3 ms·
> It was actually a bit depressing to see how much stuff is available, just not available in the US One reason for this is strict regulations. U.S. FDA Title 2
by jwr 6y ago
> It was actually a bit depressing to see how much stuff is available, just not available in the US
One reason for this is strict regulations. U.S. FDA Title 21 CFR Part 11 is very strict as to what a medical device company needs to do, and it's not easy to meet those requirements. Most people do not realize that even in the early startup stage, if you build something that is a medical device, there are rules to follow (mostly about traceability: you have to know what you've built, using what parts, and where those came from).
Shameless plug: I am the solo founder of PartsBox (https://partsbox.com/ https://partsbox.com/), which helps a lot with managing traceability when building electronics.
- pueblito 6y agoI would be interested in knowing more about the tradeoffs between their system and ours, if you could expand a bit?
- jwr 6y agoWhat do you mean by "their system"? Similar restrictions exist in the EU, Canada and Japan — I'm not familiar with the rest of the world. I suspect developing new products in China is much easier, and you can showcase them anywhere.
- blhack 6y agoYep. This was my major takeaway. There is so much incredible opportunity there, but the regulators are in the way.