Scientist to Regulatory Lawyer: Getting Medical Devices to Market

Doron Gold spent roughly a decade practicing law before realizing the profession was slowly crushing him. In this episode, Doron shares the experiences that led him to leave law for good. Doron discusses his transition to therapy and his current practice helping lawyers navigate burnout, perfectionism, and career dissatisfaction. Drawing on his own experience, Doron highlights how perfectionism, external validation, and misaligned values can undermine personal and career satisfaction. He also reflects on professional boundaries he learned as a family lawyer — maintaining objectivity while caring deeply — and how those skills transferred to therapy. Doron is a graduate of the York University Osgoode Hall Law School (JD) and the University of Windsor (Master of Social Work).This episode is hosted by Katya Valasek.Mentioned in this episode:Access LawHub today!Loyola Law SchoolLearn more about Loyola Law School

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:Colorado Law SchoolLearn more about Colorado LawLoyola Law SchoolLearn more about Loyola Law SchoolAccess LawHub today!

Nathania Reyes litigates commercial disputes on behalf of financial services organizations like banks. Nathania recounts her journey from uncertain law student to finding her place in civil litigation. She describes her diverse experiences, including immigration and in-house internships, a judicial clerkship, and her transition to private practice. She emphasizes the importance of work-life balance at her current firm, how the Hispanic Bar Association has shaped her career to date, and how she's expanding her expertise in various commercial litigation areas. Nathania touches on networking and business development, highlighting the value of persistence in the face of rejection. Nathania is a 2017 graduate of Rutgers University School of Law.This episode is hosted by Kyle McEntee.Mentioned in this episode:Colorado Law SchoolLearn more about Colorado LawLoyola Law SchoolLearn more about Loyola Law SchoolAccess LawHub today!

Artificial intelligence has arrived in the legal profession. In this special episode, Kyle and Katya examine AI's growing role in the world of law from criminal defense to M&A and much in between. Over the past few months, they've asked every guest a simple bonus question: How has AI affected your practice?The answers offer a window into a profession in transition—curious, conflicted, and actively determining AI's proper role in law. Practitioners share how AI streamlines document review and accelerates research, while candidly discussing serious limitations and risks. This highlights how lawyers are still learning to navigate the technology.Feature voices:Eric Bernheim, Episode 120, Behind the Lease: Supporting Restaurant Expansion Through Real Estate LawAlexis Taitel, Episode 121, From Clerkship to Private Practice: Research, Writing, and Challenging AssumptionsVenetia Mayhew, Episode 122, Second Chances: Rewriting Life Through ClemencyJoe Stephens, Episode 126, Trial by Algorithm: Helping Lawyers Navigate the AI RevolutionAsha Sharma, Episode 127, Administrative Hearings and Human Stories: Social Security Disability on the FrontlinesAudi Syarief, Episode 129, Trading in Gray Areas: How Sanctions Shape International BusinessRachel Frank, Episode 131, Understanding the Appeal: Supreme Litigation from First Draft to Oral ArgumentElise Bennett, Episode 133, Cool Little Dudes and Legal Battles: Environmental Protection from the Courtroom to the CommunityMolly Henry, Episode 137, Navigating International Waters: Arresting Ships and Managing Crises on the SeasMichael Kohagen, Episode 139, At the Center of the Transaction: Coordinating Business Deals from Start to FinishThis episode is hosted by Kyle McEntee and Katya Valasek.Mentioned in this episode:Colorado Law SchoolLearn more about Colorado LawAccess LawHub today!Loyola Law SchoolLearn more about Loyola Law School

Michael Kohagen structures mergers and acquisitions for clients across the deal spectrum, from family businesses selling for $5 million to headline-grabbing deals. He explains how smaller deals offer closer client relationships—often working directly with owners who lack M&A experience but know their business intimately. Michael walks through the deal process from confidentiality agreements and letters of intent through due diligence and purchase agreements, emphasizing his role coordinating specialists while drafting core transaction documents. He discusses how AI is beginning to change document review, why most M&A deals fail (time drag and initial misalignment), and how his central role creates both pressure and satisfaction. Michael is a graduate of the University of North Carolina School of Law.This episode is hosted by Kyle McEntee.Mentioned in this episode:Colorado Law SchoolLearn more about Colorado LawLoyola Law SchoolLearn more about Loyola Law SchoolAccess LawHub today!

