Changes
/* Methodology */
[[Wiki section]]
==Process to Identify Possible Acquisition Targets==
Before identifying the possible acquisition targets, first companies needs to identify the objective of the merger and acquisition.
===Advantage of Mergers and Acquisitions===
The most common motives and advantages of mergers and acquisitions are:-
*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.
*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:-
**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.
**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.
**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.
*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.
*A merger may result in financial synergy and benefits for the firm in many ways:-
**By eliminating financial constraints
**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
**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.
*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.
'''Note:''' In this research report, researcher considered two following objective of merger and acquisition:
#To Enter in emerging markets
#To improve product portfolio
===Methodology===
* '''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)
** Number of companies that were identified in this step: 20
* '''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.
**Number of companies eliminated in this step: 14
**Number of (small) companies of interest left: 6
* '''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:
**Number of potential target companies: 6
<br/>
{|border="2" cellspacing="0" cellpadding="4" width="80%" align="center"
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Company'''</font>
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Headquartered'''</font>
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Stent Details'''</font>
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Company Type'''</font>
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''2010 Revenue (Mn)'''</font>
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''No of Employees'''</font>
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Geographical Revenue Share'''</font>
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''R&D investment (Mn)'''</font>
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''No. of Patent'''</font>
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Technology Focus'''</font>
|-
|bgcolor = "#DBE5F1"|Applied Medical Resources Corp.
|bgcolor = "#DBE5F1"|USA
|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
|bgcolor = "#DBE5F1"|Manufacturer
|align = "center" bgcolor = "#DBE5F1"|$282
|align = "center" bgcolor = "#DBE5F1"|1900
|bgcolor = "#DBE5F1"|USA: 62%<br>Asia: 32%<br>Rest of World: 6%
|bgcolor = "#DBE5F1"|$38.3 (13%)
|align = "center" bgcolor = "#DBE5F1"|212
|bgcolor = "#DBE5F1"|High
|-
|Bioteque Corp.
|Taiwan
|Bioteque Double Pigta
|Contract Manufacturer; Contract Sterilizer; Manufacturer
|align = "center"|$27.85
|align = "center"|350
|Taiwan: 100%
|$1.4 (5%)
|align = "center"|16
|Medium
|-
|bgcolor = "#DBE5F1"|Hobbs Medical, Inc.
|bgcolor = "#DBE5F1"|USA
|bgcolor = "#DBE5F1"|HM Ureteral Double Pigtail Stent
|bgcolor = "#DBE5F1"|Manufacturer
|align = "center" bgcolor = "#DBE5F1"|$2.30
|align = "center" bgcolor = "#DBE5F1"|22
|bgcolor = "#DBE5F1"|USA: 97.2%<br>Japan: 2.3%<br>Others: 0.5%
|bgcolor = "#DBE5F1"|$0.06 (2.87%)
|align = "center" bgcolor = "#DBE5F1"|1
|bgcolor = "#DBE5F1"|Low
|-
|Lake Region Medical Limited
|Ireland
|M-Wires
|Contract Manufacturer
|align = "center"|$84.86
|align = "center"|611
|Europe: 68%<br>USA: 21%<br>Others: 11%
|$8.48 (3.85%)
|align = "center"|8
|Medium
|-
|bgcolor = "#DBE5F1"|Martech Medical Products
|bgcolor = "#DBE5F1"|USA
|bgcolor = "#DBE5F1"|Ureteral Stent
|bgcolor = "#DBE5F1"|Contract Manufacturer
|align = "center" bgcolor = "#DBE5F1"|$23.00
|align = "center" bgcolor = "#DBE5F1"|180
|bgcolor = "#DBE5F1"|USA: 78.3%<br>Europe: 12.7%<br>Others: 9%
|bgcolor = "#DBE5F1"|$1.1 (4.79%)
|align = "center" bgcolor = "#DBE5F1"|0
|bgcolor = "#DBE5F1"|Low
|-
|Allium Medical
|Israel
|URS - Ureteral Stent<br>TPS - Triangular Prostatic Stent<br>BUS - Bulbar Urethral Stent<br>RPS - Round Posterior Urethral Stent<br>BIS - Biliary Stent
|Manufaturer
|align = "center"|$2.04
|align = "center"|20
|Domestic: 88.6%<br>International: 11.4%
|$0.082 (4%)
|align = "center"|2
|Low
|-
|}<br clear="all">
'''Note:''' Data for Geographical segment, R&D expenditure and Technology focus has been masked.
{|align="center"
|<gflash>1000 750 http://dolcera.com/upload/files/ranking1.swf</gflash>
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<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.
