As the benefits of OLED displays become more prominent, the demand for OLED manufacturing equipment is expected to increase in the next three to seven years.<br />
<br />
<br />
'''Increasing Demand for Green Products'''<br />
<br />
* The demand for lower power consumption , reduced material usage, and simplicity is expected to propel the OLED demand in the coming years<br />
* The OLED manufacturing equipment market, however, is facing challenges due to its premium and manufacturing challenges. As Manufacturers realize the economies of scale, average selling price is expected to decline, further spurring demand.<br />
* OLED TV market continues to evolve technologically and benefit from increasing demands for energy efficiency from consumers.<br />
<br />
<br />
'''Increasing demand for OLED Displays in Mobile Phones and Signage'''<br />
<br />
* Technology innovations, better functionalities and falling prices are expected to keep up the demand for OLED displays in mobile phones<br />
* Mobile Phones accounted for over 82.0% of the Total OLED display market. With the success of mobile phones, such as the Galaxy, the demand for OLED displays for mobile applications is expected to increase<br />
* The market is also expected to benefit from increasing demand for OLED displays used for signage<br />
* These factors are expected to propel the sales of OLED during the medium and later part of the forecast period.<br />
<br />
<br />
'''Rising Potential of OLED TVs'''<br />
<br />
* The OLED market is yet to observe strong demand for TVs. High premium price and smaller display sizes are key restraints for customers. However, with increasing collaboration within the entire supply chain of the OLED market, the market is expected to experience gradual increase in attractive solutions. According to DisplaySearch, the OLED TV market is expected to generate revenue of $28 billion by 2017.<br />
* The increasing momentum is expected to help commercialize the technology in the next five to seven years. Many display manufacturers have already set up dedicated manufacturing lines from Gen 3.5 to Gen 5.5.<br />
* This is expected to propel OLED manufacturing equipment sales during the latter part of the forecasted period.<br />
<br />
Source: [http://www.frost.com Frost & Sullivan]<br />
<br />
<br />
===OLED Market Restraints===<br />
The following table illustrates the '''Impact Analysis of OLED Market Restraints''' over a period of time:<br />
{|border="2" cellspacing="0" cellpadding="2" width="60%" align="center"<br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Rank'''</font><br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Restraint'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''1-2 years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''3-4 Years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''5-7 years'''</font><br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|1<br />
|bgcolor = "#C5D9F1"|Slow Adoption Rate of New Technology<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|-<br />
|align = "center"|2<br />
|Declining Prices of competing technologies<br />
|align = "center"|High<br />
|align = "center"|High<br />
|align = "center"|High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|3<br />
|bgcolor = "#C5D9F1"|High cost of products<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
'''Slow Adoption Rate of New Technology'''<br />
<br />
* The adoption rate of OLED Technology is comparatively slower than the initial launch of LCD technology. Consumers are complacent with the current technologies it offers then a myriad o advantages and benefits.<br />
* The largest issues foreseen are consumer perception, cost effectiveness of the product, ease of implementation and the ability of the service to provide true blended services<br />
* As a result, there is a significant and vital gap between new product design to volume manufacturing in the OLED market<br />
* Increasing costs and manufacturing complexity has hindered the adoption rate of OLED manufacturing equipment, especially for larger substrate sizes<br />
* The growth of the OLED display market and, in turn equipment sales, will rely on increasing collaboration between material suppliers, technology enablers and equipment providers. Decreased time to market and focus on R&D will be the key to attaining the desired growth trajectory.<br />
<br />
<br />
'''High Cost of Products'''<br />
<br />
* The high cost of OLED display has hindered adoption rates. For Example, customers, while willing to pay a premium price for quality products, hedge until the product has reached mass adoption level. A manufacturing facility typically requires an investment of $ 1 Billion to 3 Billion.<br />
* This has restrained the demand for OLED equipment. Equipment providers are still caught in a dilemma of balancing the high cost of technology development with affordable pricing for consumers.<br />
* Careful adjustment of prices can help minimize the impact of this restraint. Pricing strategy is crucial for success for the overall OLED market.<br />
<br />
<br />
'''Declining Prices of Competing Technologies'''<br />
<br />
* The LCD market is continuing to witness strong demand despite the emergence of new products in the market.<br />
* LCD Technology is transitioning t meet increasing demands for higher switching speeds, becoming more environmentally friendly by using LED backlighting, becoming sleeker and more compact, and having better resolution.<br />
* The LCD and other existing technologies also offer consumers the ability to buy large screen displays. This had created major barriers for increasing the adoption rate for OLED manufacturing equipment.<br />
<br />
Source: [http://www.frost.com Frost & Sullivan]<br />
<br />
<br />
==Transaction Landscape==<br />
The Transaction Landscape in the OLED Market is illustrated in the following links:<br />
# [[Mergers & Acquisitions Landscape]]<br />
# [[Partnerships Landscape]]<br />
# [[Investment Landscape]]<br />
<br />
<br />
==Cluster Analysis for TFT Display Mobile Phones==<br />
The table here summarizes the objective, methodology, procedure and result of the cluster analysis <br />
[[Image:Cluster Analysis.jpg|thumb|center|1000px|[http://faculty.chass.ncsu.edu/garson/PA765/cluster.htm Source: Statnotes, North Carolina State University]]]<br><br />
<br />
===Selection of model===<br />
Using the analysis, one cluster of smart-phones likely to move to OLED technology was identified for each of the two categories. For the next stage of the research - that of forecasting sales - would need the historical sales data of one particular model. For this purpose, '''Apple iPhone''' from the 2nd cluster of candy-bar phones was selected because of constraint of availability of sales data for other models like Blackberry, Nokia N96, HTC Dreamers etc.<br />
<br />
<br />
==='''A Comparison of LCD and OLED technologies'''===<br />
<br />
<br />
The ''radar graph'' here shows the comparison between OLED and TFT LCD.<br />
<br />
[[Image:Comparison.jpg|500px|thumb|center|Comparison[http://digidelve.com/oled/problems Source]]]<br />
<br />
<br />
<br />
The graph depicts the following things:<br />
<br />
# OLEDs are ''thinner'' than LCDs.<br />
# OLEDs are ''lighter'' in weight.<br />
# OLEDs consume ''more power'' than LCDs but OLEDs have an inherent advantage in that they only consume power when they emit light while an LCD backlight consumes constant power regardless of the image being displayed.<br />
# OLEDs ''cost more'': The Cost of an AM-LCD is currently about half that of a comparable AM-OLED display. This is due to the maturity of LCD manufacturing processes and facilities. OLED manufacturing facilities suffer from low yields, currently at 60%-70%.<br />
# OLEDs have a ''shorter lifespan'' as compared to LCDs.<br />
# OLEDs have a ''faster response time'' of .01ms while LCDs have a response time about 8-12ms.<br />
# OLEDs have a ''superior viewing angle'' of 180 degree while LCDs have a lower viewing angle.<br />
<br />
==='''Cluster Analysis'''===<br />
<br />
<br />
====Methodology====<br />
<br />
'''Sample Definition:''' The sample space consists of moblie phones by leading players in the smart-phone mobile category. These models were identified from Gartner reports. The models of smart-phones launched in the last three years in North America were considered. <br />
<br />
'''Sample Space:'''After defining the sample, the various key attributes of smart-phones like camera, display, etc. were defined. The data for these attributes for all the models was collected from the company websites as well as the following websites:<br />
<br />
* www.phonearena.com<br />
* www.phonegg.com<br />
* www.mobile.am<br />
<br />
<br />
The pricing information was obtained from<br />
* www.fonearena.com<br />
* www.india-cellular.com<br />
* www.naaptaol.com<br />
* www.mobilestore.com<br />
* www.indiatimes.com.<br />
<br />
<br />
After aggregating the data we used the '''k-clustering''' method to identify the different clusters for the samples. This technique aims to partition ''n'' observations into ''k'' clusters in which each observation belongs to the cluster with the nearest mean. Hence clusters of phones with similar attributes is achieved.<br />
<br />
Samples were segregated into two broad categories - candy-bar phones and clamshell or sliding phones - with thickness being the differentiating parameter. This was done in order to mitigate any error due to the design of the phone(i.e. candybar,clamshell,slider), since the thicknes of the mobile could be a cause for erroneous results.<br />
<br />
====Cluster analysis results====<br />
<br />
The sheet below shows the clusters formed for the candy-bar phones.<br />
<br />
[[Image:Candy_bar_excels.jpg|Candy bar|1500px|center|thumb]]<br />
<br />
The sheet below shows the cluster formed for the clamshell/sliding phones.<br />
<br />
[[Image:clamshellexcel.jpg|Clamshell_slider|650px|center|thumb]]<br />
<br />
'''Definition of Attributes:'''<br />
*'''Camera''' : resolution in Megapixels<br />
*'''Input method''': two types of input methods - touchscreen and keyboard<br />
*'''Display size''': diagonal length of the displeay screen<br />
*'''Resolution''': display resolutions<br />
*'''Color''': display color<br />
*'''Thickness''': total thickness of the phone<br />
<br />
<br />
The cluster analysis results and subsequent profiling of those clusters are summarized below:<br />
<br />
<br />
''' Candy - Bar Phones'''<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center"|<font color="#262626">'''Clusters'''</font><br />
|align = "center"|<font color="#262626">'''Cell phones'''</font><br />
|align = "center"|<font color="#262626">'''Profile'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''1'''<br />
|align = "center" bgcolor = "#D3DFEE"|Apple iPhone, Samsung i910<br />
|align = "justify" bgcolor = "#D3DFEE"|* Cluster 1 consists of high end cell phones<br>* Cell phones falling in this cluster are touch screen phones with large display size<br>* This is mainly targeting the premium market which is not price sensitive as the mobile phones in this cluster are priced high<br />
|-<br />
|align = "center"|'''2'''<br />
|align = "center"|HTC P3470, HTC touch cruise, HTC touch diamond, HTC touch viva, HTC X7510, i780<br />
|align = "justify"|* This cluster includes cell phones with moderate display size and having touch screen facility<br>* Cell phones in this cluster are in the price range of medium to high, so it is targeting the upper middle to high class.<br>* Almost all the mobile phones falling in this cluster are having WLAN facility indicating that this cluster target trendy class people and people who prefer online games and downloads on mobile phones<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''3'''<br />
|align = "center" bgcolor = "#D3DFEE"|Nokia 5320 express music, Nokia 5800 express music, Nokia 6124 classic, Nokia 6220 classic, Nokia E63, i200, i450, N6120, N78, N79, Pearl 8100<br />
|align = "justify" bgcolor = "#D3DFEE"|* Mobile phones in this cluster are targeted at the middle class as these phones are of moderate price and normal input<br>* They have small display size and moderate camera resolution, which is in sync with their target market<br>* Average thickness<br />
|-<br />
|align = "center"|'''4'''<br />
|align = "center"|E71, i550W, N5700, N73, N82, Blackberry 7130c/7130g<br />
|align = "justify"|* This cluster consists of mobile phones having high camera resolution and normal input indicating that this cluster is for people who give high preference to clicking photographs on mobile phones<br>* They have small display size with most of them not having the WLAN facility, so this is for people who low on using the browsing facilities<br>* The target segment for this cluster is the middle class segment as the mobile phones are also moderately priced<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''5'''<br />
|align = "center" bgcolor = "#D3DFEE"|Curve 8310, Blackberry 8820, Curve 8300, Blackberry 8800, Blackberry bold 9000, Blackberry curve 8330<br />
|align = "justify" bgcolor = "#D3DFEE"|* It includes mobile phones having input through qwerty and with average display size<br>* Target market is Business class people who prefer using email facility on mobiles<br>* The mobile phones are low on camera resolution<br>* All the mobiles in this cluster are high priced indicating that the targeted segment for this cluster is not price sensitive<br />
|-<br />
|}<br />
<br />
<br />
<br />
'''Clamshell Phones'''<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center"|'''Clusters'''<br />
|align = "center"|'''Cell phones'''<br />
|align = "center"|'''Profile'''<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''1'''<br />
|align = "center" bgcolor = "#D3DFEE"|N6650, N95 8GB, E66, 6210 navi, N85<br />
|bgcolor = "#D3DFEE"|* This cluster consists of medium to high priced mobile phones and is targeted at upper middle class<br>* These mobile phones have high camera resolution and normal keypad input<br>* All the mobiles in this cluster have average display size having 16M colors<br />
|-<br />
|align = "center"|'''2'''<br />
|align = "center"|N96, N97<br />
|* It includes mobile phones which are high priced and targeted at affluent people who are not price sensitive<br>* The mobile phones in this cluster are characterized by high camera resolution, big display size and moderate thickness<br>* WLAN facility and high graphic resolution in these mobile phones will attract people who prefer downloading and playing online games<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''3'''<br />
|align = "center" bgcolor = "#D3DFEE"|HTC dream<br />
|bgcolor = "#D3DFEE"|* Mobile phones in this cluster are moderately priced and, targeted at the middle class and the upper middle class segment<br>* These phones have high thickness and high camera resolution<br>* These phones are WLAN enabled and have both qwerty keypad and touch screen input<br />
|-<br />
|align = "center"|'''4'''<br />
|align = "center"|N76, N6290, N75, HTC shadow, E65, i620, N6110<br />
|* This cluster consists of mobile phones with low camera resolution and mainly has normal keypad for input<br>* These phones have medium display size and medium to high thickness<br>* These are low to moderately priced phones targeted at the middle class segment<br />
|-<br />
|}<br />
<br />
=== Prices for AMOLED screens===<br />
<br />
Market data was collected for the prices of OLED screens by various manufacturers<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#FFFF00"|Company Name<br />
|bgcolor = "#FFFF00"|Model Number<br />
|bgcolor = "#FFFF00"|Size<br />
|bgcolor = "#FFFF00"|Resolution<br />
|bgcolor = "#FFFF00"|Colors<br />
|align = "center" bgcolor = "#FFFF00" colspan = "3"|Price/unit(in USD)<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|0-99<br />
|100-999<br />
|1000 <nowiki>++</nowiki><br />
<br />
|-<br />
|Chung Yuan Technology Co., Ltd<br />
|align = "right"|&nbsp;<br />
|2.2"<br />
|220x176<br />
|align = "right"|&nbsp;<br />
|20.00<br />
|16.5<br />
|align = "right"|&nbsp;<br />
<br />
|-<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
<br />
|-<br />
|Digiprotek Markcom India P Ltd.(Densitron)<br />
|C0201QILK-C<br />
|2<br />
|176xRGBx220<br />
|262K<br />
|25.69<br />
|24.92<br />
|20.67<br />
<br />
|-<br />
|&nbsp;<br />
|C0240QGLA-T&nbsp;<br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|35.97<br />
|34.9<br />
|27.83<br />
<br />
|-<br />
|&nbsp;<br />
|P0340WQLC-T&nbsp;<br />
|3.45<br />
|480xRGBx272<br />
|16M<br />
|85.65<br />
|83.1<br />
|47.72<br />
<br />
|-<br />
|&nbsp;<br />
|P0430WQLC-T&nbsp;<br />
|4.3<br />
|480xRGBx272<br />
|16M<br />
|119.90<br />
|116.32<br />
|85.84<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|GLYN GmbH & Co. KG(CMEL)<br />
|C0201QILKC&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2<br />
|176x220<br />
|262K<br />
|25.00<br />
|&nbsp;<br />
|15<br />
<br />
|-<br />
|&nbsp;<br />
|C0240QGLAT&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|30.00<br />
|&nbsp;<br />
|20<br />
<br />
|-<br />
|&nbsp;<br />
|C0283QGLDT&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2.83<br />
|240xRGBx320<br />
|262K<br />
|38&nbsp;<br />
|&nbsp;<br />
|26<br />
<br />
|-<br />
|&nbsp;<br />
|P0340WQLCT&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br />
|3.4<br />
|480xRGBx272&nbsp;<br />
|16M<br />
|60.00<br />
|&nbsp;<br />
|35<br />
<br />
|-<br />
|&nbsp;<br />
|P0430WQLCT&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br />
|4.3<br />
|480xRGBx272<br />
|16M<br />
|90&nbsp;&nbsp;<br />
|&nbsp;<br />
|63<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|A4G Technologies(OSD)<br />
|OSD020AMQCIF<br />
|2<br />
|176x220<br />
|262K<br />
|22.50<br />
|20.98 <br />
|19.10 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD024AMQV <br />
|2.4<br />
|240x320<br />
|262K<br />
|30.20<br />
|28.57 <br />
|25.40 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0283AMQV<br />
|2.83<br />
|240x320<br />
|262K<br />
|38.30<br />
|36.16 <br />
|33.63 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0340WQLC <br />
|3.4<br />
|480x272<br />
|16M<br />
|69.50<br />
|67.25 <br />
|42.48 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0430WQLC-T <br />
|4.3<br />
|480x272<br />
|16M<br />
|109.00<br />
|87.00 <br />
|72.00 <br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|Blaze Technology<br />
|BDO-0240QGLA-T<br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|20.8<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0283QGLD-T<br />
|2.83<br />
|240xRGBx320<br />
|262K<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|26.85<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0340WQLA-T<br />
|3.4<br />
|480x272<br />
|16M<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|39.5<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0430WQLA-T<br />
|4.3<br />
|480x272<br />
|16M<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|90.6<br />
<br />
|}<br />
<br />
==Bass Diffusion Analysis==<br />
<br />
One of the most important functions during the launch of a new product is to forecast the demand for that product, as it guides many other critical decisions faced by the company. Companies can schedule their production activities once they have an idea about the demand in the coming months or years. At a high level, Bass Diffusion Model is used to determine the shape of the curve representing the cumulative adoption of the new product. Bass describes the individuals who decide to adopt an innovation independently of the actions of others as ''innovators''. Those who respond to the influences of the social system and obtain information about a new product from those who have already adopted the product are termed as ''imitators''.<br />
<br />
===Proxies for analysis===<br />
<br />
The use of the model has been made by using the historical sales data of ''proxy'' products to forecast sales for OLED display mobile phones with an assumption that OLED display mobile phones would mimic the diffusion patterns of the proxies. Hence it was important to select the proxies carefully. We used the following for this forecast:<br />
* iPhone - since this was the latest revolution in mobile phone devices and consumers would show a similar adoption behavior for a new mobile phone technology even though it comes at a price premium<br />
* LCD/Plasma TVs & Monitors - consumers spent more money to purchase screens with superior quality by significantly increasing their budget<br />
** LCD and Plasma TVs and LCD monitors were treated as a single analogous product(by ascribing different weights to these) for the forecast<br />
<br />
===Forecasting OLED display phone sales using Analogous Products===<br />
<br />
<br />
<br />
'''The following products from different product categories were considered:'''<br><br />
:# LCD TV <br />
:# Plasma Display TV<br />
:# LCD Monitor<br />
<br />
They were considered to be befitting analogies because of the following similarities:<br><br />
[[Image:Similarities.jpg|center|600px]]<br><br />
<br />
'''Weighted average for the analogous products:'''<br />
Weights for modeling co-efficients for the analogous products such as LCD TV, Plasma Display TV and LCD monitor had been assigned.<br><br />
To judge the similarity of analogous products to OLED, we examined two criteria.<br><br />
::a. Market Structure<br><br />
::b. Product Characteristics<br><br />
[[Image:Criterion.jpg|center|600px]]<br><br />
<br />
The '''S-Graph''' for the cumulative projected sale of OLED display mobiles modeled on analogous products<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart1.swf</gflash></center><br />
<br />
:* In 2009 and 2010 OLED Mobile Phone market would grow slowly driven by ''innovators''<br />
:* From 2011 to 2015, market will grow rapidly due to the ''early adopters''<br />
:* In 2016 and 2017, market will growth will dwindle as ''late adopters'' take to the phones<br />
:* 2018 onwards growth will peter, as the laggards pick up the last few models and the market will saturate<br />
:* From 2016 the technology will near obsolescence and a new technology would replace it<br><br />
<br />
<br />
'''Comparison of Adoption rate of Innovators with those of Imitators'''<br><br />
The model helps to determine sales to innovators and imitators for each year:<br><br><br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart2.swf</gflash></center><br />
<br />
<br />
This graph shows that a small number of innovators will kick-start the sales. OLED display mobile Phones will get off to a slow start in first 2 years. Once a '''''critical mass''''' is reached by the end of the second year, strong imitative effects will take over as the innovators decrease.<br />
<br />
===Detailed Analysis===<br />
<br />
The detailed modeling with a description of parameters and mathematical equations can be viewed here:<br><br />
[[Bass Diffusion Analysis for OLED display phones]]<br />
<br />
==OLED Mobile Phone Projections Based on I-Phone==<br />
<br />
The '''S-Graph''' for the cumulative projected sale of OLED display mobiles modeled on analogous products<br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart3.swf</gflash></center><br />
<br />
:* From Q1,'09 to Q3,'09, the OLED display mobile phone market would grow slowly, driven by ''innovators''<br />
:* From Q4,'09 to Q4,'10 market will grow rapidly due to the ''early adopters''<br />
:* From Q1,'11 and Q3,'11 market growth will dwindle as ''late adopters'' take to the phones<br />
:* Q4,'11 onwards growth will peter, as the laggards pick up the last few models and the market will saturate<br />
:* From Q4, the technology will near obsolescence and a new technology would substitute it<br><br><br />
<br />
'''Comparison of Adoption rate of Innovators with those of Imitators'''<br><br />
The model helps to determine sales to innovators and imitators for each year:<br><br><br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart4.swf</gflash></center><br />
<br />
<br />
This graph shows that a small number of innovators will kick-start the sales. OLED display mobile Phones will get off to a slow start in first three quarters. Once a '''''critical mass''''' is reached by the end of the Q3, strong imitative effects will take over as the innovators decrease.<br />
<br />
===Detailed Analysis===<br />
<br />
The detailed modeling with a description of parameters and mathematical equations can be viewed here:<br><br />
[[Bass Diffusion Analysis for OLED display phones]]<br />
<br />
==Comparing projections==<br />
Since disparate product categories had been used for the two forecasts, the two were compared to cross validate the results [[media:Bass-Model_OLED_comparison.xls|''<<excel sheet with calculations>>'']]<br><br />
<br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart5.swf</gflash></center><br />
<br />
:* Looking at the forecast for OLED display mobile phones based on analogous products and on iPhone, both are seen to be ''convergent''<br />
:* This validates the forecast<br />
<br />
<br />
<br />
==Sneak Preview of some models using OLED technology==<br />
{| class="wikitable" style="font-size:100%" border="1" cellpadding="5" cellspacing="0" width=80%<br />
|-<br />
| width=40% valign=top | [[Image:Apple.jpg|thumb|center|200px|[http://www.appleiphoneapps.com/2009/03/next-iphone-to-have-oled-display-why-should-you-care/ Source: appleiphoneapps.com]]]<br />
| width=60% valign=top | '''1. Apple iPhone''' - It’s nothing official at the moment, but word on the street is that Apple might have chosen a series of OLED displays for its next round of handsets. Such a move would certainly be in the best interests of battery life, as the iPhone isn’t noted for its battery capabilities. Considering the amount of new features that were announced in the iPhone 3.0 firmware update, it would be fairly practical to have a capacitive OLED display in the future.<br />
|-<br />
| width=40% valign=top | [[Image:Nokia.jpg|thumb|center|200px|[http://www.mobilephonereviews.org/category/nokia/ Source: Mobile Phone Reviews]]]<br />
<br />
| width=60% valign=top | '''2. Nokia''' - '''Nokia 6600''' Slide Mobile Phone is a 3G device with large OLED display and 3.2 megapixel camera. It has curved edges and with a weight of 110g is a bit heavy to hold. The 2.2” screen supports 16 million colors and comes with QVGA resolution. The dimensions of the phone are 90 x 45 x 14mm.<br />
<br />
|-<br />
| width=40% valign=top | [[Image:Samsung.jpg|thumb|center|200px|[http://www.att-phones.org/att-samsung-a877-phone-will-be-available.html Source: ATT Phones]]]<br />
<br />
| width=60% valign=top | '''3. Samsung''' - '''Samsung A877''' features include a 3.2-inch WQVGA AMOLED touchscreen, a 3 megapixel camera, GPS, HSDPA and Bluetooth. And as well at it supports AT&T’s 3G service.<br />
|-<br />
<br />
| width=40% valign=top | [[Image:Sony.jpg|thumb|center|200px|[http://www.itechnews.net/2008/01/08/sony-ericsson-z555-stylish-phone/ Source: Itechnews]]]<br />
| width=60% valign=top | '''4. Sony''' - '''Sony Ericsson Z555''' features a 1.9-inch LCD display, an OLED 128×36 external display, a 1.3 Megapixel camera with 4x digital zoom.<br />
|-<br />
| width=40% valign=top | [[Image:LG Mobile.jpg|thumb|center|200px|[http://www.unwiredview.com/2008/02/20/lg-sh150a-gets-am-oled-display-with-26-million-colors-and-hd-support/ Source: Unwiredview]]]<br />
| width=60% valign=top | '''5. LG''' - One of the first handsets to get the new AM OLED, is already advanced '''LG SH150''' DMB TV phone. <br />
|-<br />
| width=40% valign=top | [[Image:Motorola.jpg|thumb|center|200px|[http://www.itechnews.net/2007/10/12/motorola-u9-mobile-phone/ Source: Itechnews]]]<br />
| width=60% valign=top | '''6. Motorola''' - The '''MOTO U9''' is a Quad-band phone with a 2-inch QVGA LCD display, a 1.45-inch secondary OLED display, integrated music player, Bluetooth, 25MB internal memory and a microSD card slot.<br />
<br />
|-<br />
|}<br />
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https://www.dolcera.com/wiki/index.php?title=OLED_Mobile_Phones_Market_Research_and_Analysis_Report&diff=9796
OLED Mobile Phones Market Research and Analysis Report
2011-10-04T11:04:42Z
<p>Shweta.mittal@dolcera.com: /* OLED Market Share by Application */</p>
<hr />
<div>==Executive Summary==<br />
<br />
* The '''OLED''' (Organic Light-Emitting Diode) technology is rapidly evolving, and these improvements are changing the dynamics display screens in mobile phones, TVs, camera, etc. The report provides a technological overview of OLEDS and includes comparisons with the rival technology of LCDs. <br />
* This report analyses the '''Market for OLED display mobile phones''' in terms of products, applications, market size and structure, competitive environment and technology, and determines its future prospects.<br />
* The statistical tools of '''Cluster Analysis''' and '''Regression''' are used to determine the segments of smart-phones likely to adopt OLED displays<br />
* '''Bass Diffusion Model''' for adoption of new technologies is applied to forecast sales of OLED display based mobile phones. This forecast is arrived at by modeling the sales on the historical sales data of certain proxy products and is graphically presented in the report.<br />
* The study reveals that by 2012 cumulative sale of OLED based mobile phone is expected to reach '''183 million units''' and details the trend of these sales over the years<br />
<br />
<br />
==Research Objective==<br />
<br />
* To provide a '''Technology Overview''' for OLED Mobile Phones<br />
* To provide a '''Market Overview''' for OLED Mobile Phones<br />
* To provide a '''Market Estimate''' for OLED Mobile Phones<br />
* To forecast the '''Adoption Rate''' of OLED Mobile Phones<br />
<br />
<br />
==Research Methodology==<br />
<br />
A '''four stage analysis''' was conducted:<br />
<br />
[[Image:4stageanalysis.jpg|center|500px]]<br />
<br />
===Technology Overview===<br />
<br />
A brief understanding of the Technology behind the OLED displays forms the introduction to this report.<br />
<br />
===Market Overview===<br />
<br />
A detailed overview of the OLED Technology forms the basis of the Analysis performed using Base Diffusion Model.<br />
<br />
===Cluster Analysis===<br />
<br />
Cluster Analysis was used to determine a class of mobile handsets that is most likely to use OLED displays. Cluster analysis is a technique used to assign objects to groups (called clusters), such that objects from the same cluster are ''more similar'' to each other than objects from different clusters. To determine the cluster, certain attributes of a handset like input mode, display size, camera resolution, etc. were considered.<br />
<br />
===Bass Diffusion Model===<br />
<br />
The Bass Diffusion Model was used to forecast the adoption of the OLED display mobile phones by consumers. The Bass Diffusion model is a quantitative tool that describes the process of how new products get adopted as an interaction between users and potential users. In this analysis, the model was employed to forecast the sales of a new product by utilizing historical sales data of analogous products from the same product category as well as from a diverse product category. The market penetration for mobiles with OLED displays is arrived at with result for both the proxies.<br />
<br />
== Mobile Phone Display: Technology Overview ==<br />
<br />
'''OLED (Organic Light Emitting Diodes)''' is a flat display technology, made by placing a series of organic thin films between two conductors. On applying an electric current, a bright light is emitted. OLEDs use organic semiconductor material instead of inorganic semiconductor material used in conventional Light Emitting Diodes (LEDs). Through a process called electrophosphorescence, OLEDs emit light in the presence of an electric current. Like any other diode, OLEDs permit electric current to pass only in one direction. Unlike diodes made from inorganic semiconductors, OLEDs are very flexible because they are only '''100 to 500 nanometers''' thick - the human hair is 200 times thicker than it. As a result, OLED screens are very flexible and can be made in very large sheets. OLEDs use lesser energy than LEDs as well.<br />
<br />
The easiest way to understand OLEDs is to compare them to LCDs. LCDs are made by placing a color filter over a white backlight source – filtering out the colors that are not wanted for each pixel. If you want to display blue, you'll have to filter out green and red. OLEDs, on the other hand, are emissive, which means that you simply need to display the colors you need for each pixel, which is made from three color (RGB) OLED “pixels.”<br />
<br />
<br />
=== Mobile Phone Display Types ===<br />
There are two types of display technologies which are used in mobile phones:<br />
# Liquid Crystal Display (LCD)<br />
# Organic Light-Emitting Diode (OLED)<br />
<br />
Recent developments in LCD are Super LCD (S-LCD) and IPS (In-Plane Switching technology) Panel. IPS technology is used in Apple’s Retina display and LG’s NOVA display. OLED technology includes developments such as Super AMOLED, Super AMOLED Plus and ClearBlack.<br />
<br />
<br />
=== Difference between LCD and OLED ===<br />
The LCD uses light modulating properties of liquid crystals (LCs). The liquid crystals do not emit light directly. So, a light source is needed for proper viewing. The OLED uses organic compounds that illuminate when exposed to electric currents. Hence, a backlight is not required for OLEDs. This makes OLED displays thinner than LCD displays.<br />
<br />
==== Difference between AMOLED and AMLCD ====<br />
{|border="2" cellspacing="0" cellpadding="2" width="90%" align="center"<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Properties'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''AM OLED'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''AM LCD'''</font><br />
|-<br />
|'''Thickness/Weight'''<br />
|Thinner, best is 0.05 mm; lighter<br />
|Thicker, best is 0.8 mm; heavier<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Diagonal Size'''<br />
|bgcolor = "#C5D9F1"|Limited to small and medium sizes; largest demo is around 40"<br />
|bgcolor = "#C5D9F1"|Can be manufactured larger; largest demo is <nowiki>~</nowiki>100"<br />
|-<br />
|'''Viewing Angle'''<br />
|Up to 180 degrees<br />
|Narrower, depends on liquid crystal type<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Color Gamut'''<br />
|bgcolor = "#C5D9F1"|<nowiki>></nowiki>100% NTSC (top emission), around 70% NTSC (bottom); high at all gray levels<br />
|bgcolor = "#C5D9F1"|Around 70%, up to 100% NTSC (LED backlight and new color filter); falls at low gray levels<br />
|-<br />
|'''Color Reproduction'''<br />
|Better; gamut independent of view angle<br />
|Good; gamut changes with viewing angle<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Resolution'''<br />
|bgcolor = "#C5D9F1"|Lower; 308 dpi (SM), 202 dpi (polymer)<br />
|bgcolor = "#C5D9F1"|Higher; best is 498 dpi<br />
|-<br />
|'''Response Time'''<br />
|Faster, nanoseconds. No motion blur, good for 3D<br />
|Slower, milliseconds<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Contrast Ratio'''<br />
|bgcolor = "#C5D9F1"|Higher<br />
|bgcolor = "#C5D9F1"|Lower<br />
|-<br />
|'''Sunlight Readability'''<br />
|Better than transmissive LCD, worse than transflective LCD<br />
|Ok if transflective<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Operating Temperature'''<br />
|bgcolor = "#C5D9F1"|Range is larger, can operate at low temps like -40°C<br />
|bgcolor = "#C5D9F1"|Range is smaller, lowest temp is -10°C<br />
|-<br />
|'''Power Consumption'''<br />
|Lower at typical video content, when around 30% of pixels are on<br />
|Higher at typical video content<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Lifetime'''<br />
|bgcolor = "#C5D9F1"|Shorter, 5K to 30K hour, but improving<br />
|bgcolor = "#C5D9F1"|Much longer, above 50K hour<br />
|-<br />
|'''Manufacturing Investment'''<br />
|Lower, but lack of standards keeps the investment only slightly lower<br />
|Higher<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Production Cost'''<br />
|bgcolor = "#C5D9F1"|Expensive; low yield and complex structure, potential to be low cost<br />
|bgcolor = "#C5D9F1"|Cheaper than AMOLED<br />
|-<br />
|align = "center" colspan = "3"|'''[http://www.displaysearch.com/ Source: DisplaySearch]'''<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
==== OLED Construction ====<br />
An OLED can be made of a single layer of organic material but multiple layers increase efficiency and effectiveness. A typical OLED is comprised of five layers of material:<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Layer'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|'''Substrate layer'''<br />
|bgcolor = "#DBE5F1"|This layer supports the OLED and is made of clear plastic, glass, foil or other materials.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Anode layer'''<br />
|bgcolor = "#B8CCE4"|The anode layer is transparent and is positively charged. When an electric current is applied, this layer attracts electrons as they flow through the OLED. As with a LED, the anode forms "holes" onto which electrons fall.<br />
|-<br />
|bgcolor = "#DBE5F1"|'''Conducting layer'''<br />
|bgcolor = "#DBE5F1"|This layer is made of organic plastic material and transports the "holes" from the anode layer.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Emissive layer'''<br />
|bgcolor = "#B8CCE4"|This layer transports electrons from the cathode. It is also made of organic plastic molecules but there are different from those in the conducting layer. This is the layer that determines the color of the light emitted.<br />
|-<br />
|bgcolor = "#DBE5F1"|'''Cathode layer'''<br />
|bgcolor = "#DBE5F1"|This layer injects electrons into the OLED when an electric current is applied. Depending on the OLED and the color effect desired, this layer may or may not be transparent.<br />
|-<br />
|}<br />
<br />
<br />
[[image:oledstructure.jpg|center|406*365px|thumb|Source: [http://electronics.howstuffworks.com/oled1.htm How Stuff Works]]]<br />
<br />
==== Types of OLED Construction ====<br />
OLEDs can be constructed in a variety of ways to serve a variety of functions. While each type of construction uses the layers described previously, the manner in which each layer is built alters the way the OLED functions. The six most common types of OLEDs are as follows:<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Passive-Matrix OLED'''<br />
|bgcolor = "#DBE5F1"|Anode and cathode laid perpendicular to each other<br />
|-<br />
|bgcolor = "#DBE5F1"|PM OLEDs are easy to make and display text and icons very effectively, particularly in small 2-inch to 3-inch screens<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''Active-Matrix OLED'''<br />
|bgcolor = "#B8CCE4"|AM OLEDs are constructed with continuous film materials<br />
|-<br />
|bgcolor = "#B8CCE4"|AM OLEDs use less energy than PM OLEDs and have faster refresh rates<br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Transparent OLED'''<br />
|bgcolor = "#DBE5F1"|Constructed with transparent materials for all five layers, a transparent OLED can be made as either a PM OLED or an AM OLED<br />
|-<br />
|bgcolor = "#DBE5F1"|Useful for heads-up display applications<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''Top-Emitting OLED'''<br />
|bgcolor = "#B8CCE4"|These types of OLEDs use an opaque or reflective substrate that is useful for smart card applications<br />
|-<br />
|bgcolor = "#B8CCE4"|Best suited for an active-matrix design<br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Foldable OLED'''<br />
|bgcolor = "#DBE5F1"|The substrate of this type of OLED is very flexible, allowing the OLED to be folded or rolled up<br />
|-<br />
|bgcolor = "#DBE5F1"|Because of their flexibility, foldable OLEDs could be attached to fabrics with a variety of applications<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''White OLED'''<br />
|bgcolor = "#B8CCE4"|These OLEDs emit white light that is brighter, more uniform and more energy efficient than that emitted by fluorescent lights<br />
|-<br />
|bgcolor = "#B8CCE4"|Potential to replace incandescent and fluorescent lighting in commercial industrial, and residential applications<br />
|-<br />
|}<br />
<br />
<br />
==== Advantages and Disadvantages ====<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|align = "center" bgcolor = "#DBE5F1" rowspan = "3"|'''Advantages of OLED over LCD'''<br />
|bgcolor = "#DBE5F1"|As there is no backlighting, OLED displays offer deeper black levels than LCD displays<br />
|-<br />
|bgcolor = "#DBE5F1"|OLED displays have better contrast ratios<br />
|-<br />
|bgcolor = "#DBE5F1"|Viewing angles offered by OLEDs is more than that offered by LCDs<br />
|-<br />
|align = "center" bgcolor = "#B8CCE4" rowspan = "3"|'''Disadvantages of OLED over LCD'''<br />
|bgcolor = "#B8CCE4"|Brightness levels of OLED display is less than that of LCD<br />
|-<br />
|bgcolor = "#B8CCE4"|Color in OLED displays are often oversaturated<br />
|-<br />
|bgcolor = "#B8CCE4"|The red, green and blue sub-pixels deteriorate and lose efficiency at different rates, thus color consistency worsens over time<br />
|-<br />
|}<br />
<br />
<br />
=== OLED Screen Types in Mobile Phones ===<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|align = "justify" bgcolor = "#DBE5F1"|'''AMOLED'''<br />
