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I agree with you, partially. Yes, the short-term financial implications (cost of standards) are minor compared to cost of employees and consultants (source: I
by olieidel 6y ago
I agree with you, partially.
Yes, the short-term financial implications (cost of standards) are minor compared to cost of employees and consultants (source: I am a consultant). However, non-free standards have a gazillion second-order effects which tend to get overlooked:
- Potential founders (think YC) can't "just quickly browse a standard" to see whether they'd want to build a startup in that area.
- Individuals not affiliated to a company won't purchase them for themselves (too expensive) and therefore are excluded from contributing.
- People can't write blog posts which freely cite passages from a standard --> Less public information on how to actually implement a standard in a company.
- People can't make presentations (slides) with passages from a standard --> A lot of paraphrasing and beating around the bush, making presentations more useless.
Imagine, for a second, the following thought experiment: Open source software on GitHub would be behind a similar paywall, say, 50 EUR per software package. You could make your argument again: Compared to engineering salaries, that's a minor amount. Sure. But the second-order effects are gigantic, essentially killing the open source ecosystem because individuals (like a random person from a third-world country) are entirely cut off and barred from contributing.
Or, like: Would DHH have written rails if access to Ruby would have cost 50 EUR?
- deleted 6y ago[deleted]
- ska 6y agoI'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"
- passivate 6y agoI'm in biotech and its a very similar situation here. We're a small company and dropping a few grand on regulatory documents would be a non-issue, a negligible part of our operating budget. Having said that, we would rather just pay for consulting/expertise from someone who has experience with the regs rather than interpret them ourselves. I remember buying my first ISO document (INCITS/ISO/IEC 14882-2003) for $30 in like 2005 or something, back when I was still writing code. I thought I would become a better C++ programmer, armed with the standard, but turns out it didn't help me at all (reading books/writing code helped more). I did become a better standards-lawyer though! :D