Alan Stevens

AbbVie
Global Head, Complex Devices and Drug Delivery Systems, RA CMC and Devices
Alan is a regulatory expert in drug delivery devices, emerging technologies, and combination products at AbbVie and has been with the company since October 2023. Prior to joining AbbVie, Alan worked at FDA for 20 years as a premarket device reviewer and manager for drug delivery devices and combination products. While at FDA, he led guidance development for infusion pumps, reliability of emergency use injectors, and essential performance requirements. Alan has a masters degree in reliability engineering and undergrad in mechanical engineering from the University of Maryland.

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Guiding Principles for Combination Product Reliability
Technical
Guiding Principles for Combination Product Reliability

Drug delivery devices have become an essential component for many modern medical therapies, and it’s vital that they function as intended. However, the reality of marketed products shows that this is not always achieved because drug-device combination products are becoming increasingly complex, with an increasing number of potential failure modes. Significant challenges for engineers include...