== Phase 1: Landscape overview ===== '''This is a landscape report on the Ureteral Stent: Concept ===An antimicrobial ureteral stentmarket, which inhibits encrustation including key company profiles, products, patents and bacterial colonization while maintaining patient comfortrelevant clinical trials.'''
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.
==Background==
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]
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 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.
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.
* Bacterial colonization: antimicrobial activity for up to two weeks.
* Patient Comfort: stent has a low coefficient of fiiction friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.
=== Background === Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder'''[[more on background. 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 inconjunction 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. ]]'''
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:* Treatment of ureteral or kidney stones* Ureteral trauma or stricture* Genitourinary reconstructive surgery* Hydronephrosis during pregnancy* Obstruction due to malignancy* Retroperitoneal fibrosis=Market Overview=
The need Market for ureteral stents range from a few days to several monthsstent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. For patients with serious urological problems, ureteral stent maintenance may become a lifeOther uses of Ureteral Stent include Post-long necessity. Unfortunatelysurgical swelling/infection of uterus, there are many problems associated with using ureteral stentsActive kidney infection etc.
'''[[more on market overview...]]''' === Ureteric stenting difficulties ==Interactive Mind Map=* To access the Dashboard you have to signup. You can do so by clicking [[Imagehttps:Ureteral stent//www.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]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="20" cellpadding="4" width="50100%"|align = "center" bgcolor = "#00CCFF"|<font color="#993366"mm>'''Common'''</font>[[Ureteral_Stent_Patent_Categorization.mm|align = "center" bgcolor = "#00CCFF"flash|<font color="#993366">'''Rare'''Patent Categorization|600pt]]</fontmm>
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* Trigonal irritation
* Haematuria
* Fever
* Infection
* Tissue inflammation
* Encrustation
* Biofilm formation
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* Obstruction
* Kinking
* Ureteric rupture
* Ureteric perforation
* Stent misplacement
* Stent migration
* Stent misfit
* Stent forgotten
* Tissue hyperplasia
|}
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. * 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. * 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.=Patents=
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).
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer.
* Percuflex is a proprietary olefinic block copolymer.
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==Patent Search Strategy==surface, smoothness of the surface and coefficient of friction[[Image:Patent Search Strategy.jpg|700px]]
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
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.
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
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.
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. == Dolcera Dashboard ==
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
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.
Typically, manufacturers advise periodic stent evaluation'''Dashboard Link'''<br>{|border="2" cellspacing="0" cellpadding="4" width="100%"|'''[https://www. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature)dolcera. However, stents that are intended for longcom/auth/dashboard/dashboard.php?workfile_id=1008 Ureteral Stent -term use are usually changed at regular intervals, as frequently as every 3 monthsDashboard] '''|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''']
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. = Clinical Trials =
==New trials == Encrustation ====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.
The encrusted deposits can harbor bacterial biofilms{|border "1" style="border-spacing:0;"| style="background-color:#4f81bd;padding:0. In addition079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center>|-| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center>| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, they can render the biomaterial brittle which causes fracture inUreteral Obstruction| style="background-situcolor:#dce6f1;padding:0.079cm;"| Ureteral Stent| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, a serious problem especially associated with the use Boston Scientific Corporation |-| style="padding:0.079cm;"| <center>2</center>| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of polyethylene and polyurethane ureteral stents (although silicone stents have also beenUrethral Stricture]reported | style="padding:0.079cm;"| Urethral Stricture| style="padding:0.079cm;"| Memokath stenting| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group |-| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center>| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to fracture)Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]| style="background-color:#dce6f1;padding:0. 079cm;"| Kidney Stones| style="background-color:#dce6f1;padding:0.079cm;"| N\A| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine |-| style="padding:0.079cm;"| <center>4</center>| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent fragments can migrate to Length and Patient Symptoms]| style="padding:0.079cm;"| Kidney Stones| style="padding:0.079cm;"| Ureteral Stent| style="padding:0.079cm;"| Emory University |-| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center>| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the bladder or renal pelvis with serious repercussionsMemokath Ureteral Stent]| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group |-| style="padding:0.079cm;"| <center>6</center>| style="padding:0.079cm;"| [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)]| style="padding:0.079cm;"| Kidney Disease| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent| style="padding:0.079cm;"| Rabin Medical Center |}
