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Scientist to Regulatory Lawyer: Getting Medical Devices to Market
Description
What does it take to bring medical devices to the market? It’s a question lawyer Randy Prebula thinks about every day. Randy is a partner at a global law firm who specializes in the regulatory world of medical devices and technology. In this episode, he shares how he transitioned from a more than 20-year career as a scientist into the world of law and how that informs his legal work. He breaks down FDA’s emergency use authorization, what qualifies as a device versus a drug, how products navigate FDA approval pathways, and why risk-benefit analysis drives every FDA decision. He also reflects on what it was like working in this field during the COVID-19 pandemic, helping to bring one of the first at home COVID-19 tests to market. Randy is a graduate of the Catholic University of America.
This episode is hosted by Kyle McEntee.
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