Duncan Kemp, a state government lawyer, took an unconventional path to environmental law. After working in college athletics fundraising and earning an MFA in Creative Writing, he entered law school part-time with a clear goal: protecting natural resources. But landing that environmental job proved harder than expected. Today, he manages litigation for one of Louisiana's largest landowners—from boundary disputes and coastal erosion cases to pipeline enforcement and exotic animal seizures. Duncan discusses balancing conservation with hunting traditions and economic growth, and coordinating litigation across agencies. Plus, he talks about the satisfying trade-off between lower government pay and a better work-life balance. Duncan is a graduate of Southern University Law Center.This episode is hosted by Kyle McEntee.Mentioned in this episode:Access LawHub today!Colorado Law SchoolLearn more about Colorado LawLoyola Law SchoolLearn more about Loyola Law School

Molly Henry represents international ship owners in a practice spanning oil spill response, vessel arrests, cargo disputes, and casualties at sea. She explains how admiralty law—a conglomeration of international treaties and federal common law—treats ships as legal persons that can be arrested and sold to satisfy judgments. Molly describes her crisis management role, boarding vessels to investigate crew deaths and fielding calls at all hours when maritime casualties occur. She reflects on transitioning from task-based associate work to strategic case management, and how an early opportunity to argue before the Ninth Circuit built her confidence. Molly is a graduate of the Ohio State Moritz College of Law.This episode is hosted by Kyle McEntee.Mentioned in this episode:Access LawHub today!Colorado Law SchoolLearn more about Colorado LawLoyola Law SchoolLearn more about Loyola Law School

Mia Getlin specializes in the state-legal cannabis industry in Oregon and Washington. She shares insights into the challenges and complexities of navigating the highly-regulated cannabis sector, emphasizing the importance of trust-building with clients coming from diverse backgrounds, including those transitioning from the illicit market. Mia highlights the role of advocacy in shaping industry regulations, issue spotting for compliance, and maintaining a supportive, problem-solving approach as a transactional attorney focused on finding solutions for her clients' needs. Throughout the conversation, she provides valuable perspectives on the legal intricacies and evolving dynamics of the cannabis business, from licensing to corporate structuring, offering a unique window into her role as a dedicated advocate for her clients in this rapidly changing field. Mia is a 2014 graduate of Pepperdine Caruso School of Law.This episode is hosted by Kyle McEntee.Mentioned in this episode:Access LawHub today!Learn more about Seton HallBU LawLearn more about Boston University School of LawLoyola Law SchoolLearn more about Loyola Law SchoolLearn more about Baylor LawLearn more about Blueprint

Shannon Struble has spent more than a decade prosecuting gang-related crimes in a county with a lot of violent gang activity. In this episode, she takes us inside the day-to-day life of a prosecutor. Shannon walks through the fast-paced charging process — where prosecutors have just 48 hours to review evidence and decide whether to file charges — negotiating pleas, and navigating the courtroom. She reflects on the vicarious trauma of watching crimes unfold on body cam footage, responding to homicide scenes at 2 a.m., and finding moments of reward when rehabilitation succeeds. Shannon also explores what justice really looks like and the role prosecutors can play in supporting rehabilitation, not just punishment. Shannon is a graduate of Arizona State University Sandra Day O'Connor School of Law.This episode is hosted by Kyle McEntee.Mentioned in this episode:BU LawLearn more about Boston University School of LawLearn more about Seton HallLearn more about BlueprintLearn more about Baylor LawLoyola Law SchoolLearn more about Loyola Law SchoolAccess LawHub today!

Families don’t call Matt Talbot when things are going well. They call when grief, money, and long-simmering tensions rise to the surface. He helps clients navigate conservatorships, financial elder abuse, and complex estate litigation. In this episode, Matt discusses the emotional weight of handling kidnapping cases across state lines, the challenge of proving financial abuse when the victim can no longer speak for themselves, and how the Britney Spears case fundamentally changed California conservatorship law. He candidly shares how repeated exposure to family disasters has made him both emotionally hardened to client trauma and deeply committed to preserving his own family relationships. Matt reflects on the importance of getting evidence upfront, managing clients who want to "go nuclear" on family relationships, and why sometimes the best thing for a client isn't indulging their emotions. Matt Talbot is a graduate of the University of San Francisco School of Law. This episode is hosted by Katya Valasek.Mentioned in this episode:Learn more about Seton HallBU LawLearn more about Boston University School of LawLearn more about BlueprintLoyola Law SchoolLearn more about Loyola Law SchoolLearn more about Baylor LawAccess LawHub today!