AI Is a Tool, Not a Replacement for MedTech Expertise with Mike Stuedemann, Co-Founder and Principal Consultant at agilityIRL

Move faster without losing focus: why medtech innovation must balance agility, regulation, and patient needs. In this episode, Mike Stuedemann, Co-Founder and Principal Consultant at agilityIRL, discusses how medical device companies can use agile techniques to accelerate product development while maintaining FDA compliance. He explores the regulatory challenges surrounding AI-enabled devices, particularly as technologies continue to learn and evolve after launch. Mike also explains how AI can support quality and regulatory teams by identifying potential risks, flagging requirements for review, and reducing manual work without replacing human expertise. Finally, he shares why personalized medicine, responsible data use, and practical applications of "boring AI" can drive more meaningful innovation while keeping accessibility, affordability, and patient outcomes at the center. Tune in to learn how agile development, human oversight, and patient-centered innovation can help medtech companies navigate a rapidly changing industry! Resources: Connect with and follow Mike Stuedemann on LinkedIn. Follow agilityIRL on LinkedIn and explore their website. Listen to the Take5 IRL podcast here.