Obtaining Clinical/Regulatory Approval for Medical Devices in a Global Market

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Mike Winegar, Vice President of Regulatory Affairs for Medpace Medical Device presented at the Medtech Investing conference in May 2012.
His session was titled: Obtaining Regulatory Approvals for Medical Devices in a Global Market. Here is a brief outline of his talk.
For the emerging or start-up medical device company, corporate objectives and budgets often revolve around clinical trials. Very often, the success or failure of the company mirrors the success or failure of those early clinical trials. In this session, Mike Winegar will be discussing:
• How the strategic design, geography, and execution of early-stage clinical trials can have a tremendous impact - positive or negative - on future product and company success
• Designing a trial to meet financing, regulatory, and/or marketing objectives
• The advantages and pitfalls of various global medical device clinical trial scenarios

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Obtaining Clinical/Regulatory Approval for Medical Devices in a Global Market

  1. 1. FOCUSED. TRUSTED. GLOBAL.Obtaining Clinical/Regulatory Approvalsfor Medical Devices in a Global Market Michael Winegar Vice President of Regulatory Affairs Medpace Medical Device
  2. 2. medical device EXPERTS Global Footprint North America  Europe • HQ Cincinnati, US• Munich, Germany • Minneapolis, US • Rotterdam, Netherlands South America • Leuven, Belgium • São Paulo, Brazil • London, UK • Mexico City, Mexico • Stirling, UK • Basel, Switzerland Asia/Pacific • Prague, Czech Republic • Mumbai , India • Warsaw, Poland • Beijing, China • Milan, Italy • Hong Kong • St. Petersburg, Russia Legend • Melbourne, Australia • Lyon, France Rest of World Countries where Medpace has operations • Tel Aviv, Israel • Johannesburg, S. Africa Medpace key offices © 2012 Medpace - Confidential and Proprietary
  3. 3. medical device EXPERTS Clinical/Regulatory Phases o First-In-Man  Small number of subjects (5-10)  Finalize design, use o Safety  Larger number of subjects (30-100)  Prove safety, provide indications of efficacy o Pivotal  Statistically relevant number of subjects (200- 500+)  Normally randomized  Prove efficacy and confirm safety © 2012 Medpace - Confidential and Proprietary
  4. 4. medical device EXPERTS Considerations Fast Pick 2… Good Cheap © 2012 Medpace - Confidential and Proprietary
  5. 5. medical device EXPERTS Country Selection © 2012 Medpace - Confidential and Proprietary
  6. 6. medical device EXPERTS Country Selection # of Trials by Country 70000 60000 50000 40000 30000 20000 10000 # of Trials 0 Australia Argentina India Mexico China Italy Brazil Canada France Germany US UK Source: ClinicalTrials.gov © 2012 Medpace - Confidential and Proprietary
  7. 7. medical device EXPERTS Country Selection © 2012 Medpace - Confidential and Proprietary
  8. 8. medical device EXPERTS Country Selection Cost of Clinical Trials Relative to the Country United States United States 1.00 Australia 0.67 Argentina 0.65 Germany 0.50 Brazil 0.50 China 0.50 Russia 0.41 Poland 0.39 India 0.36 Source: The National Center for Biotechnology Information © 2012 Medpace - Confidential and Proprietary
  9. 9. medical device EXPERTS United States o Pros  Quality of research/researchers  Accessibility  Data credibility o Cons  Costs  FDA • Pre-IDE/IDE Process • Current conservatism related to IDEs  Visibility © 2012 Medpace - Confidential and Proprietary
  10. 10. medical device EXPERTS United States According to the FDA Office of Device Evaluation (ODE), in fiscal 76% Fiscal 2000 year 2000, 76% of IDEs submitted would either get a full or conditional approval on the 56% Fiscal 2009 original submission. In 2009, that number dropped to 56%. And although official numbers aren’t out yet, various industry insiders state that current IDEs that get approved either conditionally or full approval on the first round are down in the upper 20’s to low 30’s. © 2012 Medpace - Confidential and Proprietary
