Generative AI in MedTech Needs Control, Not More Experimentation
The prevailing advice on Generative AI in MedTech is to launch numerous pilots, encourage widespread experimentation, and wait for the most promising use cases to emerge. That approach sounds innovative, but it is poorly matched to a sector in which evidence provenance, role competence, document status, and change control matter. Medical device manufacturers do not primarily suffer from a shortage of AI demonstrations. They suffer from disconnected evidence, ambiguous accountability, and prototypes that cannot survive design assurance, cybersecurity, privacy, or QMS scrutiny. The more productive view of Generative AI in MedTech begins with an uncomfortable premise: the model is rarely the hardest part. A credible deployment depends on knowing which records are authoritative, which decision a person must retain, how an output will be verified, and what evidence will demonstrate continuing control after a model or source repository changes. Without those foundations, a fluent assistant ...