FDA 510(K) approval for medical devices takes 3-7 years and tens of millions of dollars for all but the extreme cases (i.e. artificial heart or the new bionic eye).

If you're making stuff like pacemakers that keep people alive while implanted in their body, the vast majority of that cost will be unavoidable if you don't want to risk killing a bunch of people (which is, you know, a thing worth paying for).

And the approval process for changing one line in the polling interval in version 19.64.101 of a back-end server that converts from one file format to another file format takes WEEKS.

I'm just pointing out that all of your anecdotal stories were related to practice, not device development.

Please link me to the regulations that require you to wait weeks for approval to change a line of code during device development (BEFORE deployment). After deployment, you need to do a lot of paperwork and testing to change anything, whether it is a drug, medical device, or clinical test and for good reason. You can't just do a git push when you're building a complex system where a misplaced bit can easily kill someone.

As for my anecdotes, I worked on bringing online robotics and brand new diagnostic tests (with and without golden standards) which are under entirely different regulations than record keeping or the day to day operations of a lab.