Scientist to Regulatory Lawyer: Getting Medical Devices to Market

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 Haynes Boone LLP Learn more about Boston University School of Law Learn more about Seton Hall Learn more about Blueprint Access LawHub today!

You can listen to Scientist to Regulatory Lawyer: Getting Medical Devices to Market online on Radio and Podcast. Open the player on this page to stream the available audio.

Scientist to Regulatory Lawyer: Getting Medical Devices to Market is an episode from LST's I Am The Law by Kyle McEntee.

This episode is 33:42 long.

This episode was published on Feb 4, 2026.

Yes. Use the heart button on the episode page to add it to your favorite episodes list.

Yes. This page shows related episodes from LST's I Am The Law when more episodes are available from the podcast feed.