|align = "justify" bgcolor = "#DBE5F1"|AMOLED relies on a TFT backplane to switch individual pixels on and off. Active-matrix displays consume significantly less power than passive-matrix counterparts. This makes them well-suited for mobile devices. AMOLED displays are manufactured by printing electroluminescent materials onto a substrate. The relatively simplistic process suggests that OLEDs will ultimately become cheaper and easier to manufacture than LCDs. The creation of the substrate is the most difficult and expensive part of the process. Currently, AMOLED screens are limited in supply. Coupled with high demand, their availability is restricted and they are found in high-end smartphones.<br />
|-<br />
|align = "justify" bgcolor = "#B8CCE4"|'''Super AMOLED'''<br />
|align = "justify" bgcolor = "#B8CCE4"|Super-AMOLED displays are AMOLED displays with an integrated touch function. The original AMOLED screens had reduced visibility in direct sunlight. The thickness of the touch sensor is less than 0.001mm in Super AMOLED displays. This allows the screen to provide better images and to have great visibility even in direct sunlight.<br />
|-<br />
|align = "justify" bgcolor = "#DBE5F1"|'''ClearBlack'''<br />
|align = "justify" bgcolor = "#DBE5F1"|Nokia introduced a display similar to Samsung<nowiki>’</nowiki>s Super AMOLED known as the ClearBlack display. The ClearBlack display makes the screen more visible in direct sunlight. A polarized filter is added to the display. This allows the viewer to see through the screen<nowiki>’</nowiki>s reflection and view the images as they would appear under more ideal conditions.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Super AMOLED Plus'''<br />
|align = "justify" bgcolor = "#B8CCE4"|The Super AMOLED Plus features a traditional three sub-pixels of equal proportion within one pixel. It has an increased sub-pixel count and density. As a result, the display is much crisper, especially when it comes to text. The tighter spacing between pixels also results in better visibility under direct sunlight. The displays are also thinner, brighter and more efficient (by 18%) than the old Super AMOLED displays.<br />
|-<br />
|}<br />
<br />
<br />
=== Future OLED Mobile Screen Variations ===<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|'''Transparent Displays'''<br />
|align = "justify" bgcolor = "#DBE5F1"|Transparent OLEDs have only transparent components (substrate, cathode and anode) and, when turned off, are up to 85 percent as transparent as their substrate. When a transparent OLED display is turned on, it allows light to pass in both directions. A transparent OLED display can be either active- or passive-matrix. TDK began production of a see-through OLED earlier this year.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Flexible Displays'''<br />
|align = "justify" bgcolor = "#B8CCE4"|Flexible OLEDs have substrates made of very flexible metallic foils or plastics. Flexible OLEDs are very lightweight and durable. Their use in devices such as cell phones and PDAs can reduce breakage, a major cause for return or repair. Samsung is readying flexible AMOLED displays for production next year.<br />
|-<br />
|}<br />
<br />
<br />
==OLED Market Overview==<br />
<br />
<br />
===OLED Market: Revenue Overview===<br />
* The Global OLED Display Market was estimated at '''$964 million''' for the year 2010.<br />
* The market stood at '''$884 million''' in the year 2009, and showed a growth of '''11%''' for 2010.<br />
* The market is estimated to reach '''$1,428 million''' by the year 2013 <br />
<br />
[[Image:Global_OLED.JPG|center|760*401px|thumb|Global OLED Display Market: Revenue Forecasts 2003-2013 (in $million), Source: [http://www.marketresearch.com/Frost-Sullivan-v383/LCD-OLED-Manufacturing-Equipment-6172629/ LCD and OLED Manufacturing Equipment Market, Frost & Sullivan ]]]<br />
<br />
<br />
===OLED Market: Volume Overview===<br />
<br />
* The shipments of Organic Light-Emitting Diode (OLED) screens was estimated at '''100 million''' units in 2010<br />
* The shipments of Organic Light-Emitting Diode (OLED) screens are set to rise to '''326.8 million''' units in 2015<br />
* The market is going to be driven by booming demand for Active-Matrix (AM) displays for mobile handsets<br />
* AM-OLED segment, which will boom to '''261.5 million''' units in 2015, up more than twelve fold from '''21.1 million''' in 2009<br />
<br />
[[Image:Global_OLED_Volume.JPG|center|659*383px|thumb|Global OLED Display Shipment 2007-2015 <br />
(Millions of Unit), Source: [http://www.isuppli.com/Display-Materials-and-Systems/News/Pages/iSuppli-Issues-Fast-Facts-on-the-Display-Industry-for-SID-2010.aspx iSuppli ]]]<br />
<br />
===Market Potential by Geography===<br />
<br />
====OLED Market Potential by Geography====<br />
The following chart illustrates the OLED Market Potential by Geography over the period 2004-2014:<br />
{|align = "center"<br />
|<gflash>1050 625 http://dolcera.com/upload/files/OLED_Geography.swf</gflash><br />
|-<br />
|}<br />
<br />
Source: [http://www.icongrouponline.com/ ICON Group International]<br />
<br />
<br />
====AMOLED Market Potential by Geography====<br />
The following chart illustrates the AMOLED Market Potential by Geography over the period 2004-2014:<br />
{|align = "center"<br />
|<gflash>1050 625 http://dolcera.com/upload/files/AMOLED_Geography_01.swf</gflash><br />
|-<br />
|}<br />
<br><br />
Source: [http://www.icongrouponline.com/ ICON Group International]<br />
<br />
<br />
===OLED Market Share===<br />
* '''Samsung Mobile''' leads the OLED Display Market with a market share of 43.2% as reported in 2010<br />
* '''TDK''' is a distant 2nd with a market share of 17.5% and is closely followed by '''RiT Display''' with a share of 16.0%<br />
<br />
The following chart illustrates the Global OLED Display Unit Shipment: Market Share, for the year 2010:<br />
[[Image:Global_OLED_Market_Share.JPG|center|760*401px|thumb|Global OLED Display Unit Shipment: Market Share 2010<br />
, Source: [http://www.displaysearch.com/cps/rde/xchg/displaysearch/hs.xsl/quarterly_oled_shipment_and_forecast_report.asp Quarterly OLED Shipment and Forecast Report, DisplaySearch ]]]<br />
<br />
===OLED Market Share by Application===<br />
* '''Mobile Handset application''' forecast to account for 84%, followed by NBPC at 6% and tablet PC at 4% of 2011E total revenue.<br />
<br />
<br />
The following chart illustrates the Global OLED Display total revenue: Market Share, for the year 2011E:<br />
[[Image:OLED_app_revenue.jpg|center|760*401px|thumb|OLED Display Revenue: Market Share 20111E<br />
, Source: [http://7economy.com/archives/6051 7economy]]]<br />
<br />
==OLED Eco-System==<br />
The following dashboard illustrates all the Companies in the OLED Eco-System:<br />
{|align = "center"<br />
|<gflash>900 425 http://dolcera.com/upload/files/OLED_Ecosystem.swf</gflash><br />
|-<br />
|}<br />
Source: [http://www.oled-info.com/ OLED-info.com]<br />
<br />
<br />
==OLED Market Drivers & Restraints==<br />
<br />
The following figure illustrates a '''Forcefield Analysis of Market Drivers and Restraint'''s for OLED Market (2011-2017):<br />
[[Image:OLED_Drivers_Restraints.JPG|center|900*533px|thumb|Forcefield Analysis of Market Drivers and Restraints for OLED Market (2011-2017)<br />
, Source: [http://www.frost.com Frost & Sullivan]]]<br />
<br />
<br />
===OLED Market Drivers===<br />
The following table illustrates the '''Impact Analysis of OLED Market Drivers''' over a period of time:<br />
{|border="2" cellspacing="0" cellpadding="2" width="60%" align="center"<br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Rank'''</font><br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Driver'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''1-2 years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''3-4 Years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''5-7 years'''</font><br />
|-<br />
|align = "center"|1<br />
|Inherent Advantages of OLED Technology<br />
|align = "center"|Medium<br />
|align = "center"|High<br />
|align = "center"|Very High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|2<br />
|bgcolor = "#C5D9F1"|Increasing Demand for Green Products<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|-<br />
|align = "center"|3<br />
|Increasing demand for OLED Display in Mobile Phones and Signage<br />
|align = "center"|Medium<br />
|align = "center"|Medium<br />
|align = "center"|High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|4<br />
|bgcolor = "#C5D9F1"|Rising Potential of OLED TV<nowiki>’</nowiki>s<br />
|align = "center" bgcolor = "#C5D9F1"|Low<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
'''Inherent Advantages of OLED Technology'''<br />
<br />
* OLED display offer sharper images and better contrast ratios, crisp colors and faster refresh rates compared to any existing display technology.<br />
* OLED Technology also offers consumers better energy management as the whole system functions at optimal power and is of organic substrate.<br />
* OLED displays are created by inserting thin organic films between two conductors and require no backlight; therefore, the displays are more compact and thinner.<br />
* OLED displays, especially or television, are capable of offering viewers a viewing angle of 180 degrees<br />
* As the benefits of OLED displays become more prominent, the demand for OLED manufacturing equipment is expected to increase in the next three to seven years.<br />
<br />
<br />
'''Increasing Demand for Green Products'''<br />
<br />
* The demand for lower power consumption , reduced material usage, and simplicity is expected to propel the OLED demand in the coming years<br />
* The OLED manufacturing equipment market, however, is facing challenges due to its premium and manufacturing challenges. As Manufacturers realize the economies of scale, average selling price is expected to decline, further spurring demand.<br />
* OLED TV market continues to evolve technologically and benefit from increasing demands for energy efficiency from consumers.<br />
<br />
<br />
'''Increasing demand for OLED Displays in Mobile Phones and Signage'''<br />
<br />
* Technology innovations, better functionalities and falling prices are expected to keep up the demand for OLED displays in mobile phones<br />
* Mobile Phones accounted for over 82.0% of the Total OLED display market. With the success of mobile phones, such as the Galaxy, the demand for OLED displays for mobile applications is expected to increase<br />
* The market is also expected to benefit from increasing demand for OLED displays used for signage<br />
* These factors are expected to propel the sales of OLED during the medium and later part of the forecast period.<br />
<br />
<br />
'''Rising Potential of OLED TVs'''<br />
<br />
* The OLED market is yet to observe strong demand for TVs. High premium price and smaller display sizes are key restraints for customers. However, with increasing collaboration within the entire supply chain of the OLED market, the market is expected to experience gradual increase in attractive solutions. According to DisplaySearch, the OLED TV market is expected to generate revenue of $28 billion by 2017.<br />
* The increasing momentum is expected to help commercialize the technology in the next five to seven years. Many display manufacturers have already set up dedicated manufacturing lines from Gen 3.5 to Gen 5.5.<br />
* This is expected to propel OLED manufacturing equipment sales during the latter part of the forecasted period.<br />
<br />
Source: [http://www.frost.com Frost & Sullivan]<br />
<br />
<br />
===OLED Market Restraints===<br />
The following table illustrates the '''Impact Analysis of OLED Market Restraints''' over a period of time:<br />
{|border="2" cellspacing="0" cellpadding="2" width="60%" align="center"<br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Rank'''</font><br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Restraint'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''1-2 years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''3-4 Years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''5-7 years'''</font><br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|1<br />
|bgcolor = "#C5D9F1"|Slow Adoption Rate of New Technology<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|-<br />
|align = "center"|2<br />
|Declining Prices of competing technologies<br />
|align = "center"|High<br />
|align = "center"|High<br />
|align = "center"|High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|3<br />
|bgcolor = "#C5D9F1"|High cost of products<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
'''Slow Adoption Rate of New Technology'''<br />
<br />
* The adoption rate of OLED Technology is comparatively slower than the initial launch of LCD technology. Consumers are complacent with the current technologies it offers then a myriad o advantages and benefits.<br />
* The largest issues foreseen are consumer perception, cost effectiveness of the product, ease of implementation and the ability of the service to provide true blended services<br />
* As a result, there is a significant and vital gap between new product design to volume manufacturing in the OLED market<br />
* Increasing costs and manufacturing complexity has hindered the adoption rate of OLED manufacturing equipment, especially for larger substrate sizes<br />
* The growth of the OLED display market and, in turn equipment sales, will rely on increasing collaboration between material suppliers, technology enablers and equipment providers. Decreased time to market and focus on R&D will be the key to attaining the desired growth trajectory.<br />
<br />
<br />
'''High Cost of Products'''<br />
<br />
* The high cost of OLED display has hindered adoption rates. For Example, customers, while willing to pay a premium price for quality products, hedge until the product has reached mass adoption level. A manufacturing facility typically requires an investment of $ 1 Billion to 3 Billion.<br />
* This has restrained the demand for OLED equipment. Equipment providers are still caught in a dilemma of balancing the high cost of technology development with affordable pricing for consumers.<br />
* Careful adjustment of prices can help minimize the impact of this restraint. Pricing strategy is crucial for success for the overall OLED market.<br />
<br />
<br />
'''Declining Prices of Competing Technologies'''<br />
<br />
* The LCD market is continuing to witness strong demand despite the emergence of new products in the market.<br />
* LCD Technology is transitioning t meet increasing demands for higher switching speeds, becoming more environmentally friendly by using LED backlighting, becoming sleeker and more compact, and having better resolution.<br />
* The LCD and other existing technologies also offer consumers the ability to buy large screen displays. This had created major barriers for increasing the adoption rate for OLED manufacturing equipment.<br />
<br />
Source: [http://www.frost.com Frost & Sullivan]<br />
<br />
<br />
==Transaction Landscape==<br />
The Transaction Landscape in the OLED Market is illustrated in the following links:<br />
# [[Mergers & Acquisitions Landscape]]<br />
# [[Partnerships Landscape]]<br />
# [[Investment Landscape]]<br />
<br />
<br />
==Cluster Analysis for TFT Display Mobile Phones==<br />
The table here summarizes the objective, methodology, procedure and result of the cluster analysis <br />
[[Image:Cluster Analysis.jpg|thumb|center|1000px|[http://faculty.chass.ncsu.edu/garson/PA765/cluster.htm Source: Statnotes, North Carolina State University]]]<br><br />
<br />
===Selection of model===<br />
Using the analysis, one cluster of smart-phones likely to move to OLED technology was identified for each of the two categories. For the next stage of the research - that of forecasting sales - would need the historical sales data of one particular model. For this purpose, '''Apple iPhone''' from the 2nd cluster of candy-bar phones was selected because of constraint of availability of sales data for other models like Blackberry, Nokia N96, HTC Dreamers etc.<br />
<br />
<br />
==='''A Comparison of LCD and OLED technologies'''===<br />
<br />
<br />
The ''radar graph'' here shows the comparison between OLED and TFT LCD.<br />
<br />
[[Image:Comparison.jpg|500px|thumb|center|Comparison[http://digidelve.com/oled/problems Source]]]<br />
<br />
<br />
<br />
The graph depicts the following things:<br />
<br />
# OLEDs are ''thinner'' than LCDs.<br />
# OLEDs are ''lighter'' in weight.<br />
# OLEDs consume ''more power'' than LCDs but OLEDs have an inherent advantage in that they only consume power when they emit light while an LCD backlight consumes constant power regardless of the image being displayed.<br />
# OLEDs ''cost more'': The Cost of an AM-LCD is currently about half that of a comparable AM-OLED display. This is due to the maturity of LCD manufacturing processes and facilities. OLED manufacturing facilities suffer from low yields, currently at 60%-70%.<br />
# OLEDs have a ''shorter lifespan'' as compared to LCDs.<br />
# OLEDs have a ''faster response time'' of .01ms while LCDs have a response time about 8-12ms.<br />
# OLEDs have a ''superior viewing angle'' of 180 degree while LCDs have a lower viewing angle.<br />
<br />
==='''Cluster Analysis'''===<br />
<br />
<br />
====Methodology====<br />
<br />
'''Sample Definition:''' The sample space consists of moblie phones by leading players in the smart-phone mobile category. These models were identified from Gartner reports. The models of smart-phones launched in the last three years in North America were considered. <br />
<br />
'''Sample Space:'''After defining the sample, the various key attributes of smart-phones like camera, display, etc. were defined. The data for these attributes for all the models was collected from the company websites as well as the following websites:<br />
<br />
* www.phonearena.com<br />
* www.phonegg.com<br />
* www.mobile.am<br />
<br />
<br />
The pricing information was obtained from<br />
* www.fonearena.com<br />
* www.india-cellular.com<br />
* www.naaptaol.com<br />
* www.mobilestore.com<br />
* www.indiatimes.com.<br />
<br />
<br />
After aggregating the data we used the '''k-clustering''' method to identify the different clusters for the samples. This technique aims to partition ''n'' observations into ''k'' clusters in which each observation belongs to the cluster with the nearest mean. Hence clusters of phones with similar attributes is achieved.<br />
<br />
Samples were segregated into two broad categories - candy-bar phones and clamshell or sliding phones - with thickness being the differentiating parameter. This was done in order to mitigate any error due to the design of the phone(i.e. candybar,clamshell,slider), since the thicknes of the mobile could be a cause for erroneous results.<br />
<br />
====Cluster analysis results====<br />
<br />
The sheet below shows the clusters formed for the candy-bar phones.<br />
<br />
[[Image:Candy_bar_excels.jpg|Candy bar|1500px|center|thumb]]<br />
<br />
The sheet below shows the cluster formed for the clamshell/sliding phones.<br />
<br />
[[Image:clamshellexcel.jpg|Clamshell_slider|650px|center|thumb]]<br />
<br />
'''Definition of Attributes:'''<br />
*'''Camera''' : resolution in Megapixels<br />
*'''Input method''': two types of input methods - touchscreen and keyboard<br />
*'''Display size''': diagonal length of the displeay screen<br />
*'''Resolution''': display resolutions<br />
*'''Color''': display color<br />
*'''Thickness''': total thickness of the phone<br />
<br />
<br />
The cluster analysis results and subsequent profiling of those clusters are summarized below:<br />
<br />
<br />
''' Candy - Bar Phones'''<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center"|<font color="#262626">'''Clusters'''</font><br />
|align = "center"|<font color="#262626">'''Cell phones'''</font><br />
|align = "center"|<font color="#262626">'''Profile'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''1'''<br />
|align = "center" bgcolor = "#D3DFEE"|Apple iPhone, Samsung i910<br />
|align = "justify" bgcolor = "#D3DFEE"|* Cluster 1 consists of high end cell phones<br>* Cell phones falling in this cluster are touch screen phones with large display size<br>* This is mainly targeting the premium market which is not price sensitive as the mobile phones in this cluster are priced high<br />
|-<br />
|align = "center"|'''2'''<br />
|align = "center"|HTC P3470, HTC touch cruise, HTC touch diamond, HTC touch viva, HTC X7510, i780<br />
|align = "justify"|* This cluster includes cell phones with moderate display size and having touch screen facility<br>* Cell phones in this cluster are in the price range of medium to high, so it is targeting the upper middle to high class.<br>* Almost all the mobile phones falling in this cluster are having WLAN facility indicating that this cluster target trendy class people and people who prefer online games and downloads on mobile phones<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''3'''<br />
|align = "center" bgcolor = "#D3DFEE"|Nokia 5320 express music, Nokia 5800 express music, Nokia 6124 classic, Nokia 6220 classic, Nokia E63, i200, i450, N6120, N78, N79, Pearl 8100<br />
|align = "justify" bgcolor = "#D3DFEE"|* Mobile phones in this cluster are targeted at the middle class as these phones are of moderate price and normal input<br>* They have small display size and moderate camera resolution, which is in sync with their target market<br>* Average thickness<br />
|-<br />
|align = "center"|'''4'''<br />
|align = "center"|E71, i550W, N5700, N73, N82, Blackberry 7130c/7130g<br />
|align = "justify"|* This cluster consists of mobile phones having high camera resolution and normal input indicating that this cluster is for people who give high preference to clicking photographs on mobile phones<br>* They have small display size with most of them not having the WLAN facility, so this is for people who low on using the browsing facilities<br>* The target segment for this cluster is the middle class segment as the mobile phones are also moderately priced<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''5'''<br />
|align = "center" bgcolor = "#D3DFEE"|Curve 8310, Blackberry 8820, Curve 8300, Blackberry 8800, Blackberry bold 9000, Blackberry curve 8330<br />
|align = "justify" bgcolor = "#D3DFEE"|* It includes mobile phones having input through qwerty and with average display size<br>* Target market is Business class people who prefer using email facility on mobiles<br>* The mobile phones are low on camera resolution<br>* All the mobiles in this cluster are high priced indicating that the targeted segment for this cluster is not price sensitive<br />
|-<br />
|}<br />
<br />
<br />
<br />
'''Clamshell Phones'''<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center"|'''Clusters'''<br />
|align = "center"|'''Cell phones'''<br />
|align = "center"|'''Profile'''<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''1'''<br />
|align = "center" bgcolor = "#D3DFEE"|N6650, N95 8GB, E66, 6210 navi, N85<br />
|bgcolor = "#D3DFEE"|* This cluster consists of medium to high priced mobile phones and is targeted at upper middle class<br>* These mobile phones have high camera resolution and normal keypad input<br>* All the mobiles in this cluster have average display size having 16M colors<br />
|-<br />
|align = "center"|'''2'''<br />
|align = "center"|N96, N97<br />
|* It includes mobile phones which are high priced and targeted at affluent people who are not price sensitive<br>* The mobile phones in this cluster are characterized by high camera resolution, big display size and moderate thickness<br>* WLAN facility and high graphic resolution in these mobile phones will attract people who prefer downloading and playing online games<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''3'''<br />
|align = "center" bgcolor = "#D3DFEE"|HTC dream<br />
|bgcolor = "#D3DFEE"|* Mobile phones in this cluster are moderately priced and, targeted at the middle class and the upper middle class segment<br>* These phones have high thickness and high camera resolution<br>* These phones are WLAN enabled and have both qwerty keypad and touch screen input<br />
|-<br />
|align = "center"|'''4'''<br />
|align = "center"|N76, N6290, N75, HTC shadow, E65, i620, N6110<br />
|* This cluster consists of mobile phones with low camera resolution and mainly has normal keypad for input<br>* These phones have medium display size and medium to high thickness<br>* These are low to moderately priced phones targeted at the middle class segment<br />
|-<br />
|}<br />
<br />
=== Prices for AMOLED screens===<br />
<br />
Market data was collected for the prices of OLED screens by various manufacturers<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#FFFF00"|Company Name<br />
|bgcolor = "#FFFF00"|Model Number<br />
|bgcolor = "#FFFF00"|Size<br />
|bgcolor = "#FFFF00"|Resolution<br />
|bgcolor = "#FFFF00"|Colors<br />
|align = "center" bgcolor = "#FFFF00" colspan = "3"|Price/unit(in USD)<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|0-99<br />
|100-999<br />
|1000 <nowiki>++</nowiki><br />
<br />
|-<br />
|Chung Yuan Technology Co., Ltd<br />
|align = "right"|&nbsp;<br />
|2.2"<br />
|220x176<br />
|align = "right"|&nbsp;<br />
|20.00<br />
|16.5<br />
|align = "right"|&nbsp;<br />
<br />
|-<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
<br />
|-<br />
|Digiprotek Markcom India P Ltd.(Densitron)<br />
|C0201QILK-C<br />
|2<br />
|176xRGBx220<br />
|262K<br />
|25.69<br />
|24.92<br />
|20.67<br />
<br />
|-<br />
|&nbsp;<br />
|C0240QGLA-T&nbsp;<br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|35.97<br />
|34.9<br />
|27.83<br />
<br />
|-<br />
|&nbsp;<br />
|P0340WQLC-T&nbsp;<br />
|3.45<br />
|480xRGBx272<br />
|16M<br />
|85.65<br />
|83.1<br />
|47.72<br />
<br />
|-<br />
|&nbsp;<br />
|P0430WQLC-T&nbsp;<br />
|4.3<br />
|480xRGBx272<br />
|16M<br />
|119.90<br />
|116.32<br />
|85.84<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|GLYN GmbH & Co. KG(CMEL)<br />
|C0201QILKC&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2<br />
|176x220<br />
|262K<br />
|25.00<br />
|&nbsp;<br />
|15<br />
<br />
|-<br />
|&nbsp;<br />
|C0240QGLAT&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|30.00<br />
|&nbsp;<br />
|20<br />
<br />
|-<br />
|&nbsp;<br />
|C0283QGLDT&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2.83<br />
|240xRGBx320<br />
|262K<br />
|38&nbsp;<br />
|&nbsp;<br />
|26<br />
<br />
|-<br />
|&nbsp;<br />
|P0340WQLCT&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br />
|3.4<br />
|480xRGBx272&nbsp;<br />
|16M<br />
|60.00<br />
|&nbsp;<br />
|35<br />
<br />
|-<br />
|&nbsp;<br />
|P0430WQLCT&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br />
|4.3<br />
|480xRGBx272<br />
|16M<br />
|90&nbsp;&nbsp;<br />
|&nbsp;<br />
|63<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|A4G Technologies(OSD)<br />
|OSD020AMQCIF<br />
|2<br />
|176x220<br />
|262K<br />
|22.50<br />
|20.98 <br />
|19.10 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD024AMQV <br />
|2.4<br />
|240x320<br />
|262K<br />
|30.20<br />
|28.57 <br />
|25.40 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0283AMQV<br />
|2.83<br />
|240x320<br />
|262K<br />
|38.30<br />
|36.16 <br />
|33.63 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0340WQLC <br />
|3.4<br />
|480x272<br />
|16M<br />
|69.50<br />
|67.25 <br />
|42.48 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0430WQLC-T <br />
|4.3<br />
|480x272<br />
|16M<br />
|109.00<br />
|87.00 <br />
|72.00 <br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|Blaze Technology<br />
|BDO-0240QGLA-T<br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|20.8<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0283QGLD-T<br />
|2.83<br />
|240xRGBx320<br />
|262K<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|26.85<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0340WQLA-T<br />
|3.4<br />
|480x272<br />
|16M<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|39.5<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0430WQLA-T<br />
|4.3<br />
|480x272<br />
|16M<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|90.6<br />
<br />
|}<br />
<br />
==Bass Diffusion Analysis==<br />
<br />
One of the most important functions during the launch of a new product is to forecast the demand for that product, as it guides many other critical decisions faced by the company. Companies can schedule their production activities once they have an idea about the demand in the coming months or years. At a high level, Bass Diffusion Model is used to determine the shape of the curve representing the cumulative adoption of the new product. Bass describes the individuals who decide to adopt an innovation independently of the actions of others as ''innovators''. Those who respond to the influences of the social system and obtain information about a new product from those who have already adopted the product are termed as ''imitators''.<br />
<br />
===Proxies for analysis===<br />
<br />
The use of the model has been made by using the historical sales data of ''proxy'' products to forecast sales for OLED display mobile phones with an assumption that OLED display mobile phones would mimic the diffusion patterns of the proxies. Hence it was important to select the proxies carefully. We used the following for this forecast:<br />
* iPhone - since this was the latest revolution in mobile phone devices and consumers would show a similar adoption behavior for a new mobile phone technology even though it comes at a price premium<br />
* LCD/Plasma TVs & Monitors - consumers spent more money to purchase screens with superior quality by significantly increasing their budget<br />
** LCD and Plasma TVs and LCD monitors were treated as a single analogous product(by ascribing different weights to these) for the forecast<br />
<br />
===Forecasting OLED display phone sales using Analogous Products===<br />
<br />
<br />
<br />
'''The following products from different product categories were considered:'''<br><br />
:# LCD TV <br />
:# Plasma Display TV<br />
:# LCD Monitor<br />
<br />
They were considered to be befitting analogies because of the following similarities:<br><br />
[[Image:Similarities.jpg|center|600px]]<br><br />
<br />
'''Weighted average for the analogous products:'''<br />
Weights for modeling co-efficients for the analogous products such as LCD TV, Plasma Display TV and LCD monitor had been assigned.<br><br />
To judge the similarity of analogous products to OLED, we examined two criteria.<br><br />
::a. Market Structure<br><br />
::b. Product Characteristics<br><br />
[[Image:Criterion.jpg|center|600px]]<br><br />
<br />
The '''S-Graph''' for the cumulative projected sale of OLED display mobiles modeled on analogous products<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart1.swf</gflash></center><br />
<br />
:* In 2009 and 2010 OLED Mobile Phone market would grow slowly driven by ''innovators''<br />
:* From 2011 to 2015, market will grow rapidly due to the ''early adopters''<br />
:* In 2016 and 2017, market will growth will dwindle as ''late adopters'' take to the phones<br />
:* 2018 onwards growth will peter, as the laggards pick up the last few models and the market will saturate<br />
:* From 2016 the technology will near obsolescence and a new technology would replace it<br><br />
<br />
<br />
'''Comparison of Adoption rate of Innovators with those of Imitators'''<br><br />
The model helps to determine sales to innovators and imitators for each year:<br><br><br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart2.swf</gflash></center><br />
<br />
<br />
This graph shows that a small number of innovators will kick-start the sales. OLED display mobile Phones will get off to a slow start in first 2 years. Once a '''''critical mass''''' is reached by the end of the second year, strong imitative effects will take over as the innovators decrease.<br />
<br />
===Detailed Analysis===<br />
<br />
The detailed modeling with a description of parameters and mathematical equations can be viewed here:<br><br />
[[Bass Diffusion Analysis for OLED display phones]]<br />
<br />
==OLED Mobile Phone Projections Based on I-Phone==<br />
<br />
The '''S-Graph''' for the cumulative projected sale of OLED display mobiles modeled on analogous products<br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart3.swf</gflash></center><br />
<br />
:* From Q1,'09 to Q3,'09, the OLED display mobile phone market would grow slowly, driven by ''innovators''<br />
:* From Q4,'09 to Q4,'10 market will grow rapidly due to the ''early adopters''<br />
:* From Q1,'11 and Q3,'11 market growth will dwindle as ''late adopters'' take to the phones<br />
:* Q4,'11 onwards growth will peter, as the laggards pick up the last few models and the market will saturate<br />
:* From Q4, the technology will near obsolescence and a new technology would substitute it<br><br><br />
<br />
'''Comparison of Adoption rate of Innovators with those of Imitators'''<br><br />
The model helps to determine sales to innovators and imitators for each year:<br><br><br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart4.swf</gflash></center><br />
<br />
<br />
This graph shows that a small number of innovators will kick-start the sales. OLED display mobile Phones will get off to a slow start in first three quarters. Once a '''''critical mass''''' is reached by the end of the Q3, strong imitative effects will take over as the innovators decrease.<br />
<br />
===Detailed Analysis===<br />
<br />
The detailed modeling with a description of parameters and mathematical equations can be viewed here:<br><br />
[[Bass Diffusion Analysis for OLED display phones]]<br />
<br />
==Comparing projections==<br />
Since disparate product categories had been used for the two forecasts, the two were compared to cross validate the results [[media:Bass-Model_OLED_comparison.xls|''<<excel sheet with calculations>>'']]<br><br />
<br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart5.swf</gflash></center><br />
<br />
:* Looking at the forecast for OLED display mobile phones based on analogous products and on iPhone, both are seen to be ''convergent''<br />
:* This validates the forecast<br />
<br />
<br />
<br />
==Sneak Preview of some models using OLED technology==<br />
{| class="wikitable" style="font-size:100%" border="1" cellpadding="5" cellspacing="0" width=80%<br />
|-<br />
| width=40% valign=top | [[Image:Apple.jpg|thumb|center|200px|[http://www.appleiphoneapps.com/2009/03/next-iphone-to-have-oled-display-why-should-you-care/ Source: appleiphoneapps.com]]]<br />
| width=60% valign=top | '''1. Apple iPhone''' - It’s nothing official at the moment, but word on the street is that Apple might have chosen a series of OLED displays for its next round of handsets. Such a move would certainly be in the best interests of battery life, as the iPhone isn’t noted for its battery capabilities. Considering the amount of new features that were announced in the iPhone 3.0 firmware update, it would be fairly practical to have a capacitive OLED display in the future.<br />
|-<br />
| width=40% valign=top | [[Image:Nokia.jpg|thumb|center|200px|[http://www.mobilephonereviews.org/category/nokia/ Source: Mobile Phone Reviews]]]<br />
<br />
| width=60% valign=top | '''2. Nokia''' - '''Nokia 6600''' Slide Mobile Phone is a 3G device with large OLED display and 3.2 megapixel camera. It has curved edges and with a weight of 110g is a bit heavy to hold. The 2.2” screen supports 16 million colors and comes with QVGA resolution. The dimensions of the phone are 90 x 45 x 14mm.<br />
<br />
|-<br />
| width=40% valign=top | [[Image:Samsung.jpg|thumb|center|200px|[http://www.att-phones.org/att-samsung-a877-phone-will-be-available.html Source: ATT Phones]]]<br />
<br />
| width=60% valign=top | '''3. Samsung''' - '''Samsung A877''' features include a 3.2-inch WQVGA AMOLED touchscreen, a 3 megapixel camera, GPS, HSDPA and Bluetooth. And as well at it supports AT&T’s 3G service.<br />
|-<br />
<br />
| width=40% valign=top | [[Image:Sony.jpg|thumb|center|200px|[http://www.itechnews.net/2008/01/08/sony-ericsson-z555-stylish-phone/ Source: Itechnews]]]<br />
| width=60% valign=top | '''4. Sony''' - '''Sony Ericsson Z555''' features a 1.9-inch LCD display, an OLED 128×36 external display, a 1.3 Megapixel camera with 4x digital zoom.<br />
|-<br />
| width=40% valign=top | [[Image:LG Mobile.jpg|thumb|center|200px|[http://www.unwiredview.com/2008/02/20/lg-sh150a-gets-am-oled-display-with-26-million-colors-and-hd-support/ Source: Unwiredview]]]<br />
| width=60% valign=top | '''5. LG''' - One of the first handsets to get the new AM OLED, is already advanced '''LG SH150''' DMB TV phone. <br />
|-<br />
| width=40% valign=top | [[Image:Motorola.jpg|thumb|center|200px|[http://www.itechnews.net/2007/10/12/motorola-u9-mobile-phone/ Source: Itechnews]]]<br />
| width=60% valign=top | '''6. Motorola''' - The '''MOTO U9''' is a Quad-band phone with a 2-inch QVGA LCD display, a 1.45-inch secondary OLED display, integrated music player, Bluetooth, 25MB internal memory and a microSD card slot.<br />
<br />
|-<br />
|}<br />
<br />
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! style="background:lightgrey" | Samir Raiyani<br />
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=OLED_Mobile_Phones_Market_Research_and_Analysis_Report&diff=9795
OLED Mobile Phones Market Research and Analysis Report
2011-10-04T11:03:34Z
<p>Shweta.mittal@dolcera.com: /* OLED Market Share by Application */</p>
<hr />
<div>==Executive Summary==<br />
<br />
* The '''OLED''' (Organic Light-Emitting Diode) technology is rapidly evolving, and these improvements are changing the dynamics display screens in mobile phones, TVs, camera, etc. The report provides a technological overview of OLEDS and includes comparisons with the rival technology of LCDs. <br />
* This report analyses the '''Market for OLED display mobile phones''' in terms of products, applications, market size and structure, competitive environment and technology, and determines its future prospects.<br />
* The statistical tools of '''Cluster Analysis''' and '''Regression''' are used to determine the segments of smart-phones likely to adopt OLED displays<br />
* '''Bass Diffusion Model''' for adoption of new technologies is applied to forecast sales of OLED display based mobile phones. This forecast is arrived at by modeling the sales on the historical sales data of certain proxy products and is graphically presented in the report.<br />
* The study reveals that by 2012 cumulative sale of OLED based mobile phone is expected to reach '''183 million units''' and details the trend of these sales over the years<br />
<br />
<br />
==Research Objective==<br />
<br />
* To provide a '''Technology Overview''' for OLED Mobile Phones<br />
* To provide a '''Market Overview''' for OLED Mobile Phones<br />
* To provide a '''Market Estimate''' for OLED Mobile Phones<br />
* To forecast the '''Adoption Rate''' of OLED Mobile Phones<br />
<br />
<br />
==Research Methodology==<br />
<br />
A '''four stage analysis''' was conducted:<br />
<br />
[[Image:4stageanalysis.jpg|center|500px]]<br />
<br />
===Technology Overview===<br />
<br />
A brief understanding of the Technology behind the OLED displays forms the introduction to this report.<br />
<br />
===Market Overview===<br />
<br />
A detailed overview of the OLED Technology forms the basis of the Analysis performed using Base Diffusion Model.<br />
<br />
===Cluster Analysis===<br />
<br />
Cluster Analysis was used to determine a class of mobile handsets that is most likely to use OLED displays. Cluster analysis is a technique used to assign objects to groups (called clusters), such that objects from the same cluster are ''more similar'' to each other than objects from different clusters. To determine the cluster, certain attributes of a handset like input mode, display size, camera resolution, etc. were considered.<br />
<br />
===Bass Diffusion Model===<br />
<br />
The Bass Diffusion Model was used to forecast the adoption of the OLED display mobile phones by consumers. The Bass Diffusion model is a quantitative tool that describes the process of how new products get adopted as an interaction between users and potential users. In this analysis, the model was employed to forecast the sales of a new product by utilizing historical sales data of analogous products from the same product category as well as from a diverse product category. The market penetration for mobiles with OLED displays is arrived at with result for both the proxies.<br />
<br />
== Mobile Phone Display: Technology Overview ==<br />
<br />
'''OLED (Organic Light Emitting Diodes)''' is a flat display technology, made by placing a series of organic thin films between two conductors. On applying an electric current, a bright light is emitted. OLEDs use organic semiconductor material instead of inorganic semiconductor material used in conventional Light Emitting Diodes (LEDs). Through a process called electrophosphorescence, OLEDs emit light in the presence of an electric current. Like any other diode, OLEDs permit electric current to pass only in one direction. Unlike diodes made from inorganic semiconductors, OLEDs are very flexible because they are only '''100 to 500 nanometers''' thick - the human hair is 200 times thicker than it. As a result, OLED screens are very flexible and can be made in very large sheets. OLEDs use lesser energy than LEDs as well.<br />
<br />
