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Practical Guide - www.devicematters.com

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Information about Practical Guide - www.devicematters.com
Health & Medicine

Published on February 18, 2014

Author: vr4uglobal

Source: slideshare.net

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A Practical Guide presentation created for DeviceMatters (www.devicematters.com) by vr4U Global Presentation Team
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Practical guide to using post-market safety data to target medical device innovation How you can use DeviceMatters data to understand safety issues and market needs for targeted quality improvements April 2012 1

www.devicematters.com Terms of use The materials and information within this presentation are for your information only. Acelly LLC does not practice medicine or provide medical services or advice, and the information in this presentation should not be considered medical advice. The information in this report is provided "as is" and should not be relied upon for any specific purpose. Further, there are limitations inherent in electronic data indexing, and this report might not have captured all relevant data through the coverage date indicated. Acelly LLC, Qmed (a UBM brand) and its affiliates do not make, and hereby disclaim, any representation or warranty as to this presentation's accuracy, completeness, merchantability, or fitness for a particular purpose. Acelly LLC, Qmed (a UBM brand) and its affiliates shall not be liable to you for any losses suffered (including, without limitation, damages for any consequential loss or loss of business opportunities or projects, or loss of profits), whether in contract, tort or otherwise from your use of this presentation or its contents, or from any action or omission taken as a result of using this report or its contents. 2

www.devicematters.com Quality is an increasing concern within the public’s eye and we have been lacking objective metrics for post-market safety Increasing public concern around medical device safety  High profile recent recalls – Hip implants: Metal-on-metal hip implant recalls (Depuy ASR hip class 2 recalls 2010/2011) – Pacemaker leads: Lead fracture & insulation failure (Medtronic Fidelis lead class 1 recall 2007, St. Jude Riata lead class 1 recall 2012) – Vaginal mesh: FDA Public Health Notification* in 2008  Increased publicity – count of media mentions of “medical device safety” has grown significantly in recent years (see examples on right)  Lack of objective metrics of post-market safety makes it difficult to discuss clean facts; we lack good quality and broadly accepted industrywide data to monitor post-market device safety * FDA Publich Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence 3

www.devicematters.com With good post-market quality metrics, we could achieve a lot Spot quality trends  Early alert for potential quality and safety issues  Identify opportunities for safer next generation solutions Identify quality gaps  Learn when & why things go wrong post-market to design an improved next generation product  Help strategy teams identify patient needs Track and  Drive product strategy to help differentiate compare safety products based on post-market quality & safety performance  Refine marketing messages for existing products Understand risk factors  Refine target populations and corresponding marketing messages based on typical device failure modes 4

www.devicematters.com DeviceMatters has chosen to look at adverse event data to help decipher post-market quality performance DeviceMatters Solution  Why we have chosen to look at adverse events as the metric for post-market quality performance? Pros/Cons & Biases  What are the pros/cons and biases inherent in adverse event data and how can our data help? How to spot trends  How can DeviceMatters data help you spot quality trends and potential safety issues? How to drive innovation  How can quality information drive innovation? 5

www.devicematters.com Quiz How many adverse event reports do you believe were filed for medical devices in 2011? A. 50,000 C. 100,000 B. 200,000 D. 400,000 6

www.devicematters.com Quiz How many adverse event reports do you believe were filed for medical devices in 2011? A. 50,000 C. 100,000 B. 200,000 D. 400,000 7

www.devicematters.com Adverse event reporting has been increasing rapidly … Why are adverse events increasing so rapidly? Drivers of the rapid growth in adverse events Adverse Event Reports Submitted to the FDA  Improved reporting due to greater awareness and compliance 4,07,308 +28% p.a. 3,01,720  Increased device complexity (e.g., greater use of software) 2,40,352  Increased use of devices by high-risk populations (e.g., the elderly) 1,93,355 2008  Device prevalence that is growing much faster than the 6-9% industry growth rate due to increasing use of implants “for life” 2009 2010 2011 Note: Device safety changes for the same class of devices used in the same circumstances cannot be deduced from the data given above trends 8