Surface science techniques were used to study three == Concluded trials =={| {{table}}| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center>|-| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center>| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent types after use in the treatment of spinally injured patientswith detrusor-sphincter dyssynergia. The stent type|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, duration although secondary bladder neck obstruction is a frequent problem.|-| style="padding:0.079cm;"| <center>2</center>| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of insertion Patient Perspectives Using Quality-of-Life Survey and age Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or sex a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the patient did not correlate significantly QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with the amount 'JJ' stents have significantly more irritative urinary symptoms and a high chance of encrustation local discomfort than patients with nephrostomy tubes (Wollin et al., 1998PCN). However, it has been suggested that factors which affect based on the amount of encrustation include EuroQol analysis, there is no significant difference in the composition gross impact on the health-related QoL or the urine, the type utility between these groups indicating no patient preference for either modality of invading treatment.|-| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center>| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and colonizing bacteria and the structure and surface properties health care expenditure in renal transplant recipients: results of the biomaterial used (Gorman 1995)a prospective, randomized clinical trial. || style="background-color:#dce6f1;padding:0.079cm;"|A low surface energy surface seems randomized, prospective trial to resist encrustation compared compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a high surface energy surface (Denstedt et alureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction.However, 1998)there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.|}
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).
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
surfaces and hydrogel coatings have been attempted.
A hydrogel==Pre-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.Market Notification==
====Obstruction====Obstruction of urine flow and urinary tract sepsis can result in continued growth Some of the biofilm. Colonization of devices implanted companies active in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult totreat and device removal is usually necessary. The biofilm has been found to impede the diffusion field 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.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 been represented in the "conditioning film" adsorbed or alter its receptivity tobacterial biofilmstable below.
{| border="2" cellspacing="0" cellpadding="4" width=Infection"100%"| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center>The predictive value | style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stentsApproval '''</font></center>| style="background-color:#4f81bd;padding:0. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center>| style="background-color:#4f81bd;padding:0., 1999079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days)'''</font></center>|-| style="background-color:#dce6f1;padding:0. Patients with sterile urine culture079cm;"| <center>'''1'''</center>may benefit from prophylactic antibiotics| style="background-color:#dce6f1; however, the authors contended that the antibiotics must work against grampadding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center>| style="background-negative uropathogens and gramcolor:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]| style="background-positive bacteria including enterococcicolor:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center>It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful | style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center>| style="background-color:#dce6f1;padding:0.079cm;"| Silicone| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with ureteral stent implantmonofilament suture loop| style="background-color:#dce6f1;padding:0. However079cm;"| <center>365</center>|-| style="padding:0.079cm;"| <center>'''2'''</center>| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/, antibiotics do not seem to prevent stent colonization,/method/DevHome/navRelId/1000. Denstedt et al1003/seo. serve Boston Scientific]</center>| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1(1998) have found that ciprofloxacin, <center>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 a HydroPlus Coating| style="padding:0.079cm;"| Bladder loop design| style="padding:0.079cm;"| <center>365</center>|-| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3 day burst every '''</center>| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center>| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center>| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center>| style="background-color:#dce6f1;padding:0.079cm;"| Metal| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center>|-| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center>weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance| style="padding:0. 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 079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center>| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA510(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;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center>| style="padding:0.079cm;"| <center>Sep 2005</center>
