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Comment by ska | Hacker News Reader

> Healthcare startups are struggling with this

Healthcare startups are one place that shouldn't really have a practical problem with this - the cost of standards is a drop in the bucket compared to your overall cost of regulatory/quality implementation, filing, etc. Sure, it stings a bit to hand out a few thousand for pdfs but it isn't going to affect your business plan. If you don't have a plan to pay for all of this this you are already dead in the water.

I'm all for streamlining the implementation but a lot of it is just about implementing solid engineering practices. Note, I'm absolutely not saying you should insist on bloated slow processes, this definitely isn't required.

I also think it would be great if we could fund the ISO a different way and make all the standards freely available. It's just not going to make any real difference to your ability to execute as a healthcare startup.

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> Sure, it stings a bit to hand out a few thousand for pdfs but it isn't going to affect your business plan.

How will they even know what their business plan is without knowing what standard they will be providing?

Last time I checked in Australia, compliance with pay-for-access standards was required in many laws. It is outrageous, because it means you don't even know what you are legally required to do without paying some corporation money.

To add humour to the situation, I think that corporation got bought out by the Chinese at some point. Can't swear to that, I forget what is handled by SAI Global v. Standards Austarlia.

Anyhow the whole situation is a black stain on the idea of equal access to the law.

> How will they even know what their business plan is

If you head into something like healthcare without any idea of what you need to do, you are begging for trouble. By the time you are buying any standards, you know which ones you need and how they fit in with everything else. Any real business plan will have researched this enough to get a ballpark. This is table stakes stuff.

You can research it all yourself in a few days and get a reasonable idea. If your team is all inexperienced you should probably spend a few consulting hours on guidance.

If you have anything like a real plan for a company, this is peanuts. If you don't, you do not need any of this stuff yet.

There’s a difference b/w how things are and how things should be. The former doesn’t excuse away the latter.

I think that everything a law sets forth should be publicly accessible. No law or reference in law should be paywalled. There might be a small fee involved, but it should only exist to cover administrative costs of distributing the information.

> but it should only exist to cover administrative costs of distributing the information

and that is what created the current situation.

> There might be a small fee involved, but it should only exist to cover administrative costs of distributing the information.

Laws should be freely (as in free beer) available. Laws should not be tucked away behind a paywall or behind "case law" or behind "international standards" that the layperson can't access without a fee. No fees. That's what taxes are for.

> How will they even know what their business plan is without knowing what standard they will be providing?

Are there no drafts available for most standards? For C++ the draft is often as good as the standard, and anybody can access the drafts. Is there nothing similar in other areas?

They exist and it is possible to get them, but I have never done so in a way I could find through a search engine.

Well, if you're a single guy WFH with a cool-idea for some medical tech and you want to build a prototype to see if it's worth starting a company, then 200€+ per PDF (per person?) adds up and becomes cost-prohibitive.

You don't need any of this to build a prototype. You need it to productise your cool idea, and they you aren't a single guy WFH.

How can you build a prototype without the information in the standards that tells you the limits to how you design your prototype?

Just do it all again when you get customers, which you can only get after your’re actually approved for business, for which you need the standards.

I guess maybe you can just ‘hope’ you comply and let the inspection figure it out if they ever show up.

You are going to have many iterations after that first prototype. Your looking for proof of concept here and some early user testing, a long way to product yet; basically enough detail to know the right questions to ask.

Spend GP's €200 on some time with a consultant who has already read them.

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?

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"

I'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

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