**To improve Product Portfolio : '''Applied Medical Resources Corp.'''
**To enter in Emerging Markets : '''Bioteque Corp.'''
===Company Profile===
====Applied Medical Resources Corp.====
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''APPLIED MEDICAL RESOURCES CORP.'''</font>
|-
|bgcolor = "#C5D9F1"|'''Revenues'''
|bgcolor = "#C5D9F1"|2010: $280 million
|-
|'''Net profit (2010)'''
|$20.89 million
|-
|bgcolor = "#C5D9F1"|'''R&D Investment'''
|bgcolor = "#C5D9F1"|2010: $ 38.3 million (13% of revenues)
|-
|'''Number of employees'''
|1900
|-
|bgcolor = "#C5D9F1"|'''Year Established'''
|bgcolor = "#C5D9F1"|1987
|-
|'''Headquarters'''
|USA
|-
|bgcolor = "#C5D9F1"|'''Key People'''
|bgcolor = "#C5D9F1"|CEO: Said S. Hilal
|-
|'''Products & Technology'''
|Specialty Areas:Cardiac/Vascular, Colorectal, GYN, Urology <br>New Products:Epix (Laparoscopic Intrumentation), GelPOINT (Advanced Access Platform), Kii Fios (First EntrySystem)
|-
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent
|-
|'''Geographical revenue breakdown (2010)'''
|USA: $182.70 million (65%)<br>Others: $99.47 million (35%)
|-
|bgcolor = "#C5D9F1"|'''Company Overview'''
|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.
|-
|}
====Bioteque Corp.====
{|border="2" cellspacing="0" cellpadding="4" width="60%" align="center"
|bgcolor = "#376091" colspan = "2"|<font color="#FFFFFF">'''Bioteque Corp.'''</font>
|-
|bgcolor = "#C5D9F1"|'''Revenues'''
|bgcolor = "#C5D9F1"|2010: $27.85 million
|-
|'''Net profit (2010)'''
|$20.89 million
|-
|bgcolor = "#C5D9F1"|'''R&D Investment'''
|bgcolor = "#C5D9F1"|2010: $38.3 million (13% of revenues)
|-
|'''Number of employees'''
|350
|-
|bgcolor = "#C5D9F1"|'''Year Established'''
|bgcolor = "#C5D9F1"|1991
|-
|'''Headquarters'''
|Taiwan
|-
|bgcolor = "#C5D9F1"|'''Key People'''
|bgcolor = "#C5D9F1"|
|-
|'''Products & Technology'''
|<br> NEPHROLOGY, UROLOGY, RADIOLOGY, CARDIOLOGY, RESPIRATORY CARE<br> CRITICAL CARE, IV ADMINISTRATION THERAPY, MOLDING PARTS
|-
|bgcolor = "#C5D9F1"|'''Products in Ureteral Stent'''
|bgcolor = "#C5D9F1"|C-flex ureteral stent, Silicone ureteral stent, Tethered ureteral stent, C-flex ureteral stent, Ureteral stent<br>Silhouette pediatric stent
|-
|'''Geographical revenue breakdown (2010)'''
|NA
|-
|bgcolor = "#C5D9F1"|'''Company Overview'''
|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.
|-
|}
==M&A Due Diligence Process==
== Phase 1: Landscape overview ==
=== Ureteral Stent: Concept ===
|-
|}
==Urinary Problems in men and women==
* 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.
* The prevalence of incontinence in men of all ages is certainly lower than that for women.
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]
==Market Analysis==
* We determined market data to have an idea about the market potential for ureteral stents.
* 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.
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.
* 18% of respondents reported severe UI.
* 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.
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.