|-| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center>| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center>| style= The market need "background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[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 <center>Memokath 051</center>]]]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| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history. According to Merrill Lynch, ureteral stents represent an $80 MMaspx CE Mark]</center>US market| style="background-color:#dce6f1;padding:0. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player079cm;"| <center>1995</center>| style="background-color:#dce6f1;padding:0. There are a number of other small contenders079cm;"| Nickel-titanium shape memory alloy| style="background-color:#dce6f1;padding:0. 079cm;"| Double fluted ended spiral stent| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center>|}
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). =Products=
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 procedureFDA 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. According to survey results reported by Hollowell, et al876. (2000), there is a significant difference in opinion concerning the use of stents with ESWL4620 - Ureteral stent. * Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]
The number of ureteral stents used in patients with stones {|border="2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice" cellspacing="0" cellpadding="4" width="100%"|align = "center" bgcolor = "#4f81bd"|'''Sr. Of No.'''|align = "center" bgcolor = "#4f81bd"|'''Company'''|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''|align = "center" bgcolor = "#4f81bd"|'''Approval'''|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''|align = "center" bgcolor = "#4f81bd"|'''Material'''|bgcolor = "#4f81bd"|'''Technology'''|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''|align = "center" bgcolor = "#4f81bd"|'''Image'''|-|align = "center" bgcolor = "#dce6f1"|'''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'''|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.3%allium-medical.com/?categoryId=64772 Allium, 57Israel]</u></font>|align = "center" bgcolor = "#dce6f1"|[http://www.1 % and 87allium-medical.1 %, respectivelycom/?categoryId=64772 URS]|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5com/doc/1G1-1 0 mm165990208.html CE Mark]</font>|align = "center" bgcolor = "#dce6f1"|Jul, 2007|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer|bgcolor = "#dce6f1"|Self-expanding stent|align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]
|-|align ="center" rowspan ="2"|'''2'''|align = Intellectual property ="center" rowspan ="2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font>|align ="center" rowspan ="2"|[http://www.google.com/url?sa=t&source= Search strategy 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]* Databases searched|align = "center"|<font color="#0000FF">[http: US//www.pnnmedical.com/about-G, USpnn-A, EPmedical/company-A, EP-B, WO, JP, DE, GB, FRhistory.aspx CE Mark]</font>* Search scope: Title, Abstract or Claims|align = "center"|1995* Years: 1981|rowspan = "2"|Nickel-July 2008titanium shape memory alloy* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (|rowspan = "2"|Double fluted ended spiral stent*) AND (*microb* OR *bacter*)* Results|align = "center" rowspan = "2"|240|rowspan = "2"|[[Image: '''177 patents (82 unique patent families)'''Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]
==== Sample patents ====
{|border="2" cellspacing="0" cellpadding="4" width="95%"
!align = "center" bgcolor = "#00CCFF"|Patent
!bgcolor = "#00CCFF"|Assignee
!bgcolor = "#00CCFF"|Title
!bgcolor = "#00CCFF"|Abstract
|-
!|align = "center"|<font color="#0000FF"><u>[http://patftwww.usptozapconnect.govcom/netacgiproducts/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnumindex.htm&r=1&f=G&l=50&s1=6468649cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.PN.&OS=PNhtml FDA Listing]</6468649&RS=PNu></6468649 US6468649 B1]font>| SCIMED LIFE SYSTEMS INCalign = "center"| Antimicrobial adhesion surface| 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 100Mar, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.2004
|-
!|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://patftwww.usptofossamedical.govcom/netacginews.htm Fossa Medical]</nph-Parser?Sect1u></font>|align =PTO1&Sect2"center" bgcolor =HITOFF&d"#dce6f1" rowspan =PALL&p=1&u=%2Fnetahtml%2Fsrchnum"2"|[http://dolcera.htm&rcom/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]|align =1&f"center" bgcolor =G&l=50&s1"#dce6f1"|<font color=5554147"#0000FF"><u>[http://www.PNfossamedical.&OS=PN/5554147&RS=PNcom/5554147 US5554147 Anews.htm CE Mark]</u></font>| CApHCOalign = "center" bgcolor = "#dce6f1"|Sep, Inc. 2005| Compositions and devices for controlled release of active ingredients bgcolor = "#dce6f1" rowspan = "2"|Polyurethane| 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 timebgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper. png|thumb|center|100px|<center>Stone Sweeper</center>]]
|-
!|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://appft1www.usptofossamedical.govcom/netacginews.htm FDA 510(k)]</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]font>| SCIMED LIFE SYSTEMS INCalign = "center" bgcolor = "#dce6f1"|Implantable or insertable medical device resistant to microbial growth and biofilm formation Aug, 2002| 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
|-
|}align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"|Nov, 2003|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki>|align = "center" bgcolor = "#dce6f1" rowspan = "2"| |align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]
== Phase 2: Deeper Dive - Design History File Review ==
=== Scenario ===
Client wishes to acquire a ureteral stent company. Dolcera provides the following Design History File (DHF) review.