The easiest way to understand OLEDs is to compare them to LCDs. LCDs are made by placing a color filter over a white backlight source – filtering out the colors that are not wanted for each pixel. If you want to display blue, you'll have to filter out green and red. OLEDs, on the other hand, are emissive, which means that you simply need to display the colors you need for each pixel, which is made from three color (RGB) OLED “pixels.”<br />
<br />
<br />
=== Mobile Phone Display Types ===<br />
There are two types of display technologies which are used in mobile phones:<br />
# Liquid Crystal Display (LCD)<br />
# Organic Light-Emitting Diode (OLED)<br />
<br />
Recent developments in LCD are Super LCD (S-LCD) and IPS (In-Plane Switching technology) Panel. IPS technology is used in Apple’s Retina display and LG’s NOVA display. OLED technology includes developments such as Super AMOLED, Super AMOLED Plus and ClearBlack.<br />
<br />
<br />
=== Difference between LCD and OLED ===<br />
The LCD uses light modulating properties of liquid crystals (LCs). The liquid crystals do not emit light directly. So, a light source is needed for proper viewing. The OLED uses organic compounds that illuminate when exposed to electric currents. Hence, a backlight is not required for OLEDs. This makes OLED displays thinner than LCD displays.<br />
<br />
==== Difference between AMOLED and AMLCD ====<br />
{|border="2" cellspacing="0" cellpadding="2" width="90%" align="center"<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Properties'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''AM OLED'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''AM LCD'''</font><br />
|-<br />
|'''Thickness/Weight'''<br />
|Thinner, best is 0.05 mm; lighter<br />
|Thicker, best is 0.8 mm; heavier<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Diagonal Size'''<br />
|bgcolor = "#C5D9F1"|Limited to small and medium sizes; largest demo is around 40"<br />
|bgcolor = "#C5D9F1"|Can be manufactured larger; largest demo is <nowiki>~</nowiki>100"<br />
|-<br />
|'''Viewing Angle'''<br />
|Up to 180 degrees<br />
|Narrower, depends on liquid crystal type<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Color Gamut'''<br />
|bgcolor = "#C5D9F1"|<nowiki>></nowiki>100% NTSC (top emission), around 70% NTSC (bottom); high at all gray levels<br />
|bgcolor = "#C5D9F1"|Around 70%, up to 100% NTSC (LED backlight and new color filter); falls at low gray levels<br />
|-<br />
|'''Color Reproduction'''<br />
|Better; gamut independent of view angle<br />
|Good; gamut changes with viewing angle<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Resolution'''<br />
|bgcolor = "#C5D9F1"|Lower; 308 dpi (SM), 202 dpi (polymer)<br />
|bgcolor = "#C5D9F1"|Higher; best is 498 dpi<br />
|-<br />
|'''Response Time'''<br />
|Faster, nanoseconds. No motion blur, good for 3D<br />
|Slower, milliseconds<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Contrast Ratio'''<br />
|bgcolor = "#C5D9F1"|Higher<br />
|bgcolor = "#C5D9F1"|Lower<br />
|-<br />
|'''Sunlight Readability'''<br />
|Better than transmissive LCD, worse than transflective LCD<br />
|Ok if transflective<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Operating Temperature'''<br />
|bgcolor = "#C5D9F1"|Range is larger, can operate at low temps like -40°C<br />
|bgcolor = "#C5D9F1"|Range is smaller, lowest temp is -10°C<br />
|-<br />
|'''Power Consumption'''<br />
|Lower at typical video content, when around 30% of pixels are on<br />
|Higher at typical video content<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Lifetime'''<br />
|bgcolor = "#C5D9F1"|Shorter, 5K to 30K hour, but improving<br />
|bgcolor = "#C5D9F1"|Much longer, above 50K hour<br />
|-<br />
|'''Manufacturing Investment'''<br />
|Lower, but lack of standards keeps the investment only slightly lower<br />
|Higher<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Production Cost'''<br />
|bgcolor = "#C5D9F1"|Expensive; low yield and complex structure, potential to be low cost<br />
|bgcolor = "#C5D9F1"|Cheaper than AMOLED<br />
|-<br />
|align = "center" colspan = "3"|'''[http://www.displaysearch.com/ Source: DisplaySearch]'''<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
==== OLED Construction ====<br />
An OLED can be made of a single layer of organic material but multiple layers increase efficiency and effectiveness. A typical OLED is comprised of five layers of material:<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Layer'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|'''Substrate layer'''<br />
|bgcolor = "#DBE5F1"|This layer supports the OLED and is made of clear plastic, glass, foil or other materials.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Anode layer'''<br />
|bgcolor = "#B8CCE4"|The anode layer is transparent and is positively charged. When an electric current is applied, this layer attracts electrons as they flow through the OLED. As with a LED, the anode forms "holes" onto which electrons fall.<br />
|-<br />
|bgcolor = "#DBE5F1"|'''Conducting layer'''<br />
|bgcolor = "#DBE5F1"|This layer is made of organic plastic material and transports the "holes" from the anode layer.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Emissive layer'''<br />
|bgcolor = "#B8CCE4"|This layer transports electrons from the cathode. It is also made of organic plastic molecules but there are different from those in the conducting layer. This is the layer that determines the color of the light emitted.<br />
|-<br />
|bgcolor = "#DBE5F1"|'''Cathode layer'''<br />
|bgcolor = "#DBE5F1"|This layer injects electrons into the OLED when an electric current is applied. Depending on the OLED and the color effect desired, this layer may or may not be transparent.<br />
|-<br />
|}<br />
<br />
<br />
[[image:oledstructure.jpg|center|406*365px|thumb|Source: [http://electronics.howstuffworks.com/oled1.htm How Stuff Works]]]<br />
<br />
==== Types of OLED Construction ====<br />
OLEDs can be constructed in a variety of ways to serve a variety of functions. While each type of construction uses the layers described previously, the manner in which each layer is built alters the way the OLED functions. The six most common types of OLEDs are as follows:<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Passive-Matrix OLED'''<br />
|bgcolor = "#DBE5F1"|Anode and cathode laid perpendicular to each other<br />
|-<br />
|bgcolor = "#DBE5F1"|PM OLEDs are easy to make and display text and icons very effectively, particularly in small 2-inch to 3-inch screens<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''Active-Matrix OLED'''<br />
|bgcolor = "#B8CCE4"|AM OLEDs are constructed with continuous film materials<br />
|-<br />
|bgcolor = "#B8CCE4"|AM OLEDs use less energy than PM OLEDs and have faster refresh rates<br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Transparent OLED'''<br />
|bgcolor = "#DBE5F1"|Constructed with transparent materials for all five layers, a transparent OLED can be made as either a PM OLED or an AM OLED<br />
|-<br />
|bgcolor = "#DBE5F1"|Useful for heads-up display applications<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''Top-Emitting OLED'''<br />
|bgcolor = "#B8CCE4"|These types of OLEDs use an opaque or reflective substrate that is useful for smart card applications<br />
|-<br />
|bgcolor = "#B8CCE4"|Best suited for an active-matrix design<br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Foldable OLED'''<br />
|bgcolor = "#DBE5F1"|The substrate of this type of OLED is very flexible, allowing the OLED to be folded or rolled up<br />
|-<br />
|bgcolor = "#DBE5F1"|Because of their flexibility, foldable OLEDs could be attached to fabrics with a variety of applications<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''White OLED'''<br />
|bgcolor = "#B8CCE4"|These OLEDs emit white light that is brighter, more uniform and more energy efficient than that emitted by fluorescent lights<br />
|-<br />
|bgcolor = "#B8CCE4"|Potential to replace incandescent and fluorescent lighting in commercial industrial, and residential applications<br />
|-<br />
|}<br />
<br />
<br />
==== Advantages and Disadvantages ====<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|align = "center" bgcolor = "#DBE5F1" rowspan = "3"|'''Advantages of OLED over LCD'''<br />
|bgcolor = "#DBE5F1"|As there is no backlighting, OLED displays offer deeper black levels than LCD displays<br />
|-<br />
|bgcolor = "#DBE5F1"|OLED displays have better contrast ratios<br />
|-<br />
|bgcolor = "#DBE5F1"|Viewing angles offered by OLEDs is more than that offered by LCDs<br />
|-<br />
|align = "center" bgcolor = "#B8CCE4" rowspan = "3"|'''Disadvantages of OLED over LCD'''<br />
|bgcolor = "#B8CCE4"|Brightness levels of OLED display is less than that of LCD<br />
|-<br />
|bgcolor = "#B8CCE4"|Color in OLED displays are often oversaturated<br />
|-<br />
|bgcolor = "#B8CCE4"|The red, green and blue sub-pixels deteriorate and lose efficiency at different rates, thus color consistency worsens over time<br />
|-<br />
|}<br />
<br />
<br />
=== OLED Screen Types in Mobile Phones ===<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|align = "justify" bgcolor = "#DBE5F1"|'''AMOLED'''<br />
|align = "justify" bgcolor = "#DBE5F1"|AMOLED relies on a TFT backplane to switch individual pixels on and off. Active-matrix displays consume significantly less power than passive-matrix counterparts. This makes them well-suited for mobile devices. AMOLED displays are manufactured by printing electroluminescent materials onto a substrate. The relatively simplistic process suggests that OLEDs will ultimately become cheaper and easier to manufacture than LCDs. The creation of the substrate is the most difficult and expensive part of the process. Currently, AMOLED screens are limited in supply. Coupled with high demand, their availability is restricted and they are found in high-end smartphones.<br />
|-<br />
|align = "justify" bgcolor = "#B8CCE4"|'''Super AMOLED'''<br />
|align = "justify" bgcolor = "#B8CCE4"|Super-AMOLED displays are AMOLED displays with an integrated touch function. The original AMOLED screens had reduced visibility in direct sunlight. The thickness of the touch sensor is less than 0.001mm in Super AMOLED displays. This allows the screen to provide better images and to have great visibility even in direct sunlight.<br />
|-<br />
|align = "justify" bgcolor = "#DBE5F1"|'''ClearBlack'''<br />
|align = "justify" bgcolor = "#DBE5F1"|Nokia introduced a display similar to Samsung<nowiki>’</nowiki>s Super AMOLED known as the ClearBlack display. The ClearBlack display makes the screen more visible in direct sunlight. A polarized filter is added to the display. This allows the viewer to see through the screen<nowiki>’</nowiki>s reflection and view the images as they would appear under more ideal conditions.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Super AMOLED Plus'''<br />
|align = "justify" bgcolor = "#B8CCE4"|The Super AMOLED Plus features a traditional three sub-pixels of equal proportion within one pixel. It has an increased sub-pixel count and density. As a result, the display is much crisper, especially when it comes to text. The tighter spacing between pixels also results in better visibility under direct sunlight. The displays are also thinner, brighter and more efficient (by 18%) than the old Super AMOLED displays.<br />
|-<br />
|}<br />
<br />
<br />
=== Future OLED Mobile Screen Variations ===<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|'''Transparent Displays'''<br />
|align = "justify" bgcolor = "#DBE5F1"|Transparent OLEDs have only transparent components (substrate, cathode and anode) and, when turned off, are up to 85 percent as transparent as their substrate. When a transparent OLED display is turned on, it allows light to pass in both directions. A transparent OLED display can be either active- or passive-matrix. TDK began production of a see-through OLED earlier this year.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Flexible Displays'''<br />
|align = "justify" bgcolor = "#B8CCE4"|Flexible OLEDs have substrates made of very flexible metallic foils or plastics. Flexible OLEDs are very lightweight and durable. Their use in devices such as cell phones and PDAs can reduce breakage, a major cause for return or repair. Samsung is readying flexible AMOLED displays for production next year.<br />
|-<br />
|}<br />
<br />
<br />
==OLED Market Overview==<br />
<br />
<br />
===OLED Market: Revenue Overview===<br />
* The Global OLED Display Market was estimated at '''$964 million''' for the year 2010.<br />
* The market stood at '''$884 million''' in the year 2009, and showed a growth of '''11%''' for 2010.<br />
* The market is estimated to reach '''$1,428 million''' by the year 2013 <br />
<br />
[[Image:Global_OLED.JPG|center|760*401px|thumb|Global OLED Display Market: Revenue Forecasts 2003-2013 (in $million), Source: [http://www.marketresearch.com/Frost-Sullivan-v383/LCD-OLED-Manufacturing-Equipment-6172629/ LCD and OLED Manufacturing Equipment Market, Frost & Sullivan ]]]<br />
<br />
<br />
===OLED Market: Volume Overview===<br />
<br />
* The shipments of Organic Light-Emitting Diode (OLED) screens was estimated at '''100 million''' units in 2010<br />
* The shipments of Organic Light-Emitting Diode (OLED) screens are set to rise to '''326.8 million''' units in 2015<br />
* The market is going to be driven by booming demand for Active-Matrix (AM) displays for mobile handsets<br />
* AM-OLED segment, which will boom to '''261.5 million''' units in 2015, up more than twelve fold from '''21.1 million''' in 2009<br />
<br />
[[Image:Global_OLED_Volume.JPG|center|659*383px|thumb|Global OLED Display Shipment 2007-2015 <br />
(Millions of Unit), Source: [http://www.isuppli.com/Display-Materials-and-Systems/News/Pages/iSuppli-Issues-Fast-Facts-on-the-Display-Industry-for-SID-2010.aspx iSuppli ]]]<br />
<br />
===Market Potential by Geography===<br />
<br />
====OLED Market Potential by Geography====<br />
The following chart illustrates the OLED Market Potential by Geography over the period 2004-2014:<br />
{|align = "center"<br />
|<gflash>1050 625 http://dolcera.com/upload/files/OLED_Geography.swf</gflash><br />
|-<br />
|}<br />
<br />
Source: [http://www.icongrouponline.com/ ICON Group International]<br />
<br />
<br />
====AMOLED Market Potential by Geography====<br />
The following chart illustrates the AMOLED Market Potential by Geography over the period 2004-2014:<br />
{|align = "center"<br />
|<gflash>1050 625 http://dolcera.com/upload/files/AMOLED_Geography_01.swf</gflash><br />
|-<br />
|}<br />
<br><br />
Source: [http://www.icongrouponline.com/ ICON Group International]<br />
<br />
<br />
===OLED Market Share===<br />
* '''Samsung Mobile''' leads the OLED Display Market with a market share of 43.2% as reported in 2010<br />
* '''TDK''' is a distant 2nd with a market share of 17.5% and is closely followed by '''RiT Display''' with a share of 16.0%<br />
<br />
The following chart illustrates the Global OLED Display Unit Shipment: Market Share, for the year 2010:<br />
[[Image:Global_OLED_Market_Share.JPG|center|760*401px|thumb|Global OLED Display Unit Shipment: Market Share 2010<br />
, Source: [http://www.displaysearch.com/cps/rde/xchg/displaysearch/hs.xsl/quarterly_oled_shipment_and_forecast_report.asp Quarterly OLED Shipment and Forecast Report, DisplaySearch ]]]<br />
<br />
===OLED Market Share by Application===<br />
* '''Mobile Handset application''' forecast to account for 84%, followed by NBPC at 6% and tablet PC at 4% of 2011E total revenue.<br />
<br />
<br />
The following chart illustrates the Global OLED Display total revenue: Market Share, for the year 2011E:<br />
[[Image:OLED_app_revenue.jpg|center|760*401px|thumb|Global OLED Display Revenue: Market Share 20111E<br />
, Source: [http://7economy.com/archives/6051 7economy]]]<br />
<br />
==OLED Eco-System==<br />
The following dashboard illustrates all the Companies in the OLED Eco-System:<br />
{|align = "center"<br />
|<gflash>900 425 http://dolcera.com/upload/files/OLED_Ecosystem.swf</gflash><br />
|-<br />
|}<br />
Source: [http://www.oled-info.com/ OLED-info.com]<br />
<br />
<br />
==OLED Market Drivers & Restraints==<br />
<br />
The following figure illustrates a '''Forcefield Analysis of Market Drivers and Restraint'''s for OLED Market (2011-2017):<br />
[[Image:OLED_Drivers_Restraints.JPG|center|900*533px|thumb|Forcefield Analysis of Market Drivers and Restraints for OLED Market (2011-2017)<br />
, Source: [http://www.frost.com Frost & Sullivan]]]<br />
<br />
<br />
===OLED Market Drivers===<br />
The following table illustrates the '''Impact Analysis of OLED Market Drivers''' over a period of time:<br />
{|border="2" cellspacing="0" cellpadding="2" width="60%" align="center"<br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Rank'''</font><br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Driver'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''1-2 years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''3-4 Years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''5-7 years'''</font><br />
|-<br />
|align = "center"|1<br />
|Inherent Advantages of OLED Technology<br />
|align = "center"|Medium<br />
|align = "center"|High<br />
|align = "center"|Very High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|2<br />
|bgcolor = "#C5D9F1"|Increasing Demand for Green Products<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|-<br />
|align = "center"|3<br />
|Increasing demand for OLED Display in Mobile Phones and Signage<br />
|align = "center"|Medium<br />
|align = "center"|Medium<br />
|align = "center"|High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|4<br />
|bgcolor = "#C5D9F1"|Rising Potential of OLED TV<nowiki>’</nowiki>s<br />
|align = "center" bgcolor = "#C5D9F1"|Low<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
'''Inherent Advantages of OLED Technology'''<br />
<br />
* OLED display offer sharper images and better contrast ratios, crisp colors and faster refresh rates compared to any existing display technology.<br />
* OLED Technology also offers consumers better energy management as the whole system functions at optimal power and is of organic substrate.<br />
* OLED displays are created by inserting thin organic films between two conductors and require no backlight; therefore, the displays are more compact and thinner.<br />
* OLED displays, especially or television, are capable of offering viewers a viewing angle of 180 degrees<br />
* As the benefits of OLED displays become more prominent, the demand for OLED manufacturing equipment is expected to increase in the next three to seven years.<br />
<br />
<br />
'''Increasing Demand for Green Products'''<br />
<br />
* The demand for lower power consumption , reduced material usage, and simplicity is expected to propel the OLED demand in the coming years<br />
* The OLED manufacturing equipment market, however, is facing challenges due to its premium and manufacturing challenges. As Manufacturers realize the economies of scale, average selling price is expected to decline, further spurring demand.<br />
* OLED TV market continues to evolve technologically and benefit from increasing demands for energy efficiency from consumers.<br />
<br />
<br />
'''Increasing demand for OLED Displays in Mobile Phones and Signage'''<br />
<br />
* Technology innovations, better functionalities and falling prices are expected to keep up the demand for OLED displays in mobile phones<br />
* Mobile Phones accounted for over 82.0% of the Total OLED display market. With the success of mobile phones, such as the Galaxy, the demand for OLED displays for mobile applications is expected to increase<br />
* The market is also expected to benefit from increasing demand for OLED displays used for signage<br />
* These factors are expected to propel the sales of OLED during the medium and later part of the forecast period.<br />
<br />
<br />
'''Rising Potential of OLED TVs'''<br />
<br />
* The OLED market is yet to observe strong demand for TVs. High premium price and smaller display sizes are key restraints for customers. However, with increasing collaboration within the entire supply chain of the OLED market, the market is expected to experience gradual increase in attractive solutions. According to DisplaySearch, the OLED TV market is expected to generate revenue of $28 billion by 2017.<br />
* The increasing momentum is expected to help commercialize the technology in the next five to seven years. Many display manufacturers have already set up dedicated manufacturing lines from Gen 3.5 to Gen 5.5.<br />
* This is expected to propel OLED manufacturing equipment sales during the latter part of the forecasted period.<br />
<br />
Source: [http://www.frost.com Frost & Sullivan]<br />
<br />
<br />
===OLED Market Restraints===<br />
The following table illustrates the '''Impact Analysis of OLED Market Restraints''' over a period of time:<br />
{|border="2" cellspacing="0" cellpadding="2" width="60%" align="center"<br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Rank'''</font><br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Restraint'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''1-2 years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''3-4 Years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''5-7 years'''</font><br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|1<br />
|bgcolor = "#C5D9F1"|Slow Adoption Rate of New Technology<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|-<br />
|align = "center"|2<br />
|Declining Prices of competing technologies<br />
|align = "center"|High<br />
|align = "center"|High<br />
|align = "center"|High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|3<br />
|bgcolor = "#C5D9F1"|High cost of products<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
'''Slow Adoption Rate of New Technology'''<br />
<br />
* The adoption rate of OLED Technology is comparatively slower than the initial launch of LCD technology. Consumers are complacent with the current technologies it offers then a myriad o advantages and benefits.<br />
* The largest issues foreseen are consumer perception, cost effectiveness of the product, ease of implementation and the ability of the service to provide true blended services<br />
* As a result, there is a significant and vital gap between new product design to volume manufacturing in the OLED market<br />
* Increasing costs and manufacturing complexity has hindered the adoption rate of OLED manufacturing equipment, especially for larger substrate sizes<br />
* The growth of the OLED display market and, in turn equipment sales, will rely on increasing collaboration between material suppliers, technology enablers and equipment providers. Decreased time to market and focus on R&D will be the key to attaining the desired growth trajectory.<br />
<br />
<br />
'''High Cost of Products'''<br />
<br />
* The high cost of OLED display has hindered adoption rates. For Example, customers, while willing to pay a premium price for quality products, hedge until the product has reached mass adoption level. A manufacturing facility typically requires an investment of $ 1 Billion to 3 Billion.<br />
* This has restrained the demand for OLED equipment. Equipment providers are still caught in a dilemma of balancing the high cost of technology development with affordable pricing for consumers.<br />
* Careful adjustment of prices can help minimize the impact of this restraint. Pricing strategy is crucial for success for the overall OLED market.<br />
<br />
<br />
'''Declining Prices of Competing Technologies'''<br />
<br />
* The LCD market is continuing to witness strong demand despite the emergence of new products in the market.<br />
* LCD Technology is transitioning t meet increasing demands for higher switching speeds, becoming more environmentally friendly by using LED backlighting, becoming sleeker and more compact, and having better resolution.<br />
* The LCD and other existing technologies also offer consumers the ability to buy large screen displays. This had created major barriers for increasing the adoption rate for OLED manufacturing equipment.<br />
<br />
Source: [http://www.frost.com Frost & Sullivan]<br />
<br />
<br />
==Transaction Landscape==<br />
The Transaction Landscape in the OLED Market is illustrated in the following links:<br />
# [[Mergers & Acquisitions Landscape]]<br />
# [[Partnerships Landscape]]<br />
# [[Investment Landscape]]<br />
<br />
<br />
==Cluster Analysis for TFT Display Mobile Phones==<br />
The table here summarizes the objective, methodology, procedure and result of the cluster analysis <br />
[[Image:Cluster Analysis.jpg|thumb|center|1000px|[http://faculty.chass.ncsu.edu/garson/PA765/cluster.htm Source: Statnotes, North Carolina State University]]]<br><br />
<br />
===Selection of model===<br />
Using the analysis, one cluster of smart-phones likely to move to OLED technology was identified for each of the two categories. For the next stage of the research - that of forecasting sales - would need the historical sales data of one particular model. For this purpose, '''Apple iPhone''' from the 2nd cluster of candy-bar phones was selected because of constraint of availability of sales data for other models like Blackberry, Nokia N96, HTC Dreamers etc.<br />
<br />
<br />
==='''A Comparison of LCD and OLED technologies'''===<br />
<br />
<br />
The ''radar graph'' here shows the comparison between OLED and TFT LCD.<br />
<br />
[[Image:Comparison.jpg|500px|thumb|center|Comparison[http://digidelve.com/oled/problems Source]]]<br />
<br />
<br />
<br />
The graph depicts the following things:<br />
<br />
# OLEDs are ''thinner'' than LCDs.<br />
# OLEDs are ''lighter'' in weight.<br />
# OLEDs consume ''more power'' than LCDs but OLEDs have an inherent advantage in that they only consume power when they emit light while an LCD backlight consumes constant power regardless of the image being displayed.<br />
# OLEDs ''cost more'': The Cost of an AM-LCD is currently about half that of a comparable AM-OLED display. This is due to the maturity of LCD manufacturing processes and facilities. OLED manufacturing facilities suffer from low yields, currently at 60%-70%.<br />
# OLEDs have a ''shorter lifespan'' as compared to LCDs.<br />
# OLEDs have a ''faster response time'' of .01ms while LCDs have a response time about 8-12ms.<br />
# OLEDs have a ''superior viewing angle'' of 180 degree while LCDs have a lower viewing angle.<br />
<br />
==='''Cluster Analysis'''===<br />
<br />
<br />
====Methodology====<br />
<br />
'''Sample Definition:''' The sample space consists of moblie phones by leading players in the smart-phone mobile category. These models were identified from Gartner reports. The models of smart-phones launched in the last three years in North America were considered. <br />
<br />
'''Sample Space:'''After defining the sample, the various key attributes of smart-phones like camera, display, etc. were defined. The data for these attributes for all the models was collected from the company websites as well as the following websites:<br />
<br />
* www.phonearena.com<br />
* www.phonegg.com<br />
* www.mobile.am<br />
<br />
<br />
The pricing information was obtained from<br />
* www.fonearena.com<br />
* www.india-cellular.com<br />
* www.naaptaol.com<br />
* www.mobilestore.com<br />
* www.indiatimes.com.<br />
<br />
<br />
After aggregating the data we used the '''k-clustering''' method to identify the different clusters for the samples. This technique aims to partition ''n'' observations into ''k'' clusters in which each observation belongs to the cluster with the nearest mean. Hence clusters of phones with similar attributes is achieved.<br />
<br />
Samples were segregated into two broad categories - candy-bar phones and clamshell or sliding phones - with thickness being the differentiating parameter. This was done in order to mitigate any error due to the design of the phone(i.e. candybar,clamshell,slider), since the thicknes of the mobile could be a cause for erroneous results.<br />
<br />
====Cluster analysis results====<br />
<br />
The sheet below shows the clusters formed for the candy-bar phones.<br />
<br />
[[Image:Candy_bar_excels.jpg|Candy bar|1500px|center|thumb]]<br />
<br />
The sheet below shows the cluster formed for the clamshell/sliding phones.<br />
<br />
[[Image:clamshellexcel.jpg|Clamshell_slider|650px|center|thumb]]<br />
<br />
'''Definition of Attributes:'''<br />
*'''Camera''' : resolution in Megapixels<br />
*'''Input method''': two types of input methods - touchscreen and keyboard<br />
*'''Display size''': diagonal length of the displeay screen<br />
*'''Resolution''': display resolutions<br />
*'''Color''': display color<br />
*'''Thickness''': total thickness of the phone<br />
<br />
<br />
The cluster analysis results and subsequent profiling of those clusters are summarized below:<br />
<br />
<br />
''' Candy - Bar Phones'''<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center"|<font color="#262626">'''Clusters'''</font><br />
|align = "center"|<font color="#262626">'''Cell phones'''</font><br />
|align = "center"|<font color="#262626">'''Profile'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''1'''<br />
|align = "center" bgcolor = "#D3DFEE"|Apple iPhone, Samsung i910<br />
|align = "justify" bgcolor = "#D3DFEE"|* Cluster 1 consists of high end cell phones<br>* Cell phones falling in this cluster are touch screen phones with large display size<br>* This is mainly targeting the premium market which is not price sensitive as the mobile phones in this cluster are priced high<br />
|-<br />
|align = "center"|'''2'''<br />
|align = "center"|HTC P3470, HTC touch cruise, HTC touch diamond, HTC touch viva, HTC X7510, i780<br />
|align = "justify"|* This cluster includes cell phones with moderate display size and having touch screen facility<br>* Cell phones in this cluster are in the price range of medium to high, so it is targeting the upper middle to high class.<br>* Almost all the mobile phones falling in this cluster are having WLAN facility indicating that this cluster target trendy class people and people who prefer online games and downloads on mobile phones<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''3'''<br />
|align = "center" bgcolor = "#D3DFEE"|Nokia 5320 express music, Nokia 5800 express music, Nokia 6124 classic, Nokia 6220 classic, Nokia E63, i200, i450, N6120, N78, N79, Pearl 8100<br />
|align = "justify" bgcolor = "#D3DFEE"|* Mobile phones in this cluster are targeted at the middle class as these phones are of moderate price and normal input<br>* They have small display size and moderate camera resolution, which is in sync with their target market<br>* Average thickness<br />
|-<br />
|align = "center"|'''4'''<br />
|align = "center"|E71, i550W, N5700, N73, N82, Blackberry 7130c/7130g<br />
|align = "justify"|* This cluster consists of mobile phones having high camera resolution and normal input indicating that this cluster is for people who give high preference to clicking photographs on mobile phones<br>* They have small display size with most of them not having the WLAN facility, so this is for people who low on using the browsing facilities<br>* The target segment for this cluster is the middle class segment as the mobile phones are also moderately priced<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''5'''<br />
|align = "center" bgcolor = "#D3DFEE"|Curve 8310, Blackberry 8820, Curve 8300, Blackberry 8800, Blackberry bold 9000, Blackberry curve 8330<br />
|align = "justify" bgcolor = "#D3DFEE"|* It includes mobile phones having input through qwerty and with average display size<br>* Target market is Business class people who prefer using email facility on mobiles<br>* The mobile phones are low on camera resolution<br>* All the mobiles in this cluster are high priced indicating that the targeted segment for this cluster is not price sensitive<br />
|-<br />
|}<br />
<br />
<br />
<br />
'''Clamshell Phones'''<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center"|'''Clusters'''<br />
|align = "center"|'''Cell phones'''<br />
|align = "center"|'''Profile'''<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''1'''<br />
|align = "center" bgcolor = "#D3DFEE"|N6650, N95 8GB, E66, 6210 navi, N85<br />
|bgcolor = "#D3DFEE"|* This cluster consists of medium to high priced mobile phones and is targeted at upper middle class<br>* These mobile phones have high camera resolution and normal keypad input<br>* All the mobiles in this cluster have average display size having 16M colors<br />
|-<br />
|align = "center"|'''2'''<br />
|align = "center"|N96, N97<br />
|* It includes mobile phones which are high priced and targeted at affluent people who are not price sensitive<br>* The mobile phones in this cluster are characterized by high camera resolution, big display size and moderate thickness<br>* WLAN facility and high graphic resolution in these mobile phones will attract people who prefer downloading and playing online games<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''3'''<br />
|align = "center" bgcolor = "#D3DFEE"|HTC dream<br />
|bgcolor = "#D3DFEE"|* Mobile phones in this cluster are moderately priced and, targeted at the middle class and the upper middle class segment<br>* These phones have high thickness and high camera resolution<br>* These phones are WLAN enabled and have both qwerty keypad and touch screen input<br />
|-<br />
|align = "center"|'''4'''<br />
|align = "center"|N76, N6290, N75, HTC shadow, E65, i620, N6110<br />
|* This cluster consists of mobile phones with low camera resolution and mainly has normal keypad for input<br>* These phones have medium display size and medium to high thickness<br>* These are low to moderately priced phones targeted at the middle class segment<br />
|-<br />
|}<br />
<br />
=== Prices for AMOLED screens===<br />
<br />
Market data was collected for the prices of OLED screens by various manufacturers<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#FFFF00"|Company Name<br />
|bgcolor = "#FFFF00"|Model Number<br />
|bgcolor = "#FFFF00"|Size<br />
|bgcolor = "#FFFF00"|Resolution<br />
|bgcolor = "#FFFF00"|Colors<br />
|align = "center" bgcolor = "#FFFF00" colspan = "3"|Price/unit(in USD)<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|0-99<br />
|100-999<br />
|1000 <nowiki>++</nowiki><br />
<br />
|-<br />
|Chung Yuan Technology Co., Ltd<br />
|align = "right"|&nbsp;<br />
|2.2"<br />
|220x176<br />
|align = "right"|&nbsp;<br />
|20.00<br />
|16.5<br />
|align = "right"|&nbsp;<br />
<br />
|-<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
<br />
|-<br />
|Digiprotek Markcom India P Ltd.(Densitron)<br />
|C0201QILK-C<br />
|2<br />
|176xRGBx220<br />
|262K<br />
|25.69<br />
|24.92<br />
|20.67<br />
<br />
|-<br />
|&nbsp;<br />
|C0240QGLA-T&nbsp;<br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|35.97<br />
|34.9<br />
|27.83<br />
<br />
|-<br />
|&nbsp;<br />
|P0340WQLC-T&nbsp;<br />
|3.45<br />
|480xRGBx272<br />
|16M<br />
|85.65<br />
|83.1<br />
|47.72<br />
<br />
|-<br />
|&nbsp;<br />
|P0430WQLC-T&nbsp;<br />
|4.3<br />
|480xRGBx272<br />
|16M<br />
|119.90<br />
|116.32<br />
|85.84<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|GLYN GmbH & Co. KG(CMEL)<br />
|C0201QILKC&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2<br />
|176x220<br />
|262K<br />
|25.00<br />
|&nbsp;<br />
|15<br />
<br />
|-<br />
|&nbsp;<br />
|C0240QGLAT&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|30.00<br />
|&nbsp;<br />
|20<br />
<br />
|-<br />
|&nbsp;<br />
|C0283QGLDT&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2.83<br />
|240xRGBx320<br />
|262K<br />
|38&nbsp;<br />
|&nbsp;<br />
|26<br />
<br />
|-<br />
|&nbsp;<br />
|P0340WQLCT&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br />
|3.4<br />
|480xRGBx272&nbsp;<br />
|16M<br />
|60.00<br />
|&nbsp;<br />
|35<br />
<br />
|-<br />
|&nbsp;<br />
|P0430WQLCT&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br />
|4.3<br />
|480xRGBx272<br />
|16M<br />
|90&nbsp;&nbsp;<br />
|&nbsp;<br />
|63<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|A4G Technologies(OSD)<br />
|OSD020AMQCIF<br />
|2<br />
|176x220<br />
|262K<br />
|22.50<br />
|20.98 <br />
|19.10 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD024AMQV <br />
|2.4<br />
|240x320<br />
|262K<br />
|30.20<br />
|28.57 <br />
|25.40 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0283AMQV<br />
|2.83<br />
|240x320<br />
|262K<br />
|38.30<br />
|36.16 <br />
|33.63 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0340WQLC <br />
|3.4<br />
|480x272<br />
|16M<br />
|69.50<br />
|67.25 <br />
|42.48 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0430WQLC-T <br />
|4.3<br />
|480x272<br />
|16M<br />
|109.00<br />
|87.00 <br />
|72.00 <br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|Blaze Technology<br />
|BDO-0240QGLA-T<br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|20.8<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0283QGLD-T<br />
|2.83<br />
|240xRGBx320<br />
|262K<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|26.85<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0340WQLA-T<br />
|3.4<br />
|480x272<br />
|16M<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|39.5<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0430WQLA-T<br />
|4.3<br />
|480x272<br />
|16M<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|90.6<br />
<br />
|}<br />
<br />
==Bass Diffusion Analysis==<br />
<br />
One of the most important functions during the launch of a new product is to forecast the demand for that product, as it guides many other critical decisions faced by the company. Companies can schedule their production activities once they have an idea about the demand in the coming months or years. At a high level, Bass Diffusion Model is used to determine the shape of the curve representing the cumulative adoption of the new product. Bass describes the individuals who decide to adopt an innovation independently of the actions of others as ''innovators''. Those who respond to the influences of the social system and obtain information about a new product from those who have already adopted the product are termed as ''imitators''.<br />
<br />
===Proxies for analysis===<br />
<br />
The use of the model has been made by using the historical sales data of ''proxy'' products to forecast sales for OLED display mobile phones with an assumption that OLED display mobile phones would mimic the diffusion patterns of the proxies. Hence it was important to select the proxies carefully. We used the following for this forecast:<br />
* iPhone - since this was the latest revolution in mobile phone devices and consumers would show a similar adoption behavior for a new mobile phone technology even though it comes at a price premium<br />
* LCD/Plasma TVs & Monitors - consumers spent more money to purchase screens with superior quality by significantly increasing their budget<br />
** LCD and Plasma TVs and LCD monitors were treated as a single analogous product(by ascribing different weights to these) for the forecast<br />
<br />
===Forecasting OLED display phone sales using Analogous Products===<br />
<br />
<br />
<br />
'''The following products from different product categories were considered:'''<br><br />
:# LCD TV <br />
:# Plasma Display TV<br />
:# LCD Monitor<br />
<br />
They were considered to be befitting analogies because of the following similarities:<br><br />
[[Image:Similarities.jpg|center|600px]]<br><br />
<br />
'''Weighted average for the analogous products:'''<br />
Weights for modeling co-efficients for the analogous products such as LCD TV, Plasma Display TV and LCD monitor had been assigned.<br><br />
To judge the similarity of analogous products to OLED, we examined two criteria.<br><br />
::a. Market Structure<br><br />
::b. Product Characteristics<br><br />
[[Image:Criterion.jpg|center|600px]]<br><br />
<br />
The '''S-Graph''' for the cumulative projected sale of OLED display mobiles modeled on analogous products<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart1.swf</gflash></center><br />
<br />
:* In 2009 and 2010 OLED Mobile Phone market would grow slowly driven by ''innovators''<br />
:* From 2011 to 2015, market will grow rapidly due to the ''early adopters''<br />
:* In 2016 and 2017, market will growth will dwindle as ''late adopters'' take to the phones<br />
:* 2018 onwards growth will peter, as the laggards pick up the last few models and the market will saturate<br />
:* From 2016 the technology will near obsolescence and a new technology would replace it<br><br />
<br />
<br />
'''Comparison of Adoption rate of Innovators with those of Imitators'''<br><br />
The model helps to determine sales to innovators and imitators for each year:<br><br><br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart2.swf</gflash></center><br />
<br />
<br />
This graph shows that a small number of innovators will kick-start the sales. OLED display mobile Phones will get off to a slow start in first 2 years. Once a '''''critical mass''''' is reached by the end of the second year, strong imitative effects will take over as the innovators decrease.<br />
<br />
===Detailed Analysis===<br />
<br />
The detailed modeling with a description of parameters and mathematical equations can be viewed here:<br><br />
[[Bass Diffusion Analysis for OLED display phones]]<br />
<br />
==OLED Mobile Phone Projections Based on I-Phone==<br />
<br />