<BR>
===Methodology===
[[Image:methodology-ureteral stents.jpg|center|650px]]
===Prevalence rate in US (women)===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font>
|-
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)
|-
|align = "center"|30-39
|align = "center"|28%
|-
|align = "center" bgcolor = "#D3DFEE"|40-49
|align = "center" bgcolor = "#D3DFEE"|41%
|-
|align = "center"|50-59
|align = "center"|48%
|-
|align = "center" bgcolor = "#D3DFEE"|60-69
|align = "center" bgcolor = "#D3DFEE"|51%
|-
|align = "center"|70-79
|align = "center"|55%
|-
|align = "center" bgcolor = "#D3DFEE"|80-90
|align = "center" bgcolor = "#D3DFEE"|54%
|-
|}
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]
===Urinary incontinence severity among different age groups in US women===
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]
===Market potential for ureteral stent in US (women)===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font>
|-
|bgcolor = "#D3DFEE"|1. Age groups<br>
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br>
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)
|-
|30-39
|20128402
|28%
|5635953
|0.043%
|2423
|-
|bgcolor = "#D3DFEE"|40-49
|bgcolor = "#D3DFEE"|22074384
|bgcolor = "#D3DFEE"|41%
|bgcolor = "#D3DFEE"|9050497
|bgcolor = "#D3DFEE"|0.123%
|bgcolor = "#D3DFEE"|11132
|-
|50-59
|20929761
|48%
|10046285
|0.124%
|12457
|-
|bgcolor = "#D3DFEE"|60-69
|bgcolor = "#D3DFEE"|14605565
|bgcolor = "#D3DFEE"|51%
|bgcolor = "#D3DFEE"|7448838
|bgcolor = "#D3DFEE"|0.160%
|bgcolor = "#D3DFEE"|11918
|-
|70-79
|9046207
|55%
|4975414
|0.172%
|8558
|-
|bgcolor = "#D3DFEE"|≥ 80
|bgcolor = "#D3DFEE"|7216598
|bgcolor = "#D3DFEE"|54%
|bgcolor = "#D3DFEE"|3896963
|bgcolor = "#D3DFEE"|0.044%
|bgcolor = "#D3DFEE"|1715
|-
|'''Total'''
|
|
|'''41053950'''
|
|'''48203'''
|-
|}
* Prevalence rate in US women is growing at a CAGR of 1.19%
* Ureteral stent market is growing at a CAGR of 1.47%
<Br>
===Ureteral stent market forecast in US (women)===
[[Image:stent market forecast1.jpg|center|600px]]
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]
===Ureteral stent companies===
Various companies offering ureteral stents are:
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]
====Ureteral stents of various companies====
=====Boston Scientific=====
* Contour VL Variable Length Percuflex Stents<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.
[[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]]]
* Percuflex Stents<Br>
:* High coil strength pigtail shape prevent stent migration
:* Thin wall promotes drainage and patency
:* Multiple, large side ports promote drainage
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]
* Polaris Ultra Ureteral Stent
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal
[[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]]]
=====Cook Group=====
* Bander Ureteral Diversion Stent Set
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.
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]
* C-Flex Double Pigtail Ureteral Stent Set
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.
[[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]]]
* Towers Peripheral Ureteral Stent Set
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.
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]
=====Applied medicals=====
* 7-10 endopyelotomy stent
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.
[[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]]]
=====Redi-Tech Medical Products=====
* Ureteral stents set
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy
:* Multiple, large side ports promote drainage
:* Radiopaque stent markings aid in placement and sizing
[[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]]]
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<br>
=== Clinical Trials ===
====New trials ====
{| {{table}}
| align="center"|'''Title'''
| align="center"|'''Conditions'''
| align="center"|'''Intervention'''
| align="center"|'''Sponsors and Collaborators'''
|-
| [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
|-
| [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
|-
| [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
|-
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University
|-
| [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
|-
| [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
|-
|}
==== Concluded trials ====
{| {{table}}
| align="center" |'''Title'''
| align="center" |'''Abstract'''
| align="center" |'''Enrollment'''
| align="center" |'''Disorder'''
| align="center" |'''Conclusion'''
|-
| 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.
|-
| 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.
|-
| 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.
|}
====Adverse Events====
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''
|-
|align = "center" bgcolor = "#00CCFF"|'''1'''
|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>
|align = "justify"|Stent broke into pieces while removing it from the patients body.
|align = "center"|12/14/2005
|-
|align = "center" bgcolor = "#00CCFF"|'''2'''
|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>
|align = "justify"|Fractured stent seen under Fluroscopy
|align = "center"|10/17/2007
|-
|align = "center" bgcolor = "#00CCFF"|'''3'''
|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>
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.
|align = "center"|10/14/2005
|-
|align = "center" bgcolor = "#00CCFF"|'''4'''
|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>
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.
|align = "center"|1/5/2005
|-
|align = "center" bgcolor = "#00CCFF"|'''5'''
|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>
|align = "justify"|Broken stent observed during x-ray procedure.
|align = "center"|12/12/2003
|-
|}
[[Media: non patent upload.xls|'''Review Articles''']]<br>
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]
=== Products ===
{| {{table}}
| align="center"|'''Boston Scientific Scimed, Inc.'''
| align="center"|'''Cook Urological Incorporated'''
| align="center"|'''OptiMed Global Care'''
|-
| Polaris™ Ultra Ureteral Stent
| Firlit-Kluge Urethral Stent
| Opti-J Ureteral Stent System
|-
| Polaris™ Loop Ureteral Stent
| Koyle Diaper Stent
| Ureteral Stent Sets, ureterorenoscope
|-
| Stretch™ VL Variable Length Flexima® Stents
| Silicone Universal Drainage Stent
| Extra Strong Stent Sets (-Tumor)
|-
|
| Tarkington Urethral Stent Set
| Steerable Ureteral Stent Sets
|-
|
| Zaontz Urethral Stent
| Multilength
|-
|
| Pediatric Urethral C-Stent
|
|-
|}
=== Startup activity ===
* [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.