{|border="2" cellspacing="0" cellpadding="4" width="95%"
!align = "center" bgcolor = "#00CCFF" width="15%"|Review
!bgcolor = "#00CCFF" width="30%"|Activity
!bgcolor = "#00CCFF" width="40%"|Tasks
!bgcolor = "#00CCFF" width="15%"|Expertise
|-
!rowspan|align ="2center" bgcolor = "#dce6f1"|Design Input| Verify if design input documents are sufficient| <font color="# Access electronic data room0000FF"><u>[http://www.# Check what documents are providedfossamedical.# Compare document list with standard client document listcom/news.htm CE Mark]</u></font>|align = "center" bgcolor = "# Check whether each specified document has appropriate content.dce6f1"| Biomedical engineerSep, 2005
|-
| Verify if these input documents have been adequately linked to the product performance specificationsalign = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]| align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font>| Biomedical engineeralign = "center" bgcolor = "#dce6f1"|Jun, Mechanical engineer2002|bgcolor = "#dce6f1"|Polyurethane|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| N/A
|-
!|align = "center" rowspan="37"|Product Performance Specifications '''4'''|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font>|align = "center"|<font color="#0000FF"><u>Contour</u></font>|align = "center"| |align = "center"| |Percuflex - proprietary polyolefin copolymer; Hydroplus coating|Fixed and variable length; Tapered tip|align = "center"|365|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] |-|align = "center"|<font color="#0000FF"><u>Percuflex</u></font>|align = "center"| |align = "center"||align = "center"| Percuflex|Pigtail|align = "center"|365|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] |-|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(PPSk) ]</u></font>| Verify that align = "center"|Jan, 2001|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.|Double pigtail|align = "center"|365|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] |-|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font>|align = "center"|Mar, 2003|Dual Durometer Percuflex with HydroPlus Coating|Bladder loop design inputs correlate adequately to the specifications |align = "center"|365|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] |-|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font>|align = "center"| |align = "center"| |Percuflex material and that appropriate design verification Hydroplus coating|Endopyelotomy stent|align = "center"|Post-procedure healing|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] |-|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font>|align = "center"| |align = "center"| |Hydroplus Coating|Variable length coil on distal and validations proximal ends|align = "center"|90|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] |-|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]|align = "center"| |align = "center"| |Percuflex - proprietary polyolefin copolymer|Ketorolac trimethamine loaded stent|align = "center"||align = "center"| N/A|-|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(DVk)]</u></font>|align = "center" bgcolor = "#dce6f1"|May, 2007|bgcolor = "#dce6f1"|Metal|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|365|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] |-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|AQ® Hydrophilic Coating|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning |align = "center" bgcolor = "#dce6f1"|180|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] |-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|AQ® Hydrophilic Coating|bgcolor = "#dce6f1"|Double pigtail|align = "center" bgcolor = "#dce6f1"|365|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] |-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Double Pigtail|align = "center" bgcolor = "#dce6f1"|180|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] |-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent|align = "center" bgcolor = "#dce6f1"|60|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] |-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font>|align = "center" bgcolor = "#dce6f1"|Dec, 2007|bgcolor = "#dce6f1"|Heparin-bonded stent|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"||-|align = "center"|'''6'''|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font>|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font>|align = "center"|Jan, 2010|Hydrogel|Differentially larger end (no pigtail)|align = "center"|30|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] |-|align = "center" bgcolor = "#dce6f1"|'''7'''|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&Vseries=4 Bioteque Corp.]</font>|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) are performed]</u></font>|align = "center" bgcolor = "#dce6f1"|Apr, 2010|bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|30|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] | -| Biomedical engineeralign = "center" rowspan = "4"|'''8'''|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font>|align = "center"|Jul, 2001|Polyester mesh|Double-pigtail|align = "center"| |align = "center"| N/A|-|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font>|align = "center"| |align = "center"| |Coil-reinforced; SL-6® hydrophilic coating|Patency Device|align = "center"| |align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] |-|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font>|align = "center"|Jun, 1999|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating|Unique wall construction and enlarged drainage holes |align = "center"| |align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] |-|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font>|align = "center"| |align = "center"| |Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating|Dual Diameter stent|align = "center"| |align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] |-|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"|Dec, 