The '''S-Graph''' for the cumulative projected sale of OLED display mobiles modeled on analogous products<br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart3.swf</gflash></center><br />
<br />
:* From Q1,'09 to Q3,'09, the OLED display mobile phone market would grow slowly, driven by ''innovators''<br />
:* From Q4,'09 to Q4,'10 market will grow rapidly due to the ''early adopters''<br />
:* From Q1,'11 and Q3,'11 market growth will dwindle as ''late adopters'' take to the phones<br />
:* Q4,'11 onwards growth will peter, as the laggards pick up the last few models and the market will saturate<br />
:* From Q4, the technology will near obsolescence and a new technology would substitute it<br><br><br />
<br />
'''Comparison of Adoption rate of Innovators with those of Imitators'''<br><br />
The model helps to determine sales to innovators and imitators for each year:<br><br><br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart4.swf</gflash></center><br />
<br />
<br />
This graph shows that a small number of innovators will kick-start the sales. OLED display mobile Phones will get off to a slow start in first three quarters. Once a '''''critical mass''''' is reached by the end of the Q3, strong imitative effects will take over as the innovators decrease.<br />
<br />
===Detailed Analysis===<br />
<br />
The detailed modeling with a description of parameters and mathematical equations can be viewed here:<br><br />
[[Bass Diffusion Analysis for OLED display phones]]<br />
<br />
==Comparing projections==<br />
Since disparate product categories had been used for the two forecasts, the two were compared to cross validate the results [[media:Bass-Model_OLED_comparison.xls|''<<excel sheet with calculations>>'']]<br><br />
<br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart5.swf</gflash></center><br />
<br />
:* Looking at the forecast for OLED display mobile phones based on analogous products and on iPhone, both are seen to be ''convergent''<br />
:* This validates the forecast<br />
<br />
<br />
<br />
==Sneak Preview of some models using OLED technology==<br />
{| class="wikitable" style="font-size:100%" border="1" cellpadding="5" cellspacing="0" width=80%<br />
|-<br />
| width=40% valign=top | [[Image:Apple.jpg|thumb|center|200px|[http://www.appleiphoneapps.com/2009/03/next-iphone-to-have-oled-display-why-should-you-care/ Source: appleiphoneapps.com]]]<br />
| width=60% valign=top | '''1. Apple iPhone''' - It’s nothing official at the moment, but word on the street is that Apple might have chosen a series of OLED displays for its next round of handsets. Such a move would certainly be in the best interests of battery life, as the iPhone isn’t noted for its battery capabilities. Considering the amount of new features that were announced in the iPhone 3.0 firmware update, it would be fairly practical to have a capacitive OLED display in the future.<br />
|-<br />
| width=40% valign=top | [[Image:Nokia.jpg|thumb|center|200px|[http://www.mobilephonereviews.org/category/nokia/ Source: Mobile Phone Reviews]]]<br />
<br />
| width=60% valign=top | '''2. Nokia''' - '''Nokia 6600''' Slide Mobile Phone is a 3G device with large OLED display and 3.2 megapixel camera. It has curved edges and with a weight of 110g is a bit heavy to hold. The 2.2” screen supports 16 million colors and comes with QVGA resolution. The dimensions of the phone are 90 x 45 x 14mm.<br />
<br />
|-<br />
| width=40% valign=top | [[Image:Samsung.jpg|thumb|center|200px|[http://www.att-phones.org/att-samsung-a877-phone-will-be-available.html Source: ATT Phones]]]<br />
<br />
| width=60% valign=top | '''3. Samsung''' - '''Samsung A877''' features include a 3.2-inch WQVGA AMOLED touchscreen, a 3 megapixel camera, GPS, HSDPA and Bluetooth. And as well at it supports AT&T’s 3G service.<br />
|-<br />
<br />
| width=40% valign=top | [[Image:Sony.jpg|thumb|center|200px|[http://www.itechnews.net/2008/01/08/sony-ericsson-z555-stylish-phone/ Source: Itechnews]]]<br />
| width=60% valign=top | '''4. Sony''' - '''Sony Ericsson Z555''' features a 1.9-inch LCD display, an OLED 128×36 external display, a 1.3 Megapixel camera with 4x digital zoom.<br />
|-<br />
| width=40% valign=top | [[Image:LG Mobile.jpg|thumb|center|200px|[http://www.unwiredview.com/2008/02/20/lg-sh150a-gets-am-oled-display-with-26-million-colors-and-hd-support/ Source: Unwiredview]]]<br />
| width=60% valign=top | '''5. LG''' - One of the first handsets to get the new AM OLED, is already advanced '''LG SH150''' DMB TV phone. <br />
|-<br />
| width=40% valign=top | [[Image:Motorola.jpg|thumb|center|200px|[http://www.itechnews.net/2007/10/12/motorola-u9-mobile-phone/ Source: Itechnews]]]<br />
| width=60% valign=top | '''6. Motorola''' - The '''MOTO U9''' is a Quad-band phone with a 2-inch QVGA LCD display, a 1.45-inch secondary OLED display, integrated music player, Bluetooth, 25MB internal memory and a microSD card slot.<br />
<br />
|-<br />
|}<br />
<br />
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=File:OLED_app_revenue.jpg&diff=9794
File:OLED app revenue.jpg
2011-10-04T11:02:39Z
<p>Shweta.mittal@dolcera.com: </p>
<hr />
<div></div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=OLED_Mobile_Phones_Market_Research_and_Analysis_Report&diff=9793
OLED Mobile Phones Market Research and Analysis Report
2011-10-04T11:02:11Z
<p>Shweta.mittal@dolcera.com: /* OLED Market Share */</p>
<hr />
<div>==Executive Summary==<br />
<br />
* The '''OLED''' (Organic Light-Emitting Diode) technology is rapidly evolving, and these improvements are changing the dynamics display screens in mobile phones, TVs, camera, etc. The report provides a technological overview of OLEDS and includes comparisons with the rival technology of LCDs. <br />
* This report analyses the '''Market for OLED display mobile phones''' in terms of products, applications, market size and structure, competitive environment and technology, and determines its future prospects.<br />
* The statistical tools of '''Cluster Analysis''' and '''Regression''' are used to determine the segments of smart-phones likely to adopt OLED displays<br />
* '''Bass Diffusion Model''' for adoption of new technologies is applied to forecast sales of OLED display based mobile phones. This forecast is arrived at by modeling the sales on the historical sales data of certain proxy products and is graphically presented in the report.<br />
* The study reveals that by 2012 cumulative sale of OLED based mobile phone is expected to reach '''183 million units''' and details the trend of these sales over the years<br />
<br />
<br />
==Research Objective==<br />
<br />
* To provide a '''Technology Overview''' for OLED Mobile Phones<br />
* To provide a '''Market Overview''' for OLED Mobile Phones<br />
* To provide a '''Market Estimate''' for OLED Mobile Phones<br />
* To forecast the '''Adoption Rate''' of OLED Mobile Phones<br />
<br />
<br />
==Research Methodology==<br />
<br />
A '''four stage analysis''' was conducted:<br />
<br />
[[Image:4stageanalysis.jpg|center|500px]]<br />
<br />
===Technology Overview===<br />
<br />
A brief understanding of the Technology behind the OLED displays forms the introduction to this report.<br />
<br />
===Market Overview===<br />
<br />
A detailed overview of the OLED Technology forms the basis of the Analysis performed using Base Diffusion Model.<br />
<br />
===Cluster Analysis===<br />
<br />
Cluster Analysis was used to determine a class of mobile handsets that is most likely to use OLED displays. Cluster analysis is a technique used to assign objects to groups (called clusters), such that objects from the same cluster are ''more similar'' to each other than objects from different clusters. To determine the cluster, certain attributes of a handset like input mode, display size, camera resolution, etc. were considered.<br />
<br />
===Bass Diffusion Model===<br />
<br />
The Bass Diffusion Model was used to forecast the adoption of the OLED display mobile phones by consumers. The Bass Diffusion model is a quantitative tool that describes the process of how new products get adopted as an interaction between users and potential users. In this analysis, the model was employed to forecast the sales of a new product by utilizing historical sales data of analogous products from the same product category as well as from a diverse product category. The market penetration for mobiles with OLED displays is arrived at with result for both the proxies.<br />
<br />
== Mobile Phone Display: Technology Overview ==<br />
<br />
'''OLED (Organic Light Emitting Diodes)''' is a flat display technology, made by placing a series of organic thin films between two conductors. On applying an electric current, a bright light is emitted. OLEDs use organic semiconductor material instead of inorganic semiconductor material used in conventional Light Emitting Diodes (LEDs). Through a process called electrophosphorescence, OLEDs emit light in the presence of an electric current. Like any other diode, OLEDs permit electric current to pass only in one direction. Unlike diodes made from inorganic semiconductors, OLEDs are very flexible because they are only '''100 to 500 nanometers''' thick - the human hair is 200 times thicker than it. As a result, OLED screens are very flexible and can be made in very large sheets. OLEDs use lesser energy than LEDs as well.<br />
<br />
The easiest way to understand OLEDs is to compare them to LCDs. LCDs are made by placing a color filter over a white backlight source – filtering out the colors that are not wanted for each pixel. If you want to display blue, you'll have to filter out green and red. OLEDs, on the other hand, are emissive, which means that you simply need to display the colors you need for each pixel, which is made from three color (RGB) OLED “pixels.”<br />
<br />
<br />
=== Mobile Phone Display Types ===<br />
There are two types of display technologies which are used in mobile phones:<br />
# Liquid Crystal Display (LCD)<br />
# Organic Light-Emitting Diode (OLED)<br />
<br />
Recent developments in LCD are Super LCD (S-LCD) and IPS (In-Plane Switching technology) Panel. IPS technology is used in Apple’s Retina display and LG’s NOVA display. OLED technology includes developments such as Super AMOLED, Super AMOLED Plus and ClearBlack.<br />
<br />
<br />
=== Difference between LCD and OLED ===<br />
The LCD uses light modulating properties of liquid crystals (LCs). The liquid crystals do not emit light directly. So, a light source is needed for proper viewing. The OLED uses organic compounds that illuminate when exposed to electric currents. Hence, a backlight is not required for OLEDs. This makes OLED displays thinner than LCD displays.<br />
<br />
==== Difference between AMOLED and AMLCD ====<br />
{|border="2" cellspacing="0" cellpadding="2" width="90%" align="center"<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Properties'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''AM OLED'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''AM LCD'''</font><br />
|-<br />
|'''Thickness/Weight'''<br />
|Thinner, best is 0.05 mm; lighter<br />
|Thicker, best is 0.8 mm; heavier<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Diagonal Size'''<br />
|bgcolor = "#C5D9F1"|Limited to small and medium sizes; largest demo is around 40"<br />
|bgcolor = "#C5D9F1"|Can be manufactured larger; largest demo is <nowiki>~</nowiki>100"<br />
|-<br />
|'''Viewing Angle'''<br />
|Up to 180 degrees<br />
|Narrower, depends on liquid crystal type<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Color Gamut'''<br />
|bgcolor = "#C5D9F1"|<nowiki>></nowiki>100% NTSC (top emission), around 70% NTSC (bottom); high at all gray levels<br />
|bgcolor = "#C5D9F1"|Around 70%, up to 100% NTSC (LED backlight and new color filter); falls at low gray levels<br />
|-<br />
|'''Color Reproduction'''<br />
|Better; gamut independent of view angle<br />
|Good; gamut changes with viewing angle<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Resolution'''<br />
|bgcolor = "#C5D9F1"|Lower; 308 dpi (SM), 202 dpi (polymer)<br />
|bgcolor = "#C5D9F1"|Higher; best is 498 dpi<br />
|-<br />
|'''Response Time'''<br />
|Faster, nanoseconds. No motion blur, good for 3D<br />
|Slower, milliseconds<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Contrast Ratio'''<br />
|bgcolor = "#C5D9F1"|Higher<br />
|bgcolor = "#C5D9F1"|Lower<br />
|-<br />
|'''Sunlight Readability'''<br />
|Better than transmissive LCD, worse than transflective LCD<br />
|Ok if transflective<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Operating Temperature'''<br />
|bgcolor = "#C5D9F1"|Range is larger, can operate at low temps like -40°C<br />
|bgcolor = "#C5D9F1"|Range is smaller, lowest temp is -10°C<br />
|-<br />
|'''Power Consumption'''<br />
|Lower at typical video content, when around 30% of pixels are on<br />
|Higher at typical video content<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Lifetime'''<br />
|bgcolor = "#C5D9F1"|Shorter, 5K to 30K hour, but improving<br />
|bgcolor = "#C5D9F1"|Much longer, above 50K hour<br />
|-<br />
|'''Manufacturing Investment'''<br />
|Lower, but lack of standards keeps the investment only slightly lower<br />
|Higher<br />
|-<br />
|bgcolor = "#C5D9F1"|'''Production Cost'''<br />
|bgcolor = "#C5D9F1"|Expensive; low yield and complex structure, potential to be low cost<br />
|bgcolor = "#C5D9F1"|Cheaper than AMOLED<br />
|-<br />
|align = "center" colspan = "3"|'''[http://www.displaysearch.com/ Source: DisplaySearch]'''<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
==== OLED Construction ====<br />
An OLED can be made of a single layer of organic material but multiple layers increase efficiency and effectiveness. A typical OLED is comprised of five layers of material:<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Layer'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|'''Substrate layer'''<br />
|bgcolor = "#DBE5F1"|This layer supports the OLED and is made of clear plastic, glass, foil or other materials.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Anode layer'''<br />
|bgcolor = "#B8CCE4"|The anode layer is transparent and is positively charged. When an electric current is applied, this layer attracts electrons as they flow through the OLED. As with a LED, the anode forms "holes" onto which electrons fall.<br />
|-<br />
|bgcolor = "#DBE5F1"|'''Conducting layer'''<br />
|bgcolor = "#DBE5F1"|This layer is made of organic plastic material and transports the "holes" from the anode layer.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Emissive layer'''<br />
|bgcolor = "#B8CCE4"|This layer transports electrons from the cathode. It is also made of organic plastic molecules but there are different from those in the conducting layer. This is the layer that determines the color of the light emitted.<br />
|-<br />
|bgcolor = "#DBE5F1"|'''Cathode layer'''<br />
|bgcolor = "#DBE5F1"|This layer injects electrons into the OLED when an electric current is applied. Depending on the OLED and the color effect desired, this layer may or may not be transparent.<br />
|-<br />
|}<br />
<br />
<br />
[[image:oledstructure.jpg|center|406*365px|thumb|Source: [http://electronics.howstuffworks.com/oled1.htm How Stuff Works]]]<br />
<br />
==== Types of OLED Construction ====<br />
OLEDs can be constructed in a variety of ways to serve a variety of functions. While each type of construction uses the layers described previously, the manner in which each layer is built alters the way the OLED functions. The six most common types of OLEDs are as follows:<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Passive-Matrix OLED'''<br />
|bgcolor = "#DBE5F1"|Anode and cathode laid perpendicular to each other<br />
|-<br />
|bgcolor = "#DBE5F1"|PM OLEDs are easy to make and display text and icons very effectively, particularly in small 2-inch to 3-inch screens<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''Active-Matrix OLED'''<br />
|bgcolor = "#B8CCE4"|AM OLEDs are constructed with continuous film materials<br />
|-<br />
|bgcolor = "#B8CCE4"|AM OLEDs use less energy than PM OLEDs and have faster refresh rates<br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Transparent OLED'''<br />
|bgcolor = "#DBE5F1"|Constructed with transparent materials for all five layers, a transparent OLED can be made as either a PM OLED or an AM OLED<br />
|-<br />
|bgcolor = "#DBE5F1"|Useful for heads-up display applications<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''Top-Emitting OLED'''<br />
|bgcolor = "#B8CCE4"|These types of OLEDs use an opaque or reflective substrate that is useful for smart card applications<br />
|-<br />
|bgcolor = "#B8CCE4"|Best suited for an active-matrix design<br />
|-<br />
|bgcolor = "#DBE5F1" rowspan = "2"|'''Foldable OLED'''<br />
|bgcolor = "#DBE5F1"|The substrate of this type of OLED is very flexible, allowing the OLED to be folded or rolled up<br />
|-<br />
|bgcolor = "#DBE5F1"|Because of their flexibility, foldable OLEDs could be attached to fabrics with a variety of applications<br />
|-<br />
|bgcolor = "#B8CCE4" rowspan = "2"|'''White OLED'''<br />
|bgcolor = "#B8CCE4"|These OLEDs emit white light that is brighter, more uniform and more energy efficient than that emitted by fluorescent lights<br />
|-<br />
|bgcolor = "#B8CCE4"|Potential to replace incandescent and fluorescent lighting in commercial industrial, and residential applications<br />
|-<br />
|}<br />
<br />
<br />
==== Advantages and Disadvantages ====<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|align = "center" bgcolor = "#DBE5F1" rowspan = "3"|'''Advantages of OLED over LCD'''<br />
|bgcolor = "#DBE5F1"|As there is no backlighting, OLED displays offer deeper black levels than LCD displays<br />
|-<br />
|bgcolor = "#DBE5F1"|OLED displays have better contrast ratios<br />
|-<br />
|bgcolor = "#DBE5F1"|Viewing angles offered by OLEDs is more than that offered by LCDs<br />
|-<br />
|align = "center" bgcolor = "#B8CCE4" rowspan = "3"|'''Disadvantages of OLED over LCD'''<br />
|bgcolor = "#B8CCE4"|Brightness levels of OLED display is less than that of LCD<br />
|-<br />
|bgcolor = "#B8CCE4"|Color in OLED displays are often oversaturated<br />
|-<br />
|bgcolor = "#B8CCE4"|The red, green and blue sub-pixels deteriorate and lose efficiency at different rates, thus color consistency worsens over time<br />
|-<br />
|}<br />
<br />
<br />
=== OLED Screen Types in Mobile Phones ===<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|align = "justify" bgcolor = "#DBE5F1"|'''AMOLED'''<br />
|align = "justify" bgcolor = "#DBE5F1"|AMOLED relies on a TFT backplane to switch individual pixels on and off. Active-matrix displays consume significantly less power than passive-matrix counterparts. This makes them well-suited for mobile devices. AMOLED displays are manufactured by printing electroluminescent materials onto a substrate. The relatively simplistic process suggests that OLEDs will ultimately become cheaper and easier to manufacture than LCDs. The creation of the substrate is the most difficult and expensive part of the process. Currently, AMOLED screens are limited in supply. Coupled with high demand, their availability is restricted and they are found in high-end smartphones.<br />
|-<br />
|align = "justify" bgcolor = "#B8CCE4"|'''Super AMOLED'''<br />
|align = "justify" bgcolor = "#B8CCE4"|Super-AMOLED displays are AMOLED displays with an integrated touch function. The original AMOLED screens had reduced visibility in direct sunlight. The thickness of the touch sensor is less than 0.001mm in Super AMOLED displays. This allows the screen to provide better images and to have great visibility even in direct sunlight.<br />
|-<br />
|align = "justify" bgcolor = "#DBE5F1"|'''ClearBlack'''<br />
|align = "justify" bgcolor = "#DBE5F1"|Nokia introduced a display similar to Samsung<nowiki>’</nowiki>s Super AMOLED known as the ClearBlack display. The ClearBlack display makes the screen more visible in direct sunlight. A polarized filter is added to the display. This allows the viewer to see through the screen<nowiki>’</nowiki>s reflection and view the images as they would appear under more ideal conditions.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Super AMOLED Plus'''<br />
|align = "justify" bgcolor = "#B8CCE4"|The Super AMOLED Plus features a traditional three sub-pixels of equal proportion within one pixel. It has an increased sub-pixel count and density. As a result, the display is much crisper, especially when it comes to text. The tighter spacing between pixels also results in better visibility under direct sunlight. The displays are also thinner, brighter and more efficient (by 18%) than the old Super AMOLED displays.<br />
|-<br />
|}<br />
<br />
<br />
=== Future OLED Mobile Screen Variations ===<br />
{|border="2" cellspacing="0" cellpadding="4" width="75%" align="center"<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Type'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Description'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|'''Transparent Displays'''<br />
|align = "justify" bgcolor = "#DBE5F1"|Transparent OLEDs have only transparent components (substrate, cathode and anode) and, when turned off, are up to 85 percent as transparent as their substrate. When a transparent OLED display is turned on, it allows light to pass in both directions. A transparent OLED display can be either active- or passive-matrix. TDK began production of a see-through OLED earlier this year.<br />
|-<br />
|bgcolor = "#B8CCE4"|'''Flexible Displays'''<br />
|align = "justify" bgcolor = "#B8CCE4"|Flexible OLEDs have substrates made of very flexible metallic foils or plastics. Flexible OLEDs are very lightweight and durable. Their use in devices such as cell phones and PDAs can reduce breakage, a major cause for return or repair. Samsung is readying flexible AMOLED displays for production next year.<br />
|-<br />
|}<br />
<br />
<br />
==OLED Market Overview==<br />
<br />
<br />
===OLED Market: Revenue Overview===<br />
* The Global OLED Display Market was estimated at '''$964 million''' for the year 2010.<br />
* The market stood at '''$884 million''' in the year 2009, and showed a growth of '''11%''' for 2010.<br />
* The market is estimated to reach '''$1,428 million''' by the year 2013 <br />
<br />
[[Image:Global_OLED.JPG|center|760*401px|thumb|Global OLED Display Market: Revenue Forecasts 2003-2013 (in $million), Source: [http://www.marketresearch.com/Frost-Sullivan-v383/LCD-OLED-Manufacturing-Equipment-6172629/ LCD and OLED Manufacturing Equipment Market, Frost & Sullivan ]]]<br />
<br />
<br />
===OLED Market: Volume Overview===<br />
<br />
* The shipments of Organic Light-Emitting Diode (OLED) screens was estimated at '''100 million''' units in 2010<br />
* The shipments of Organic Light-Emitting Diode (OLED) screens are set to rise to '''326.8 million''' units in 2015<br />
* The market is going to be driven by booming demand for Active-Matrix (AM) displays for mobile handsets<br />
* AM-OLED segment, which will boom to '''261.5 million''' units in 2015, up more than twelve fold from '''21.1 million''' in 2009<br />
<br />
[[Image:Global_OLED_Volume.JPG|center|659*383px|thumb|Global OLED Display Shipment 2007-2015 <br />
(Millions of Unit), Source: [http://www.isuppli.com/Display-Materials-and-Systems/News/Pages/iSuppli-Issues-Fast-Facts-on-the-Display-Industry-for-SID-2010.aspx iSuppli ]]]<br />
<br />
===Market Potential by Geography===<br />
<br />
====OLED Market Potential by Geography====<br />
The following chart illustrates the OLED Market Potential by Geography over the period 2004-2014:<br />
{|align = "center"<br />
|<gflash>1050 625 http://dolcera.com/upload/files/OLED_Geography.swf</gflash><br />
|-<br />
|}<br />
<br />
Source: [http://www.icongrouponline.com/ ICON Group International]<br />
<br />
<br />
====AMOLED Market Potential by Geography====<br />
The following chart illustrates the AMOLED Market Potential by Geography over the period 2004-2014:<br />
{|align = "center"<br />
|<gflash>1050 625 http://dolcera.com/upload/files/AMOLED_Geography_01.swf</gflash><br />
|-<br />
|}<br />
<br><br />
Source: [http://www.icongrouponline.com/ ICON Group International]<br />
<br />
<br />
===OLED Market Share===<br />
* '''Samsung Mobile''' leads the OLED Display Market with a market share of 43.2% as reported in 2010<br />
* '''TDK''' is a distant 2nd with a market share of 17.5% and is closely followed by '''RiT Display''' with a share of 16.0%<br />
<br />
The following chart illustrates the Global OLED Display Unit Shipment: Market Share, for the year 2010:<br />
[[Image:Global_OLED_Market_Share.JPG|center|760*401px|thumb|Global OLED Display Unit Shipment: Market Share 2010<br />
, Source: [http://www.displaysearch.com/cps/rde/xchg/displaysearch/hs.xsl/quarterly_oled_shipment_and_forecast_report.asp Quarterly OLED Shipment and Forecast Report, DisplaySearch ]]]<br />
<br />
===OLED Market Share by Application===<br />
* '''Mobile Handset application''' forecast to account for 84%, followed by NBPC at 6% and tablet PC at 4% of 2011E total revenue.<br />
<br />
<br />
The following chart illustrates the Global OLED Display total revenue: Market Share, for the year 2011E:<br />
[[Image:OLED_app_revenue.jpg|center|760*401px|thumb|Global OLED Display Revenue: Market Share 20111E<br />
, Source: [http://7economy.com/archives/6051 ]]]<br />
<br />
==OLED Eco-System==<br />
The following dashboard illustrates all the Companies in the OLED Eco-System:<br />
{|align = "center"<br />
|<gflash>900 425 http://dolcera.com/upload/files/OLED_Ecosystem.swf</gflash><br />
|-<br />
|}<br />
Source: [http://www.oled-info.com/ OLED-info.com]<br />
<br />
<br />
==OLED Market Drivers & Restraints==<br />
<br />
The following figure illustrates a '''Forcefield Analysis of Market Drivers and Restraint'''s for OLED Market (2011-2017):<br />
[[Image:OLED_Drivers_Restraints.JPG|center|900*533px|thumb|Forcefield Analysis of Market Drivers and Restraints for OLED Market (2011-2017)<br />
, Source: [http://www.frost.com Frost & Sullivan]]]<br />
<br />
<br />
===OLED Market Drivers===<br />
The following table illustrates the '''Impact Analysis of OLED Market Drivers''' over a period of time:<br />
{|border="2" cellspacing="0" cellpadding="2" width="60%" align="center"<br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Rank'''</font><br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Driver'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''1-2 years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''3-4 Years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''5-7 years'''</font><br />
|-<br />
|align = "center"|1<br />
|Inherent Advantages of OLED Technology<br />
|align = "center"|Medium<br />
|align = "center"|High<br />
|align = "center"|Very High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|2<br />
|bgcolor = "#C5D9F1"|Increasing Demand for Green Products<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|-<br />
|align = "center"|3<br />
|Increasing demand for OLED Display in Mobile Phones and Signage<br />
|align = "center"|Medium<br />
|align = "center"|Medium<br />
|align = "center"|High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|4<br />
|bgcolor = "#C5D9F1"|Rising Potential of OLED TV<nowiki>’</nowiki>s<br />
|align = "center" bgcolor = "#C5D9F1"|Low<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
'''Inherent Advantages of OLED Technology'''<br />
<br />
* OLED display offer sharper images and better contrast ratios, crisp colors and faster refresh rates compared to any existing display technology.<br />
* OLED Technology also offers consumers better energy management as the whole system functions at optimal power and is of organic substrate.<br />
* OLED displays are created by inserting thin organic films between two conductors and require no backlight; therefore, the displays are more compact and thinner.<br />
* OLED displays, especially or television, are capable of offering viewers a viewing angle of 180 degrees<br />
* As the benefits of OLED displays become more prominent, the demand for OLED manufacturing equipment is expected to increase in the next three to seven years.<br />
<br />
<br />
'''Increasing Demand for Green Products'''<br />
<br />
* The demand for lower power consumption , reduced material usage, and simplicity is expected to propel the OLED demand in the coming years<br />
* The OLED manufacturing equipment market, however, is facing challenges due to its premium and manufacturing challenges. As Manufacturers realize the economies of scale, average selling price is expected to decline, further spurring demand.<br />
* OLED TV market continues to evolve technologically and benefit from increasing demands for energy efficiency from consumers.<br />
<br />
<br />
'''Increasing demand for OLED Displays in Mobile Phones and Signage'''<br />
<br />
* Technology innovations, better functionalities and falling prices are expected to keep up the demand for OLED displays in mobile phones<br />
* Mobile Phones accounted for over 82.0% of the Total OLED display market. With the success of mobile phones, such as the Galaxy, the demand for OLED displays for mobile applications is expected to increase<br />
* The market is also expected to benefit from increasing demand for OLED displays used for signage<br />
* These factors are expected to propel the sales of OLED during the medium and later part of the forecast period.<br />
<br />
<br />
'''Rising Potential of OLED TVs'''<br />
<br />
* The OLED market is yet to observe strong demand for TVs. High premium price and smaller display sizes are key restraints for customers. However, with increasing collaboration within the entire supply chain of the OLED market, the market is expected to experience gradual increase in attractive solutions. According to DisplaySearch, the OLED TV market is expected to generate revenue of $28 billion by 2017.<br />
* The increasing momentum is expected to help commercialize the technology in the next five to seven years. Many display manufacturers have already set up dedicated manufacturing lines from Gen 3.5 to Gen 5.5.<br />
* This is expected to propel OLED manufacturing equipment sales during the latter part of the forecasted period.<br />
<br />
Source: [http://www.frost.com Frost & Sullivan]<br />
<br />
<br />
===OLED Market Restraints===<br />
The following table illustrates the '''Impact Analysis of OLED Market Restraints''' over a period of time:<br />
{|border="2" cellspacing="0" cellpadding="2" width="60%" align="center"<br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Rank'''</font><br />
|bgcolor = "#376091"|<font color="#FFFFFF">'''Restraint'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''1-2 years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''3-4 Years'''</font><br />
|align = "center" bgcolor = "#376091"|<font color="#FFFFFF">'''5-7 years'''</font><br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|1<br />
|bgcolor = "#C5D9F1"|Slow Adoption Rate of New Technology<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|-<br />
|align = "center"|2<br />
|Declining Prices of competing technologies<br />
|align = "center"|High<br />
|align = "center"|High<br />
|align = "center"|High<br />
|-<br />
|align = "center" bgcolor = "#C5D9F1"|3<br />
|bgcolor = "#C5D9F1"|High cost of products<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|High<br />
|align = "center" bgcolor = "#C5D9F1"|Medium<br />
|-<br />
|}<br clear="all"><br />
<br />
<br />
'''Slow Adoption Rate of New Technology'''<br />
<br />
* The adoption rate of OLED Technology is comparatively slower than the initial launch of LCD technology. Consumers are complacent with the current technologies it offers then a myriad o advantages and benefits.<br />
* The largest issues foreseen are consumer perception, cost effectiveness of the product, ease of implementation and the ability of the service to provide true blended services<br />
* As a result, there is a significant and vital gap between new product design to volume manufacturing in the OLED market<br />
* Increasing costs and manufacturing complexity has hindered the adoption rate of OLED manufacturing equipment, especially for larger substrate sizes<br />
* The growth of the OLED display market and, in turn equipment sales, will rely on increasing collaboration between material suppliers, technology enablers and equipment providers. Decreased time to market and focus on R&D will be the key to attaining the desired growth trajectory.<br />
<br />
<br />
'''High Cost of Products'''<br />
<br />
* The high cost of OLED display has hindered adoption rates. For Example, customers, while willing to pay a premium price for quality products, hedge until the product has reached mass adoption level. A manufacturing facility typically requires an investment of $ 1 Billion to 3 Billion.<br />
* This has restrained the demand for OLED equipment. Equipment providers are still caught in a dilemma of balancing the high cost of technology development with affordable pricing for consumers.<br />
* Careful adjustment of prices can help minimize the impact of this restraint. Pricing strategy is crucial for success for the overall OLED market.<br />
<br />
<br />
'''Declining Prices of Competing Technologies'''<br />
<br />
* The LCD market is continuing to witness strong demand despite the emergence of new products in the market.<br />
* LCD Technology is transitioning t meet increasing demands for higher switching speeds, becoming more environmentally friendly by using LED backlighting, becoming sleeker and more compact, and having better resolution.<br />
* The LCD and other existing technologies also offer consumers the ability to buy large screen displays. This had created major barriers for increasing the adoption rate for OLED manufacturing equipment.<br />
<br />
Source: [http://www.frost.com Frost & Sullivan]<br />
<br />
<br />
==Transaction Landscape==<br />
The Transaction Landscape in the OLED Market is illustrated in the following links:<br />
# [[Mergers & Acquisitions Landscape]]<br />
# [[Partnerships Landscape]]<br />
# [[Investment Landscape]]<br />
<br />
<br />
==Cluster Analysis for TFT Display Mobile Phones==<br />
The table here summarizes the objective, methodology, procedure and result of the cluster analysis <br />
[[Image:Cluster Analysis.jpg|thumb|center|1000px|[http://faculty.chass.ncsu.edu/garson/PA765/cluster.htm Source: Statnotes, North Carolina State University]]]<br><br />
<br />
===Selection of model===<br />
Using the analysis, one cluster of smart-phones likely to move to OLED technology was identified for each of the two categories. For the next stage of the research - that of forecasting sales - would need the historical sales data of one particular model. For this purpose, '''Apple iPhone''' from the 2nd cluster of candy-bar phones was selected because of constraint of availability of sales data for other models like Blackberry, Nokia N96, HTC Dreamers etc.<br />
<br />
<br />
==='''A Comparison of LCD and OLED technologies'''===<br />
<br />
<br />
The ''radar graph'' here shows the comparison between OLED and TFT LCD.<br />
<br />
[[Image:Comparison.jpg|500px|thumb|center|Comparison[http://digidelve.com/oled/problems Source]]]<br />
<br />
<br />
<br />
The graph depicts the following things:<br />
<br />
# OLEDs are ''thinner'' than LCDs.<br />
# OLEDs are ''lighter'' in weight.<br />
# OLEDs consume ''more power'' than LCDs but OLEDs have an inherent advantage in that they only consume power when they emit light while an LCD backlight consumes constant power regardless of the image being displayed.<br />
# OLEDs ''cost more'': The Cost of an AM-LCD is currently about half that of a comparable AM-OLED display. This is due to the maturity of LCD manufacturing processes and facilities. OLED manufacturing facilities suffer from low yields, currently at 60%-70%.<br />
# OLEDs have a ''shorter lifespan'' as compared to LCDs.<br />
# OLEDs have a ''faster response time'' of .01ms while LCDs have a response time about 8-12ms.<br />
# OLEDs have a ''superior viewing angle'' of 180 degree while LCDs have a lower viewing angle.<br />
<br />
==='''Cluster Analysis'''===<br />
<br />
<br />
====Methodology====<br />
<br />
'''Sample Definition:''' The sample space consists of moblie phones by leading players in the smart-phone mobile category. These models were identified from Gartner reports. The models of smart-phones launched in the last three years in North America were considered. <br />
<br />
'''Sample Space:'''After defining the sample, the various key attributes of smart-phones like camera, display, etc. were defined. The data for these attributes for all the models was collected from the company websites as well as the following websites:<br />
<br />
* www.phonearena.com<br />
* www.phonegg.com<br />
* www.mobile.am<br />
<br />
<br />
The pricing information was obtained from<br />
* www.fonearena.com<br />
* www.india-cellular.com<br />
* www.naaptaol.com<br />
* www.mobilestore.com<br />
* www.indiatimes.com.<br />
<br />
<br />
After aggregating the data we used the '''k-clustering''' method to identify the different clusters for the samples. This technique aims to partition ''n'' observations into ''k'' clusters in which each observation belongs to the cluster with the nearest mean. Hence clusters of phones with similar attributes is achieved.<br />
<br />
Samples were segregated into two broad categories - candy-bar phones and clamshell or sliding phones - with thickness being the differentiating parameter. This was done in order to mitigate any error due to the design of the phone(i.e. candybar,clamshell,slider), since the thicknes of the mobile could be a cause for erroneous results.<br />
<br />
====Cluster analysis results====<br />
<br />
The sheet below shows the clusters formed for the candy-bar phones.<br />
<br />
[[Image:Candy_bar_excels.jpg|Candy bar|1500px|center|thumb]]<br />
<br />
The sheet below shows the cluster formed for the clamshell/sliding phones.<br />
<br />
[[Image:clamshellexcel.jpg|Clamshell_slider|650px|center|thumb]]<br />
<br />
'''Definition of Attributes:'''<br />
*'''Camera''' : resolution in Megapixels<br />
*'''Input method''': two types of input methods - touchscreen and keyboard<br />
*'''Display size''': diagonal length of the displeay screen<br />
*'''Resolution''': display resolutions<br />
*'''Color''': display color<br />
*'''Thickness''': total thickness of the phone<br />
<br />
<br />
The cluster analysis results and subsequent profiling of those clusters are summarized below:<br />
<br />
<br />
''' Candy - Bar Phones'''<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center"|<font color="#262626">'''Clusters'''</font><br />
|align = "center"|<font color="#262626">'''Cell phones'''</font><br />
|align = "center"|<font color="#262626">'''Profile'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''1'''<br />
|align = "center" bgcolor = "#D3DFEE"|Apple iPhone, Samsung i910<br />
|align = "justify" bgcolor = "#D3DFEE"|* Cluster 1 consists of high end cell phones<br>* Cell phones falling in this cluster are touch screen phones with large display size<br>* This is mainly targeting the premium market which is not price sensitive as the mobile phones in this cluster are priced high<br />
|-<br />
|align = "center"|'''2'''<br />
|align = "center"|HTC P3470, HTC touch cruise, HTC touch diamond, HTC touch viva, HTC X7510, i780<br />
|align = "justify"|* This cluster includes cell phones with moderate display size and having touch screen facility<br>* Cell phones in this cluster are in the price range of medium to high, so it is targeting the upper middle to high class.<br>* Almost all the mobile phones falling in this cluster are having WLAN facility indicating that this cluster target trendy class people and people who prefer online games and downloads on mobile phones<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''3'''<br />
|align = "center" bgcolor = "#D3DFEE"|Nokia 5320 express music, Nokia 5800 express music, Nokia 6124 classic, Nokia 6220 classic, Nokia E63, i200, i450, N6120, N78, N79, Pearl 8100<br />
|align = "justify" bgcolor = "#D3DFEE"|* Mobile phones in this cluster are targeted at the middle class as these phones are of moderate price and normal input<br>* They have small display size and moderate camera resolution, which is in sync with their target market<br>* Average thickness<br />
|-<br />
|align = "center"|'''4'''<br />
|align = "center"|E71, i550W, N5700, N73, N82, Blackberry 7130c/7130g<br />
|align = "justify"|* This cluster consists of mobile phones having high camera resolution and normal input indicating that this cluster is for people who give high preference to clicking photographs on mobile phones<br>* They have small display size with most of them not having the WLAN facility, so this is for people who low on using the browsing facilities<br>* The target segment for this cluster is the middle class segment as the mobile phones are also moderately priced<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''5'''<br />
|align = "center" bgcolor = "#D3DFEE"|Curve 8310, Blackberry 8820, Curve 8300, Blackberry 8800, Blackberry bold 9000, Blackberry curve 8330<br />
|align = "justify" bgcolor = "#D3DFEE"|* It includes mobile phones having input through qwerty and with average display size<br>* Target market is Business class people who prefer using email facility on mobiles<br>* The mobile phones are low on camera resolution<br>* All the mobiles in this cluster are high priced indicating that the targeted segment for this cluster is not price sensitive<br />
|-<br />
|}<br />
<br />
<br />