www.devicematters.com … yet, little attention has been paid to what it means or how it could be used Issues with current adverse event database  Dataset is difficult to manage (millions of data points require specialized database skills just to load the data) DeviceMatters has cleaned up the adverse  “Dirty” data with prevalent company and product misspellings, and misclassifications event data & provides  “Keys” are not always used or are sometimes overlapping & confusing patient and device analytics on unique outcomes  Multiple reports are sometimes recorded for the same event 9

www.devicematters.com DeviceMatters has cleaned up the adverse event data & provides analytics on unique patient and device outcomes Adverse Event Patient Outcomes Serious Adverse Event Patient Outcomes (Hospitalization or worse) 54,816 343,094 +30% p.a. +45% p.a. 155,838 18,028 2008 2009 2010 2011 Note: Increased reporting rates does not necessarily mean less safe devices. 2008 2009 2010 2011 10

www.devicematters.com The key question remains: Is adverse event data reliable enough to make product-critical decisions? Data characteristics Number of product codes Number of product codes by number of adverse event patient outcomes in 2011  Data is plenty for a large number of product codes 110  Biases exist (as for most data), but provides unique insights with smart & cautious interpretations – Product bias – Limit comparisons to similar devices 78 69 59 35 50-100 101-200 201-500 501-1000 1001+ Range of adverse event patient outcomes reported in 2011 – Manufacturer bias – More emphasis should be given to serious adverse events & trends  Normalization factor overall is lacking – For individual areas where product sales or numbers are known, the data can be normalized  Historically, we have been able to “spot” major issues before major recalls 11

www.devicematters.com What We Knew Before: Medtronic Fidelis Leads Could we have seen there was a potential issue with Medtronic leads earlier? Event history Adverse event patient outcomes All Medtronic pacemaker and defibrillator pulse generators & leads 4703 2840 1646 2002 1521 2003  Leads approved as 510k and started selling in Sept 2004  FDA was alerted in February of 2007 (2.5 years post launch) that there were some issues 1774  FDA/Medtronic issued a class I recall 8 months later (10/17/2007) 2005  268,000 leads sold, an estimated 2.3% of leads fractured leading to ~6160 lead fractures and at least 5 deaths 1294 2004 2006 Y-o-y growth: 37% 60% 2007 66% Note: Medtronic’s CRDM sales growth in the mean time for Medtronic was 9%, 13%, -6% 12

www.devicematters.com What We Knew Before: DePuy Metal-on-Metal Hip Implants Could we have seen there was a potential issue with DePuy hip implants? Event history Adverse event patient outcomes All J&J hip implants 5,256  Aug 2005 first Depuy ASR cup system approved  Mid-2009 FDA notifies DePuy of issues with metal-on-metal hip early failures and sends a non-approvable letter to a J&J 510k application 2,576 1,805 1,053 218 1,348 1,639  August 2010, DePuy ASR metal-onmetal hip recall was issued (1/8 found to fail within five years, >93,000 of the ASR components implanted) 269 2003 2004 2005 2006 2007 2008 2009 2010 Note: Depuy’s hip implant sales have been noted to show strong sales prior to 2010 13

www.devicematters.com Could management or quality have spotted these trends earlier based on DeviceMatters analytics? J&J adverse event patient outcome trend 2008-09 adverse event growth & drivers of growth 55414 +47% ` 33726 27651 19854 18874 2007 2008 2009 2010 2011 Quick drill-down yields 9 product codes responsible for 8,646 out of 8,777* of the increase  Clinical Chemistry & Toxicology > Clinical Chemistry > Sugar Test Systems > NBW  Gastroenterology & Urology > GU Diagnostic Devices > Other Scopes > GCJ  Orthopedics > Orthopedic implants > Partial & Complete Hip Implants > KWA, KWB, LPH  General & Plastic Surgery > Surgical Tools > – Staples, Surgical Tapes, & Access. > FZP, GDW – Powered Surgical Instruments > GEI, LFL Code Name NBW GCJ KWB KWA LPH FZP GDW GEI LFL Over the Counter Blood Glucose Test Systems General & Plastic Surgery Laparoscopes Metal Cemented Acetabular Hemi- Hip Prostheses Metal Uncemented Acetabular Component Semi-Constrained Hip Pros. Metal/Polymer Porous Uncemented Semi-Constrained Hip Prostheses Implantable Clips Implantable Staples Electrosurgical Cutting & Coagulation & Accessories Ultrasonic Surgical Instruments * Some product codes showed a decline during this period. Abs. growth 4307 269 229 146 317 817 1117 176 1268 % growth 148% 80% 83% 54% 90% 121% 106% 35% 111% 14

