Solving the Systems Interconnectivity Problem
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This article originally appeared in MD+DI on June 1, 2023.
An essential feature of GxP industries is the productive tension between operations and quality. Operations (development in the case of medtech) pulls in the direction of action and constraints. Quality pulls in the direction of deliberation and ideals. In a high-functioning organization, the groups maintain a tenuous balance, but there is inevitable conflict by design.
I was first exposed to this tension as a major non-conformance investigator at a massive biopharmaceutical manufacturing plant. My team investigated, corrected, and reported on the thorniest and most subtle failures of a complex quality management system. The team was highly skilled, consisting of PhDs and multi-decade veterans of pharmaceutical manufacturing. While I had no experience in GxP when I joined the team, I had a keen eye for operations improvement, honed by a career in construction project management.
Jake brings experience that fuses technology and quality systems. His professional journey began in operations, fostering a deep understanding of complex, safety-critical systems; prior to Ketryx, he was a manager in a GMP pharmaceutical plant at Amgen. This foundation has profoundly shaped his approach to tech, where he currently serves as the Vice President of Client Operations at Ketryx. Jake holds an MBA in Operations and Logistics and a Master's degree in Systems Engineering from MIT, where he was a Leaders for Global Operations (LGO) Fellow.