  11. 11. medical device EXPERTS United States Source: FDA *Times may not add due to rounding **2009, 2010 some cohorts still open as of July 5, 2011; data may change © 2012 Medpace - Confidential and Proprietary
  12. 12. medical device EXPERTS United States Source: FDA © 2012 Medpace - Confidential and Proprietary
  13. 13. medical device EXPERTS United States Source: FDA © 2012 Medpace - Confidential and Proprietary
  14. 14. medical device EXPERTS Europe o Pros  Quality of research/researchers  Data credibility  Ease of startup o Cons  Costs  Varying regulation • ISO 14155 • MEDDEVs • Country Regulations  Varying standards of care © 2012 Medpace - Confidential and Proprietary
  15. 15. medical device EXPERTS Australia o Pros  Quality of research/researchers  Low regulatory barrier • CTN System • Tier I country  Data credibility o Cons  Distance  Sometimes limited patient population  Varying standard of care © 2012 Medpace - Confidential and Proprietary
  16. 16. medical device EXPERTS India # of Trials 2000 1500 1000 # of Trials 500 0 2007 2009 2013 Source: RNCOS India © 2012 Medpace - Confidential and Proprietary
  17. 17. medical device EXPERTS India o Pros  Costs  Large population  Motivated researchers o Cons  Data use/credibility  Regulatory barriers, including US export • Relatively new regulations • 801(e) export process for Class III devices  Varying standards of care © 2012 Medpace - Confidential and Proprietary
  18. 18. medical device EXPERTS China Cost in China ($) Cost in United States ($) 750–1000 One-day stay in hospital 40–100 150–300 Magnetic resonance 1500–3500 imaging Yearly salary for senior 40,000 225,000 oncologist Typical cost to develop 120 million 1 billion new drug Source: MDDI © 2012 Medpace - Confidential and Proprietary
  19. 19. medical device EXPERTS China o Pros  Costs  Large population  Motivated researchers o Cons  Data use/credibility  Regulatory barriers, including US export • In-country testing • Minimum of 2 sites • 801(e) export issues for Class III devices  Varying standards of care © 2012 Medpace - Confidential and Proprietary
  20. 20. medical device EXPERTS Latin America Adrian Ebner, M.D. 12 trials in Paraguay per ClinicalTrials.gov © 2012 Medpace - Confidential and Proprietary
  21. 21. medical device EXPERTS Latin America o Pros  Costs  Large populations  Motivated researchers o Cons  Data use/credibility  Regulatory barriers, including US export • Many countries have no specific device clinical regulations • 801(e) export issues for Class III devices  Varying standards of care © 2012 Medpace - Confidential and Proprietary
  22. 22. medical device EXPERTS FIM Trial o Design  Small, nonrandomized  Safety focus o Study Sites  1-2  EU, Australia site o Goals  Proof of concept  Final iterations to device design and use © 2012 Medpace - Confidential and Proprietary
  23. 23. medical device EXPERTS Safety Trial o Design  50-100 subjects, non-randomized o Study Sites  Primarily EU o Goals  CE Mark  FDA feasibility • Begin pre-IDE/IDE process  Initial publications  Regulatory submissions to additional markets © 2012 Medpace - Confidential and Proprietary
  24. 24. medical device EXPERTS Pivotal Trial o Design  Randomized  Statistically powered primary endpoints o Study Sites  Primarily US  Additional sites from Safety study o Outcomes  FDA approval  Marketing and reimbursement data  Regulatory submissions to additional markets © 2012 Medpace - Confidential and Proprietary
  25. 25. medical device EXPERTS Summary o Protocol Design  Stepwise progression  Data collection based on study size/goals  Assume device/protocol changes will be made over time o Country/Site Selection  Consider real costs  Country ease of access  Data use and credibility o Regulatory Considerations  Understand site/country timelines and requirements  Engage FDA early  Don’t ignore export/import requirements © 2012 Medpace - Confidential and Proprietary
  26. 26. FOCUSED. TRUSTED. GLOBAL. Thank You! Mike Winegar Vice President, Regulatory Affairs Medpace Medical Device 3787 95th Ave. NE Suite 100 Blaine, MN 55014Tel: +1.612.234.8491 ○ Cell: +1.763.639.0700 ○ Fax: +1.612.392.0468 E-mail: m.winegar@medpace.com website: www.medpace.com/device

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