Why FDA Guardrails Still Matter in a Fast-Moving MedTech Industry with Suzanne Levy Friedman, Partner at Honigman

As AI and software become embedded in more medical technologies, companies must balance the pressure to innovate quickly with the responsibility to protect patients. In this episode, Suzanne Levy Friedman, Partner at Honigman, discusses how medical device and digital health companies can navigate evolving FDA regulations and bring products to market more efficiently. She explains how regulatory counsel helps organizations determine whether products fall under FDA oversight, distinguish wellness technologies from regulated devices, and build effective commercialization strategies. Suzanne also explores the growing tension between rapid innovation, particularly in AI, and the FDA's responsibility to protect public health. Finally, she shares how clearer regulatory guidance and early legal involvement can help manufacturers avoid costly setbacks and better operationalize compliance. Tune in to learn how early regulatory planning can help medtech companies innovate responsibly, reduce risk, and bring valuable technologies to patients more efficiently! Resources: Connect with and follow Suzanne Levy Friedman on LinkedIn. Follow Honigman on LinkedIn and explore their website. Contact Suzanne at [email protected].