Comment by zomg
11 hours ago
> 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.
Yeah, it seems that their pitch is that they want to move at consumer electronics speed, I mean, their website explicitly says
“Our tech-driven approach leverages software, hardware and AI […]
That means we can iterate at the speed of consumer electronics”
Which is kind of scary but also a bit interesting.
How would you go about regulating an open source medical device? The user can just plop whatever software on there that they want, and ultrasound themselves wherever… play with resonance and focusing, right?
> How would you go about regulating an open source medical device? The user can just plop whatever software on there that they want, and ultrasound themselves wherever… play with resonance and focusing, right?
The manufacturer will still need to validate their own firmware and subsequent updates. Whether it’s open source or not doesn’t matter because a huge part of the approval process is quality control tied to a specific manufacturer.
Anyone who plops their own software will be liable for the consequences and I doubt malpractice insurance would allow it in the vast majority of cases.