== Phase 2: Deeper Dive ==
=== Scenario ===
Client wishes to acquire a ureteral stent company.
=== Deal analysis for a target company ===
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]
=== Design History File Review: Review components ===
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0"
|- style="background:lightgrey"
!align = "center" bgcolor = "#00CCFF" width="15%"|Review
!bgcolor = "#00CCFF" width="30%"|Verification
!bgcolor = "#00CCFF" width="40%"|Tasks
!bgcolor = "#00CCFF" width="15%"|Expertise
|-
!rowspan="2"|Design Input
| Design input documents for sufficiency
|
# Access electronic data room.
# Check what documents are provided.
# Compare document list with standard client document list.
# Check whether each specified document has appropriate content.
| rowspan="2"|Quality systems
|-
| Design input documents linked to the product performance specifications
|
# Compare product specifications to design inputs
# Check whether appropriate verifications and validations are performed
# Establish if all specifications are linked to design inputs
|-
!rowspan="3"|Product Performance Specifications (PPS)
| 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
|
# Compare product specifications to design inputs
# Check whether appropriate verifications and validations are performed
# Establish if all specifications are linked to design inputs
| rowspan="3"|Quality systems, CAD
|-
| Appropriate design verification and validations (DV&V) are performed
|
# Show DV&V criteria are based on risk management requirements
|-
| Product performance specifications correspond to appropriate design output documents
|
# Correlate design drawings with the specifications
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range
|-
!rowspan="4"|Risk Management Documents
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation
|
# Check whether documentation is available
# Check whether it adheres to appropriate ISO 14971 standards
# Check whether it adheres to appropriate client standards
|rowspan="4"| Quality systems
|-
| DFMEA links appropriately to the PPS
|
# Verify whether DFMEA and product specifications are correlated
|-
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA
|
# Validate the process and correlate with design inputs
# Validate that sizes used are within range of risk mitigation criteria
|-
| 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
|
# Validate the process protocol
# Validate the inspection procedures used
|-
!rowspan="2"|Design Output Documents
| Completeness of drawings
|
# Check if the CAD diagrams overlay and "fit" perfectly
# Check tolerance stackups
|rowspan="2"| Quality systems, CAD
|-
| Correlate First Article Inspection data to the dimensions on the drawings
|
# Obtain First Article Inspection data
# Check if this data correlates with the completeness of drawings
|-
!rowspan="4"|Manufacturing Documents
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness
|
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures
# Correlate incoming and in-process inspection procedures with the process specifications
| rowspan="4"|Material science, manufacturing engineering, quality systems
|-
| Linkage between component and raw material specifications and appropriate incoming inspection procedures
|
# Identify any missing documentation for inspection procedures
|-
|-
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials
|
# Review supplier audit reports for compliance
|-
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations
|
# Check the entire equipment-related lifecycle
# Check if machine operational qualification was performed
# Check if the measurement equipment was validated
|-
!rowspan="2"|Validation Report
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports
|
# Ensure all reports are available and linked together appropriately
# Identify all inconsistencies across different reports
| rowspan="2"| Quality systems
|-
| Design test methods and related test method validations
|
# Compare test methods used to those in client and ISO standards
# Identify inconsistencies across test methods
|-
|}
=== Sample report ===
==== Performance/Functional Characteristics ====
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0"
|- style="background:lightgrey"
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)
|-
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale
|-
|Provide antimicrobial resistance for up to 2 weeks
|Ureteral Stent User Survey (Document #XXXXX)
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks
|Document #XXXXX
|Test Document #XXXXX
|Report 01-005-06-007
|P
|Report 01-005-06-007
|P
|-
|}
=== Potential DHF Review Outcomes ===
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.
# 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.
# 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.
# Updating drawings based on results from the FAI data.
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.
# 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.
# 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.
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.
