129 - Reliability for Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens

On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, expect to learn from Alan about how reliability engineering concepts can be used for single use combination products. Why infusion pumps are susceptible to recalls. Why people call Allen captain Allen Stevens. And the roles of standards and guidance in combination product approval.

03:32 The Story Behind 'Captain' Allen Stevens

06:52 The Challenges of Infusion Pumps and Recalls

13:34 The Intricacies of FDA's Rule-making and Guidance Process

21:44 The Future of Reliability in Combination Products

30:46 A Book That Changed Life: Systems Thinking in Safety

32:44 Wrapping Up: The Impact of Engineering on Public Health

Alan is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie within the RA Emerging Technologies, Devices and Combination Products team. Prior to joining AbbVie, Alan spent 20 years at the FDA/CDRH leading premarket review and policy development for drug delivery devices and combination products.