> Tech folks pivoting to medical always throws off some alarm bells to me
Same for me. I've been in the medical device industry for 15+ years now and came from "tech". What a lot of techies under/don't appreciate is that the medical device industry is heavily regulated and moves at a muuuch slower pace than other technologies.
There are lots of regulatory and quality/testing hurdles that you must clear (namely verification and validation testing, in addition to your 510(k) clearance or approval, if PMA) before you can market and sell your device.
I tell customers, on average, a Class II medical device project can take 18-24 months and cost $3M to 4M, minimum.
Same for me. I've been in the medical device industry for 15+ years now and came from "tech". What a lot of techies under/don't appreciate is that the medical device industry is heavily regulated and moves at a muuuch slower pace than other technologies.
There are lots of regulatory and quality/testing hurdles that you must clear (namely verification and validation testing, in addition to your 510(k) clearance or approval, if PMA) before you can market and sell your device.
I tell customers, on average, a Class II medical device project can take 18-24 months and cost $3M to 4M, minimum.