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Software/firmware defects account for 12 Class I medical device recalls, the most of any category. The root cause is not poor engineering. It is planning fallacy, a cognitive bias that makes every team overestimate their timeline and underestimate their defect rate.
A deep dive into conflict avoidance as the root cause of FDA quality system failures. Analysis of 500 enforcement actions shows that CAPA failures are not procedural problems. They are cognitive problems that require a different objective function.
What 500 FDA enforcement actions reveal about how organizations think. The same seven failure patterns appear across medical device companies, decade after decade. The root cause is not poor procedures. It is cognitive biases that evolved for small-group survival but break down in modern industrial settings.
At Andrews-Cooper, the most important part of the Defibrio work was the protocol boundary. The host CLI, the firmware, the cellphone UI, and the product itself were organized around it.
