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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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FOCUSED. TRUSTED. GLOBAL.
Obtaining Clinical/Regulatory Approvals for Medical Devices in a Global MarketMichael Winegar
Vice President of Regulatory Affairs Medpace Medical Device
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
Global Footprint
North America• HQ Cincinnati, US• Minneapolis, US
South America• São Paulo, Brazil• Mexico City, Mexico
Asia/Pacific• Mumbai , India• Beijing, China• Hong Kong• Melbourne, Australia
Rest of World• Tel Aviv, Israel• Johannesburg, S. Africa
Europe• Munich, Germany• Rotterdam, Netherlands • Leuven, Belgium• London, UK• Stirling, UK• Basel, Switzerland• Prague, Czech Republic• Warsaw, Poland• Milan, Italy• St. Petersburg, Russia• Lyon, France
Legend
Countries where Medpace has operations
Medpace key offices
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
Clinical/Regulatory Phaseso 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
medical device EXPERTS
Considerations
Pick 2…
Fast
CheapGood
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
Country Selection
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
Country Selection
Source: ClinicalTrials.gov
US
Germ
any UK
Aust
ralia
Braz
il
Mex
ico
010000200003000040000500006000070000
# of Trials by Country
# of Trials
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
Country Selection
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
Country Selection
CountryCost of Clinical Trials Relative to the 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
medical device EXPERTS
o Pros Quality of research/researchers Accessibility Data credibility
o Cons Costs FDA• Pre-IDE/IDE Process• Current conservatism related to IDEs
Visibility
United States
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
United States
76% Fiscal 2000
56% Fiscal 2009
According to the FDA Office of Device Evaluation (ODE), in fiscal year 2000, 76% of IDEs submitted would either get a full or conditional approval on the 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
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
medical device EXPERTS
United States
Source: FDA
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
United States
Source: FDA
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
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
Europe
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
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
Australia
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
India
Source: RNCOS India
2007 2009 20130
200400600800
100012001400160018002000
# of Trials
# of Trials
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
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
India
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
Cost in China ($) Cost in United States ($)
One-day stay in hospital 40–100 750–1000
Magnetic resonance imaging
150–300 1500–3500
Yearly salary for senior oncologist 40,000 225,000
Typical cost to develop new drug 120 million 1 billion
Source: MDDI
China
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
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
China
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
Latin America
Adrian Ebner, M.D.
12 trials in Paraguay per ClinicalTrials.gov
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
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
Latin America
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
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
FIM Trial
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
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
Safety Trial
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
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
Pivotal Trial
© 2012 Medpace - Confidential and Proprietary
medical device EXPERTS
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
Summary
FOCUSED. TRUSTED. GLOBAL.
Thank You!Mike Winegar
Vice President, Regulatory AffairsMedpace Medical Device
3787 95th Ave. NE Suite 100Blaine, MN 55014
Tel: +1.612.234.8491 ○ Cell: +1.763.639.0700 ○ Fax: +1.612.392.0468E-mail: [email protected] website: www.medpace.com/device