<br />
'''Clamshell Phones'''<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center"|'''Clusters'''<br />
|align = "center"|'''Cell phones'''<br />
|align = "center"|'''Profile'''<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''1'''<br />
|align = "center" bgcolor = "#D3DFEE"|N6650, N95 8GB, E66, 6210 navi, N85<br />
|bgcolor = "#D3DFEE"|* This cluster consists of medium to high priced mobile phones and is targeted at upper middle class<br>* These mobile phones have high camera resolution and normal keypad input<br>* All the mobiles in this cluster have average display size having 16M colors<br />
|-<br />
|align = "center"|'''2'''<br />
|align = "center"|N96, N97<br />
|* It includes mobile phones which are high priced and targeted at affluent people who are not price sensitive<br>* The mobile phones in this cluster are characterized by high camera resolution, big display size and moderate thickness<br>* WLAN facility and high graphic resolution in these mobile phones will attract people who prefer downloading and playing online games<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|'''3'''<br />
|align = "center" bgcolor = "#D3DFEE"|HTC dream<br />
|bgcolor = "#D3DFEE"|* Mobile phones in this cluster are moderately priced and, targeted at the middle class and the upper middle class segment<br>* These phones have high thickness and high camera resolution<br>* These phones are WLAN enabled and have both qwerty keypad and touch screen input<br />
|-<br />
|align = "center"|'''4'''<br />
|align = "center"|N76, N6290, N75, HTC shadow, E65, i620, N6110<br />
|* This cluster consists of mobile phones with low camera resolution and mainly has normal keypad for input<br>* These phones have medium display size and medium to high thickness<br>* These are low to moderately priced phones targeted at the middle class segment<br />
|-<br />
|}<br />
<br />
=== Prices for AMOLED screens===<br />
<br />
Market data was collected for the prices of OLED screens by various manufacturers<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#FFFF00"|Company Name<br />
|bgcolor = "#FFFF00"|Model Number<br />
|bgcolor = "#FFFF00"|Size<br />
|bgcolor = "#FFFF00"|Resolution<br />
|bgcolor = "#FFFF00"|Colors<br />
|align = "center" bgcolor = "#FFFF00" colspan = "3"|Price/unit(in USD)<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|0-99<br />
|100-999<br />
|1000 <nowiki>++</nowiki><br />
<br />
|-<br />
|Chung Yuan Technology Co., Ltd<br />
|align = "right"|&nbsp;<br />
|2.2"<br />
|220x176<br />
|align = "right"|&nbsp;<br />
|20.00<br />
|16.5<br />
|align = "right"|&nbsp;<br />
<br />
|-<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
<br />
|-<br />
|Digiprotek Markcom India P Ltd.(Densitron)<br />
|C0201QILK-C<br />
|2<br />
|176xRGBx220<br />
|262K<br />
|25.69<br />
|24.92<br />
|20.67<br />
<br />
|-<br />
|&nbsp;<br />
|C0240QGLA-T&nbsp;<br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|35.97<br />
|34.9<br />
|27.83<br />
<br />
|-<br />
|&nbsp;<br />
|P0340WQLC-T&nbsp;<br />
|3.45<br />
|480xRGBx272<br />
|16M<br />
|85.65<br />
|83.1<br />
|47.72<br />
<br />
|-<br />
|&nbsp;<br />
|P0430WQLC-T&nbsp;<br />
|4.3<br />
|480xRGBx272<br />
|16M<br />
|119.90<br />
|116.32<br />
|85.84<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|GLYN GmbH & Co. KG(CMEL)<br />
|C0201QILKC&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2<br />
|176x220<br />
|262K<br />
|25.00<br />
|&nbsp;<br />
|15<br />
<br />
|-<br />
|&nbsp;<br />
|C0240QGLAT&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|30.00<br />
|&nbsp;<br />
|20<br />
<br />
|-<br />
|&nbsp;<br />
|C0283QGLDT&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <br />
|2.83<br />
|240xRGBx320<br />
|262K<br />
|38&nbsp;<br />
|&nbsp;<br />
|26<br />
<br />
|-<br />
|&nbsp;<br />
|P0340WQLCT&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br />
|3.4<br />
|480xRGBx272&nbsp;<br />
|16M<br />
|60.00<br />
|&nbsp;<br />
|35<br />
<br />
|-<br />
|&nbsp;<br />
|P0430WQLCT&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<br />
|4.3<br />
|480xRGBx272<br />
|16M<br />
|90&nbsp;&nbsp;<br />
|&nbsp;<br />
|63<br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|A4G Technologies(OSD)<br />
|OSD020AMQCIF<br />
|2<br />
|176x220<br />
|262K<br />
|22.50<br />
|20.98 <br />
|19.10 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD024AMQV <br />
|2.4<br />
|240x320<br />
|262K<br />
|30.20<br />
|28.57 <br />
|25.40 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0283AMQV<br />
|2.83<br />
|240x320<br />
|262K<br />
|38.30<br />
|36.16 <br />
|33.63 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0340WQLC <br />
|3.4<br />
|480x272<br />
|16M<br />
|69.50<br />
|67.25 <br />
|42.48 <br />
<br />
|-<br />
|&nbsp;<br />
|OSD0430WQLC-T <br />
|4.3<br />
|480x272<br />
|16M<br />
|109.00<br />
|87.00 <br />
|72.00 <br />
<br />
|-<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|&nbsp;<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|&nbsp;<br />
<br />
|-<br />
|Blaze Technology<br />
|BDO-0240QGLA-T<br />
|2.4<br />
|240xRGBx320<br />
|262K<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|20.8<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0283QGLD-T<br />
|2.83<br />
|240xRGBx320<br />
|262K<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|26.85<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0340WQLA-T<br />
|3.4<br />
|480x272<br />
|16M<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|39.5<br />
<br />
|-<br />
|&nbsp;<br />
|BDO-0430WQLA-T<br />
|4.3<br />
|480x272<br />
|16M<br />
|align = "right"|&nbsp;<br />
|align = "right"|&nbsp;<br />
|90.6<br />
<br />
|}<br />
<br />
==Bass Diffusion Analysis==<br />
<br />
One of the most important functions during the launch of a new product is to forecast the demand for that product, as it guides many other critical decisions faced by the company. Companies can schedule their production activities once they have an idea about the demand in the coming months or years. At a high level, Bass Diffusion Model is used to determine the shape of the curve representing the cumulative adoption of the new product. Bass describes the individuals who decide to adopt an innovation independently of the actions of others as ''innovators''. Those who respond to the influences of the social system and obtain information about a new product from those who have already adopted the product are termed as ''imitators''.<br />
<br />
===Proxies for analysis===<br />
<br />
The use of the model has been made by using the historical sales data of ''proxy'' products to forecast sales for OLED display mobile phones with an assumption that OLED display mobile phones would mimic the diffusion patterns of the proxies. Hence it was important to select the proxies carefully. We used the following for this forecast:<br />
* iPhone - since this was the latest revolution in mobile phone devices and consumers would show a similar adoption behavior for a new mobile phone technology even though it comes at a price premium<br />
* LCD/Plasma TVs & Monitors - consumers spent more money to purchase screens with superior quality by significantly increasing their budget<br />
** LCD and Plasma TVs and LCD monitors were treated as a single analogous product(by ascribing different weights to these) for the forecast<br />
<br />
===Forecasting OLED display phone sales using Analogous Products===<br />
<br />
<br />
<br />
'''The following products from different product categories were considered:'''<br><br />
:# LCD TV <br />
:# Plasma Display TV<br />
:# LCD Monitor<br />
<br />
They were considered to be befitting analogies because of the following similarities:<br><br />
[[Image:Similarities.jpg|center|600px]]<br><br />
<br />
'''Weighted average for the analogous products:'''<br />
Weights for modeling co-efficients for the analogous products such as LCD TV, Plasma Display TV and LCD monitor had been assigned.<br><br />
To judge the similarity of analogous products to OLED, we examined two criteria.<br><br />
::a. Market Structure<br><br />
::b. Product Characteristics<br><br />
[[Image:Criterion.jpg|center|600px]]<br><br />
<br />
The '''S-Graph''' for the cumulative projected sale of OLED display mobiles modeled on analogous products<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart1.swf</gflash></center><br />
<br />
:* In 2009 and 2010 OLED Mobile Phone market would grow slowly driven by ''innovators''<br />
:* From 2011 to 2015, market will grow rapidly due to the ''early adopters''<br />
:* In 2016 and 2017, market will growth will dwindle as ''late adopters'' take to the phones<br />
:* 2018 onwards growth will peter, as the laggards pick up the last few models and the market will saturate<br />
:* From 2016 the technology will near obsolescence and a new technology would replace it<br><br />
<br />
<br />
'''Comparison of Adoption rate of Innovators with those of Imitators'''<br><br />
The model helps to determine sales to innovators and imitators for each year:<br><br><br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart2.swf</gflash></center><br />
<br />
<br />
This graph shows that a small number of innovators will kick-start the sales. OLED display mobile Phones will get off to a slow start in first 2 years. Once a '''''critical mass''''' is reached by the end of the second year, strong imitative effects will take over as the innovators decrease.<br />
<br />
===Detailed Analysis===<br />
<br />
The detailed modeling with a description of parameters and mathematical equations can be viewed here:<br><br />
[[Bass Diffusion Analysis for OLED display phones]]<br />
<br />
==OLED Mobile Phone Projections Based on I-Phone==<br />
<br />
The '''S-Graph''' for the cumulative projected sale of OLED display mobiles modeled on analogous products<br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart3.swf</gflash></center><br />
<br />
:* From Q1,'09 to Q3,'09, the OLED display mobile phone market would grow slowly, driven by ''innovators''<br />
:* From Q4,'09 to Q4,'10 market will grow rapidly due to the ''early adopters''<br />
:* From Q1,'11 and Q3,'11 market growth will dwindle as ''late adopters'' take to the phones<br />
:* Q4,'11 onwards growth will peter, as the laggards pick up the last few models and the market will saturate<br />
:* From Q4, the technology will near obsolescence and a new technology would substitute it<br><br><br />
<br />
'''Comparison of Adoption rate of Innovators with those of Imitators'''<br><br />
The model helps to determine sales to innovators and imitators for each year:<br><br><br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart4.swf</gflash></center><br />
<br />
<br />
This graph shows that a small number of innovators will kick-start the sales. OLED display mobile Phones will get off to a slow start in first three quarters. Once a '''''critical mass''''' is reached by the end of the Q3, strong imitative effects will take over as the innovators decrease.<br />
<br />
===Detailed Analysis===<br />
<br />
The detailed modeling with a description of parameters and mathematical equations can be viewed here:<br><br />
[[Bass Diffusion Analysis for OLED display phones]]<br />
<br />
==Comparing projections==<br />
Since disparate product categories had been used for the two forecasts, the two were compared to cross validate the results [[media:Bass-Model_OLED_comparison.xls|''<<excel sheet with calculations>>'']]<br><br />
<br />
<br />
<center><gflash>650 430 http://www.dolcera.com/website/assets/Chart5.swf</gflash></center><br />
<br />
:* Looking at the forecast for OLED display mobile phones based on analogous products and on iPhone, both are seen to be ''convergent''<br />
:* This validates the forecast<br />
<br />
<br />
<br />
==Sneak Preview of some models using OLED technology==<br />
{| class="wikitable" style="font-size:100%" border="1" cellpadding="5" cellspacing="0" width=80%<br />
|-<br />
| width=40% valign=top | [[Image:Apple.jpg|thumb|center|200px|[http://www.appleiphoneapps.com/2009/03/next-iphone-to-have-oled-display-why-should-you-care/ Source: appleiphoneapps.com]]]<br />
| width=60% valign=top | '''1. Apple iPhone''' - It’s nothing official at the moment, but word on the street is that Apple might have chosen a series of OLED displays for its next round of handsets. Such a move would certainly be in the best interests of battery life, as the iPhone isn’t noted for its battery capabilities. Considering the amount of new features that were announced in the iPhone 3.0 firmware update, it would be fairly practical to have a capacitive OLED display in the future.<br />
|-<br />
| width=40% valign=top | [[Image:Nokia.jpg|thumb|center|200px|[http://www.mobilephonereviews.org/category/nokia/ Source: Mobile Phone Reviews]]]<br />
<br />
| width=60% valign=top | '''2. Nokia''' - '''Nokia 6600''' Slide Mobile Phone is a 3G device with large OLED display and 3.2 megapixel camera. It has curved edges and with a weight of 110g is a bit heavy to hold. The 2.2” screen supports 16 million colors and comes with QVGA resolution. The dimensions of the phone are 90 x 45 x 14mm.<br />
<br />
|-<br />
| width=40% valign=top | [[Image:Samsung.jpg|thumb|center|200px|[http://www.att-phones.org/att-samsung-a877-phone-will-be-available.html Source: ATT Phones]]]<br />
<br />
| width=60% valign=top | '''3. Samsung''' - '''Samsung A877''' features include a 3.2-inch WQVGA AMOLED touchscreen, a 3 megapixel camera, GPS, HSDPA and Bluetooth. And as well at it supports AT&T’s 3G service.<br />
|-<br />
<br />
| width=40% valign=top | [[Image:Sony.jpg|thumb|center|200px|[http://www.itechnews.net/2008/01/08/sony-ericsson-z555-stylish-phone/ Source: Itechnews]]]<br />
| width=60% valign=top | '''4. Sony''' - '''Sony Ericsson Z555''' features a 1.9-inch LCD display, an OLED 128×36 external display, a 1.3 Megapixel camera with 4x digital zoom.<br />
|-<br />
| width=40% valign=top | [[Image:LG Mobile.jpg|thumb|center|200px|[http://www.unwiredview.com/2008/02/20/lg-sh150a-gets-am-oled-display-with-26-million-colors-and-hd-support/ Source: Unwiredview]]]<br />
| width=60% valign=top | '''5. LG''' - One of the first handsets to get the new AM OLED, is already advanced '''LG SH150''' DMB TV phone. <br />
|-<br />
| width=40% valign=top | [[Image:Motorola.jpg|thumb|center|200px|[http://www.itechnews.net/2007/10/12/motorola-u9-mobile-phone/ Source: Itechnews]]]<br />
| width=60% valign=top | '''6. Motorola''' - The '''MOTO U9''' is a Quad-band phone with a 2-inch QVGA LCD display, a 1.45-inch secondary OLED display, integrated music player, Bluetooth, 25MB internal memory and a microSD card slot.<br />
<br />
|-<br />
|}<br />
<br />
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Main_Page&diff=9319
Main Page
2011-07-28T13:24:43Z
<p>Shweta.mittal@dolcera.com: /* Technology */</p>
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{| style="border:1px solid #AAA; background:#E9E9E9;width:100%" align="center"<br />
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===Life Sciences and Chemistry===<br />
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===Technology===<br />
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=== Landscape reports ===<br />
* [[Alopecia - Hair Loss]] | ([http://www.youtube.com/watch?v=jAIoyKuKQ6o Video])<br />
* [[Inflammation and cardiovascular drugs]] | ([http://www.youtube.com/watch?v=FVUFcz2dpIM Video])<br />
* [[RNAi Database sample wiki]] | ([http://www.youtube.com/watch?v=nsZLUSPn3cg Video])<br />
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* [[Pressure sensitive adhesives]] | ([http://www.youtube.com/watch?v=plP3TzjYsiQ Video])<br />
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent_-_Market_Analysis&diff=9318
Ureteral Stent - Market Analysis
2011-07-28T13:20:35Z
<p>Shweta.mittal@dolcera.com: /* Boston Scientific */</p>
<hr />
<div>==Introduction==<br />
<br />
A ureteral stent, sometimes as well called ureteric stent, is a thin tube inserted into the ureter to prevent or treat obstruction of the urine flow from the kidney. The length of the stents used in adult patients varies between 24 to 30 cm. Additionally, stents come in differing diameters or gauges, to fit different size ureters. The stent is usually inserted with the aid of a cystoscope. One or both ends of the stent may be coiled to prevent it from moving out of place, this is called a JJ stent, double J stent or pig-tail stent.<br />
<br />
[[image:Vaious_ureteric_stents.jpeg|200px]]<br />
<br />
==Prevalence and Incidence==<br />
<font color="#212121">Urinary incontinence (any involuntary leakage of urine) is a significant health problem in the United States and worldwide. It has a considerable social and economic impact on individuals and society. When discussing the epidemiology and impact of incontinence, it is important to distinguish between prevalence and incidence.<br />
<br />
'''Prevalence''' is the probability of having a disease or condition, in this case incontinence, within a defined population at a defined point in time. For example, prevalence would be the number of 60-year-old women in the United States in the year 2001 experiencing the symptom of incontinence.<br />
<br />
'''Incidence''', on the other hand, is the probability of developing a disease or condition during a defined period of time. Thus, the percentage of continent women in 2001 that will develop incontinence over the next year would define the incidence of incontinence over a 1-year period.<br />
<br />
</font><br />
===Incontinence in Women===<br />
<br />
<font color="#212121">A 1995 review on the prevalence of incontinence in the general population summarized 11 studies conducted with a mixed population of females of various ages and a variety of causes of incontinence. Figure 1 shows that the prevalence is relatively low early in life, has a peak around the time of menopause, and then rises steadily between the ages of 60 and 80 years. The prevalence of 10% in 15–19-year-olds and 18% in 20–24-year-olds seems a bit high when one considers the number of young women who actually seek treatment for incontinence. This may be a result of including a large number of young women with "insignificant" or non-bothersome incontinence in the survey. ([http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1476070/ National Institutes of Health ])<br />
<br />
</font>'''[http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1476070/figure/F1/ Figure 1]'''<br />
[[Image:P&I.jpg]]<br />
<br />
<br />
<font color="#212121">Prevalence of incontinence in general population of females reported in 13 different studies. Young adult, 20% to 30%; Middle age, 30% to 40%; Elderly, 30% to 50%. Reprinted from Sandvik, with permission.</font><br />
<br />
<font color="#212121">Many studies have looked at the relative prevalence of stress, urge, and mixed incontinence in specific populations. The overall prevalence of stress incontinence and mixed incontinence (stress and urge incontinence) is quite high, whereas the overall percentage of urge incontinence is lower. When looking at such data, it is important to consider that although a majority of patients have the symptom of stress incontinence, urge incontinence (including lesser degrees of urge incontinence), tends to be considerably more bothersome than similar degrees of stress incontinence.</font><br />
<br />
===Incontinence in Men===<br />
<font color="#212121">The prevalence of incontinence in men of all ages is certainly lower than that for women. Large studies have indicated that there is a 3% to 11% overall prevalence rate of incontinence in the male population with urge incontinence being the prominent symptom reported in 40% to 80% of patients. Next, mixed incontinence is the most prevalent at 10% to 30%, whereas isolated stress incontinence accounts for less than 10% of incontinence in male patients. Stress incontinence in men is rare unless the patient has undergone some type of prostate surgery or has suffered neurological injury or trauma. Incontinence in men increases with age and appears to rise more steadily than it does in women. That is, there are no spikes in prevalence similar to those that occur for women around menopause. However, the estimates for severe incontinence in men in their 70<nowiki>’</nowiki>s and 80<nowiki>’</nowiki>s is still only about half of that in women. A major consideration in the incontinent male patient, especially with urge incontinence, is the potential contribution of bladder outlet obstruction to bladder over activity. Many men suffering from bladder over activity will also have bladder outlet obstruction. Such a situation can affect therapeutic options for patients.</font><br />
<br />
===Habitual patterns===<br />
<br />
Before analyzing the habitual and behavioral patterns that lead to implantation of a ureteral stent we must understand what all medical conditions require a stent.<br />
<br />
There are a variety of reasons why a stent has been placed. For patients with stone surgery, the stent allows passage of residual fragments without blocking the ureter.<br />
<br />
Patients who have had ureteroscopy (a look up the ureter) have a stent placed to allow the ureter to remain open while the normal postoperative swelling of the ureter resolves.<br />
<br />
Patients who have had any form of surgery on the ureter have a stent placed to allow healing of the ureter in the proper open fashion.<br />
<br />
The following prominent medical problems that may lead to a ureteral stent have been analyzed -<br />
<br />
====Kidney stone====<br />
<br />
[[Inhibitors of stone formation]]<br />
<br />
[[Calcium]]<br />
<br />
[[Role of dietary animal protein]]<br />
<br />
[[Other factors]](Alcohol, vitamin supplements, temperature, space travel etc)<br />
<br />
Source [http://en.wikipedia.org/wiki/Kidney_stone Source]<br />
<br />
====Urinary Tract Infection (UTI) and Diabetes====<br />
<br />
Urinary Tract Infection, (UTI) is a common ailment and can affect people of all ages, sex, and from all cultures. However, there are certain groups of people that are more prone to UTI than others. Women, for example, for reasons yet to be firmly established, carry a greater risk of UTI. Diabetic patients too fall under this category. Going further, pregnant women with diabetes are probably amongst the most vulnerable to UTI.<br />
<br />
[[UTI and diabetes complete article]]<br />
<br />
'''Habitual patterns causing or worsening diabetes include'''<br />
<br />
* [[Alcohol Consumption]]<br />
<br />
* [[Smoking]]<br />
<br />
====Other causes====<br />
<br />
Other prominent reasons like prostrate cancers and tumours, narrowing of the ureter, scarring of the ureter wall etc do not directly relate to any behavioral or habitual patterns.<br />
<br />
Though genes and hereditary increase the probability of these.<br />
<br />
==Prevalence rate of Urinary Incontinence in USA for the year 2009 & 2010==<br />
Uretral stents are used to ensure the patency of a [http://en.wikipedia.org/wiki/Ureter ureter], which may be compromised, for example, by a [http://en.wikipedia.org/wiki/Kidney_stone kidney stone]. This method is sometimes used as a temporary measure, to prevent damage to a blocked kidney, until a procedure to remove the stone can be performed. Following are the statistics from the national institute of diabetes and digestive and kidney diseases showing the prevalence and incidence rate of urinary incontinence which might result from any of these primary diseases: ([http://www.usrds.org/qtr/default.html Source])<br />
<br />
• Diabetes<br />
<br />
• Hypertension<br />
<br />
• Glomerulonephritis<br />
<br />
• Cystic kidney<br />
<br />
• Urologic disease<br />
<br />
• All other<br />
<br />
==Market Analysis==<br />
<br />
====Methodology====<br />
''' <br />
[[Image:Method1.JPG|700px]]<br />
'''<br />
==Market Analysis for Ureteral Stent==<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent<nowiki>’</nowiki>s fundamental use. Following tree-diagram shows the fundamental uses of Ureteral Stent.<br />
<br />
Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
===Kidney Stones Market for Ureteral Stent===<br />
There are four main types of treatments available for curing kidney stones based on type of Kidney Stone, listed as follows<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Sr. No.'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Treatment'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Indications'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Requirement of Ureteral Stent'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''% of cases in general'''</font><br />
|-<br />
|align = "right" bgcolor = "#DBE5F1"|1<br />
|bgcolor = "#DBE5F1"|Lithotripsy<br />
|bgcolor = "#DBE5F1"|Radiolucent calculi, Renal stones <nowiki><</nowiki>2 cm, Ureteral stones <nowiki><</nowiki>1 cm<br />
|bgcolor = "#DBE5F1"|No<br />
|align = "right" bgcolor = "#DBE5F1"|49.07%<nowiki>*</nowiki><br />
|-<br />
|align = "right"|2<br />
|Ureteroscopy<br />
|Ureteral stones<br />
|Yes<br />
|align = "right"|15.48%<nowiki>*</nowiki><br />
|-<br />
|align = "right" bgcolor = "#DBE5F1"|3<br />
|bgcolor = "#DBE5F1"|Ureterorenoscopy<br />
|bgcolor = "#DBE5F1"|Renal stones <nowiki><</nowiki>2 cm<br />
|bgcolor = "#DBE5F1"|Yes<br />
|align = "right" bgcolor = "#DBE5F1"|0.47%<nowiki>*</nowiki><br />
|-<br />
|align = "right"|4<br />
|Percutaneous nephrolithotomy<br />
|Renal stones <nowiki>></nowiki>2 cm, Proximal ureteral stones <nowiki>></nowiki>1 cm<br />
|No<br />
|align = "right"|34.98%<nowiki>*</nowiki><br />
|-<br />
|}<br />
<br />
<nowiki>*</nowiki>Dolcera Estimate 2011<br />
<br />
As seen in table ureteral stent is required for Ureteroscopy and Ureterorenoscopy which together constitute for around 16% of Kidney stone cases.<br />
<br />
Total Number of Kidney Stone Cases in US in 2006: 166,000<br />
<br />
Approximate Stents required in 2006 = 166,000<nowiki>*</nowiki>0.16=26560<br />
<br />
===Kidney Transplant Market for Ureteral Stent===<br />
Every kidney transplant operation required ureteral stent to be placed in Patient<nowiki>’</nowiki>s body for few days till newly placed kidney adapts to Patients<nowiki>’</nowiki> body<br />
<br />
Total No. of Kidney Transplants done in United States in 2007 are approx. 17,513<br />
<br />
Total Market for Ureteral Stents in 2007 is 17,513<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="54%"<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Year'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''No. of Kidney Transplants'''</font><br />
|-<br />
|align = "right"|'''2007'''<br />
| 17,513<br />
|-<br />
|align = "right"|'''2006'''<br />
| 18,056<br />
|-<br />
|align = "right"|'''2005'''<br />
| 17,443<br />
|-<br />
|align = "right"|'''2000'''<br />
| 14,611<br />
|-<br />
|align = "right"|'''1995'''<br />
| 12,160<br />
|-<br />
|align = "right"|'''1990'''<br />
| 10,029<br />
|-<br />
|align = "right"|'''1985'''<br />
| 7,504<br />
|-<br />
|align = "right"|'''1980'''<br />
| 3,785<br />
|-<br />
|}<br />
<br />
===Urinary Incontinence Market For Stents===<br />
'''Inpatient hospital stays:'''The estimated number of hospital admissions among adults ages 18 or older with urinary incontinence listed as a diagnosis:<br>'''(2000):''' 47,802 hospital stays (1,332 men; 46,470 women)<br />
<br />
====Prevalence rate in US (women)====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="40%" <br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|'''Prevalence of Urinary Incontinece in US (Women)'''<br />
|-<br />
|bgcolor = "#4F81BD"|'''Age (in years)'''<br />
|'''Population with Urinary Incontinence (in %)'''<br />
|-<br />
|bgcolor = "#4F81BD"|30-39<br />
|align = "center"|28<br />
|-<br />
|bgcolor = "#4F81BD"|40-49<br />
|align = "center"|41<br />
|-<br />
|bgcolor = "#4F81BD"|50-59<br />
|align = "center"|48<br />
|-<br />
|bgcolor = "#4F81BD"|60-69<br />
|align = "center"|51<br />
|-<br />
|bgcolor = "#4F81BD"|70-79<br />
|align = "center"|55<br />
|-<br />
|bgcolor = "#4F81BD"|≥ 80<br />
|align = "center"|54<br />
|-<br />
|}<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="102%"<br />
|align = "center" colspan = "6"|'''Estimated cases for ureteral stents in US, 2010'''<br />
|-<br />
|bgcolor = "#4F81BD"|Age groups<br />
|bgcolor = "#4F81BD"|A) Female population (Million)<br />
|bgcolor = "#4F81BD"|B) Prevalence rate in female (%)<br />
|bgcolor = "#4F81BD"|C=A<nowiki>*</nowiki>B Affected population<br>(Million)<br />
|bgcolor = "#4F81BD"|D) Catherization rate (%)<br />
|bgcolor = "#4F81BD"|E=C<nowiki>*</nowiki>D<br>Stent market based on catherization<br />
|-<br />
|bgcolor = "#4F81BD"|30-39<br />
|align = "right"|20.10<br />
|align = "right"|28<br />
|align = "right"|5.62<br />
|align = "right"|0.043<br />
|2420.42<br />
|-<br />
|bgcolor = "#4F81BD"|40-49<br />
|align = "right"|21.99<br />
|align = "right"|41<br />
|align = "right"|9.01<br />
|align = "right"|0.123<br />
|11092.83<br />
|-<br />
|bgcolor = "#4F81BD"|50-59<br />
|align = "right"|21.50<br />
|align = "right"|48<br />
|align = "right"|10.32<br />
|align = "right"|0.124<br />
|12800.37<br />
|-<br />
|bgcolor = "#4F81BD"|60-69<br />
|align = "right"|15.32<br />
|align = "right"|51<br />
|align = "right"|7.81<br />
|align = "right"|0.160<br />
|12503.68<br />
|-<br />
|bgcolor = "#4F81BD"|70-79<br />
|align = "right"|9.16<br />
|align = "right"|55<br />
|align = "right"|5.04<br />
|align = "right"|0.172<br />
|8674.44<br />
|-<br />
|bgcolor = "#4F81BD"|≥ 80<br />
|align = "right"|7.15<br />
|align = "right"|54<br />
|align = "right"|3.86<br />
|align = "right"|0.044<br />
|1699.48<br />
|-<br />
|bgcolor = "#4F81BD"|Total<br />
|align = "right"|95.25<br />
|&nbsp;<br />
|align = "right"|41.69<br />
| <br />
| <br />
|-<br />
|}<br />
<br />
<br />
* '''Catherization rate''' depicts the actual number of people going in for ureteral stents.<br />
* Prevalence rate in US women is growing at a CAGR of 1.26%<br />
<br />
Assuming that each admission in hospital required one ureteral stent, market from Urinary Incontinence is around 47,802 stents per year<br />
<br />
===Total Market for Ureteral Stent===<br />
Following table displays approximate stent market per year<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="64%"<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Category'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''No. of Stents Required'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|Stent Market for Kidney Stones<br />
|align = "center" bgcolor = "#DBE5F1"|26560<br />
|-<br />
|Stent Market for Kidney Transplant<br />
|align = "center"|17513<br />
|-<br />
|bgcolor = "#DBE5F1"|Stent Market for Urinary Incontinence<br />
|align = "center" bgcolor = "#DBE5F1"|47802<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">Total</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">91875</font><br />
|-<br />
|}<br />
<br />
<br />
<br />
* Ureteral stent market is growing at a CAGR of 1.58%<br />
<br />
==== Government Policy====<br />
<br />
Medicare carriers may issue local coverage decisions (LCDs) listing criteria that must be met prior to coverage.<br />
<br />
Physicians are urged to review these policies [http://www.cms.hhs.gov/mcd/search.asp], and are encouraged to contact their local carrier medical director or commercial insurers to determine if a procedure is covered.<br />
<br />
The coding covers the following -<br />
<br />
* Placement<br />
<br />
* Removal<br />
<br />
* Imaging<br />
<br />
* Outpatient hospital<br />
<br />
* Inpatient hospital<br />
<br />
[[media:cook.pdf|Click here]] for coding details and payment.<br />
<br />
====Ureteral stent market forecast in US (women)====<br />
''' <br />
[[Image:stent_forcast.jpeg]]<br />
'''<br />
<br/><br />
<br/><br />
[[media:4887766.xls|Detailed_calculation_workbook]]<br />
<br />
==Ureteral Stent Pricing==<br />
<br />
<u>'''Boston Scientific and Cook INC'''</u><br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD"|'''Manufacturer'''<br />
|align = "center" bgcolor = "#4F81BD"|'''Stent'''<br />
|align = "center" bgcolor = "#4F81BD"|'''Price (in USD)'''<br />
|-<br />
|bgcolor = "#4F81BD"|Boston Scientific<br />
|Percuflex Plus Ureteral Stent<br />
|16.99-24.99<br />
|-<br />
|bgcolor = "#4F81BD"|Boston Scientific<br />
|Polaris Ureteral Stent<br />
|24.99<br />
|-<br />
|bgcolor = "#4F81BD"|Boston Scientific<br />
|Polaris Ultra Ureteral Stent<br />
|16.99-24.99<br />
|-<br />
|bgcolor = "#4F81BD"|Cook INC<br />
|Ureteral Stent Set<br />
|19.99<br />
|-<br />
|bgcolor = "#4F81BD"|Cook INC<br />
|Resonance Metallic Ureteral Stent and Introducer<br />
|179.99-224.99<br />
|-<br />
|}<br />
<br />
<br />
<br />
<br />
'''Source'''<br />
<br />
[http://www.medsurplusonline.com/ medsurplusonline]<br />
<br />
'''<nowiki>*</nowiki>''' Most of the products apart from speciality products of both the companies have the same name and price.<br />
<br />
Their is just a slight modification in the stent which can be found out on the website given above according to the item number.<br />
<br />
Paid report ([http://www.medtechinsight.com/ReportA251.html medtechinsight] and [http://www.lifescienceintelligence.com/market-reports-page.php?id=A255 lifescienceintelligence]) on pricing and ordering information.<br />
<br />
===Ureteral Stent Substitutes===<br />
<br />
Ureteral Stents are not very expensive so the primary reason to seek alternatives arise out of the disadvantages of using a ureteral stent.<br />
<br />
About 50% of patients will have some type of side-effect associated with their stent. It is not possible to predict who will have stent-associated difficulties or when the stent symptoms will resolve. Some patients have stent symptoms for just a few days, while others find their symptoms persist throughout their entire stent duration. <br />
<br />
[[Main article- Ureteral stent difficulties]]<br />
<br />
It may be reasonable not to leave a ureteral stent if obstruction is likely to be transient. Your surgeon decides at the time of the procedure whether or not your circumstance warrants “stent free.” Occasionally, it may be possible to place a tube externally that drains the kidney. This tube is placed directly through the skin, through the kidney, and into the urinary space, called a [http://en.wikipedia.org/wiki/Nephrostomy nephrostomy] tube. This is placed under ultrasound or fluoroscopic Xray guidance. As the tube remains outside the body, it is slightly more inconvenient, has higher infection rates, and can sometimes get pulled out by accident. The advantage of a nephrostomy tube is better drainage, ability to place contrast into the kidney to evaluate for obstruction or leakage, and removal that does not require a [http://en.wikipedia.org/wiki/Cystoscopy cystoscopic] procedure.<br />
<br />
Other alternative methods for treating or removing stones are<br />
<br />
1) [http://en.wikipedia.org/wiki/Extracorporeal_shock_wave_lithotripsy Extracorporeal shock wave lithotripsy]<br />
<br />
2) [http://en.wikipedia.org/wiki/Laser_lithotripsy Laser lithotripsy]<br />
<br />
3) [[Alpha Blockers]]<br />
<br />
4) [[Urine alkalinization]]<br />
<br />
5) [[Allopurinol]]<br />
<br />
<br />
<font size = "4">'''Cost analysis of different treatments'''</font><br />
<br />
<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD"|'''Treatment/Procedure'''<br />
|align = "center" bgcolor = "#4F81BD"|'''Cost (In USD)'''<br />
|-<br />
|bgcolor = "#4F81BD"|Ureteral Stent implant<br />
|1500-2500<br />
|-<br />
|bgcolor = "#4F81BD"|Laser lithotripsy<br />
|5000-7000<br />
|-<br />
|bgcolor = "#4F81BD"|Urine Alkalization<br />
|<font color="#0000FF"><u>[http://www.everydayhealth.com/drugs/c/urinary-alkalinization Cost comparison (Drug based)]</u></font><br />
|-<br />
|bgcolor = "#4F81BD"|Allopurinol<br />
|<font color="#0000FF"><u>[http://pharmacychecker.com/Pricing.asp?DrugName=Allopurinol&DrugId=18415&DrugStrengthId=30083 Drug wise prices]</u></font><br />
|-<br />
|bgcolor = "#4F81BD"|Extracorporeal shock wave lithotripsy<br />
|Not available<br />
|-<br />
|}<br />
<br />
<br />
Source - [http://www.medsolution.com/surgery_urogen-lithotripsy.asp medsolution]<br />
<br />
===Trends in stent R&D===<br />
<br />
* Given that the first bare metal stent entered the market in 1994, the technology is far from mature.<br />
<br />
* Whilst drug eluting stents will be improved through the use of what are described as more ‘cell friendly’ (i.e. more hydrophobic) coatings and adapted (by using CFD in stent design) to varying wall sheer conditions, the industry is already well down the road of developing bioresorbable coatings and even bioresorbable stents.<br />
<br />
* Such systems are already on limited trial in Europe with FDA trials aimed at 2012 and approval by 2015.<br />
<br />
* There are still other areas under study including thinner struts which are important in terms of giving improved stent flexibility, a reduced cross-sectional profile within the vessel and potentially reduced restenosis (due to reduced vascular trauma).<br />
<br />
* Silicon carbides, carbon coatings, titanium nitride/oxide and sputtered indium oxide have all been trialled as routes to reducing the incidence of restenosis and/or thrombosis.<br />
<br />
* Click here for recent news and developments in [[Boston Scientific]] and [[Cook INC]]<br />
<br />
'''Source''' [http://www.ceram.com/newsroom/news-releases/ceram-examines-the-future-of-stent-materials/ Ceram-newsrelease]<br />
<br />
==Reimbursements==<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|colspan = "7"|'''2011 MEDICARE REIMBURSEMENT FOR URETERAL STENT PLACEMENT OR REMOVAL - PHYSICIAN AND OUTPATIENT FACILITY'''<br />
|-<br />
|align = "center" bgcolor = "#4F81BD" colspan = "5"|''Ambulatory Surgery Center''<br />
|align = "center" bgcolor = "#4F81BD"|''Outpatient Facility''<br />
|align = "center" bgcolor = "#4F81BD"|''Physician Services''<br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|CPT<br>Code<br />
|align = "center" bgcolor = "#4F81BD"|Procedure Description<br />
|align = "center" bgcolor = "#4F81BD"|Facility Payment<sup>1</sup><br />
|align = "center" bgcolor = "#4F81BD"|APC<br />
|align = "center" bgcolor = "#4F81BD"|Facility Fee Schedule<br>(National Medicare Avg)2<br />
|align = "center" bgcolor = "#4F81BD"|Fee When Services Are Provided in the Hospital or ASC (National Medicare Avg)3<br />
|align = "center" bgcolor = "#4F81BD"|Fee When Services Are Provided in the Office<br>(National Medicare Avg)4<br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|50393<br />
|Introduction of ureteral catheter or stent into ureter through renal pelvis for drainage and/or injection, percutaneous<br />
|align = "center"|$1,020.24<br />
|align = "center"|0162<br />
|align = "center"|$1,813.74<br />
|align = "center"|$224.92<br />
|align = "center"|N/A<nowiki>*</nowiki><br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|50605<br />
|Ureterotomy for insertion of indwelling stent, all types<br />
|align = "center" colspan = "3"|Procedure not permitted in outpatient setting<br />
|align = "center"|$982.60<br />
|align = "center"|N/A<nowiki>*</nowiki><br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|50947<br />
|Laparoscopy, surgical; ureteroneocystostomy with cystoscopy and ureteral stent placement<br />
|align = "center"|$1,853.68<br />
|align = "center"|0131<br />
|align = "center"|$3,295.39<br />
|align = "center"|$1,424.97<br />
|align = "center"|N/A<nowiki>*</nowiki><br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|51045<br />
|Cystotomy, with insertion of ureteral catheter or stent (separate procedure)<br />
|align = "center"|$288.27<br />
|align = "center"|0160<br />
|align = "center"|$512.48<br />
|align = "center"|$500.13<br />
|align = "center"|N/A<nowiki>*</nowiki><br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|52310<br />
|Cystourethroscopy, with removal of foreign body, calculus, or ureteral stent from urethra or bladder (separate procedure); simple<br />
|align = "center"|$680.87<br />
|align = "center"|0161<br />
|align = "center"|$1,210.41<br />
|align = "center"|$157.65<br />
|align = "center"|$253.80<br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|52315<br />
|Cystourethroscopy, with removal of foreign body, calculus, or ureteral stent from urethra or bladder (separate procedure); complicated<br />
|align = "center"|$1,020.24<br />
|align = "center"|0162<br />
|align = "center"|$1,813.74<br />
|align = "center"|$284.72<br />
|align = "center"|$444.41<br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|52332<br />
|Cystourethroscopy, with insertion of indwelling ureteral stent (eg, Gibbons or double-J type)<br />
|align = "center"|$1,020.24<br />
|align = "center"|0162<br />
|align = "center"|$1,813.74<br />
|align = "center"|$151.87<br />
|align = "center"|$501.15<br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|74480<br />
|Introduction of ureteral catheter or stent into ureter through renal pelvis for drainage and/or injection, percutaneous, radiological supervision and interpretation<br />
|align = "center" colspan = "3"|Imaging is included in allowance for ureteral stent placement or removal<br />
|align = "center"|$27.18<br />
|align = "center"|$112.80<br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|76942<br />
|Ultrasonic guidance for needle placement (eg, biopsy, aspiration, injection, localization device), imaging supervision and interpretation<br />
|align = "center" colspan = "3"|Imaging is included in allowance for ureteral stent placement or removal<br />
|align = "center"|$33.64<br />
|align = "center"|$198.08<br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|77002<br />
