137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. 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, Alan walks through:

00:38 Exploring Reliability in Combination Products

01:17 The Importance of Subscribing and Feedback

01:36 Alan Stevens Shares His Expertise

02:40 Understanding Reliability: Definitions and Nuances

03:46 Component vs. System Reliability in Device Design

08:55 From FDA Reviews to Industry Insights

11:29 Fault Tree Analysis and Risk Management

14:17 Setting Reliability Expectations for Combination Products

15:32 Navigating Risk Culture and Acceptable Levels of Risk

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.