2004|bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop|align = "center" bgcolor = "#dce6f1"|365|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] |-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"|Jan, 2003|bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"|Attached with suture for ease of removal|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]|-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Silicone/tantalum|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]|-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"|Three dimensional design|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]|-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"|Dec, 1998|bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating |align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]|-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"|Apr, 1991|bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]|-|align = "center" rowspan = "4"|'''10'''|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font>|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font>|align = "center"|Oct, 1998|Silicone|Double coating for easy maneuverability as well as flexibility|align = "center"| |align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font>|align = "center"|Oct, 1998|Silicone|Extreme flexibility|align = "center"| |align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font>|align = "center"| |align = "center"| |Hard or soft Polyurethane|Designed for short-term use|align = "center"| 90|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font>|align = "center"|Oct, 2002|Silicone|''Pyatiprofilnaya'' technology |align = "center"| |align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]|-|align = "center" bgcolor = "#dce6f1"|'''11'''|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"|Jul, 1999|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating|bgcolor = "#dce6f1"| Directable and detachable|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]
|-
| Also verify if DValign = "center" rowspan = "9"|'''12'''|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&V criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plansmaincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font>|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font>|align = "center"|Dec, 1986
|
| Biomedical engineer, Mechanical engineerClassic Closed Tip|align = "center"| |align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]
|-
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font>
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font>
|align = "center"|Mar, 1996
|Tecoflex® construction
|Balanced-curled double pigtail design
|align = "center"|
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]
|-
| align = "center"|<font color="# Verify that 0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product performance specifications correspond &pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font>|align = "center"|Apr, 1988|Silicone|Double-J closed-tip |align = "center"| |align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font>|align = "center"| |align = "center"| |Tecoflex® |Grooved design|align = "center"| |align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font>|align = "center"|Nov, 1991|Tecoflex®|“Rememberance” of shape with a chemically bonded wettable solution |align = "center"| |align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font>|align = "center"| |align = "center"| |Tecoflex®|Two durometers with helical kidney curls|align = "center"| |align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font>|align = "center"|Mar, 1996|Tecoflex®|Accomodate ureteral lengths from 22cm to appropriate 28cm|align = "center"| |align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font>|align = "center"| |align = "center"| |Tecoflex®|Dual-durometer design output documentsand exclusive soft bladder helix |align = "center"| |align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font>|align = "center"| |align = "center"| |Silicone|Classic Double J with open tip|align = "center"| |align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]|-|align = "center" bgcolor = "#dce6f1"|'''13'''|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]|bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating|bgcolor = "#dce6f1"|Double loop stent|align = "center" bgcolor = "#dce6f1"|Short-term and long-term|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]|-|align = "center"|'''14'''|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index. cfm?db=pmn&id=K864225 FDA 510(k)]|align = "center"|Jan, 1987|Nitinol|Self-expanding stent
|
| Biomedical engineer, Mechanical engineeralign = "center"|N/A
|-
|}
=Product to Clinical Trial Mapping== Review: Design Input ===# Verify if design input documents are sufficient.# Verify if these input documents have been adequately linked to the product performance specifications.
=== Review: Product Performance Specifications (PPS) =Clinical Timeline Visualization ==# Verify that design inputs correlate adequately to the specifications and that appropriate design verification and validations (DV&V) are performed. # Also verify if DV&V criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans. # Verify that product performance specifications correspond to appropriate design output documents[[Image:Timeline.jpg]]
=== Review[[Media: Risk Management documents ===# Review Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation. # Verify that DFMEA links appropriately to the PPS. # Also verify that appropriate DV&V reports and design output documents are reference correctly as risk mitigation activities in the DFMEA. # Similarly verify that PFMEA links appropriately to the process validation protocol acceptance criteria and that in-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEAUreteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]
