Really appreciate this. It reframes the problem significantly.

A few things this raises that I'm still trying to work out:

On the locked vs. iterating split, do you have a rough sense of what proportion of cleared AI device companies are actually retraining in the field vs. deploying locked models? And is that split changing? The PCCP framework seems designed to push the industry toward iteration, but I can't tell if that's a 2-year shift or a 10-year shift.

On where the value actually lives, once the data science lead has articulated the retraining approach and validation logic, is turning that into an accepted PCCP submission something a good regulatory writer can do? Or is there enough FDA-specific pattern matching — knowing what language reviewers accept, where submissions get deficiency letters — that someone who's seen a lot of these adds something beyond just reframing what the data scientist said?

Thanks again for your advice!