Leadership

Steve Silverman is the President of The Silverman Group, a consultancy that serves medical companies on regulatory, strategy, and policy issues.

Steve previously served as Vice President, Technology and Regulatory Affairs at the Advanced Medical Technology Association. In that role, he represented member companies before federal agencies on medical product legislative and regulatory matters. Additionally, he engaged federal regulators and member firms to implement medical product quality strategies, provided expert insight to Congress and state legislators, and led policy development on regulatory and legislative issues.

As Senior Expert, Pharmaceutical and Medical Products, at McKinsey & Co., Steve advised pharmaceutical, medical device, health technology, and biologics clients on regulatory strategies, compliance and quality initiatives, and stakeholder communication. Steve helped clients strengthen relationships with regulators and inform device regulatory policies. Steve also helped companies resolve manufacturing quality violations, and directed clients on quality-related regulatory policies, including implications for product review and post-market oversight.

Steve held senior leadership positions across the FDA, providing him with unique regulatory insights. From 2010 to 2015, Steve served as Director, Office of Compliance, Center for Devices and Radiological Health. There he established and drove strategic and policy objectives, directing a staff of 180+ scientific and regulatory professionals in promoting device quality while assuring compliance with applicable federal laws. He led Center and Agency interactions with Congress, the press, and industry on topics such as product quality and digital health oversight. Steve also set CDRH regulatory and policy positions on issues including clinical data integrity, product labeling, promotion and advertising, global manufacturing practices, and proposed legislation.

Steve’s FDA experience includes Assistant Director, CDER Office of Compliance, where he oversaw drug regulations, policy, and public communications about prescription and over the counter drugs. Steve began his FDA work as an Associate Chief Counsel, where he led enforcement actions against drug and medical device companies.

Steve graduated from The University of Michigan, Ann Arbor, MI, and The University of Pennsylvania School of Law and currently holds memberships in the State of Illinois and Washington, DC Bars.