Jeff Gagel

As medical devices transition from product development into manufacturing, early design decisions around design requirements and production strategy can significantly impact operational efficiency, cost, quality, and time to scale.  This presentation describes an engineering driven approach to designing medical devices for process robustness and clinical success by aligning material selection, operational processes, and validation planning from the outset.  Emphasis is placed on using design to improve operations through manufacturability, assembly, automation, and lights out readiness.  This is articulated through a surgical device case study that includes reshoring considerations, reduced process variability, and improved manufacturing KPIs such as yield, cycle time, labor content, and scrap.  Attendees will learn how early, intentional design choices enable faster operational response to material or process changes while minimizing risk during the transition to sustained manufacturing.

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