# 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.
# 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.
== Phase 3: Post-acquisition integration ==
=== Deadlines ===
'''Goal''': Switch production transparently to new facilities transparently to the distribution system
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0"
|- style="background:lightgrey"
!align = "center" bgcolor = "#00CCFF" |Stage
!align = "center" bgcolor = "#00CCFF" |Tasks
!align = "center" bgcolor = "#00CCFF" |Milestone payment
!align = "center" bgcolor = "#00CCFF" |Date
|-
|Design center integration plan
|
* Gap analysis completion (acquiree)
* Gap analysis completion (acquirer)
|
|September 15, 2008
|-
|Design to manufacturing transfer
|
|
|December 15, 2008
|-
|Equipment transfer
|
|Milestone I payment
|Jan 7, 2009
|-
|Shut production at acquiree facility
|Negotiation for contract extension
|Milestone II payment
|Feb 15, 2009
|-
|Start production in acquirer facility
|
|
|Feb 7, 2009
|-
|Switch to new SKU
|
|
|Feb 15, 2009
|-
|End development of new generation product/s in old facility
|
|
|Feb 7, 2009
|-
|Restart development of new generation product/s post-acquisition
|
|Final milestone payment
|Mar 1, 2009
|-
|}
=== Documents and Ownership ===
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0"
|- style="background:lightgrey"
!align = "center" bgcolor = "#00CCFF" |Document
!align = "center" bgcolor = "#00CCFF" |Owner
!align = "center" bgcolor = "#00CCFF" |Last update date
|-
|Product performance specifications
|Paul Swain
|07/27/2008 08:15:35 PST
|-
|Component specifications
|Kevin Teller
|06/12/2008 12:22:07 PST
|-
|Preclinical test results
|Joanne Krannert
|07/03/2008 14:17:00 PST
|-
|Clinical tests
|Joanne Krannert
|08/01/2008 08:00:55 PST
|-
|}
==Ureteral stents regulatory issues==
The FDA classifies a ureteric stent as follows:
* TITLE 21 - FOOD AND DRUGS
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
* SUBCHAPTER H - MEDICAL DEVICES
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES
* Subpart E - Surgical Devices
* Sec. 876.4620 - Ureteral stent.
* 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]
===Pre-Market Notification===
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.
A 510(k) is required when:
* Introducing a device into commercial distribution (marketing) for the first time.
* Proposed different intended use for a device already in commercial distribution.
* Change or modification of a legally marketed device.
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]
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)
{| border="2" cellspacing="0" cellpadding="4" width="100%"
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center>
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center>
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center>
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center>
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center>
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center>
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center>
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center>
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center>
|-
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center>
| 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>
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center>
| style="background-color:#ccffff;padding:0.079cm;"| Silicone
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center>
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]
|-
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center>
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center>
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center>
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center>
| style="padding:0.079cm;"| <center>Mar 2003</center>
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating
| style="padding:0.079cm;"| Bladder loop design
| style="padding:0.079cm;"| <center>365</center>
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]
|-
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center>
| 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>
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center>
| style="background-color:#ccffff;padding:0.079cm;"| Metal
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center>
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]
|-
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center>
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center>
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center>
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center>
| style="padding:0.079cm;"| <center>Aug 2002</center>
| style="padding:0.079cm;" rowspan="2"| Polyurethane
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent
| style="padding:0.079cm;" rowspan="2"| <center>13</center>
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]
|-
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center>
| style="padding:0.079cm;"| <center>Sep 2005</center>
|-
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center>
| 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>
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center>
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center>
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center>
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]
|}
===Timeline Sheet===
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]
*References
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]
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]
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==Contact Dolcera==
{| style="border:1px solid #AAA; background:#E9E9E9" align="center"
|-
! style="background:lightgrey" | Samir Raiyani
|-
| '''Email''': [mailto:info@dolcera.com info@dolcera.com]
|-
| '''Phone''': +1-650-269-7952
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= Addition =
=== Patent Categorization: Interactive mind map linked to Dolcera Dashboard ===
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard''
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm>
|}
=== Product-Patent-Clinical Trials Mapping ===
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard''
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm>
|}
=== Product to Patent Mapping ===
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''here ''']]to download the excel file.
* Mapped Patent vs Not Mapped Patents
{|border="0" cellspacing="0" cellpadding="4" width="100%"
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]
|-
|}
=== Dolcera Dashboard ===
[[Image:dashboard_features.png|center|750px|]]
'''Dashboard Link'''<br>
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]
|-
|}
*Flash Player is essential to view the Dolcera Dashboard
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']
= Key Artifacts =
* [[Investment Heat Map ]]
* [[Revenue Heat Map ]]
* [[Patent Heat Map]]
* [http://www.dolcera.com/website/demos/dental/main.html Dynamic Patent Dashboard]
* [http://www.dolcera.com/ipmapdemo/stent_model.swf Stent Landscape-Flash]
* [[Company Profile - Flash]]
=Removed Sections=
[[Removed Sections]]
