Supply chain disruptions are forcing an inordinate amount of change to critical components of medical devices. The burden placed on medical device OEMs to validate these changes distracts engineering, quality, and operations teams from more strategic activities. Reacting to an unpredictable supply chain endangers new development as well as ongoing production.
Anna Bredy
Medical device designs are complex – from the technological advancements that created them and interconnects between different functional facets, to their enclosures and regulatory requirements.