MedTech Innovator Recruits Former FDA CDRH Director as an Advisor

Dr. Jeffrey Shuren, former director of the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH), has joined MedTech Innovator (MTI) as an advisor.

Dr. Shuren has more than two decades of leadership experience at the FDA and the Centers for Medicare and Medicaid Services. Under his leadership at the FDA, CDRH advanced regulatory modernization efforts, strengthened patient protections, created innovation pathways, established new frameworks for digital health/artificial intelligence, advanced the use of real-world evidence, and improved patient access to safe and effective medical technologies.

As an MTI Advisor, Dr. Shuren will provide strategic guidance to the organization, its accelerator, portfolio companies, and ecosystem on regulatory strategy, policy trends, and global market access, helping early- and mid-stage startups navigate increasingly complex regulatory environments.

“Jeff’s leadership at FDA transformed how medical technologies are evaluated and brought to market,” MedTech Innovator Founder/CEO Paul Grand stated. “His experience accelerating innovation while maintaining rigorous patient safety standards will be invaluable to our portfolio companies, to help avoid costly delays and increase the chance of success as they advance innovative solutions to benefit patients.”

During his FDA tenure, Dr. Shuren led initiatives that included the Breakthrough Devices Program, the Patient Engagement Program, the Digital Health Center for Excellence, the Total Product Life Cycle Advisory Program (TAP), and Home as a Healthcare Hub. His work helped modernize regulatory science while supporting rapid innovation across medtech sectors, including artificial intelligence (AI), diagnostics, wearables, and other life-saving therapeutic devices.

“MedTech Innovator plays a critical role in supporting the next generation of medical technology leaders,” Dr. Shuren said. “I’m excited to contribute to an organization that helps entrepreneurs translate transformative ideas into solutions that improve the health and quality of life of people globally.”

MedTech Innovator is the world’s largest accelerator of medical device, digital health, and diagnostic companies. Its mission is to improve human health by accelerating the growth of companies transforming patient care. MTI has been a catalyst for groundbreaking healthcare solutions, sourcing more than 20,000 applicants and fostering the growth of 838 graduates. Alumni have collectively raised $12 billion in follow-on funding, achieved 63 acquisitions, and introduced 500-plus products to the market.