Hi- I used to work in regulated pharma and I want to be clear: " The core problem is that the FDA-approved devices are optimized not for getting the best result, but for ensuring the manufacturer can't be blamed if something goes wrong" is a misleading statement. The reason everything is regulated is that sometimes things do go wrong, and it's necessary to have root cause attribution so the problem can be remedied and a fix deployed, and, if somebody did something illegal or dumb, they can be sanctioned.
I wish your project success, but I think (and I've got a bit of experience) if you can't accept that regulation of health products is almost certainly necessary, and that not producing the "best" results is a reasonable if conservative approach, I will never trust your product.
I wish your project success, but I think (and I've got a bit of experience) if you can't accept that regulation of health products is almost certainly necessary, and that not producing the "best" results is a reasonable if conservative approach, I will never trust your product.