> Beyond that, regulation is the next limit. Normally, for every diagnostic medical capability you need FDA approval. We’re starting by just giving you detailed body composition maps — and we’ll be submitting regular test results to the FDA for increased capabilities.
This is just not how the FDA works. At all. You can't just email them slideware and marketing materials to keep them in the loop.
You have to hire an army of expensive compliance people (cheap ones aren't nimble enough for startups), develop the whole thing start to finish under strict design controls, and usually throw a lot of time and capital into convincing regulators your very innovative and disruptive new R&D endeavor is actually derivative enough to draft behind some existing medical device.
This is just not how the FDA works. At all. You can't just email them slideware and marketing materials to keep them in the loop.
You have to hire an army of expensive compliance people (cheap ones aren't nimble enough for startups), develop the whole thing start to finish under strict design controls, and usually throw a lot of time and capital into convincing regulators your very innovative and disruptive new R&D endeavor is actually derivative enough to draft behind some existing medical device.