Solving the Systems Interconnectivity Problem
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.
