Innovation: A Priority for FDA William H. Maisel, MD, MPH Deputy Center Director for Science Chief Scientist Center for Devices and Radiological Health February 7, 2012

CRT 2012 William H. Maisel, MD, MPH NOTHING to DISCLOSE

FDA Regulates a Wide Variety of Products William H. Maisel, MD, MPH – CRT 2012

FDA on Innovation The United States is the global leader in medical device innovation. FDA wants American patients to have timely access to safe, important new technologies and next generation products. We want to bring MORE safe and effective products to market FASTER. William H. Maisel, MD, MPH – CRT 2012

Health Care Delivery is Changing Home Mobile Wireless William H. Maisel, MD, MPH – CRT 2012

Emerging Technology Trends Robotics Miniaturized Devices (including nanotechnology) Home Use Combination Products Sophisticated, Computer-Related Technologies Organ Replacements and Assist Devices Personalized Medicine Wireless Systems William H. Maisel, MD, MPH – CRT 2012

U.S. Medical Device Manufacturing Companies by Number of Employees Total Number of Device Manufacturing Companies = 15,952 Source: Dun and Bradstreet, Inc. Date: June 2009

Device Development William H. Maisel, MD, MPH – CRT 2012

CDRH Innovation Initiative Strengthen the U.S. research infrastructure and promote high-quality regulatory science Facilitate the development and regulatory evaluation of innovative medical devices Prepare for and respond to transformative innovative technologies and scientific breakthroughs William H. Maisel, MD, MPH – CRT 2012

Regulatory Science The science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. William H. Maisel, MD, MPH – CRT 2012

Computational Modeling and Simulation Lochner D, Takai E, Carroll J, Chen J, Hansgen A, Salcedo E. Morrison T, Fillinger M, Mitchell M, Fairman R, Glickman M

Innovative Methods for Device Evaluation Bench‐top testing methods are often based on poor understanding of actual in vivo conditions. Animal testing is suboptimal because animals do not typically present with diseased pathologies (atherosclerosis, aneurysms, …). Human testing is limited by ethical issues and plagued by difficulties in determining failure mechanisms. William H. Maisel, MD, MPH – CRT 2012

William H. Maisel, MD, MPH – CRT 2012

Leverage External Expertise Innovation Leverage External Expertise Advisory Panels with SGE’s SGE’s Complete Homework Assignments Scientific Literature/Scientific Meetings Public Workshops that Include Scientific Experts Speak 1-on-1 with Outside Experts Reach Out to Other Federal Scientists NETWORK OF EXPERTS William H. Maisel, MD, MPH – CRT 2012

Synergistic Collaborations Multiple stakeholders (other government agencies, academia, industry, professional societies. Leverage available expertise and resources. Formal agreements or Public-Private Partnership. William H. Maisel, MD, MPH – CRT 2012

Conclusions FDA is committed to facilitating medical device innovation Science and technology are rapidly evolving Need to strengthen the U.S. research infrastructure and promote high-quality regulatory science Shared responsibility William H. Maisel, MD, MPH – CRt 2012

Innovation: A Priority for FDA William H. Maisel, MD, MPH Deputy Center Director for Science Chief Scientist Center for Devices and Radiological Health February 7, 2012