Episode
Scientist to Regulatory Lawyer: Getting Medical Devices to Market
- Podcast
- I Am The Law
- Published
- Feb 4, 2026
- Duration seconds
- 2084
- Processing state
not_requested- Canonical source
- https://www.lawhub.org/podcasts/i-am-the-law
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Summary
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. Mentioned in this episode: Learn more about Oklahoma City University School of Law Learn more about Haynes Boone LLP Learn more about Juno and private student loans Learn more about Boston University School of Law Learn more about Seton Hall Learn more about Blueprint Access LawHub today!