|Fluoroscopic guidance for needle placement (eg, biopsy, aspiration, injection, localization device)<br />
|align = "center" colspan = "3"|Imaging is included in allowance for ureteral stent placement or removal<br />
|align = "center"|$27.52<br />
|align = "center"|$75.77<br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|77012<br />
|Computed tomography guidance for needle placement (eg, biopsy, aspiration, injection, localization device), radiological supervision and interpretation<br><br />
|align = "center" colspan = "3"|Imaging is included in allowance for ureteral stent placement or removal<br />
|align = "center"|$57.08<br />
|align = "center"|$163.77<br />
|-<br />
|colspan = "7"|1. 2011 Medicare Ambulatory Surgery Center Fee Schedule<br>2. 2011 Medicare Hospital Outpatient Prospective Payment System Fee Schedule<br>3. 2011 Medicare Physician Fee Schedule<br />
|-<br />
|colspan = "7"|N/A<nowiki>*</nowiki> Medicare has not developed a rate for the in-office setting as these procedures are typically performed in a hospital setting. Physicians should contact the Medicare contractor to determine if the service can be performed in-office. If the contractor determines the service or procedure may be performed in-office, the physician will receive Medicare<nowiki>’</nowiki>s physician fee schedule amount for procedures performed in the hospital/ASC.<br />
|-<br />
|colspan = "7"|CPT© 2010 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.<br />
|-<br />
|}<br />
<br />
<br />
<br />
2 "Allowed Amount" is the amount Medicare determines to be the maximum allowance for any Medicare covered procedure. Actual payment will vary based on the maximum allowance less any applicable deductibles, co-insurance, etc.<br />
<br />
<sup>3 </sup>The hospital outpatient payment rates are 2011 Medicare national averages. Source: November 2, 2010 Federal Register, CMS-1504-FC.<br />
<br />
<sup>4 </sup>The ASC payments rates are 2011 Medicare national averages. ASC rates are from the 2011 Ambulatory Surgical Center Covered Procedures List – Addendum AA. Source: November 2, 2010 Federal Register, CMS-1504-FC.<br />
<br />
==Competitor Analysis==<br />
<br />
===Boston Scientific===<br />
<br />
[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Ureteral Stent portfolio]<br />
<br />
<br />
Net sales in 2010 – USD 7.8 Billion<br />
<br />
Share of Urology- 8.48 %<br />
<br />
Net sales from Urology- USD 661 Million<br />
<br />
<br />
Source [http://phx.corporate-ir.net/phoenix.zhtml?c=62272&p=irol-reportsother BSsalesdata]<br />
<br />
===CR BARD===<br />
<br />
[[Urology portfolio]]<br />
<br />
<br />
Net sales in 2010 – USD 2.7 Billion<br />
<br />
Share of Urology- 26%<br />
<br />
Net sales from Urology- USD 702 Million<br />
<br />
Source – CR BARD annual report<br />
<br />
===Cook Medical===<br />
<br />
[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Ureteral Stent portfolio]<br />
<br />
Total Sales - USD 1.7 Billion<br />
<br />
[http://www.nytimes.com/2011/04/26/business/26cook.html?_r=1 Source]<br />
<br />
===Medline===<br />
<br />
[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Ureteral Stent Portfolio]<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4F81BD"|'''Company'''<br />
|bgcolor = "#4F81BD"|'''Total Sales in 2010'''<br />
|bgcolor = "#4F81BD"|'''Urological sales'''<br />
|bgcolor = "#4F81BD"|'''Percentage share'''<br />
|bgcolor = "#4F81BD"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4F81BD"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4F81BD"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4F81BD"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4F81BD"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
All figures in USD million<br />
<br />
[[image:stentshare.jpg]]<br />
<br />
===Research Work===<br />
<br />
Research at University of Minnesota about symptoms and pain associated with ureteral stent<br />
<br />
[[Research Team]]<br />
<br />
====Background and Purpose====<br />
<br />
*Ureteral stents are associated with significant pain and urinary symptoms.<br />
<br />
*Manufacturers have altered stent designs and materials in an attempt to minimize this morbidity.<br />
<br />
*This study evaluated the impact of these modifications.<br />
<br />
====Patients and Methods====<br />
<br />
*Stent manufacturers were asked to provide the 6F ureteral stent they believed would be associated with the least patient discomfort.<br />
<br />
*Patients undergoing uncomplicated ureteroscopy were randomized to the Bard Inlay, Cook Endo-Sof, Microvasive Contour, Applied Medical Vertex, or Surgitek Classic Double-Pigtail stent.<br />
<br />
*The Ureteric Stent Symptom Questionnaire (USSQ) was administered on days 1, 3, and 5, and the patients maintained a narcotic diary. The data were analyzed using ANOVA and nonparametric methods.<br />
<br />
====Results====<br />
<br />
*A total of 44 patients (73%) completed all USSQ questionnaires.<br />
<br />
*Urinary symptom scores were significantly lower for the Inlay stent on day 3 than for the Vertex (P = 0.01), Contour (P = 0.05), Endo-Sof (P = 0.03), and Classic (P = 0.02) stents. No significant differences were noted in pain and general symptom scores or narcotic use.<br />
<br />
====Conclusion====<br />
<br />
*'''The Bard Inlay stent is associated with less-severe urinary symptoms than other ureteral stents.'''<br />
<br />
*The USSQ is a sensitive tool to measure differences between stents.<br />
<br />
The complete USSQ form is available at [http://www.bui.ac.uk/ BUI] and [http://www.endourology.org/ endourology].<br />
<br />
Source [http://www.liebertonline.com/doi/abs/10.1089/end.2005.19.990?journalCode=end University of Minnesota]<br />
<br />
==Boston Scientific==<br />
<br />
[http://dolcera.com/wiki/index.php?title=Boston_Scientific_-_Company_Profile Click here for the company profile]<br />
<br />
==References==<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Main_Page&diff=9316
Main Page
2011-07-28T13:16:41Z
<p>Shweta.mittal@dolcera.com: /* Technology */</p>
<hr />
<div>__NOTOC__<br />
===[[#Intellectual Property (IP) Services|Intellectual Property(IP) Services]]===<br />
===[[#Business & Information Research Services|Business and Information Research Services]]===<br />
===[[#Dolcera Technology Platforms|Dolcera Technology Platform]]===<br />
<br />
== Intellectual Property (IP) Services ==<br />
{| style="border:1px solid #AAA; background:#E9E9E9;width:100%" align="center"<br />
|-<br />
! style="background:lightgrey;width:50%" valign = "top" | <br />
===Life Sciences and Chemistry===<br />
! style="background:lightgrey;width:50%" valign = "top" | <br />
===Technology===<br />
|-<br />
| valign = "top" |<br />
=== Landscape reports ===<br />
* [[Alopecia - Hair Loss]] | ([http://www.youtube.com/watch?v=jAIoyKuKQ6o Video])<br />
* [[Inflammation and cardiovascular drugs]] | ([http://www.youtube.com/watch?v=FVUFcz2dpIM Video])<br />
* [[RNAi Database sample wiki]] | ([http://www.youtube.com/watch?v=nsZLUSPn3cg Video])<br />
* [[Choline Bitartarate]]<br />
* [[Non-wovens]]<br />
* [[Pressure sensitive adhesives]] | ([http://www.youtube.com/watch?v=plP3TzjYsiQ Video])<br />
* [[Ureteral Stent]]<br />
* [[Smart Drug Delivery Systems]] | ([http://www.youtube.com/watch?v=vARe9eBFsq4 Video])<br />
* [[Silicone Hydrogel contact lens]]<br />
* [[SC Johnson]]<br />
* [[Pinene: An off flavor in mango juice]] | ([http://www.youtube.com/watch?v=P4fI1rjPjSg Video])<br />
* [[Bio-PET]]<br />
* [[Interferon For Treatment of Melanoma]]<br />
* [[Antibody against TNF]]<br />
* [[Pressure sensitive adhesives in packaging]] <br />
| valign = "top" |<br />
<br />
=== Landscape Reports ===<br />
* [[Hybrid Electric Vehicle Battery System]]<br />
* [[Supply Chain RFID Applications]]<br />
* [[Insurance sector]]<br />
* [[CDMA Basics]]<br />
* [[Quality of Service on CDMA platforms]]<br />
* [[OLED - Organic Light Emitting Diode]]<br />
* [[Carbon Nanotubes (CNT)]] | ([http://www.youtube.com/watch?v=HvZqBy8XvIE Video])<br />
* [[Metallic and Ceramic construction materials]]<br />
* [[Transactional memory]]<br />
* [[Invalidation Search on a patent in the semiconductors space|Invalidation Search]]<br />
* [[Golf Club Head Landscape]]<br />
* [[Variable Valve Timing - Sample]]<br />
* [[Wind Energy]]<br />
|-<br />
| valign = "top" |<br />
<br />
===STN Search Reports===<br />
* [[Markush Search Report]]<br />
<br />
=== Dashboard ===<br />
* [http://client.dolcera.com/dashboard/dashboard.html?workfilegroup_id=10 Alopecia areata dashboard - live] <br />
** ([[Alopecia Areata Dashboard Screenshots|Screenshots only]]) <br />
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* [http://www.dolcera.com/website/demos/dna/main.html Sequence dashboard]<br />
* [[Legal Updates Demo|Legal updates dashboard]]<br />
* [http://client.dolcera.com/dashboard/dashboard.html?workfile_id=587 RNAi Dashboard]<br />
| valign = "top" |<br />
<br />
=== Dashboard ===<br />
* [http://client.dolcera.com/dashboard/dashboard.html?workfilegroup_id=27 Automotive dashboard - live]<br />
** [[Automotive Dashboard Screenshots|Screenshots only]]<br />
* [http://client.dolcera.com/dashboard/dashboard.html?workfile_id=54 WiMAX dashboard - live] <br />
** [[WiMAX Dashboard Screenshots|Screenshots only]]<br />
* [http://www.dolcera.com/ipmapdemo/rfid_model.swf RFID dashboard]<br />
<br />
<br />
=== IP Valuation ===<br />
<br />
*[[Holographic Image Display]]<br />
|-<br />
| valign = "top" |<br />
<br />
=== Prior Art / Invalidation / FTO Search ===<br />
* [http://dolcera.com/client/d8r3/hairloss_map.htm Alopecia/Hair loss IPMap]<br />
* [[Markush Structure Search Sample]]<br />
==== Study: In re Bilski Impact ====<br />
* [[In re Bilski Impact assessed from US PAIR Information]]<br />
| valign = "top" |<br />
<br />
=== Prior Art / Invalidation / FTO Search ===<br />
* [[Prior Art Search Process]]<br />
* [http://www.dolcera.com/ipmapdemo/satellite_antenna/ipmap.html Satellite Antenna IPMap]<br />
* [http://www.dolcera.com/ipmapdemo/rfid/ipmap.html RFID IPMap]<br />
* [http://www.dolcera.com/ipmapdemo/multimodal_apps/ipmap.html Multimodal Applications IPMap]<br />
* [http://www.dolcera.com/ipmapdemo/Invalidation_US4825448.htm Invalidation Claim Chart Sample]<br />
|-<br />
|}<br />
<br />
===Clinical Trial Database===<br />
*[[Clinical Trial Database]]<br />
<br />
== Business & Information Research Services ==<br />
{| style="border:1px solid #AAA; background:#E9E9E9;width:100%" align="center"<br />
|-<br />
! style="background:lightgrey" valign=top width=50%| <br />
===Life Sciences and Chemistry===<br />
! style="background:lightgrey" valign=top width=50%|<br />
===Technology===<br />
|-<br />
| valign=top |<br />
* [[Diabetes products and services]]<br />
* [[Drug Metabolism]]<br />
* [[Toxicology]]<br />
* [[Osteoporosis]]<br />
* [[Oral Diabetes Drugs]]<br />
* [[Ureteral Stent]]<br />
* [[Premium Coffee Consumers Market Segmentation|Premium Coffee - Market Positioning]]<br />
* [[Dolcera's Poster on Industrial Biotechnology|Industrial biotechnology]]<br />
* [[OTC products for acne treatment]]<br />
* [[Botox - from Medical Procedure to Household Word]]<br />
* [[Digestive Remedies Market in India and China]]<br />
* [[OTC vs. Prescription Drugs]]<br />
* [[Rx to OTC Switch-Market Analysis]]<br />
* [[Vaccines Market in Western Countries]]<br />
* [[Cardiac Pacemakers]], Company Profile:[http://dolcera.com/wiki/index.php?title=Cardiac_Pacemakers#2.11_Cardiac_Science_Corporation Cardiac Science Corporation]<br />
* [[Ureteral Stent - Market Analysis]], Company Profile:[[Boston Scientific - Company Profile |Boston Scientific ]]<br />
| valign=top |<br />
* [[4G wireless technology developments]]<br />
* [[LTE]]<br />
* [[Femtocells]]<br />
* [[HDTV in the US]]<br />
* [http://www.dolcera.com/ipmapdemo/innovation_explorer/innovation_explorer.html Household robotics Innovation Explorer]<br />
* [[Web video]]<br />
* [[OLED Mobile Phones Market Research and Analysis Report]] | ([http://www.viddler.com/explore/dolcera/videos/6/ Video])<br />
* [[Virtualization]]<br />
* [[Cloud Computing]]<br />
* [[Estimation of liquid carrying vehicles in USA]]<br />
* [[A market study on Hybrid vehicles and the concept of V2G]]<br />
* [[Patent Valuation]]<br />
* [[LCD Technology]], Company Profile: [[Samsung]]<br />
* [[Wireless Power Transmission]], [[Electric Vehicles Market]], [[Patent Valuation-Auckland Uniservices]]<br />
|-<br />
! style="background:lightgrey" valign=top colspan=2 |<br />
<br />
===Finance===<br />
|-<br />
| valign=top colspan=2 |<br />
* [[Innovative personal finance products]]<br />
* [[Life Insurance Industry in US]]<br />
|}<br />
<br />
== Dolcera Technology Platforms ==<br />
{| style="border:1px solid #AAA; background:#E9E9E9;width:100%" align="center"<br />
|-<br />
| align = "top" |<br />
<br />
==== Dashboard 1.1 ====<br />
* [http://www.dolcera.com/auth/dashboarddemo/dashboard.php?workfilegroup_id=154 Demo Dashboard (Alopecia)] <br />
** [[Access details]]<br />
* [[Sample list of patent numbers]]<br />
* [http://www.dolcera.com/auth/index.php Dashboard login page]<br />
<br />
==== [[Workflow for creating a Dashboard]] ====<br />
<br />
==== IP and Products dashboard ====<br />
* [http://client.dolcera.com/dashboard/dashboard.html?workfilegroup_id=10 Alopecia areata dashboard] <br />
* [http://www.dolcera.com/ipmapdemo/stent_model.swf Stent dashboard]<br />
* [[Legal Updates Demo|Legal updates dashboard]]<br />
* [http://client.dolcera.com/dashboard/dashboard.html?workfile_id=54 4G wireless product and patent dashboard]<br />
<br />
==== Patent-pathway mapping ====<br />
* [[Inflammation and cardiovascular drugs#Interactive signaling pathways and patents|Patent-pathway mapping]]<br />
==== Sequence dashboard ====<br />
* [http://www.dolcera.com/website/demos/dna/main.html Sequence dashboard]<br />
<br />
==== Design analysis ====<br />
* [http://www.dolcera.com/website/demos/dental/main.html Dental Implant Design Analysis]<br />
<br />
==== Innovation explorer ====<br />
* [http://www.dolcera.com/ipmapdemo/innovation_explorer/innovation_explorer.html Household robotics innovation explorer]<br />
==== KPort ====<br />
* [http://dolcera.com/website/demos/kport/main.html Collaboration Portal]<br />
<br />
|-<br />
|}<br />
<br />
=== Dolcera Offerings summary ===<br />
* [[Dolcera Offerings|Dolcera offerings summary]]<br />
<br />
=== [[Technology Support]] ===<br />
<br />
==<span style="color:#C41E3A">Like any of these sample reports?</span>==<br />
<p align="center"> '''These are sample reports with brief analysis''' <br><br />
'''Dolcera can provide a comprehensive report customized to your needs'''</p><br />
{|border="2" cellspacing="0" cellpadding="4" align="center" "<br />
|style="background:lightgrey" align = "center" colspan = "3"|'''[mailto:info@dolcera.com <span style="color:#0047AB">Buy the customized report from Dolcera</span>]''' <br />
|-<br />
| align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services Patent Analytics Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/business-research-services Market Research Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/tools/patent-dashboard Purchase Patent Dashboard]<br />
|-<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Landscape Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/research-processes Dolcera Processes]<br />
|align = "center"| [http://www.dolcera.com/website_prod/industries Industry Focus]<br />
|-<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Search Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/alerts-and-updates Patent Alerting Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/tools Dolcera Tools]<br />
|-<br />
|}<br />
<br><br />
<br />
----<br />
{| style="border:1px solid #AAA; background:#E9E9E9" align="center"<br />
|-<br />
! style="background:lightgrey" | Contact Dolcera<br />
|-<br />
! style="background:lightgrey" | Samir Raiyani<br />
|-<br />
| '''Email''': [mailto:info@dolcera.com info@dolcera.com]<br />
|-<br />
| '''Phone''': +1-650-269-7952, +91-40-2355-3493<br />
|}</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Main_Page&diff=9315
Main Page
2011-07-28T13:15:39Z
<p>Shweta.mittal@dolcera.com: /* Technology */</p>
<hr />
<div>__NOTOC__<br />
===[[#Intellectual Property (IP) Services|Intellectual Property(IP) Services]]===<br />
===[[#Business & Information Research Services|Business and Information Research Services]]===<br />
===[[#Dolcera Technology Platforms|Dolcera Technology Platform]]===<br />
<br />
== Intellectual Property (IP) Services ==<br />
{| style="border:1px solid #AAA; background:#E9E9E9;width:100%" align="center"<br />
|-<br />
! style="background:lightgrey;width:50%" valign = "top" | <br />
===Life Sciences and Chemistry===<br />
! style="background:lightgrey;width:50%" valign = "top" | <br />
===Technology===<br />
|-<br />
| valign = "top" |<br />
=== Landscape reports ===<br />
* [[Alopecia - Hair Loss]] | ([http://www.youtube.com/watch?v=jAIoyKuKQ6o Video])<br />
* [[Inflammation and cardiovascular drugs]] | ([http://www.youtube.com/watch?v=FVUFcz2dpIM Video])<br />
* [[RNAi Database sample wiki]] | ([http://www.youtube.com/watch?v=nsZLUSPn3cg Video])<br />
* [[Choline Bitartarate]]<br />
* [[Non-wovens]]<br />
* [[Pressure sensitive adhesives]] | ([http://www.youtube.com/watch?v=plP3TzjYsiQ Video])<br />
* [[Ureteral Stent]]<br />
* [[Smart Drug Delivery Systems]] | ([http://www.youtube.com/watch?v=vARe9eBFsq4 Video])<br />
* [[Silicone Hydrogel contact lens]]<br />
* [[SC Johnson]]<br />
* [[Pinene: An off flavor in mango juice]] | ([http://www.youtube.com/watch?v=P4fI1rjPjSg Video])<br />
* [[Bio-PET]]<br />
* [[Interferon For Treatment of Melanoma]]<br />
* [[Antibody against TNF]]<br />
* [[Pressure sensitive adhesives in packaging]] <br />
| valign = "top" |<br />
<br />
=== Landscape Reports ===<br />
* [[Hybrid Electric Vehicle Battery System]]<br />
* [[Supply Chain RFID Applications]]<br />
* [[Insurance sector]]<br />
* [[CDMA Basics]]<br />
* [[Quality of Service on CDMA platforms]]<br />
* [[OLED - Organic Light Emitting Diode]]<br />
* [[Carbon Nanotubes (CNT)]] | ([http://www.youtube.com/watch?v=HvZqBy8XvIE Video])<br />
* [[Metallic and Ceramic construction materials]]<br />
* [[Transactional memory]]<br />
* [[Invalidation Search on a patent in the semiconductors space|Invalidation Search]]<br />
* [[Golf Club Head Landscape]]<br />
* [[Variable Valve Timing - Sample]]<br />
* [[Wind Energy]]<br />
|-<br />
| valign = "top" |<br />
<br />
===STN Search Reports===<br />
* [[Markush Search Report]]<br />
<br />
=== Dashboard ===<br />
* [http://client.dolcera.com/dashboard/dashboard.html?workfilegroup_id=10 Alopecia areata dashboard - live] <br />
** ([[Alopecia Areata Dashboard Screenshots|Screenshots only]]) <br />
* [http://www.dolcera.com/ipmapdemo/stent_model.swf Stent dashboard]<br />
* [http://www.dolcera.com/website/demos/dna/main.html Sequence dashboard]<br />
* [[Legal Updates Demo|Legal updates dashboard]]<br />
* [http://client.dolcera.com/dashboard/dashboard.html?workfile_id=587 RNAi Dashboard]<br />
| valign = "top" |<br />
<br />
=== Dashboard ===<br />
* [http://client.dolcera.com/dashboard/dashboard.html?workfilegroup_id=27 Automotive dashboard - live]<br />
** [[Automotive Dashboard Screenshots|Screenshots only]]<br />
* [http://client.dolcera.com/dashboard/dashboard.html?workfile_id=54 WiMAX dashboard - live] <br />
** [[WiMAX Dashboard Screenshots|Screenshots only]]<br />
* [http://www.dolcera.com/ipmapdemo/rfid_model.swf RFID dashboard]<br />
<br />
<br />
=== IP Valuation ===<br />
<br />
*[[Holographic Image Display]]<br />
|-<br />
| valign = "top" |<br />
<br />
=== Prior Art / Invalidation / FTO Search ===<br />
* [http://dolcera.com/client/d8r3/hairloss_map.htm Alopecia/Hair loss IPMap]<br />
* [[Markush Structure Search Sample]]<br />
==== Study: In re Bilski Impact ====<br />
* [[In re Bilski Impact assessed from US PAIR Information]]<br />
| valign = "top" |<br />
<br />
=== Prior Art / Invalidation / FTO Search ===<br />
* [[Prior Art Search Process]]<br />
* [http://www.dolcera.com/ipmapdemo/satellite_antenna/ipmap.html Satellite Antenna IPMap]<br />
* [http://www.dolcera.com/ipmapdemo/rfid/ipmap.html RFID IPMap]<br />
* [http://www.dolcera.com/ipmapdemo/multimodal_apps/ipmap.html Multimodal Applications IPMap]<br />
* [http://www.dolcera.com/ipmapdemo/Invalidation_US4825448.htm Invalidation Claim Chart Sample]<br />
|-<br />
|}<br />
<br />
===Clinical Trial Database===<br />
*[[Clinical Trial Database]]<br />
<br />
== Business & Information Research Services ==<br />
{| style="border:1px solid #AAA; background:#E9E9E9;width:100%" align="center"<br />
|-<br />
! style="background:lightgrey" valign=top width=50%| <br />
===Life Sciences and Chemistry===<br />
! style="background:lightgrey" valign=top width=50%|<br />
===Technology===<br />
|-<br />
| valign=top |<br />
* [[Diabetes products and services]]<br />
* [[Drug Metabolism]]<br />
* [[Toxicology]]<br />
* [[Osteoporosis]]<br />
* [[Oral Diabetes Drugs]]<br />
* [[Ureteral Stent]]<br />
* [[Premium Coffee Consumers Market Segmentation|Premium Coffee - Market Positioning]]<br />
* [[Dolcera's Poster on Industrial Biotechnology|Industrial biotechnology]]<br />
* [[OTC products for acne treatment]]<br />
* [[Botox - from Medical Procedure to Household Word]]<br />
* [[Digestive Remedies Market in India and China]]<br />
* [[OTC vs. Prescription Drugs]]<br />
* [[Rx to OTC Switch-Market Analysis]]<br />
* [[Vaccines Market in Western Countries]]<br />
* [[Cardiac Pacemakers]], Company Profile:[http://dolcera.com/wiki/index.php?title=Cardiac_Pacemakers#2.11_Cardiac_Science_Corporation]<br />
* [[Ureteral Stent - Market Analysis]], Company Profile:[[Boston Scientific - Company Profile |Boston Scientific ]]<br />
| valign=top |<br />
* [[4G wireless technology developments]]<br />
* [[LTE]]<br />
* [[Femtocells]]<br />
* [[HDTV in the US]]<br />
* [http://www.dolcera.com/ipmapdemo/innovation_explorer/innovation_explorer.html Household robotics Innovation Explorer]<br />
* [[Web video]]<br />
* [[OLED Mobile Phones Market Research and Analysis Report]] | ([http://www.viddler.com/explore/dolcera/videos/6/ Video])<br />
* [[Virtualization]]<br />
* [[Cloud Computing]]<br />
* [[Estimation of liquid carrying vehicles in USA]]<br />
* [[A market study on Hybrid vehicles and the concept of V2G]]<br />
* [[Patent Valuation]]<br />
* [[LCD Technology]], Company Profile: [[Samsung]]<br />
* [[Wireless Power Transmission]], [[Electric Vehicles Market]], [[Patent Valuation-Auckland Uniservices]]<br />
|-<br />
! style="background:lightgrey" valign=top colspan=2 |<br />
<br />
===Finance===<br />
|-<br />
| valign=top colspan=2 |<br />
* [[Innovative personal finance products]]<br />
* [[Life Insurance Industry in US]]<br />
|}<br />
<br />
== Dolcera Technology Platforms ==<br />
{| style="border:1px solid #AAA; background:#E9E9E9;width:100%" align="center"<br />
|-<br />
| align = "top" |<br />
<br />
==== Dashboard 1.1 ====<br />
* [http://www.dolcera.com/auth/dashboarddemo/dashboard.php?workfilegroup_id=154 Demo Dashboard (Alopecia)] <br />
** [[Access details]]<br />
* [[Sample list of patent numbers]]<br />
* [http://www.dolcera.com/auth/index.php Dashboard login page]<br />
<br />
==== [[Workflow for creating a Dashboard]] ====<br />
<br />
==== IP and Products dashboard ====<br />
* [http://client.dolcera.com/dashboard/dashboard.html?workfilegroup_id=10 Alopecia areata dashboard] <br />
* [http://www.dolcera.com/ipmapdemo/stent_model.swf Stent dashboard]<br />
* [[Legal Updates Demo|Legal updates dashboard]]<br />
* [http://client.dolcera.com/dashboard/dashboard.html?workfile_id=54 4G wireless product and patent dashboard]<br />
<br />
==== Patent-pathway mapping ====<br />
* [[Inflammation and cardiovascular drugs#Interactive signaling pathways and patents|Patent-pathway mapping]]<br />
==== Sequence dashboard ====<br />
* [http://www.dolcera.com/website/demos/dna/main.html Sequence dashboard]<br />
<br />
==== Design analysis ====<br />
* [http://www.dolcera.com/website/demos/dental/main.html Dental Implant Design Analysis]<br />
<br />
==== Innovation explorer ====<br />
* [http://www.dolcera.com/ipmapdemo/innovation_explorer/innovation_explorer.html Household robotics innovation explorer]<br />
==== KPort ====<br />
* [http://dolcera.com/website/demos/kport/main.html Collaboration Portal]<br />
<br />
|-<br />
|}<br />
<br />
=== Dolcera Offerings summary ===<br />
* [[Dolcera Offerings|Dolcera offerings summary]]<br />
<br />
=== [[Technology Support]] ===<br />
<br />
==<span style="color:#C41E3A">Like any of these sample reports?</span>==<br />
<p align="center"> '''These are sample reports with brief analysis''' <br><br />
'''Dolcera can provide a comprehensive report customized to your needs'''</p><br />
{|border="2" cellspacing="0" cellpadding="4" align="center" "<br />
|style="background:lightgrey" align = "center" colspan = "3"|'''[mailto:info@dolcera.com <span style="color:#0047AB">Buy the customized report from Dolcera</span>]''' <br />
|-<br />
| align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services Patent Analytics Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/business-research-services Market Research Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/tools/patent-dashboard Purchase Patent Dashboard]<br />
|-<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Landscape Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/research-processes Dolcera Processes]<br />
|align = "center"| [http://www.dolcera.com/website_prod/industries Industry Focus]<br />
|-<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Search Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/alerts-and-updates Patent Alerting Services]<br />
|align = "center"| [http://www.dolcera.com/website_prod/tools Dolcera Tools]<br />
|-<br />
|}<br />
<br><br />
<br />
----<br />
{| style="border:1px solid #AAA; background:#E9E9E9" align="center"<br />
|-<br />
! style="background:lightgrey" | Contact Dolcera<br />
|-<br />
! style="background:lightgrey" | Samir Raiyani<br />
|-<br />
| '''Email''': [mailto:info@dolcera.com info@dolcera.com]<br />
|-<br />
| '''Phone''': +1-650-269-7952, +91-40-2355-3493<br />
|}</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent_-_Market_Analysis&diff=9314
Ureteral Stent - Market Analysis
2011-07-28T13:12:02Z
<p>Shweta.mittal@dolcera.com: /* Ureteral stent market forecast in US (women) */</p>
<hr />
<div>==Introduction==<br />
<br />
A ureteral stent, sometimes as well called ureteric stent, is a thin tube inserted into the ureter to prevent or treat obstruction of the urine flow from the kidney. The length of the stents used in adult patients varies between 24 to 30 cm. Additionally, stents come in differing diameters or gauges, to fit different size ureters. The stent is usually inserted with the aid of a cystoscope. One or both ends of the stent may be coiled to prevent it from moving out of place, this is called a JJ stent, double J stent or pig-tail stent.<br />
<br />
[[image:Vaious_ureteric_stents.jpeg|200px]]<br />
<br />
==Prevalence and Incidence==<br />
<font color="#212121">Urinary incontinence (any involuntary leakage of urine) is a significant health problem in the United States and worldwide. It has a considerable social and economic impact on individuals and society. When discussing the epidemiology and impact of incontinence, it is important to distinguish between prevalence and incidence.<br />
<br />
'''Prevalence''' is the probability of having a disease or condition, in this case incontinence, within a defined population at a defined point in time. For example, prevalence would be the number of 60-year-old women in the United States in the year 2001 experiencing the symptom of incontinence.<br />
<br />
'''Incidence''', on the other hand, is the probability of developing a disease or condition during a defined period of time. Thus, the percentage of continent women in 2001 that will develop incontinence over the next year would define the incidence of incontinence over a 1-year period.<br />
<br />
</font><br />
===Incontinence in Women===<br />
<br />
<font color="#212121">A 1995 review on the prevalence of incontinence in the general population summarized 11 studies conducted with a mixed population of females of various ages and a variety of causes of incontinence. Figure 1 shows that the prevalence is relatively low early in life, has a peak around the time of menopause, and then rises steadily between the ages of 60 and 80 years. The prevalence of 10% in 15–19-year-olds and 18% in 20–24-year-olds seems a bit high when one considers the number of young women who actually seek treatment for incontinence. This may be a result of including a large number of young women with "insignificant" or non-bothersome incontinence in the survey. ([http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1476070/ National Institutes of Health ])<br />
<br />
</font>'''[http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1476070/figure/F1/ Figure 1]'''<br />
[[Image:P&I.jpg]]<br />
<br />
<br />
<font color="#212121">Prevalence of incontinence in general population of females reported in 13 different studies. Young adult, 20% to 30%; Middle age, 30% to 40%; Elderly, 30% to 50%. Reprinted from Sandvik, with permission.</font><br />
<br />
<font color="#212121">Many studies have looked at the relative prevalence of stress, urge, and mixed incontinence in specific populations. The overall prevalence of stress incontinence and mixed incontinence (stress and urge incontinence) is quite high, whereas the overall percentage of urge incontinence is lower. When looking at such data, it is important to consider that although a majority of patients have the symptom of stress incontinence, urge incontinence (including lesser degrees of urge incontinence), tends to be considerably more bothersome than similar degrees of stress incontinence.</font><br />
<br />
===Incontinence in Men===<br />
<font color="#212121">The prevalence of incontinence in men of all ages is certainly lower than that for women. Large studies have indicated that there is a 3% to 11% overall prevalence rate of incontinence in the male population with urge incontinence being the prominent symptom reported in 40% to 80% of patients. Next, mixed incontinence is the most prevalent at 10% to 30%, whereas isolated stress incontinence accounts for less than 10% of incontinence in male patients. Stress incontinence in men is rare unless the patient has undergone some type of prostate surgery or has suffered neurological injury or trauma. Incontinence in men increases with age and appears to rise more steadily than it does in women. That is, there are no spikes in prevalence similar to those that occur for women around menopause. However, the estimates for severe incontinence in men in their 70<nowiki>’</nowiki>s and 80<nowiki>’</nowiki>s is still only about half of that in women. A major consideration in the incontinent male patient, especially with urge incontinence, is the potential contribution of bladder outlet obstruction to bladder over activity. Many men suffering from bladder over activity will also have bladder outlet obstruction. Such a situation can affect therapeutic options for patients.</font><br />
<br />
===Habitual patterns===<br />
<br />
Before analyzing the habitual and behavioral patterns that lead to implantation of a ureteral stent we must understand what all medical conditions require a stent.<br />
<br />
There are a variety of reasons why a stent has been placed. For patients with stone surgery, the stent allows passage of residual fragments without blocking the ureter.<br />
<br />
Patients who have had ureteroscopy (a look up the ureter) have a stent placed to allow the ureter to remain open while the normal postoperative swelling of the ureter resolves.<br />
<br />
Patients who have had any form of surgery on the ureter have a stent placed to allow healing of the ureter in the proper open fashion.<br />
<br />
The following prominent medical problems that may lead to a ureteral stent have been analyzed -<br />
<br />
====Kidney stone====<br />
<br />
[[Inhibitors of stone formation]]<br />
<br />
[[Calcium]]<br />
<br />
[[Role of dietary animal protein]]<br />
<br />
[[Other factors]](Alcohol, vitamin supplements, temperature, space travel etc)<br />
<br />
Source [http://en.wikipedia.org/wiki/Kidney_stone Source]<br />
<br />
====Urinary Tract Infection (UTI) and Diabetes====<br />
<br />
Urinary Tract Infection, (UTI) is a common ailment and can affect people of all ages, sex, and from all cultures. However, there are certain groups of people that are more prone to UTI than others. Women, for example, for reasons yet to be firmly established, carry a greater risk of UTI. Diabetic patients too fall under this category. Going further, pregnant women with diabetes are probably amongst the most vulnerable to UTI.<br />
<br />
[[UTI and diabetes complete article]]<br />
<br />
'''Habitual patterns causing or worsening diabetes include'''<br />
<br />
* [[Alcohol Consumption]]<br />
<br />
* [[Smoking]]<br />
<br />
====Other causes====<br />
<br />
Other prominent reasons like prostrate cancers and tumours, narrowing of the ureter, scarring of the ureter wall etc do not directly relate to any behavioral or habitual patterns.<br />
<br />
Though genes and hereditary increase the probability of these.<br />
<br />
==Prevalence rate of Urinary Incontinence in USA for the year 2009 & 2010==<br />
Uretral stents are used to ensure the patency of a [http://en.wikipedia.org/wiki/Ureter ureter], which may be compromised, for example, by a [http://en.wikipedia.org/wiki/Kidney_stone kidney stone]. This method is sometimes used as a temporary measure, to prevent damage to a blocked kidney, until a procedure to remove the stone can be performed. Following are the statistics from the national institute of diabetes and digestive and kidney diseases showing the prevalence and incidence rate of urinary incontinence which might result from any of these primary diseases: ([http://www.usrds.org/qtr/default.html Source])<br />
<br />
• Diabetes<br />
<br />
• Hypertension<br />
<br />
• Glomerulonephritis<br />
<br />
• Cystic kidney<br />
<br />
• Urologic disease<br />
<br />
• All other<br />
<br />
==Market Analysis==<br />
<br />
====Methodology====<br />
''' <br />
[[Image:Method1.JPG|700px]]<br />
'''<br />
==Market Analysis for Ureteral Stent==<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent<nowiki>’</nowiki>s fundamental use. Following tree-diagram shows the fundamental uses of Ureteral Stent.<br />
<br />
Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
===Kidney Stones Market for Ureteral Stent===<br />
There are four main types of treatments available for curing kidney stones based on type of Kidney Stone, listed as follows<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Sr. No.'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Treatment'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Indications'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Requirement of Ureteral Stent'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''% of cases in general'''</font><br />
|-<br />
|align = "right" bgcolor = "#DBE5F1"|1<br />
|bgcolor = "#DBE5F1"|Lithotripsy<br />
|bgcolor = "#DBE5F1"|Radiolucent calculi, Renal stones <nowiki><</nowiki>2 cm, Ureteral stones <nowiki><</nowiki>1 cm<br />
|bgcolor = "#DBE5F1"|No<br />
|align = "right" bgcolor = "#DBE5F1"|49.07%<nowiki>*</nowiki><br />
|-<br />
|align = "right"|2<br />
|Ureteroscopy<br />
|Ureteral stones<br />
|Yes<br />
|align = "right"|15.48%<nowiki>*</nowiki><br />
|-<br />
|align = "right" bgcolor = "#DBE5F1"|3<br />
|bgcolor = "#DBE5F1"|Ureterorenoscopy<br />
|bgcolor = "#DBE5F1"|Renal stones <nowiki><</nowiki>2 cm<br />
|bgcolor = "#DBE5F1"|Yes<br />
|align = "right" bgcolor = "#DBE5F1"|0.47%<nowiki>*</nowiki><br />
|-<br />
|align = "right"|4<br />
|Percutaneous nephrolithotomy<br />
|Renal stones <nowiki>></nowiki>2 cm, Proximal ureteral stones <nowiki>></nowiki>1 cm<br />
|No<br />
|align = "right"|34.98%<nowiki>*</nowiki><br />
|-<br />
|}<br />
<br />
<nowiki>*</nowiki>Dolcera Estimate 2011<br />
<br />
As seen in table ureteral stent is required for Ureteroscopy and Ureterorenoscopy which together constitute for around 16% of Kidney stone cases.<br />
<br />
Total Number of Kidney Stone Cases in US in 2006: 166,000<br />
<br />
Approximate Stents required in 2006 = 166,000<nowiki>*</nowiki>0.16=26560<br />
<br />
===Kidney Transplant Market for Ureteral Stent===<br />
Every kidney transplant operation required ureteral stent to be placed in Patient<nowiki>’</nowiki>s body for few days till newly placed kidney adapts to Patients<nowiki>’</nowiki> body<br />
<br />
Total No. of Kidney Transplants done in United States in 2007 are approx. 17,513<br />
<br />
Total Market for Ureteral Stents in 2007 is 17,513<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="54%"<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Year'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''No. of Kidney Transplants'''</font><br />
|-<br />
|align = "right"|'''2007'''<br />
| 17,513<br />
|-<br />
|align = "right"|'''2006'''<br />
| 18,056<br />
|-<br />
|align = "right"|'''2005'''<br />
| 17,443<br />
|-<br />
|align = "right"|'''2000'''<br />
| 14,611<br />
|-<br />
|align = "right"|'''1995'''<br />
| 12,160<br />
|-<br />
|align = "right"|'''1990'''<br />
| 10,029<br />
|-<br />
|align = "right"|'''1985'''<br />
| 7,504<br />
|-<br />
|align = "right"|'''1980'''<br />
| 3,785<br />
|-<br />
|}<br />
<br />
===Urinary Incontinence Market For Stents===<br />
'''Inpatient hospital stays:'''The estimated number of hospital admissions among adults ages 18 or older with urinary incontinence listed as a diagnosis:<br>'''(2000):''' 47,802 hospital stays (1,332 men; 46,470 women)<br />
<br />
====Prevalence rate in US (women)====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="40%" <br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|'''Prevalence of Urinary Incontinece in US (Women)'''<br />
|-<br />
|bgcolor = "#4F81BD"|'''Age (in years)'''<br />
|'''Population with Urinary Incontinence (in %)'''<br />
|-<br />
|bgcolor = "#4F81BD"|30-39<br />
|align = "center"|28<br />
|-<br />
|bgcolor = "#4F81BD"|40-49<br />
|align = "center"|41<br />
|-<br />
|bgcolor = "#4F81BD"|50-59<br />
|align = "center"|48<br />
|-<br />
|bgcolor = "#4F81BD"|60-69<br />
|align = "center"|51<br />
|-<br />
|bgcolor = "#4F81BD"|70-79<br />
|align = "center"|55<br />
|-<br />
|bgcolor = "#4F81BD"|≥ 80<br />
|align = "center"|54<br />
|-<br />
|}<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="102%"<br />
|align = "center" colspan = "6"|'''Estimated cases for ureteral stents in US, 2010'''<br />
|-<br />
|bgcolor = "#4F81BD"|Age groups<br />
|bgcolor = "#4F81BD"|A) Female population (Million)<br />
|bgcolor = "#4F81BD"|B) Prevalence rate in female (%)<br />
|bgcolor = "#4F81BD"|C=A<nowiki>*</nowiki>B Affected population<br>(Million)<br />
|bgcolor = "#4F81BD"|D) Catherization rate (%)<br />
|bgcolor = "#4F81BD"|E=C<nowiki>*</nowiki>D<br>Stent market based on catherization<br />
|-<br />
|bgcolor = "#4F81BD"|30-39<br />
|align = "right"|20.10<br />
|align = "right"|28<br />
|align = "right"|5.62<br />
|align = "right"|0.043<br />
|2420.42<br />
|-<br />
|bgcolor = "#4F81BD"|40-49<br />
|align = "right"|21.99<br />
|align = "right"|41<br />
|align = "right"|9.01<br />
|align = "right"|0.123<br />
|11092.83<br />
|-<br />
|bgcolor = "#4F81BD"|50-59<br />
|align = "right"|21.50<br />
|align = "right"|48<br />
|align = "right"|10.32<br />
|align = "right"|0.124<br />
|12800.37<br />
|-<br />
|bgcolor = "#4F81BD"|60-69<br />
|align = "right"|15.32<br />
|align = "right"|51<br />
|align = "right"|7.81<br />
|align = "right"|0.160<br />
|12503.68<br />
|-<br />
|bgcolor = "#4F81BD"|70-79<br />
|align = "right"|9.16<br />
|align = "right"|55<br />
|align = "right"|5.04<br />
|align = "right"|0.172<br />
|8674.44<br />
|-<br />
|bgcolor = "#4F81BD"|≥ 80<br />
|align = "right"|7.15<br />
|align = "right"|54<br />
|align = "right"|3.86<br />
|align = "right"|0.044<br />
|1699.48<br />
|-<br />
|bgcolor = "#4F81BD"|Total<br />
|align = "right"|95.25<br />
|&nbsp;<br />
|align = "right"|41.69<br />
| <br />
| <br />
|-<br />
|}<br />
<br />
<br />
* '''Catherization rate''' depicts the actual number of people going in for ureteral stents.<br />
* Prevalence rate in US women is growing at a CAGR of 1.26%<br />
<br />
Assuming that each admission in hospital required one ureteral stent, market from Urinary Incontinence is around 47,802 stents per year<br />
<br />
===Total Market for Ureteral Stent===<br />
Following table displays approximate stent market per year<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="64%"<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Category'''</font><br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''No. of Stents Required'''</font><br />
|-<br />
|bgcolor = "#DBE5F1"|Stent Market for Kidney Stones<br />
|align = "center" bgcolor = "#DBE5F1"|26560<br />
|-<br />
|Stent Market for Kidney Transplant<br />
|align = "center"|17513<br />
|-<br />
|bgcolor = "#DBE5F1"|Stent Market for Urinary Incontinence<br />
|align = "center" bgcolor = "#DBE5F1"|47802<br />
|-<br />
|bgcolor = "#4F81BD"|<font color="#FFFFFF">Total</font><br />
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">91875</font><br />
|-<br />
|}<br />
<br />
<br />
<br />
* Ureteral stent market is growing at a CAGR of 1.58%<br />
<br />
==== Government Policy====<br />
