{"href":"https:\/\/lawhuborg-www-dev.azurewebsites.net\/podcasts\/i-am-the-law\/oembed\/142\/scientist-to-regulatory-lawyer-getting-medical-devices-to-market","version":"1.0","provider_name":"LawHub","provider_url":"https:\/\/lawhuborg-www-dev.azurewebsites.net","width":640,"height":280,"type":"rich","html":"<iframe width=\"100%\" height=\"280\" src=\"https:\/\/lawhuborg-www-dev.azurewebsites.net\/podcasts\/i-am-the-law\/player\/142\/scientist-to-regulatory-lawyer-getting-medical-devices-to-market\" title=\"I Am The Law Episode 142: Scientist to Regulatory Lawyer: Getting Medical Devices to Market w\/ Kyle McEntee\" allow=\"autoplay; clipboard-write; encrypted-media; fullscreen; picture-in-picture\" frameBorder=\"0\" loading=\"lazy\" style=\"border-radius: 12px;\"><\/iframe>","title":"I Am The Law Episode 142: Scientist to Regulatory Lawyer: Getting Medical Devices to Market w\/ Kyle McEntee","description":"What does it take to bring medical devices to the market? It\u2019s 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\u2019s 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.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https:\/\/artwork.captivate.fm\/47d36d7e-d826-4ff2-a955-b409c76ef769\/white-logo-even.jpg"}