Agile + FDA?

Can Agile really work in FDA-regulated medical device environments? In this episode of Take Five IRL, Mike Stuedemann and Jeff Lee reflect on their experience at DeviceTalks Boston—one of the largest medical device conferences in the U.S.—and unpack what they heard from medtech leaders about innovation, agility, AI, quality systems, and the future of product development in regulated environments. From customer-centered development and rapid iteration to FDA compliance and AI-enabled documentation tools, this conversation explores how medical device organizations are adapting to an increasingly fast-paced and complex world. Key topics include: • Can Agile work in medical device and FDA-regulated environments? • Why medtech leaders are rethinking traditional stage-gated development • The role of AI in design controls, traceability, and documentation • Breaking down silos between Quality, PMO, R&D, and leadership teams • Lessons learned from DeviceTalks Boston and real conversations with medtech organizations • A real-world case study with Smith+Nephew on iterative delivery in regulated environments Whether you're in medical devices, medtech leadership, product development, quality, PMO, software, or engineering, this episode offers practical insights into how organizations can move faster—without sacrificing compliance. 🎙️ About Take Five IRL Take Five IRL is a podcast from AgilityIRL focused on leadership, agility, organizational transformation, and helping teams perform better in the real world. 👉 Subscribe for more conversations on Agile, leadership, medtech transformation, and high-performing teams. #MedTech #MedicalDevice #Agile #FDA #Leadership #BusinessAgility #HealthcareInnovation