<br />
Medicare carriers may issue local coverage decisions (LCDs) listing criteria that must be met prior to coverage.<br />
<br />
Physicians are urged to review these policies [http://www.cms.hhs.gov/mcd/search.asp], and are encouraged to contact their local carrier medical director or commercial insurers to determine if a procedure is covered.<br />
<br />
The coding covers the following -<br />
<br />
* Placement<br />
<br />
* Removal<br />
<br />
* Imaging<br />
<br />
* Outpatient hospital<br />
<br />
* Inpatient hospital<br />
<br />
[[media:cook.pdf|Click here]] for coding details and payment.<br />
<br />
====Ureteral stent market forecast in US (women)====<br />
''' <br />
[[Image:stent_forcast.jpeg]]<br />
'''<br />
<br/><br />
<br/><br />
[[media:4887766.xls|Detailed_calculation_workbook]]<br />
<br />
==Ureteral Stent Pricing==<br />
<br />
<u>'''Boston Scientific and Cook INC'''</u><br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD"|'''Manufacturer'''<br />
|align = "center" bgcolor = "#4F81BD"|'''Stent'''<br />
|align = "center" bgcolor = "#4F81BD"|'''Price (in USD)'''<br />
|-<br />
|bgcolor = "#4F81BD"|Boston Scientific<br />
|Percuflex Plus Ureteral Stent<br />
|16.99-24.99<br />
|-<br />
|bgcolor = "#4F81BD"|Boston Scientific<br />
|Polaris Ureteral Stent<br />
|24.99<br />
|-<br />
|bgcolor = "#4F81BD"|Boston Scientific<br />
|Polaris Ultra Ureteral Stent<br />
|16.99-24.99<br />
|-<br />
|bgcolor = "#4F81BD"|Cook INC<br />
|Ureteral Stent Set<br />
|19.99<br />
|-<br />
|bgcolor = "#4F81BD"|Cook INC<br />
|Resonance Metallic Ureteral Stent and Introducer<br />
|179.99-224.99<br />
|-<br />
|}<br />
<br />
<br />
<br />
<br />
'''Source'''<br />
<br />
[http://www.medsurplusonline.com/ medsurplusonline]<br />
<br />
'''<nowiki>*</nowiki>''' Most of the products apart from speciality products of both the companies have the same name and price.<br />
<br />
Their is just a slight modification in the stent which can be found out on the website given above according to the item number.<br />
<br />
Paid report ([http://www.medtechinsight.com/ReportA251.html medtechinsight] and [http://www.lifescienceintelligence.com/market-reports-page.php?id=A255 lifescienceintelligence]) on pricing and ordering information.<br />
<br />
===Ureteral Stent Substitutes===<br />
<br />
Ureteral Stents are not very expensive so the primary reason to seek alternatives arise out of the disadvantages of using a ureteral stent.<br />
<br />
About 50% of patients will have some type of side-effect associated with their stent. It is not possible to predict who will have stent-associated difficulties or when the stent symptoms will resolve. Some patients have stent symptoms for just a few days, while others find their symptoms persist throughout their entire stent duration. <br />
<br />
[[Main article- Ureteral stent difficulties]]<br />
<br />
It may be reasonable not to leave a ureteral stent if obstruction is likely to be transient. Your surgeon decides at the time of the procedure whether or not your circumstance warrants “stent free.” Occasionally, it may be possible to place a tube externally that drains the kidney. This tube is placed directly through the skin, through the kidney, and into the urinary space, called a [http://en.wikipedia.org/wiki/Nephrostomy nephrostomy] tube. This is placed under ultrasound or fluoroscopic Xray guidance. As the tube remains outside the body, it is slightly more inconvenient, has higher infection rates, and can sometimes get pulled out by accident. The advantage of a nephrostomy tube is better drainage, ability to place contrast into the kidney to evaluate for obstruction or leakage, and removal that does not require a [http://en.wikipedia.org/wiki/Cystoscopy cystoscopic] procedure.<br />
<br />
Other alternative methods for treating or removing stones are<br />
<br />
1) [http://en.wikipedia.org/wiki/Extracorporeal_shock_wave_lithotripsy Extracorporeal shock wave lithotripsy]<br />
<br />
2) [http://en.wikipedia.org/wiki/Laser_lithotripsy Laser lithotripsy]<br />
<br />
3) [[Alpha Blockers]]<br />
<br />
4) [[Urine alkalinization]]<br />
<br />
5) [[Allopurinol]]<br />
<br />
<br />
<font size = "4">'''Cost analysis of different treatments'''</font><br />
<br />
<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD"|'''Treatment/Procedure'''<br />
|align = "center" bgcolor = "#4F81BD"|'''Cost (In USD)'''<br />
|-<br />
|bgcolor = "#4F81BD"|Ureteral Stent implant<br />
|1500-2500<br />
|-<br />
|bgcolor = "#4F81BD"|Laser lithotripsy<br />
|5000-7000<br />
|-<br />
|bgcolor = "#4F81BD"|Urine Alkalization<br />
|<font color="#0000FF"><u>[http://www.everydayhealth.com/drugs/c/urinary-alkalinization Cost comparison (Drug based)]</u></font><br />
|-<br />
|bgcolor = "#4F81BD"|Allopurinol<br />
|<font color="#0000FF"><u>[http://pharmacychecker.com/Pricing.asp?DrugName=Allopurinol&DrugId=18415&DrugStrengthId=30083 Drug wise prices]</u></font><br />
|-<br />
|bgcolor = "#4F81BD"|Extracorporeal shock wave lithotripsy<br />
|Not available<br />
|-<br />
|}<br />
<br />
<br />
Source - [http://www.medsolution.com/surgery_urogen-lithotripsy.asp medsolution]<br />
<br />
===Trends in stent R&D===<br />
<br />
* Given that the first bare metal stent entered the market in 1994, the technology is far from mature.<br />
<br />
* Whilst drug eluting stents will be improved through the use of what are described as more ‘cell friendly’ (i.e. more hydrophobic) coatings and adapted (by using CFD in stent design) to varying wall sheer conditions, the industry is already well down the road of developing bioresorbable coatings and even bioresorbable stents.<br />
<br />
* Such systems are already on limited trial in Europe with FDA trials aimed at 2012 and approval by 2015.<br />
<br />
* There are still other areas under study including thinner struts which are important in terms of giving improved stent flexibility, a reduced cross-sectional profile within the vessel and potentially reduced restenosis (due to reduced vascular trauma).<br />
<br />
* Silicon carbides, carbon coatings, titanium nitride/oxide and sputtered indium oxide have all been trialled as routes to reducing the incidence of restenosis and/or thrombosis.<br />
<br />
* Click here for recent news and developments in [[Boston Scientific]] and [[Cook INC]]<br />
<br />
'''Source''' [http://www.ceram.com/newsroom/news-releases/ceram-examines-the-future-of-stent-materials/ Ceram-newsrelease]<br />
<br />
==Reimbursements==<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|colspan = "7"|'''2011 MEDICARE REIMBURSEMENT FOR URETERAL STENT PLACEMENT OR REMOVAL - PHYSICIAN AND OUTPATIENT FACILITY'''<br />
|-<br />
|align = "center" bgcolor = "#4F81BD" colspan = "5"|''Ambulatory Surgery Center''<br />
|align = "center" bgcolor = "#4F81BD"|''Outpatient Facility''<br />
|align = "center" bgcolor = "#4F81BD"|''Physician Services''<br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|CPT<br>Code<br />
|align = "center" bgcolor = "#4F81BD"|Procedure Description<br />
|align = "center" bgcolor = "#4F81BD"|Facility Payment<sup>1</sup><br />
|align = "center" bgcolor = "#4F81BD"|APC<br />
|align = "center" bgcolor = "#4F81BD"|Facility Fee Schedule<br>(National Medicare Avg)2<br />
|align = "center" bgcolor = "#4F81BD"|Fee When Services Are Provided in the Hospital or ASC (National Medicare Avg)3<br />
|align = "center" bgcolor = "#4F81BD"|Fee When Services Are Provided in the Office<br>(National Medicare Avg)4<br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|50393<br />
|Introduction of ureteral catheter or stent into ureter through renal pelvis for drainage and/or injection, percutaneous<br />
|align = "center"|$1,020.24<br />
|align = "center"|0162<br />
|align = "center"|$1,813.74<br />
|align = "center"|$224.92<br />
|align = "center"|N/A<nowiki>*</nowiki><br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|50605<br />
|Ureterotomy for insertion of indwelling stent, all types<br />
|align = "center" colspan = "3"|Procedure not permitted in outpatient setting<br />
|align = "center"|$982.60<br />
|align = "center"|N/A<nowiki>*</nowiki><br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|50947<br />
|Laparoscopy, surgical; ureteroneocystostomy with cystoscopy and ureteral stent placement<br />
|align = "center"|$1,853.68<br />
|align = "center"|0131<br />
|align = "center"|$3,295.39<br />
|align = "center"|$1,424.97<br />
|align = "center"|N/A<nowiki>*</nowiki><br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|51045<br />
|Cystotomy, with insertion of ureteral catheter or stent (separate procedure)<br />
|align = "center"|$288.27<br />
|align = "center"|0160<br />
|align = "center"|$512.48<br />
|align = "center"|$500.13<br />
|align = "center"|N/A<nowiki>*</nowiki><br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|52310<br />
|Cystourethroscopy, with removal of foreign body, calculus, or ureteral stent from urethra or bladder (separate procedure); simple<br />
|align = "center"|$680.87<br />
|align = "center"|0161<br />
|align = "center"|$1,210.41<br />
|align = "center"|$157.65<br />
|align = "center"|$253.80<br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|52315<br />
|Cystourethroscopy, with removal of foreign body, calculus, or ureteral stent from urethra or bladder (separate procedure); complicated<br />
|align = "center"|$1,020.24<br />
|align = "center"|0162<br />
|align = "center"|$1,813.74<br />
|align = "center"|$284.72<br />
|align = "center"|$444.41<br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|52332<br />
|Cystourethroscopy, with insertion of indwelling ureteral stent (eg, Gibbons or double-J type)<br />
|align = "center"|$1,020.24<br />
|align = "center"|0162<br />
|align = "center"|$1,813.74<br />
|align = "center"|$151.87<br />
|align = "center"|$501.15<br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|74480<br />
|Introduction of ureteral catheter or stent into ureter through renal pelvis for drainage and/or injection, percutaneous, radiological supervision and interpretation<br />
|align = "center" colspan = "3"|Imaging is included in allowance for ureteral stent placement or removal<br />
|align = "center"|$27.18<br />
|align = "center"|$112.80<br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|76942<br />
|Ultrasonic guidance for needle placement (eg, biopsy, aspiration, injection, localization device), imaging supervision and interpretation<br />
|align = "center" colspan = "3"|Imaging is included in allowance for ureteral stent placement or removal<br />
|align = "center"|$33.64<br />
|align = "center"|$198.08<br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|77002<br />
|Fluoroscopic guidance for needle placement (eg, biopsy, aspiration, injection, localization device)<br />
|align = "center" colspan = "3"|Imaging is included in allowance for ureteral stent placement or removal<br />
|align = "center"|$27.52<br />
|align = "center"|$75.77<br />
|-<br />
|align = "center" bgcolor = "#4F81BD"|77012<br />
|Computed tomography guidance for needle placement (eg, biopsy, aspiration, injection, localization device), radiological supervision and interpretation<br><br />
|align = "center" colspan = "3"|Imaging is included in allowance for ureteral stent placement or removal<br />
|align = "center"|$57.08<br />
|align = "center"|$163.77<br />
|-<br />
|colspan = "7"|1. 2011 Medicare Ambulatory Surgery Center Fee Schedule<br>2. 2011 Medicare Hospital Outpatient Prospective Payment System Fee Schedule<br>3. 2011 Medicare Physician Fee Schedule<br />
|-<br />
|colspan = "7"|N/A<nowiki>*</nowiki> Medicare has not developed a rate for the in-office setting as these procedures are typically performed in a hospital setting. Physicians should contact the Medicare contractor to determine if the service can be performed in-office. If the contractor determines the service or procedure may be performed in-office, the physician will receive Medicare<nowiki>’</nowiki>s physician fee schedule amount for procedures performed in the hospital/ASC.<br />
|-<br />
|colspan = "7"|CPT© 2010 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.<br />
|-<br />
|}<br />
<br />
<br />
<br />
2 "Allowed Amount" is the amount Medicare determines to be the maximum allowance for any Medicare covered procedure. Actual payment will vary based on the maximum allowance less any applicable deductibles, co-insurance, etc.<br />
<br />
<sup>3 </sup>The hospital outpatient payment rates are 2011 Medicare national averages. Source: November 2, 2010 Federal Register, CMS-1504-FC.<br />
<br />
<sup>4 </sup>The ASC payments rates are 2011 Medicare national averages. ASC rates are from the 2011 Ambulatory Surgical Center Covered Procedures List – Addendum AA. Source: November 2, 2010 Federal Register, CMS-1504-FC.<br />
<br />
==Competitor Analysis==<br />
<br />
===Boston Scientific===<br />
<br />
[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Ureteral Stent portfolio]<br />
<br />
<br />
Net sales in 2010 – USD 7.8 Billion<br />
<br />
Share of Urology- 8.48 %<br />
<br />
Net sales from Urology- USD 661 Million<br />
<br />
<br />
Source [http://phx.corporate-ir.net/phoenix.zhtml?c=62272&p=irol-reportsother BSsalesdata]<br />
<br />
===CR BARD===<br />
<br />
[[Urology portfolio]]<br />
<br />
<br />
Net sales in 2010 – USD 2.7 Billion<br />
<br />
Share of Urology- 26%<br />
<br />
Net sales from Urology- USD 702 Million<br />
<br />
Source – CR BARD annual report<br />
<br />
===Cook Medical===<br />
<br />
[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Ureteral Stent portfolio]<br />
<br />
Total Sales - USD 1.7 Billion<br />
<br />
[http://www.nytimes.com/2011/04/26/business/26cook.html?_r=1 Source]<br />
<br />
===Medline===<br />
<br />
[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Ureteral Stent Portfolio]<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4F81BD"|'''Company'''<br />
|bgcolor = "#4F81BD"|'''Total Sales in 2010'''<br />
|bgcolor = "#4F81BD"|'''Urological sales'''<br />
|bgcolor = "#4F81BD"|'''Percentage share'''<br />
|bgcolor = "#4F81BD"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4F81BD"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4F81BD"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4F81BD"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4F81BD"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
All figures in USD million<br />
<br />
[[image:stentshare.jpg]]<br />
<br />
===Research Work===<br />
<br />
Research at University of Minnesota about symptoms and pain associated with ureteral stent<br />
<br />
[[Research Team]]<br />
<br />
====Background and Purpose====<br />
<br />
*Ureteral stents are associated with significant pain and urinary symptoms.<br />
<br />
*Manufacturers have altered stent designs and materials in an attempt to minimize this morbidity.<br />
<br />
*This study evaluated the impact of these modifications.<br />
<br />
====Patients and Methods====<br />
<br />
*Stent manufacturers were asked to provide the 6F ureteral stent they believed would be associated with the least patient discomfort.<br />
<br />
*Patients undergoing uncomplicated ureteroscopy were randomized to the Bard Inlay, Cook Endo-Sof, Microvasive Contour, Applied Medical Vertex, or Surgitek Classic Double-Pigtail stent.<br />
<br />
*The Ureteric Stent Symptom Questionnaire (USSQ) was administered on days 1, 3, and 5, and the patients maintained a narcotic diary. The data were analyzed using ANOVA and nonparametric methods.<br />
<br />
====Results====<br />
<br />
*A total of 44 patients (73%) completed all USSQ questionnaires.<br />
<br />
*Urinary symptom scores were significantly lower for the Inlay stent on day 3 than for the Vertex (P = 0.01), Contour (P = 0.05), Endo-Sof (P = 0.03), and Classic (P = 0.02) stents. No significant differences were noted in pain and general symptom scores or narcotic use.<br />
<br />
====Conclusion====<br />
<br />
*'''The Bard Inlay stent is associated with less-severe urinary symptoms than other ureteral stents.'''<br />
<br />
*The USSQ is a sensitive tool to measure differences between stents.<br />
<br />
The complete USSQ form is available at [http://www.bui.ac.uk/ BUI] and [http://www.endourology.org/ endourology].<br />
<br />
Source [http://www.liebertonline.com/doi/abs/10.1089/end.2005.19.990?journalCode=end University of Minnesota]<br />
<br />
==Boston Scientific==<br />
<br />
[https://dolcera.net/teamwiki_prod/index.php/Boston_Scientific_-_Company_Profile Click here for the company profile]<br />
<br />
<br />
<br />
==References==<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Boston_Scientific_-_Company_Profile&diff=9312
Boston Scientific - Company Profile
2011-07-28T13:07:44Z
<p>Shweta.mittal@dolcera.com: /* Company<nowiki>’</nowiki>s focus on R&D */</p>
<hr />
<div>==Boston Scientific==<br />
===Company Overview===<br />
====Key Facts====<br />
Boston Scientific (founded in 1979) is a worldwide developer, manufacturer and marketer of medical devices with approximately 25,000 employees and revenue of $7.8 billion in 2010. For more than 30 years, Boston Scientific has advanced the practice of less-invasive medicine by providing a broad and deep portfolio of innovative products, technologies and services across a wide range of medical specialties. The company<nowiki>’</nowiki>s products help physicians and other medical professionals improve their patients<nowiki>’</nowiki> quality of life by providing alternatives to surgery. <br />
<br />
{|border="2" cellspacing="0" cellpadding="1" width="50%" align="center"<br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Type'''</font><br />
|<font color="#333333">Public Company</font><br />
|-<br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Company Size'''</font><br />
|<font color="#333333">10,001<nowiki>+</nowiki> employees</font><br />
|-<br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Website'''</font><br />
|<font color="#0000FF"><u>[http://www.linkedin.com/redirect?url=http%3A%2F%2Fwww%2Ebostonscientific%2Ecom&urlhash=a7R8 http://www.bostonscientific.com]</u></font><br />
|-<br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Industry'''</font><br />
|<font color="#333333">Medical Devices</font><br />
|-<br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Founded'''</font><br />
|<font color="#333333">1979</font><br />
|-<br />
|}<br />
<br />
=====Primary business divisions=====<br />
# Cardiology, Rhythm and Vascular<br />
# Endoscopy<br />
# Urology and Women<nowiki>’</nowiki>s Health<br />
# Neuromodulation<br />
<br />
=====Key products=====<br />
<br />
1) Taxus, Liberté, and Express coronary stents<br />
<br />
2) Cognis cardiac resynchronization therapy defibrillator<br />
<br />
3) Confient, Teligen, and Vitality implantable cardioverter defibrillators<br />
<br />
4) Explorer and Inquiry diagnostic cardiology catheters<br />
<br />
5) iLab ultrasound imaging system; Atlantis SR Pro ultrasound imaging catheter<br />
<br />
6) Polyflex, Ultraflex and Wallflex esophageal, duodenal, and colonic stents<br />
<br />
7) Sterling balloon dilation catheters<br />
<br />
8) VersaPulse PowerSuite holmium urology laser systems<br />
<br />
([http://www.pharmalive.com/special_reports/sample.cfm?reportID=309 Pharmalive])<br />
<br />
=====Significant subsidiaries===== <br />
<br />
1) Advanced Stent Technologies Inc.<br />
<br />
2) Boston Scientific Neuromodulation Corp.<br />
<br />
3) Cardiac Pacemakers Inc.<br />
<br />
4) Catheter Innovations Inc.<br />
<br />
5) Corvita Corp.<br />
<br />
6) EndoVascular Technologies Inc.<br />
<br />
7) Enteric Medical Technologies Inc.<br />
<br />
8) Guidant Corp.<br />
<br />
9) Intermedics Inc.<br />
<br />
10) Interventional Technologies LLC<br />
<br />
11) Precision Vascular Systems Inc<br />
<br />
([http://www.pharmalive.com/special_reports/sample.cfm?reportID=309 Pharmalive])<br />
<br />
====Key Financials====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="49%"<br />
|align = "center" bgcolor = "#002060" colspan = "2"|<font color="#FFFFFF">'''Financials of Boston Scientific in 2010 (in $M)'''</font><br />
|-<br />
|Revenue (Fiscal Year)<br />
|align = "right"|7,806<br />
|-<br />
|Revenue Growth (1 yr)<br />
|align = "right"|(-4.70%)<br />
|-<br />
|Gross Profit <br />
|align = "right"|5,207<br />
|-<br />
|EBITDA <br />
|align = "right"|1,859<br />
|-<br />
|bgcolor = "#002060" colspan = "2"|<font color="#FFFFFF">'''Trading Statistics (in $M)'''</font><br />
|-<br />
|Market Capitalization<br />
|align = "right"|10,758.57<br />
|-<br />
|Shares Outstanding<br />
|align = "right"|1,528.21<br />
|-<br />
|bgcolor = "#002060" colspan = "2"|<font color="#FFFFFF">'''Ratios'''</font><br />
|-<br />
|Current Ratio<br />
|align = "right"|1.75<br />
|-<br />
|P/E Ratio<br />
|align = "right"|18.9<br />
|-<br />
|Debt to Equity Ratio<br />
|align = "right"|43.31<br />
|-<br />
|}<br />
<br />
=====Segment contribution=====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="53%"<br />
|align = "center" bgcolor = "#002060" colspan = "3"|<font color="#FFFFFF">'''Segment Contribution to the revenue (in $M)'''</font><br />
|-<br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Segment'''</font><br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Growth'''</font><br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Sales (2010)'''</font><br />
|-<br />
|Cardiovascular<br />
|align = "right"|(-5%)<br />
|align = "right"|811<br />
|-<br />
|Interventional Cardiology<br />
|align = "right"|(-8%)<br />
|align = "right"|635<br />
|-<br />
|Peripheral Interventions<br />
|align = "right"|7%<br />
|align = "right"|176<br />
|-<br />
|Coronary stent system<br />
|align = "right"|(-7.9%)<br />
|align = "right"|409<br />
|-<br />
|Cardiac Rhythm Management<br />
|align = "right"|4%<br />
|align = "right"|559<br />
|-<br />
|Defibrillators <br />
|align = "right"|6.9%<br />
|align = "right"|417<br />
|-<br />
|Pacemakers<br />
|align = "right"|(-4%)<br />
|align = "right"|142<br />
|-<br />
|Electrophysiology<br />
|align = "right"|(-3%)<br />
|align = "right"|37<br />
|-<br />
|Endoscopy<br />
|align = "right"|(-3%)<br />
|align = "right"|287<br />
|-<br />
|Urology/Women<nowiki>’</nowiki>s health<br />
|align = "right"|10%<br />
|align = "right"|120<br />
|-<br />
|Neuromodulation<br />
|align = "right"|14%<br />
|align = "right"|77<br />
|-<br />
|}<br />
<br />
Boston Scientific derives maximum contribution from Cardiovascular, which recorded a 5% year-over-year decline in sales to $811 million. While sales from Interventional Cardiology declined 8% to $635 million, Peripheral Interventions increased 7% to $176 million. Global sales of coronary stent system (within Interventional Cardiology) at $409 million declined 7.9% driven by lower sales of both drug-eluting stents (DES, 6.9% to $379 million) and bare-metal stents (18.9% to $30 million). It is encouraging to note that the company maintained its leadership position in the global DES market with 36% share and 46% in the US market.<br />
<br />
The next biggest contributor to Boston Scientific<nowiki>’</nowiki>s top line, Cardiac Rhythm Management, recorded a 4% increase in sales to $559 million. A 6.9% rise in defibrillators sales to $417 million coupled with a 4% decline in sales of pacemakers to $142 million contributed to the overall increase.<br />
<br />
Hence, the overall revenue of Boston Scientific declined by 4.7%. ([http://seekingalpha.com/article/264756-boston-scientific-boosts-bottom-line-despite-revenue-decline Seekingalpha.com])<br />
<br />
====Revenue Distribution of Boston Scientific====<br />
=====By Product Category=====<br />
<br />
[[Image:revenue - productwise - Boston scientific.jpg]]<br />
<br />
The graph clearly shows the declining cardiovascular market, which constitutes the major part of Boston Scientific<nowiki>’</nowiki>s revenue. It gives a strong signal to the company to diversify its business into other business units and not be very dependent on one market.<br />
<br />
=====By Geography=====<br />
[[Image:revenue - geogwise - Boston scientific.jpg]]<br />
<br />
<nowiki>*</nowiki>EMEA – Europe, Middle East and Africa<br />
<br />
The graph clearly shows that U.S. contributes to more than 50% of the company<nowiki>’</nowiki>s revenues. It shows an opportunity for the company to expand in other markets. They have started selling their products in Japan, which has already started contributing majorly to the revenues.<br />
<br />
===Business Overview===<br />
====Product Portfolio====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#002060" colspan = "5"|<font color="#FFFFFF"><font size = "4">'''Product Portfolio of Boston Scientific'''</font></font><br />
|-<br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Cardiovascular Group'''</font><br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Cardiac Rhythm Management'''</font><br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Endoscopy'''</font><br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Urology and Women<nowiki>’</nowiki>s Health'''</font><br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Neuromodulation'''</font><br />
|-<br />
|Drug-Eluting Stents<br />
|Remote Patient Management<br />
|Biliary Devices<br />
|Stone Management<br />
|Spinal Cord Stimulation<br />
|-<br />
|Coronary Balloons<br />
|Pacemakers<br />
|Cholangioscopy<br />
|Benign Prostatic Hyperplasia<br />
| <br />
|-<br />
|Coronary Atherectomy<br />
|Implantable Cardioverter Defibrillators<br />
|Biliary Stents<br />
|Pelvic Floor Reconstruction<br />
| <br />
|-<br />
|Embolic Protection<br />
|Cardiac Resynchronization<br />
|Gastrointestinal Stents<br />
|Abnormal Uterine Bleeding<br />
| <br />
|-<br />
|Inflation Devices<br />
|Therapy Defibrillators<br />
|Tissue Acquisition<br />
| <br />
| <br />
|-<br />
|Peripheral Balloons<br />
|Cardiac Resynchronization<br />
|Gastrointestinal Bleeding<br />
| <br />
| <br />
|-<br />
|Interventional Oncology<br />
|Therapy Pacemakers<br />
|Balloon Dilatation<br />
| <br />
| <br />
|-<br />
|Guide Wires<br />
|Electrophysiology<br />
|Pulmonary Devices<br />
| <br />
| <br />
|-<br />
|Diagnostic Catheters<br />
|Ablation Catheters<br />
|Airway Stents<br />
| <br />
| <br />
|-<br />
|Guide Catheters<br />
|Intracardiac Echocardiography<br />
|Bronchial Thermoplasty<br />
| <br />
| <br />
|-<br />
|Intravascular Ultrasound<br />
|Diagnostic Catheters<br />
| <br />
| <br />
| <br />
|-<br />
|Vascular Access/Chronic Total Occlusion<br />
| <br />
| <br />
| <br />
| <br />
|-<br />
|Peripheral Stents<br />
| <br />
| <br />
| <br />
| <br />
|-<br />
|}<br />
<br />
====Geographical Presence====<br />
The Corporate headquarters of Boston Scientific is in Natick, Massachusetts. The company is present in the following locations in Europe/Middle East/Africa, America and Asia Pacific/Japan.<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="55%"<br />
|align = "justify" bgcolor = "#002060"|<font color="#FFFFFF">'''Europe/Middle East/Africa'''</font><br />
|align = "justify" bgcolor = "#002060"|<font color="#FFFFFF">'''America'''</font><br />
|align = "justify" bgcolor = "#002060"|<font color="#FFFFFF">'''Asia Pacific/Japan'''</font><br />
|-<br />
|align = "justify"|Austria<br />
|align = "justify"|Argentina<br />
|align = "justify"|New Zealand<br />
|-<br />
|align = "justify"|Belgium<br />
|align = "justify"|Brazil<br />
|align = "justify"|China<br />
|-<br />
|align = "justify"|Czech Republic<br />
|align = "justify"|Canada<br />
|align = "justify"|Hong Kong<br />
|-<br />
|align = "justify"|Denmark<br />
|align = "justify"|Chile<br />
|align = "justify"|India<br />
|-<br />
|align = "justify"|Finland<br />
|align = "justify"|Colombia<br />
|align = "justify"|Korea<br />
|-<br />
|align = "justify"|France<br />
|align = "justify"|Costa Rica<br />
|align = "justify"|Tokyo<br />
|-<br />
|align = "justify"|Germany<br />
|align = "justify"|Mexico<br />
|align = "justify"|<font color="#333333">Fukuoka</font><br />
|-<br />
|align = "justify"|Greece<br />
|align = "justify"|Uruguay<br />
|align = "justify"|<font color="#333333">Hiroshima</font><br />
|-<br />
|align = "justify"|Hungary<br />
|align = "justify"|Venezuela<br />
|align = "justify"|<font color="#333333">Kanagawa </font><br />
|-<br />
|align = "justify"|Ireland<br />
|align = "justify"|West Indies<br />
|align = "justify"|<font color="#333333">Ishikawa</font><br />
|-<br />
|align = "justify"|Israel<br />
|align = "justify"|Massachusetts<br />
|align = "justify"|<font color="#333333">Saitama </font><br />
|-<br />
|align = "justify"|Italy<br />
|align = "justify"|California<br />
|align = "justify"|<font color="#333333">Miyazaki</font><br />
|-<br />
|align = "justify"|Lebanon<br />
|align = "justify"|Florida<br />
|align = "justify"|<font color="#333333">Aichi </font><br />
|-<br />
|align = "justify"|Netherlands<br />
|align = "justify"|Indiana<br />
|align = "justify"|<font color="#333333">Osaka </font><br />
|-<br />
|align = "justify"|Norway<br />
|align = "justify"|Minnesota<br />
|align = "justify"|<font color="#333333">Hokkaido</font><br />
|-<br />
|align = "justify"|Poland<br />
|align = "justify"|Utah<br />
|align = "justify"|<font color="#333333">Miyagi </font><br />
|-<br />
|align = "justify"|Portugal<br />
|align = "justify"|Washington<br />
|align = "justify"|<font color="#333333">Kanagawa </font><br />
|-<br />
|align = "justify"|Spain<br />
|align = "justify"| <br />
|align = "justify"|Malaysia<br />
|-<br />
|align = "justify"|South Africa<br />
|align = "justify"| <br />
|align = "justify"|Philippines<br />
|-<br />
|align = "justify"|Sweden<br />
|align = "justify"| <br />
|align = "justify"|Singapore<br />
|-<br />
|align = "justify"|Switzerland<br />
|align = "justify"| <br />
|align = "justify"|Taiwan<br />
|-<br />
|align = "justify"|Turkey<br />
|align = "justify"| <br />
|align = "justify"|Thailand<br />
|-<br />
|align = "justify"|United Kingdom<br />
|align = "justify"| <br />
|align = "justify"| <br />
|-<br />
|}<br />
<br />
====Organization Structure====<br />
[[Image:Organization Structure of Boston Scientific.jpg]]<br />
([http://www.theofficialboard.com/org-chart/boston-scientific Theofficialboard.com])<br />
<br />
'''Key Executives'''<br />
<br />
* Chairman: Peter M. (Pete) Nicholas<br />
* EVP and COO: Samuel R. (Sam) Leno<br />
* EVP and CFO: Jeffrey D. (Jeff) Capello<br />
<br />
===Market Overview===<br />
====Market Share====<br />
[[Image:Market Share - Medical Devices (2010).jpg]]<br />
<br />
====Top 10 companies in the medical devices industry====<br />
{|border="2" cellspacing="0" cellpadding="4" width="44%"<br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Top 10 companies in the medical devices industry'''</font><br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Sales in 2010 ($B)'''</font><br />
|-<br />
|Johnson & Johnson<br />
|align = "right"|23.60<br />
|-<br />
|Siemens Healthcare<br />
|align = "right"|17.40<br />
|-<br />
|GE Healthcare<br />
|align = "right"|16.00<br />
|-<br />
|Medtronic<br />
|align = "right"|15.82<br />
|-<br />
|Baxter International<br />
|align = "right"|12.60<br />
|-<br />
|Philips Healthcare<br />
|align = "right"|11.20<br />
|-<br />
|Abbott Laboratories<br />
|align = "right"|8.40<br />
|-<br />
|Boston Scientific<br />
|align = "right"|8.00<br />
|-<br />
|Covidien<br />
|align = "right"|7.81<br />
|-<br />
|Becton Dickinson<br />
|align = "right"|7.16<br />
|-<br />
|}<br />
<br />
====SWOT Analysis of Boston Scientific====<br />
<br />
[[Image:SWOT - Boston Scientific.jpg]]<br />
<br />
===Transactional Activities===<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%" align="center"<br />
|bgcolor = "#002060" colspan = "4"|<font color="white"> <font size = "4">Mergers & Acquisitions done by Boston Scientific</font><br><font size = "4"> </font> <br />
|-<br />
|bgcolor = "#0000"|<width="100%">|align = "right"|<font color="white"> '''Acquired Company'''<br />
|bgcolor = "#0000"|<width="100%">|<font color="white"> '''Date''' <br />
|bgcolor = "#0000"|<width="100%">|<font color="white"> '''Value ($) M'''<br />
|bgcolor = "#0000"|<width="100%">|<font color="white"> '''Reason for Acquisition'''<br />
|-<br />
|<font color="#333333">Atritech Inc</font><br />
|align = "right"|<font color="#181818"> Jan-11 </font> <br />
|align = "right"|<font color="#181818">100</font><br />
|* <font color="#181818">It strengthens the BS<nowiki>’</nowiki>s product offerings in the fast-growing areas of structural heart therapy</font><br>* <font color="#181818">Also a trial fibrillation, which represent two of their Priority Growth Initiatives.</font><br><font color="#181818">([http://www.alacrastore.com/mergers-acquisitions/Boston_Scientific_Corporation-1060228 Alacrastore.com])</font><br />
|-<br />
|<font color="#333333">ReVascular Therapeutics Inc</font><br />
|align = "right"|<font color="#333333"> Feb-11 </font><br />
|align = "right"|N/A<br />
|* These two novel technologies treat peripheral chronic total occlusions (CTOs).<br>* BSX made the acquisitions because the devices cover areas with promise of high growth potential. ([http://finance.yahoo.com/news/Boston-Scientific-Strengthens-prnews-2182311141.html?x=0&.v=1 Yahoo Finance])<br />
|-<br />
|<font color="#333333">Intelect Medical Inc</font><br />
|align = "right"|Jan -11<br />
|align = "right"|78<br />
|* It supports BSX long-term strategy of enhancing the product portfolio and gaining market share in the Neuromodulation space<br>* It will help them to provide the most advanced deep brain stimulation technology solutions for neurologists, neurosurgeons and their patients.<br>* The GUIDE DBS system would be a major advance in deep brain stimulation therapy, especially when used in conjunction with BSX<nowiki>’</nowiki>s Vercise DBS System. ([http://www.massdevice.com/news/boston-scientific-adds-two-blocked-artery-treatment-devices-acquisitions-roundup Massdevice.com], [http://blog.medicaldesign.com/perspectives/2011/02/16/ Medicaldesign.com])<br />
|-<br />
|<font color="#333333">Sadra Medical Inc</font><br />
|align = "right"| Jan -11<br />
|align = "right"|193<br />
|* Will Help BSX leverage on its clinical expertise and existing sales channels in the fast-growing area of structural heart therapy.( [http://www.reuters.com/article/2011/01/04/idUS196379+04-Jan-2011+PRN20110104 Reuters])<br />
|-<br />
|<font color="#333333">Asthmatx Inc</font><br />
|align = "right"|<font color="#333333"> Oct-10 </font><br />
|align = "right"|<font color="#333333">193.5</font><br />
|* <font color="#333333">Named as Top Ten Medical Innovations for 2007" by the Cleveland Clinic Foundation.</font><br>* <font color="#333333">The transaction is expected to provide meaningful revenue growth in the midterm ([http://www.asthmatx.com/news-events/press-releases/?i=450 Asthmatx.com])</font><br />
|-<br />
|Labcoat Ltd . (Ireland)<br />
|align = "right"|Sep- 10<br />
|align = "right"|N/A<br />
|* The Technology represents a major advance for drug-eluting stents and would help BSX maintain their strong position in this market ([http://bostonscientific.mediaroom.com/index.php?s=43&item=793 Bostonscientific])<br />
|-<br />
|Remon Medical Technologies Inc<br />
|align = "right"|Aug-07<br />
|align = "right"|. 73<br />
|* Provides BSX with innovative sensor and wireless communication technology that complements their Cardiac Rhythm Management product line.<br>* Also to maintain the leadership position ([http://salesandmarketingnetwork.com/news_release.php?ID=2015814 Salesandmarketingnetwork.com])<br />
|-<br />
| EndoTex Interventional Systems Inc .<br />
|align = "right"|Jan-07<br />
|align = "right"|142<br />
|* <font color="#333333">leadership in treating carotid artery disease ([http://uk.reuters.com/article/2007/01/04/bostonscientific-acquisition-idUKN0419620070104 Reuters])</font><br />
|-<br />
| Guidant Corp<br />
|align = "right"|Apr-06<br />
|align = "right"|27000<br />
|* <font color="#333333">To be a global leader in cardiovascular devices ([http://www.cbsnews.com/stories/2006/01/25/business/main1236024.shtml Cbsnews])</font><br />
|-<br />
|TriVascular<br />
|align = "right"|Apr-05<br />
|align = "right"|110<br />
|* To increase its share in the overall market for abdominal aortic aneurysms (AAA)device ([http://www.fdanews.com/newsletter/article?issueId=7456&articleId=71208 Fdanews])<br />
|-<br />
|}<br />
<br />
===Roadmap===<br />
====Company<nowiki>’</nowiki>s focus on R&D====<br />
[[Image:Employees split-2.jpg]]<br />
[[Image:US Patents issued (Boston Scientific).jpg]]<br />
[[Image:R&D investment - Boston.jpg]]<br />
<br />
(Similar companies are based on the same industry and similar size for the year 2011)<br />
<br />
* The first chart shows the number of employees in the R&D department in Boston Scientific is 9% higher than the industry standards (in 2011). The other chart shows that over the span of 8 years (2002-2009), the investment by Boston Scientific in R&D has increased by 200%. Also, by the end of 2009, 7240 US patents have been granted to Boston Scientific and 10,009 patents are pending. It shows that Boston Scientific is clearly focused on investing in new technology through R&D.<br />
* In addition to the Company<nowiki>’</nowiki>s internal investments, Boston Scientific is committed to investing in external, or acquired, R&D through acquisitions and investments in new businesses.<br />
* Boston Scientific in future is committed to developing less-invasive products and procedures, and through the acquisition of new technologies, to better enable physicians to treat their patients.<br />
* The sales force of Boston Scientific is 3% lower than the industry standards. This shows that the company has an established customer base that are loyal to the company and Boston Scientific does not have to push is products in the market.<br />
<br />
====Key Insights====<br />
* Boston Scientific continues to focus on strategic initiatives to drive growth and profitability. <br />
* Recent acquisitions made by the company along with promising new technologies are expected to boost the company<nowiki>’</nowiki>s pipeline. <br />
* However, the concern is with its core business where Boston is witnessing significant pricing pressure and market decline. <br />
* Moreover, economic uncertainty is impacting procedure volume<br />
* For the fiscal year 2010 the revenues of the company has gone down by 4.70%<br />
* The same decline has been contributed by the various segments like<br />
* Cardiovascular, Interventional Cardiology<br />
* Coronary stent system<br />
* Pacemakers<br />
* Electrophysiology and endoscopy<br />
* The decline in these individual segments ranges from 3- 8 %<br />
* These businesses are witnessing several challenges including pricing pressure, intense competition and slower market growth<br />
* With respect to these declining figures new strategies need to be worked on, to either increase the contribution from this segment or diversify in to other segments<br />
* The company has adopted <nowiki>’</nowiki>priority growth initiatives<nowiki>’</nowiki> based on which it will target non-DES and non-CRM areas that holds potential<br />
* There are segments which have shown higher growth percentage that reaches up to 14% but the contribution of these segments is very low despite higher growth rate<br />
* This higher growth rate can be a signal of growth potential for future concentration of efforts<br />
* Segments like urology/ women<nowiki>’</nowiki>s health, neurovascular & Neuromodulation are growing post 2006 not significantly though<br />
* Though company has diversified in neuromodulation which according to industry professionals has been considered a good decision<br />
* Though the dependence on Cardiovascular is very high and cannot be ignored<br />
* USA has been the major geographical market for this company but Japan is emerging post 2008<br />
* Co also faces certain industry risks such as failure of approval from FDA, approved devices being pulled from market due to safety reasons along with eroding market share and expiring patents<br />
* The recent example of pull back is iCross Coronary Imaging Catheters<br />
* It<nowiki>’</nowiki>s being noted that their long standing approach to growth is by strategic acquisitions of , investments in or alliances with other businesses or companies<br />
* But the co. may not always be successful in generating growth this way<br />
* Co should try and leverage well on all the recent acquisitions so that the benefits can be reaped well<br />
* Need to control costs, grow foreign market revenue and continue to get timely regulatory approval<br />
* Company needs to realign their business portfolio to improve leverage and accelerate profitable revenue growth<br />
* Expansion of global sales and marketing focus is important. Increasing the presence in markets such as China, India and Brazil by increasing their sales forces in emerging markets, expanding the number of our product registrations outside the U.S.<br />
<br />
===Contact===<br />
<br />
'''Boston Scientific Corporate Headquarters''' <br />
<br />
One Boston Scientific Place<br />
<br />
Natick, MA 01760-1537<br />
<br />
Main Number: 1-508-650-8000</div>
Shweta.mittal@dolcera.com
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File:R&D investment - Boston.jpg
2011-07-28T13:05:57Z
<p>Shweta.mittal@dolcera.com: </p>
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Shweta.mittal@dolcera.com
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File:US Patents issued (Boston Scientific).jpg
2011-07-28T13:05:27Z
<p>Shweta.mittal@dolcera.com: </p>
