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Too often we define the Medtech sector by the number of dollars raised, IPOs helped or companies sold. But the focus neglects the very foundation of the sector - the People. Join the Medtech Talk Podcast each week to hear from entrepreneurs, investors and executives who spend their days developing the tools that make sick people well and health care more efficient.



Douglas Kelly on the Value of Innovation and Breakthrough Designation

March 27, 2025

 

This month at Medtech Talk, co-host Justin Klein, co-founder and managing partner at Vensana Capital, debuts in his first episode with a discussion with Douglas Kelly, former deputy center director for science and chief scientist at the Center for Devices and Radiological Health at the FDA. Kelly talks about his time at the FDA and the fundamental changes he implemented to make a helpful impact on patients, including when the pandemic was at its peak. Kelly also shares his thoughts on the value of fostering innovation and the importance of breakthrough designation, as well as how to approach the process of advocacy and get in better alignment with shared priorities with the FDA, CMS, and other stakeholders.

 

Douglas Kelly

Former Deputy Center Director for Science, Chief Scientist

Center for Devices and Radiological Health at the FDA

Doug Kelly, MD became Deputy Center Director and Chief Scientist at CDRH, the FDA’s device, diagnostics and digital health branch at the start of the Covid pandemic in 2020. One of the first physician venture capitalists, he worked for nearly three decades as a General Partner at Asset Management/Alloy Ventures doing seed and early-stage venture capital starting, financing, growing and exiting companies spanning biotech, medical devices, robotics, laboratory tools, healthcare IT, ADME/Tox simulation and clinical trial software. At CDRH, Doug was the interface between the FDA and patient advocates and physician specialty societies, CMS and private payers, industry, academia, innovators, investors, and other agencies and governments. He was FDA’s first representative at the AMA’s CPT Editorial Panel and the RUC. His focus is on public health impact and bringing real innovation to patients faster to relieve suffering, especially in unserved and underserved populations.

Doug received his BA in Biochemistry and Cell Biology with honors from University of California, San Diego, his MD from the Albert Einstein College of Medicine, and his MBA at the Stanford University Graduate School of Business. In addition to lecturing at the GSB and Stanford Medical School, he started and taught the class “Financing The Start-up.”

Meet Our Host, Geoff Pardo

Geoff has been in medtech for over two decades in both operational and investment roles. He is passionate about the industry potential and sharing stories from the front lines of innovation.