=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|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.= Review= Mapped Patent vs Not Mapped Patents =={|border="0" cellspacing="0" cellpadding="4" width="100%"|[[Image: Design Output documents CRB_Pat.png|center|500px|thumb|'''C R Bard''']]|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]|-|} =Patent-Product-Clinical Trial 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> |} =Insights= {|border="2" cellspacing="0" cellpadding="4" width="100%"|bgcolor = "# Drawings would be reviewed 538ED5"|<font size = "4">''' '''</font>|bgcolor = "#538ED5"|<font size = "4">''' '''</font>|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font>|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font>|-|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''|'''Portfolio'''|8 Products|6 Products|-|'''Material'''|Percuflex - Biocompatible Polymer|Silicone|-|'''Coating'''|Hydroplus|Licensed from pHreecoat|-|'''Shape'''|Pigtailed and More|Figure 4 and more|-|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''|'''Current Trials'''|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)|None|-|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''|'''Coating'''|Therapeutic / Medicinal coatings <br>Magnetic nano particles for completeness. MRI Imaging <br>Lubricious coatings helping easy insertion|Therapeutic coatings|-|'''Structure'''|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs|Expandable stents for reducing discomfort|-|'''Material'''|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness|Biodegradable polymers<br>Shape memory alloys<br>General polymer based|-|} == Inference == {|border="2" cellspacing="0" cellpadding="4" width="82%"|bgcolor = "# Help perform 538ED5"|<font size = "4">'''Boston Scientific'''</font>|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font>|-|Relatively late entrant with patents filed post mid 90s|Early mover with patents filed in mid 80s|-|Increased patent activity since 2000|Patent activity never gained traction|-|Large number of patents yet to be "productized"|Few patents yet to be "productized"|-|Some products undergoing clinical trails|No products undergoing clinical trails|-|Diverse range of products with variation in material <br>and structure|Small product portfolio|-|Seem to be strengthening they market position|Seem to be moving focus away from Ureteral stents market|-|} = Competitive Landscape ===Major Players==*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. [[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]] ==IP Activity==*Patenting activity has been high growth rate during the period 2001 to 2005 with a First Article Inspection peak no. of patents in order year 2005, followed by saturation during the period 2006 to verify 2008 and after that a gradual declination upto year 2010 in the dimensions on ureteral stent research area.[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the drawingsyears]] ==Sales == Total Sales in 2010 - 4.04 Billion USD {|border="2" cellspacing="0" cellpadding="4" width="100%"|bgcolor = "#4f81bd"|'''Company'''|bgcolor = "#4f81bd"|'''Total Sales in 2010'''|bgcolor = "#4f81bd"|'''Urological sales'''|bgcolor = "#4f81bd"|'''Percentage share'''|bgcolor = "#4f81bd"|'''Product portfolio'''|-|bgcolor = "#4f81bd"|'''Boston Scientific'''|7800|661|8.48|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font>|-|bgcolor = "#4f81bd"|'''CR BARD'''|2700|702|26.00|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font>|-|bgcolor = "#4f81bd"|'''Cook Medical'''|1700|<nowiki>-</nowiki>|<nowiki>-</nowiki>|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font>|-|bgcolor = "#4f81bd"|'''Medline'''|4040|<nowiki>-</nowiki>|<nowiki>-</nowiki>|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font>|-|} [[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]] =<span style="color:#C41E3A">Like this report?</span>=<p align="center"> '''This is only a sample report with brief analysis''' <br>'''Dolcera can provide a comprehensive report customized to your needs'''</p>{|border="2" cellspacing="0" cellpadding="4" align="center" "|style="background:lightgrey" align = "center" colspan = "3"|'''[mailto:info@dolcera.com <span style="color:#0047AB">Buy the customized report from Dolcera</span>]''' |-| align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services Patent Analytics Services]|align = "center"| [http://www.dolcera.com/website_prod/services/business-research-services Market Research Services]|align = "center"| [http://www.dolcera.com/website_prod/tools/patent-dashboard Purchase Patent Dashboard]|-|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Landscape Services]|align = "center"| [http://www.dolcera.com/website_prod/research-processes Dolcera Processes]|align = "center"| [http://www.dolcera.com/website_prod/industries Industry Focus]|-|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Search Services]|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/alerts-and-updates Patent Alerting Services]|align = "center"| [http://www.dolcera.com/website_prod/tools Dolcera Tools]|-|}<br>
=== Review: Manufacturing documents ===
# Review manufacturing procedures, component specifications, raw material specifications, in-coming and in-process inspection procedures for completeness.
# Review linkage between component and raw material specifications and appropriate in-coming inspection procedures.
# Ensure inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials.
# Review of calibration records and preventive maintenance records would be also performed. This would also include a review of the in-process / incoming inspection test methods and related test method validations.
=== Validation Report Review ===
# DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports would be reviewed.
# This would also include a review of the design test methods and related test method validations.
=[[Backup]]== 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 for eg. 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.