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https://www.dolcera.com/wiki/index.php?title=File:SWOT_-_Boston_Scientific.jpg&diff=9308
File:SWOT - Boston Scientific.jpg
2011-07-28T13:04:53Z
<p>Shweta.mittal@dolcera.com: </p>
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=File:Employees_split-2.jpg&diff=9307
File:Employees split-2.jpg
2011-07-28T13:03:36Z
<p>Shweta.mittal@dolcera.com: </p>
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Shweta.mittal@dolcera.com
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File:Market Share - Medical Devices (2010).jpg
2011-07-28T12:02:06Z
<p>Shweta.mittal@dolcera.com: </p>
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Shweta.mittal@dolcera.com
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File:Organization Structure of Boston Scientific.jpg
2011-07-28T11:59:36Z
<p>Shweta.mittal@dolcera.com: </p>
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=File:Revenue_-_geogwise_-_Boston_scientific.jpg&diff=9304
File:Revenue - geogwise - Boston scientific.jpg
2011-07-28T11:54:29Z
<p>Shweta.mittal@dolcera.com: </p>
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Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=File:Revenue_-_productwise_-_Boston_scientific.jpg&diff=9303
File:Revenue - productwise - Boston scientific.jpg
2011-07-28T11:54:06Z
<p>Shweta.mittal@dolcera.com: </p>
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<div></div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Boston_Scientific_-_Company_Profile&diff=9302
Boston Scientific - Company Profile
2011-07-28T11:52:17Z
<p>Shweta.mittal@dolcera.com: </p>
<hr />
<div>==Boston Scientific==<br />
===Company Overview===<br />
====Key Facts====<br />
Boston Scientific (founded in 1979) is a worldwide developer, manufacturer and marketer of medical devices with approximately 25,000 employees and revenue of $7.8 billion in 2010. For more than 30 years, Boston Scientific has advanced the practice of less-invasive medicine by providing a broad and deep portfolio of innovative products, technologies and services across a wide range of medical specialties. The company<nowiki>’</nowiki>s products help physicians and other medical professionals improve their patients<nowiki>’</nowiki> quality of life by providing alternatives to surgery. <br />
<br />
{|border="2" cellspacing="0" cellpadding="1" width="50%" align="center"<br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Type'''</font><br />
|<font color="#333333">Public Company</font><br />
|-<br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Company Size'''</font><br />
|<font color="#333333">10,001<nowiki>+</nowiki> employees</font><br />
|-<br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Website'''</font><br />
|<font color="#0000FF"><u>[http://www.linkedin.com/redirect?url=http%3A%2F%2Fwww%2Ebostonscientific%2Ecom&urlhash=a7R8 http://www.bostonscientific.com]</u></font><br />
|-<br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Industry'''</font><br />
|<font color="#333333">Medical Devices</font><br />
|-<br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Founded'''</font><br />
|<font color="#333333">1979</font><br />
|-<br />
|}<br />
<br />
=====Primary business divisions=====<br />
# Cardiology, Rhythm and Vascular<br />
# Endoscopy<br />
# Urology and Women<nowiki>’</nowiki>s Health<br />
# Neuromodulation<br />
<br />
=====Key products=====<br />
<br />
1) Taxus, Liberté, and Express coronary stents<br />
<br />
2) Cognis cardiac resynchronization therapy defibrillator<br />
<br />
3) Confient, Teligen, and Vitality implantable cardioverter defibrillators<br />
<br />
4) Explorer and Inquiry diagnostic cardiology catheters<br />
<br />
5) iLab ultrasound imaging system; Atlantis SR Pro ultrasound imaging catheter<br />
<br />
6) Polyflex, Ultraflex and Wallflex esophageal, duodenal, and colonic stents<br />
<br />
7) Sterling balloon dilation catheters<br />
<br />
8) VersaPulse PowerSuite holmium urology laser systems<br />
<br />
([http://www.pharmalive.com/special_reports/sample.cfm?reportID=309 Pharmalive])<br />
<br />
=====Significant subsidiaries===== <br />
<br />
1) Advanced Stent Technologies Inc.<br />
<br />
2) Boston Scientific Neuromodulation Corp.<br />
<br />
3) Cardiac Pacemakers Inc.<br />
<br />
4) Catheter Innovations Inc.<br />
<br />
5) Corvita Corp.<br />
<br />
6) EndoVascular Technologies Inc.<br />
<br />
7) Enteric Medical Technologies Inc.<br />
<br />
8) Guidant Corp.<br />
<br />
9) Intermedics Inc.<br />
<br />
10) Interventional Technologies LLC<br />
<br />
11) Precision Vascular Systems Inc<br />
<br />
([http://www.pharmalive.com/special_reports/sample.cfm?reportID=309 Pharmalive])<br />
<br />
====Key Financials====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="49%"<br />
|align = "center" bgcolor = "#002060" colspan = "2"|<font color="#FFFFFF">'''Financials of Boston Scientific in 2010 (in $M)'''</font><br />
|-<br />
|Revenue (Fiscal Year)<br />
|align = "right"|7,806<br />
|-<br />
|Revenue Growth (1 yr)<br />
|align = "right"|(-4.70%)<br />
|-<br />
|Gross Profit <br />
|align = "right"|5,207<br />
|-<br />
|EBITDA <br />
|align = "right"|1,859<br />
|-<br />
|bgcolor = "#002060" colspan = "2"|<font color="#FFFFFF">'''Trading Statistics (in $M)'''</font><br />
|-<br />
|Market Capitalization<br />
|align = "right"|10,758.57<br />
|-<br />
|Shares Outstanding<br />
|align = "right"|1,528.21<br />
|-<br />
|bgcolor = "#002060" colspan = "2"|<font color="#FFFFFF">'''Ratios'''</font><br />
|-<br />
|Current Ratio<br />
|align = "right"|1.75<br />
|-<br />
|P/E Ratio<br />
|align = "right"|18.9<br />
|-<br />
|Debt to Equity Ratio<br />
|align = "right"|43.31<br />
|-<br />
|}<br />
<br />
=====Segment contribution=====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="53%"<br />
|align = "center" bgcolor = "#002060" colspan = "3"|<font color="#FFFFFF">'''Segment Contribution to the revenue (in $M)'''</font><br />
|-<br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Segment'''</font><br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Growth'''</font><br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Sales (2010)'''</font><br />
|-<br />
|Cardiovascular<br />
|align = "right"|(-5%)<br />
|align = "right"|811<br />
|-<br />
|Interventional Cardiology<br />
|align = "right"|(-8%)<br />
|align = "right"|635<br />
|-<br />
|Peripheral Interventions<br />
|align = "right"|7%<br />
|align = "right"|176<br />
|-<br />
|Coronary stent system<br />
|align = "right"|(-7.9%)<br />
|align = "right"|409<br />
|-<br />
|Cardiac Rhythm Management<br />
|align = "right"|4%<br />
|align = "right"|559<br />
|-<br />
|Defibrillators <br />
|align = "right"|6.9%<br />
|align = "right"|417<br />
|-<br />
|Pacemakers<br />
|align = "right"|(-4%)<br />
|align = "right"|142<br />
|-<br />
|Electrophysiology<br />
|align = "right"|(-3%)<br />
|align = "right"|37<br />
|-<br />
|Endoscopy<br />
|align = "right"|(-3%)<br />
|align = "right"|287<br />
|-<br />
|Urology/Women<nowiki>’</nowiki>s health<br />
|align = "right"|10%<br />
|align = "right"|120<br />
|-<br />
|Neuromodulation<br />
|align = "right"|14%<br />
|align = "right"|77<br />
|-<br />
|}<br />
<br />
Boston Scientific derives maximum contribution from Cardiovascular, which recorded a 5% year-over-year decline in sales to $811 million. While sales from Interventional Cardiology declined 8% to $635 million, Peripheral Interventions increased 7% to $176 million. Global sales of coronary stent system (within Interventional Cardiology) at $409 million declined 7.9% driven by lower sales of both drug-eluting stents (DES, 6.9% to $379 million) and bare-metal stents (18.9% to $30 million). It is encouraging to note that the company maintained its leadership position in the global DES market with 36% share and 46% in the US market.<br />
<br />
The next biggest contributor to Boston Scientific<nowiki>’</nowiki>s top line, Cardiac Rhythm Management, recorded a 4% increase in sales to $559 million. A 6.9% rise in defibrillators sales to $417 million coupled with a 4% decline in sales of pacemakers to $142 million contributed to the overall increase.<br />
<br />
Hence, the overall revenue of Boston Scientific declined by 4.7%. ([http://seekingalpha.com/article/264756-boston-scientific-boosts-bottom-line-despite-revenue-decline Seekingalpha.com])<br />
<br />
====Revenue Distribution of Boston Scientific====<br />
=====By Product Category=====<br />
<br />
[[Image:revenue - productwise - Boston scientific.jpg]]<br />
<br />
The graph clearly shows the declining cardiovascular market, which constitutes the major part of Boston Scientific<nowiki>’</nowiki>s revenue. It gives a strong signal to the company to diversify its business into other business units and not be very dependent on one market.<br />
<br />
=====By Geography=====<br />
[[Image:revenue - geogwise - Boston scientific.jpg]]<br />
<br />
<nowiki>*</nowiki>EMEA – Europe, Middle East and Africa<br />
<br />
The graph clearly shows that U.S. contributes to more than 50% of the company<nowiki>’</nowiki>s revenues. It shows an opportunity for the company to expand in other markets. They have started selling their products in Japan, which has already started contributing majorly to the revenues.<br />
<br />
===Business Overview===<br />
====Product Portfolio====<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#002060" colspan = "5"|<font color="#FFFFFF"><font size = "4">'''Product Portfolio of Boston Scientific'''</font></font><br />
|-<br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Cardiovascular Group'''</font><br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Cardiac Rhythm Management'''</font><br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Endoscopy'''</font><br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Urology and Women<nowiki>’</nowiki>s Health'''</font><br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Neuromodulation'''</font><br />
|-<br />
|Drug-Eluting Stents<br />
|Remote Patient Management<br />
|Biliary Devices<br />
|Stone Management<br />
|Spinal Cord Stimulation<br />
|-<br />
|Coronary Balloons<br />
|Pacemakers<br />
|Cholangioscopy<br />
|Benign Prostatic Hyperplasia<br />
| <br />
|-<br />
|Coronary Atherectomy<br />
|Implantable Cardioverter Defibrillators<br />
|Biliary Stents<br />
|Pelvic Floor Reconstruction<br />
| <br />
|-<br />
|Embolic Protection<br />
|Cardiac Resynchronization<br />
|Gastrointestinal Stents<br />
|Abnormal Uterine Bleeding<br />
| <br />
|-<br />
|Inflation Devices<br />
|Therapy Defibrillators<br />
|Tissue Acquisition<br />
| <br />
| <br />
|-<br />
|Peripheral Balloons<br />
|Cardiac Resynchronization<br />
|Gastrointestinal Bleeding<br />
| <br />
| <br />
|-<br />
|Interventional Oncology<br />
|Therapy Pacemakers<br />
|Balloon Dilatation<br />
| <br />
| <br />
|-<br />
|Guide Wires<br />
|Electrophysiology<br />
|Pulmonary Devices<br />
| <br />
| <br />
|-<br />
|Diagnostic Catheters<br />
|Ablation Catheters<br />
|Airway Stents<br />
| <br />
| <br />
|-<br />
|Guide Catheters<br />
|Intracardiac Echocardiography<br />
|Bronchial Thermoplasty<br />
| <br />
| <br />
|-<br />
|Intravascular Ultrasound<br />
|Diagnostic Catheters<br />
| <br />
| <br />
| <br />
|-<br />
|Vascular Access/Chronic Total Occlusion<br />
| <br />
| <br />
| <br />
| <br />
|-<br />
|Peripheral Stents<br />
| <br />
| <br />
| <br />
| <br />
|-<br />
|}<br />
<br />
====Geographical Presence====<br />
The Corporate headquarters of Boston Scientific is in Natick, Massachusetts. The company is present in the following locations in Europe/Middle East/Africa, America and Asia Pacific/Japan.<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="55%"<br />
|align = "justify" bgcolor = "#002060"|<font color="#FFFFFF">'''Europe/Middle East/Africa'''</font><br />
|align = "justify" bgcolor = "#002060"|<font color="#FFFFFF">'''America'''</font><br />
|align = "justify" bgcolor = "#002060"|<font color="#FFFFFF">'''Asia Pacific/Japan'''</font><br />
|-<br />
|align = "justify"|Austria<br />
|align = "justify"|Argentina<br />
|align = "justify"|New Zealand<br />
|-<br />
|align = "justify"|Belgium<br />
|align = "justify"|Brazil<br />
|align = "justify"|China<br />
|-<br />
|align = "justify"|Czech Republic<br />
|align = "justify"|Canada<br />
|align = "justify"|Hong Kong<br />
|-<br />
|align = "justify"|Denmark<br />
|align = "justify"|Chile<br />
|align = "justify"|India<br />
|-<br />
|align = "justify"|Finland<br />
|align = "justify"|Colombia<br />
|align = "justify"|Korea<br />
|-<br />
|align = "justify"|France<br />
|align = "justify"|Costa Rica<br />
|align = "justify"|Tokyo<br />
|-<br />
|align = "justify"|Germany<br />
|align = "justify"|Mexico<br />
|align = "justify"|<font color="#333333">Fukuoka</font><br />
|-<br />
|align = "justify"|Greece<br />
|align = "justify"|Uruguay<br />
|align = "justify"|<font color="#333333">Hiroshima</font><br />
|-<br />
|align = "justify"|Hungary<br />
|align = "justify"|Venezuela<br />
|align = "justify"|<font color="#333333">Kanagawa </font><br />
|-<br />
|align = "justify"|Ireland<br />
|align = "justify"|West Indies<br />
|align = "justify"|<font color="#333333">Ishikawa</font><br />
|-<br />
|align = "justify"|Israel<br />
|align = "justify"|Massachusetts<br />
|align = "justify"|<font color="#333333">Saitama </font><br />
|-<br />
|align = "justify"|Italy<br />
|align = "justify"|California<br />
|align = "justify"|<font color="#333333">Miyazaki</font><br />
|-<br />
|align = "justify"|Lebanon<br />
|align = "justify"|Florida<br />
|align = "justify"|<font color="#333333">Aichi </font><br />
|-<br />
|align = "justify"|Netherlands<br />
|align = "justify"|Indiana<br />
|align = "justify"|<font color="#333333">Osaka </font><br />
|-<br />
|align = "justify"|Norway<br />
|align = "justify"|Minnesota<br />
|align = "justify"|<font color="#333333">Hokkaido</font><br />
|-<br />
|align = "justify"|Poland<br />
|align = "justify"|Utah<br />
|align = "justify"|<font color="#333333">Miyagi </font><br />
|-<br />
|align = "justify"|Portugal<br />
|align = "justify"|Washington<br />
|align = "justify"|<font color="#333333">Kanagawa </font><br />
|-<br />
|align = "justify"|Spain<br />
|align = "justify"| <br />
|align = "justify"|Malaysia<br />
|-<br />
|align = "justify"|South Africa<br />
|align = "justify"| <br />
|align = "justify"|Philippines<br />
|-<br />
|align = "justify"|Sweden<br />
|align = "justify"| <br />
|align = "justify"|Singapore<br />
|-<br />
|align = "justify"|Switzerland<br />
|align = "justify"| <br />
|align = "justify"|Taiwan<br />
|-<br />
|align = "justify"|Turkey<br />
|align = "justify"| <br />
|align = "justify"|Thailand<br />
|-<br />
|align = "justify"|United Kingdom<br />
|align = "justify"| <br />
|align = "justify"| <br />
|-<br />
|}<br />
<br />
====Organization Structure====<br />
[[Image:Organization Structure of Boston Scientific.jpg]]<br />
([http://www.theofficialboard.com/org-chart/boston-scientific Theofficialboard.com])<br />
<br />
'''Key Executives'''<br />
<br />
* Chairman: Peter M. (Pete) Nicholas<br />
* EVP and COO: Samuel R. (Sam) Leno<br />
* EVP and CFO: Jeffrey D. (Jeff) Capello<br />
<br />
===Market Overview===<br />
====Market Share====<br />
[[Image:Market Share - Medical Devices (2010).jpg]]<br />
<br />
====Top 10 companies in the medical devices industry====<br />
{|border="2" cellspacing="0" cellpadding="4" width="44%"<br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Top 10 companies in the medical devices industry'''</font><br />
|bgcolor = "#002060"|<font color="#FFFFFF">'''Sales in 2010 ($B)'''</font><br />
|-<br />
|Johnson & Johnson<br />
|align = "right"|23.60<br />
|-<br />
|Siemens Healthcare<br />
|align = "right"|17.40<br />
|-<br />
|GE Healthcare<br />
|align = "right"|16.00<br />
|-<br />
|Medtronic<br />
|align = "right"|15.82<br />
|-<br />
|Baxter International<br />
|align = "right"|12.60<br />
|-<br />
|Philips Healthcare<br />
|align = "right"|11.20<br />
|-<br />
|Abbott Laboratories<br />
|align = "right"|8.40<br />
|-<br />
|Boston Scientific<br />
|align = "right"|8.00<br />
|-<br />
|Covidien<br />
|align = "right"|7.81<br />
|-<br />
|Becton Dickinson<br />
|align = "right"|7.16<br />
|-<br />
|}<br />
<br />
====SWOT Analysis of Boston Scientific====<br />
<br />
[[Image:SWOT - Boston Scientific.jpg]]<br />
<br />
===Transactional Activities===<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%" align="center"<br />
|bgcolor = "#002060" colspan = "4"|<font color="white"> <font size = "4">Mergers & Acquisitions done by Boston Scientific</font><br><font size = "4"> </font> <br />
|-<br />
|bgcolor = "#0000"|<width="100%">|align = "right"|<font color="white"> '''Acquired Company'''<br />
|bgcolor = "#0000"|<width="100%">|<font color="white"> '''Date''' <br />
|bgcolor = "#0000"|<width="100%">|<font color="white"> '''Value ($) M'''<br />
|bgcolor = "#0000"|<width="100%">|<font color="white"> '''Reason for Acquisition'''<br />
|-<br />
|<font color="#333333">Atritech Inc</font><br />
|align = "right"|<font color="#181818"> Jan-11 </font> <br />
|align = "right"|<font color="#181818">100</font><br />
|* <font color="#181818">It strengthens the BS<nowiki>’</nowiki>s product offerings in the fast-growing areas of structural heart therapy</font><br>* <font color="#181818">Also a trial fibrillation, which represent two of their Priority Growth Initiatives.</font><br><font color="#181818">([http://www.alacrastore.com/mergers-acquisitions/Boston_Scientific_Corporation-1060228 Alacrastore.com])</font><br />
|-<br />
|<font color="#333333">ReVascular Therapeutics Inc</font><br />
|align = "right"|<font color="#333333"> Feb-11 </font><br />
|align = "right"|N/A<br />
|* These two novel technologies treat peripheral chronic total occlusions (CTOs).<br>* BSX made the acquisitions because the devices cover areas with promise of high growth potential. ([http://finance.yahoo.com/news/Boston-Scientific-Strengthens-prnews-2182311141.html?x=0&.v=1 Yahoo Finance])<br />
|-<br />
|<font color="#333333">Intelect Medical Inc</font><br />
|align = "right"|Jan -11<br />
|align = "right"|78<br />
|* It supports BSX long-term strategy of enhancing the product portfolio and gaining market share in the Neuromodulation space<br>* It will help them to provide the most advanced deep brain stimulation technology solutions for neurologists, neurosurgeons and their patients.<br>* The GUIDE DBS system would be a major advance in deep brain stimulation therapy, especially when used in conjunction with BSX<nowiki>’</nowiki>s Vercise DBS System. ([http://www.massdevice.com/news/boston-scientific-adds-two-blocked-artery-treatment-devices-acquisitions-roundup Massdevice.com], [http://blog.medicaldesign.com/perspectives/2011/02/16/ Medicaldesign.com])<br />
|-<br />
|<font color="#333333">Sadra Medical Inc</font><br />
|align = "right"| Jan -11<br />
|align = "right"|193<br />
|* Will Help BSX leverage on its clinical expertise and existing sales channels in the fast-growing area of structural heart therapy.( [http://www.reuters.com/article/2011/01/04/idUS196379+04-Jan-2011+PRN20110104 Reuters])<br />
|-<br />
|<font color="#333333">Asthmatx Inc</font><br />
|align = "right"|<font color="#333333"> Oct-10 </font><br />
|align = "right"|<font color="#333333">193.5</font><br />
|* <font color="#333333">Named as Top Ten Medical Innovations for 2007" by the Cleveland Clinic Foundation.</font><br>* <font color="#333333">The transaction is expected to provide meaningful revenue growth in the midterm ([http://www.asthmatx.com/news-events/press-releases/?i=450 Asthmatx.com])</font><br />
|-<br />
|Labcoat Ltd . (Ireland)<br />
|align = "right"|Sep- 10<br />
|align = "right"|N/A<br />
|* The Technology represents a major advance for drug-eluting stents and would help BSX maintain their strong position in this market ([http://bostonscientific.mediaroom.com/index.php?s=43&item=793 Bostonscientific])<br />
|-<br />
|Remon Medical Technologies Inc<br />
|align = "right"|Aug-07<br />
|align = "right"|. 73<br />
|* Provides BSX with innovative sensor and wireless communication technology that complements their Cardiac Rhythm Management product line.<br>* Also to maintain the leadership position ([http://salesandmarketingnetwork.com/news_release.php?ID=2015814 Salesandmarketingnetwork.com])<br />
|-<br />
| EndoTex Interventional Systems Inc .<br />
|align = "right"|Jan-07<br />
|align = "right"|142<br />
|* <font color="#333333">leadership in treating carotid artery disease ([http://uk.reuters.com/article/2007/01/04/bostonscientific-acquisition-idUKN0419620070104 Reuters])</font><br />
|-<br />
| Guidant Corp<br />
|align = "right"|Apr-06<br />
|align = "right"|27000<br />
|* <font color="#333333">To be a global leader in cardiovascular devices ([http://www.cbsnews.com/stories/2006/01/25/business/main1236024.shtml Cbsnews])</font><br />
|-<br />
|TriVascular<br />
|align = "right"|Apr-05<br />
|align = "right"|110<br />
|* To increase its share in the overall market for abdominal aortic aneurysms (AAA)device ([http://www.fdanews.com/newsletter/article?issueId=7456&articleId=71208 Fdanews])<br />
|-<br />
|}<br />
<br />
===Roadmap===<br />
====Company<nowiki>’</nowiki>s focus on R&D====<br />
[[Image:Employees split-2.jpg]][[Image:US Patents issued (Boston Scientific).jpg]][[Image:R&D investment - Boston.jpg]]<br />
<br />
(Similar companies are based on the same industry and similar size for the year 2011)<br />
<br />
* The first chart shows the number of employees in the R&D department in Boston Scientific is 9% higher than the industry standards (in 2011). The other chart shows that over the span of 8 years (2002-2009), the investment by Boston Scientific in R&D has increased by 200%. Also, by the end of 2009, 7240 US patents have been granted to Boston Scientific and 10,009 patents are pending. It shows that Boston Scientific is clearly focused on investing in new technology through R&D.<br />
* In addition to the Company<nowiki>’</nowiki>s internal investments, Boston Scientific is committed to investing in external, or acquired, R&D through acquisitions and investments in new businesses.<br />
* Boston Scientific in future is committed to developing less-invasive products and procedures, and through the acquisition of new technologies, to better enable physicians to treat their patients.<br />
* The sales force of Boston Scientific is 3% lower than the industry standards. This shows that the company has an established customer base that are loyal to the company and Boston Scientific does not have to push is products in the market.<br />
<br />
====Key Insights====<br />
* Boston Scientific continues to focus on strategic initiatives to drive growth and profitability. <br />
* Recent acquisitions made by the company along with promising new technologies are expected to boost the company<nowiki>’</nowiki>s pipeline. <br />
* However, the concern is with its core business where Boston is witnessing significant pricing pressure and market decline. <br />
* Moreover, economic uncertainty is impacting procedure volume<br />
* For the fiscal year 2010 the revenues of the company has gone down by 4.70%<br />
* The same decline has been contributed by the various segments like<br />
* Cardiovascular, Interventional Cardiology<br />
* Coronary stent system<br />
* Pacemakers<br />
* Electrophysiology and endoscopy<br />
* The decline in these individual segments ranges from 3- 8 %<br />
* These businesses are witnessing several challenges including pricing pressure, intense competition and slower market growth<br />
* With respect to these declining figures new strategies need to be worked on, to either increase the contribution from this segment or diversify in to other segments<br />
* The company has adopted <nowiki>’</nowiki>priority growth initiatives<nowiki>’</nowiki> based on which it will target non-DES and non-CRM areas that holds potential<br />
* There are segments which have shown higher growth percentage that reaches up to 14% but the contribution of these segments is very low despite higher growth rate<br />
* This higher growth rate can be a signal of growth potential for future concentration of efforts<br />
* Segments like urology/ women<nowiki>’</nowiki>s health, neurovascular & Neuromodulation are growing post 2006 not significantly though<br />
* Though company has diversified in neuromodulation which according to industry professionals has been considered a good decision<br />
* Though the dependence on Cardiovascular is very high and cannot be ignored<br />
* USA has been the major geographical market for this company but Japan is emerging post 2008<br />
* Co also faces certain industry risks such as failure of approval from FDA, approved devices being pulled from market due to safety reasons along with eroding market share and expiring patents<br />
* The recent example of pull back is iCross Coronary Imaging Catheters<br />
* It<nowiki>’</nowiki>s being noted that their long standing approach to growth is by strategic acquisitions of , investments in or alliances with other businesses or companies<br />
* But the co. may not always be successful in generating growth this way<br />
* Co should try and leverage well on all the recent acquisitions so that the benefits can be reaped well<br />
* Need to control costs, grow foreign market revenue and continue to get timely regulatory approval<br />
* Company needs to realign their business portfolio to improve leverage and accelerate profitable revenue growth<br />
* Expansion of global sales and marketing focus is important. Increasing the presence in markets such as China, India and Brazil by increasing their sales forces in emerging markets, expanding the number of our product registrations outside the U.S.<br />
<br />
===Contact===<br />
<br />
'''Boston Scientific Corporate Headquarters''' <br />
<br />
One Boston Scientific Place<br />
<br />
Natick, MA 01760-1537<br />
<br />
Main Number: 1-508-650-8000</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Cook_INC&diff=9299
Cook INC
2011-07-28T11:42:23Z
<p>Shweta.mittal@dolcera.com: </p>
<hr />
<div>1. Cook Medical Awarded New Contract with Amerinet, Expanding Antibiotic-Impregnated Catheter Access to 54,000 U.S. Health Care Providers May 18, 2011. <br />
<br />
2. Advanced Technique for Treating Esophageal Lesions Deemed Safe and Effective in European Endoscopy Journal<br />
May 9, 2011. <br />
<br />
3.Cook Expands Raw Materials Manufacturing to Canton, Ill.<br />
May 9, 2011 <br />
<br />
4.Cook Medical Announces Addition to Liberator® Locking Stylet with Beacon® Tip Technology to Support Physician Control in Lead Extraction<br />
May 4, 2011</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Boston_Scientific&diff=9298
Boston Scientific
2011-07-28T11:41:35Z
<p>Shweta.mittal@dolcera.com: </p>
<hr />
<div>1. Boston Scientific Announces FDA Approval and U.S. Launch of PROMUS® 2.25 mm Everolimus-Eluting Coronary Stent System. <br />
<br />
2 PROMUS Element(TM) Stent Demonstrates Exceptional Safety and Effectiveness in PLATINUM Small Vessel Study. <br />
<br />
3.Favorable Clinical Study Results Reported With Dual Anti-Platelet Therapy After LAA Closure With WATCHMAN® Device</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Urine_alkalinization&diff=9297
Urine alkalinization
2011-07-28T11:40:28Z
<p>Shweta.mittal@dolcera.com: </p>
<hr />
<div>The mainstay for medical management of uric acid stones is alkalinization (increasing the pH) of the urine.<br />
<br />
Uric acid stones are among the few types amenable to dissolution therapy, referred to as chemolysis. Chemolysis is usually achieved through the use of oral medications, although in some cases intravenous agents or even instillation of certain irrigating agents directly onto the stone can be performed, using antegrade nephrostomy or retrograde ureteral catheters.<br />
<br />
Acetazolamide (Diamox) is a medication that alkalinizes the urine. In addition to acetazolamide or as an alternative, certain dietary supplements are available that produce a similar alkalinization of the urine.<br />
<br />
These include sodium bicarbonate, potassium citrate, magnesium citrate, and Bicitra (a combination of citric acid monohydrate and sodium citrate dihydrate).<br />
<br />
Aside from alkalinization of the urine, these supplements have the added advantage of increasing the urinary citrate level, which helps to reduce the aggregation of calcium oxalate stones.<br />
<br />
Increasing the urine pH to around 6.5 provides optimal conditions for dissolution of uric acid stones.<br />
<br />
Increasing the urine pH to a value higher than 7.0 increases the risk of calcium phosphate stone formation.<br />
<br />
Testing the urine periodically with nitrazine paper can help to ensure that the urine pH remains in this optimal range. Using this approach, stone dissolution rate can be expected to be around 10 millimeters of stone radius per month</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Alpha_Blockers&diff=9296
Alpha Blockers
2011-07-28T11:40:01Z
<p>Shweta.mittal@dolcera.com: </p>
<hr />
<div>Alpha adrenergic blockers such as tamsulosin (Flomax) may increase the spontaneous passage of the stone by 30%. Recent studies have, however, questioned this claim, finding no benefit from these medications.</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Main_article-_Ureteral_stent_difficulties&diff=9295
Main article- Ureteral stent difficulties
2011-07-28T11:39:23Z
<p>Shweta.mittal@dolcera.com: </p>
<hr />
<div>Ureteral stent symptoms may include:<br />
<br />
1. Hematuria - Stents can cause blood to appear in the urine at various times. Usually, physical activity of one kind or other results in movement of the stent inside the body. This can give rise to blood in the urine. Pain may be felt in the back (loin), bladder area, groin, penis in men or urethra in women, and sometimes the testicles. The discomfort or pain may be more noticeable after physical activities and after passing urine.<br />
<br />
2. Bladder spasms - The stent can rub and irritate the lining of the bladder, making it necessary to pass urine more frequently during the day and at night. These symptoms can occasionally be improved by medication.<br />
<br />
3. Incontinence - Rarely, a stent may cause such bladder spasms leading to urinary leakage. This can usually be controlled with oral medications or with stent removal.<br />
<br />
4. Stent migration – Stents may move from their intended positions to other parts of the urinary tract, causing pain or incontinence.<br />
<br />
5. Infection – As stents are foreign bodies, bacteria can attach to their surface and become protected by a layer of slime known as a “biofilm.” These bacteria may then be released into the urine, causing infection and fever. These infections may temporarily be cleared with antibiotics, but usually recur 2-3 weeks after antibiotics as the antibiotics are unable to penetrate the biofilm.<br />
<br />
6. Encrustation - Stents may be forgotten by patients and their care-givers. Over time, they can become coated with urinary salts and minerals and eventually become one very large calcified stone. This may lead to chronic obstruction, pain, chronic infections, or even complete atrophy (death) of that kidney. Typically, 2-3 procedures are necessary to remove these calcified stents.<br />
<br />
Source - [http://urology.ufl.edu/MIS/stone/ureteroscopy.php Stent problems]</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=File:Cook.pdf&diff=9294
File:Cook.pdf
2011-07-28T11:38:06Z
<p>Shweta.mittal@dolcera.com: </p>
<hr />
<div></div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Smoking&diff=9293
Smoking
2011-07-28T11:36:36Z
<p>Shweta.mittal@dolcera.com: </p>
<hr />
<div>The University of Lausanne looked at 25 studies involving 1.2m patients.<br />
<br />
They found smokers had a 44% increased risk of type 2 diabetes compared with non-smokers - with the risk rising with the number of cigarettes smoked.<br />
<br />
The Journal of the American Medical Association study found the increased risk for those who smoked at least 20 cigarettes a day rose to 61%.<br />
<br />
<br />
Smoking may be one of the pieces missing from the diabetes jigsaw which could help us to identify who is at higher risk<br />
Douglas Smallwood<br />
Diabetes UK<br />
<br />
For lighter smokers the risk was 29% higher than for a non-smoker.<br />
<br />
The increased risk of developing diabetes in former smokers was 23%.<br />
<br />
The researchers said: "We conclude that the relevant question should no longer be whether this association exists, but rather whether this established connection is causal."<br />
<br />
They admitted that the research did not prove that smoking contributed to the development of diabetes.<br />
<br />
But they suggest the fact that people who smoked most heavily were most at risk is significant.<br />
<br />
Previous research has linked smoking to insulin resistance - a condition which often leads to diabetes.<br />
<br />
Source - [http://news.bbc.co.uk/2/hi/health/7138901.stm BBC]</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Alcohol_Consumption&diff=9290
Alcohol Consumption
2011-07-28T11:36:06Z
<p>Shweta.mittal@dolcera.com: </p>
<hr />
<div>The sugar glucose is the main energy source for all tissues. Glucose is derived from three sources: from food; from synthesis (manufacture) in the body; and from the breakdown of glycogen, a form of glucose that the body stores in the liver. Hormones help to maintain a constant concentration of glucose in the blood. This is especially important for the brain because it cannot make or store glucose but depends on glucose supplied by the blood. Even brief periods of low glucose levels (hypoglycemia) can cause brain damage.<br />
<br />
Two hormones that are secreted by the pancreas and that regulate blood glucose levels are insulin and glucagon. Insulin lowers the glucose concentration in the blood; glucagon raises it. Because prevention of hypoglycemia is vital for the body, several hormones from the adrenal glands and pituitary back up glucagon function.<br />
<br />
Alcohol consumption interferes with all three glucose sources and with the actions of the regulatory hormones. Chronic heavy drinkers often have insufficient dietary intake of glucose. Without eating, glycogen stores are exhausted in a few hours. In addition, the body's glucose production is inhibited while alcohol is being metabolized. The combination of these effects can cause severe hypoglycemia 6 to 36 hours after a binge- drinking episode.<br />
<br />
Even in well-nourished people, alcohol can disturb blood sugar levels. Acute alcohol consumption, especially in combination with sugar, augments insulin secretion and causes temporary hypoglycemia. In addition, studies in healthy subjects and insulin-dependent diabetics have shown that acute alcohol consumption can impair the hormonal response to hypoglycemia.<br />
<br />
Chronic heavy drinking, in contrast, has been associated with excessive blood glucose levels (hyperglycemia). Chronic alcohol abuse can reduce the body's responsiveness to insulin and cause glucose intolerance in both healthy individuals and alcoholics with liver cirrhosis. In fact, 45 to 70 percent of patients with alcoholic liver disease are glucose intolerant or are frankly diabetic. In animals, chronic alcohol administration also increases secretion of glucagon and other hormones that raise blood g lucose levels.<br />
<br />
Alcohol consumption can be especially harmful in people with a predisposition to hypoglycemia, such as patients who are being treated for diabetes. Alcohol can interfere with the management of diabetes in different ways. Acute as well as chronic alcohol consumption can alter the effectiveness of hypoglycemic medications. Treatment of diabetes by tight control of blood glucose levels is difficult in alcoholics, and both hypoglycemic and hyperglycemic episodes are common.</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=UTI_and_diabetes_complete_article&diff=9289
UTI and diabetes complete article
2011-07-28T11:35:26Z
<p>Shweta.mittal@dolcera.com: </p>
<hr />
<div>Urinary Tract Infection, (UTI) is a common ailment and can affect people of all ages, sex, and from all cultures. However, there are certain groups of people that are more prone to UTI than others. Women, for example, for reasons yet to be firmly established, carry a greater risk of UTI. Diabetic patients too fall under this category. Going further, pregnant women with diabetes are probably amongst the most vulnerable to UTI.<br />
<br />
Diabetic women are at a higher risk of developing to urinary tract infection (UTI) after menopause as compared to non-diabetic women. In fact, a study by University of Washington, Seattle revealed that the risk of UTI in diabetic women was 80% higher than others. UTI in diabetic patients is not only more severe but also is more recurrent as compared to non-diabetic patients.<br />
<br />
The sugar content of urine in a diabetic patient provides a breeding ground for bacteria once they enter the bladder. The most serious but rare types of UTI like pyelonephritis, widespread infections, abscesses, inflammation of the bladder wall, occur mostly in diabetic individuals.<br />
<br />
The risk of UTI increases with any negative change in the immune system of the body. Diabetes, like many other disorders, affects the immune system, increasing the risk of a urinary tract infection.<br />
<br />
Another characteristic of UTI in diabetic patients is that of the risk of presence of asymptomatic (having no symptoms of illness or disease) bacteriuria - presence of bacteria in urine - is much greater than in others. Treating this condition, according to study conducted in 2003, is of little value as it does not prevent complications.<br />
<br />
Diabetes may cause conditions of overactive bladder or neurogenic bladder. Whereas, an overactive bladder is common, neurogenic bladder is rare but more a severe condition.<br />
<br />
Diabetic men and women commonly face problems like feeling of urinary urgency, incontinence, frequency and getting up at night often to urinate. A severe condition often manifests in the shape of painful urination and retention of urine in the bladder. Bladder infection treatment in cases of neurogenic bladder involve a urinary tract infection cure with medication targeting better bladder emptying and a course of action called timed urination. Timed urination refers to behavior changes for promoting efficient urination. Occasionally, an insertion of a catheter is necessitated to empty the bladder, if other procedures, including massaging of the lower bladder, do not work with the patient.<br />
<br />
For diagnostic purposes, the procedures involved include a check up of the nervous system, x-rays, and evaluation of bladder function.<br />
<br />
UTI in diabetic patients can be a traumatic experience leading to complications if not treated in time. Urinary tract infection cure for diabetic patients requires a longer period, lasting from anything between seven to fourteen days, of antibiotic treatment even for uncomplicated infections. In many cases it may have to be accompanied by bladder infection treatment.<br />
<br />
Source [http://www.nativeremedies.com/articles/complications-diabetes-uti.html UTI&Diabetes]</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Other_factors&diff=9288
Other factors
2011-07-28T11:34:35Z
<p>Shweta.mittal@dolcera.com: </p>
<hr />
<div>There is some evidence that water fluoridation may increase the risk of kidney stone formation. In one study, patients with symptoms of '''skeletal fluorosis''' were 4.6 times as likely to develop kidney stones.<br />
<br />
Despite a widely-held belief in the medical community that ingestion of vitamin C supplements is associated with an increased incidence of kidney stones, '''the evidence for a causal relationship between vitamin C supplements and kidney stones is inconclusive.'''<br />
<br />
There are no conclusive data demonstrating a cause and effect relationship between '''alcohol consumption''' and kidney stones.<br />
<br />
However, some have theorized that certain behaviors associated with frequent and binge drinking can lead to systemic dehydration, which can in turn lead to the development of kidney stones.<br />
<br />
The American Urological Association has projected that increasing '''global temperatures''' will lead to an increased incidence of kidney stones in the United States by expanding the "kidney stone belt" of the southern United States. '''Astronauts''' seem to show a higher risk of developing kidney stones during or after space flights of long duration.</div>
Shweta.mittal@dolcera.com
https://www.dolcera.com/wiki/index.php?title=Role_of_dietary_animal_protein&diff=9287
Role of dietary animal protein
2011-07-28T11:32:36Z
<p>Shweta.mittal@dolcera.com: </p>
<hr />
<div>Diets in Western nations typically contain more animal protein than the body needs, and as the excess amino acids are broken down and excreted, the sulfurous amino acids (typically derived from animal rather than vegetarian foods) cause calcium to be excreted in the urine; calcium is one component of the most common type of human kidney stones, calcium oxalate.<br />
<br />
Red meat also contains acids that need to be excreted and this acidity constitutes another risk factor for kidney stones. High intake of animal protein also presents a greater uric acid load to be excreted by the kidney. This in turn acidifies the urine, increasing the risk of uric acid stones. In either case, the body often balances this acidic urinary pH by leaching calcium from the bones.</div>
Shweta.mittal@dolcera.com