I'm just finding the healthcare example among the weakest. To be a bit US specific (this varies worldwide); the FDA publishes a ton of information on what the

I'm just finding the healthcare example among the weakest. To be a bit US specific (this varies worldwide); the FDA publishes a ton of information on what their expectations are. You absolutely should be reading their guidance documents, filing process, etc. That gets you past the "is this something we should do" phase. You'll likely get to the point you have a conformance plan for 13485 or similar, at which point you have a real project committed so the small fraction cost thing applies. The most impactful healthcare standards aren't about "here's how you build a device", they are about "here's how you build an organization capable of building, shipping, and supporting a device". Once you've got your head around that, you're off and running. On the R&D side of things, there is actually little bureaucracy for it's own sake, mostly it's about implementing good engineering practices in a traceable way. I guess my response is to your "Healthcare startups are struggling with this" is that I know a lot of healthcare startups, and they struggle with a lot of things, but this typically isn't one of them. To me ISO-8601 not being freely available is obviously counterproductive. ISO 13485 or 60601 not being freely available is more "well, not optimal but doesn't make much difference"