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:
Timestamps
- 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.