www.devicematters.com Could management or quality have spotted these trends even earlier based on DeviceMatters analytics? J&J adverse event patient outcome trend 2007-08 adverse event growth & drivers of growth 55414 ` 33726 -5% 27651 19854 18874 2007 2008 2009 2010 Using the same threshold for cutoff as on the earlier slide, 7 product codes added 2,526 adverse event patient outcome reports between 2007 and 2008 2011 Code Name NBW LTI KWA NIM MLR NJL HET Over the Counter Blood Glucose Test Systems Intragastric Implants for Morbid Obesity Metal Uncemented Acetabular Component Semi-Constrained Hip Pros. Carotid Stents Chemical Sterilizers Metal/Polymer Mobile Bearing Semi-Constrained Patellofemorotibial Knee Pros. Gynecologic Laparoscopes & Accessories Abs. growth 1471 205 198 196 159 153 144 % growth 102% 1708% 268% 700% 130% 62% 127% 15

www.devicematters.com Assuming metal-on-metal hip implants did emerge on top, how do we know if it is a concern or artifact? What does the data for KWA and KWB look like exactly? Adverse event patient outcomes (KWA+KWB, J&J.) 2,381 Specific failure reasons reported for KWA and KWB 68% 69% 325 549 74 251 277 272 2007 2008 924 2,031 506 418 2009 2010 Is the increase real or artifact?  Was there increased media attention (e.g., recalls)?  Is it a combination of sales trends and expected timing of implant failure? What is the root cause of adverse events?  Is it a design, manufacturing, procedure, etc impact? How broad is the impact?  Is it a product code-wide issue?  Is it specific to a specific model?  Is it specific to a specific batch? Implant removed Metal shedding debris (emerged later) 3. Loose, dislodged, dislocated, mallocated 4. 350 1. 2. 158% Loss of osteointegration (emerged later) 5. Naturally worn What is the call for action?  Should we recall? Stop selling?  Notify users about the potential risk?  Acceptable risk. Queue up improvements or do nothing How can this drive innovation?  Can the design/material/etc be tweaked to achieve higher safety?  Is there a radically new way to avoid the type of problem seen? 16

www.devicematters.com With good post-market quality metrics, we could achieve a lot Spot quality trends  Early alert for potential quality and safety issues  Identify opportunities for safer next generation solutions Identify quality gaps  Learn when & why things go wrong post-market to design an improved next generation product  Help strategy teams identify patient needs Track and  Drive product strategy to help differentiate compare safety products based on post-market quality & safety performance  Refine marketing messages for existing products Understand risk factors  Refine target populations and corresponding marketing messages based on typical device failure modes 17

www.devicematters.com How do I find and access this information? Visit www.devicematters.com Find the device category, product code or manufacturer you want to learn about Sign in and download the Basic Report FREE to learn more and find out what the Comprehensive Report offers Download or request the Comprehensive Report 18

www.devicematters.com Contact Us Clarimed & DeviceMatters Qmed, a UBM Canon brand www.devicematters.com www.qmed.com http://www.qmed.com/contact-us TERMS OF USE The materials and information within this presentation are for your information only. Acelly LLC does not practice medicine or provide medical services or advice, and the information in this presentation should not be considered medical advice. The information in this report is provided "as is" and should not be relied upon for any specific purpose. Further, there are limitations inherent in electronic data indexing, and this report might not have captured all relevant data through the coverage date indicated. Acelly LLC, Qmed (a UBM brand) and its affiliates do not make, and hereby disclaim, any representation or warranty as to this presentation's accuracy, completeness, merchantability, or fitness for a particular purpose. Acelly LLC, Qmed (a UBM brand) and its affiliates shall not be liable to you for any losses suffered (including, without limitation, damages for any consequential loss or loss of business opportunities or projects, or loss of profits), whether in contract, tort or otherwise from your use of this presentation or its contents, or from any action or omission taken as a result of using this report or its contents. 19

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