> is it smart to be the first company to start mass-producing an open-source medical device?

Certainly none of the existing ventilator companies would have that incentive. The best case would be public funding -- a country with a large enough single-payer system could potentially justify as cost-saving and building supply chain resiliency.

A new company, that doesn't have to worry about cannibalizing its existing line of business, may be able to make it work also. Just because a business model is less lucrative than another doesn't mean it's infeasible.

Would another manufacturer automatically inherit your certifications? I'm ignorant here, but I would be very surprised to learn that merely having the same basic schematics means no certification cost.

No they won't indeed. And that's a common misunderstanding within the "makers" community that Regulatory bodies approve or authorize a "Design". They approve a design and its supply chain, in the context of a specific market, intended use and indication for use.

"even after it became clear that ventilators aren't uniquely useful for treating covid."

Is that established knowledge now?

I remember the discussions about it here on HN quite early, but for example here in germany, I believe lung ventilators are still the tool of choice for serious cases. At least, I never found information, that they changed policy towards it.

ventilation is the standard course of care for ARDS and most covid crisis cases present as ARDS. it’s great. don’t look it up.

in the first few months, ventilation was used extensively as both a last line of defense and a preventative (maybe we can keep your spo2 above 60% and you will therefore have a better chance to survive).

covid presents very strangely for a respiratory infection, especially in regards to spo2 measurement where patients have greatly diminished capacity to carry oxygen but otherwise seem fine—having conscious conversation, walking. there were a couple of months of basically expert trial and error—take what we know of best practices and apply it in a real world setting with no ability to test effectivity other than whether or not your patient lives or dies. this has been awful for hc worker morale, stacked on top of all the other things (bad ppe availability, long hours for months with no end in sight, hospital administration getting paid while they fire hc workers due to lack of elective surgery, etc).

we are intervening earlier in more proven ways now (such as proning the patient with supplemental o2 rather than immediately ventilating). we know what we are doing better than we did in march (when we knew almost nothing). but it is still extremely difficult to intervene once a patient declines past a certain threshhold. ventilation is still being used as the “keep this patient alive and hope for the best”, but something like 50% of patients with ARDS die within 3 years anyway so you really don’t want to need to be vented.

everyone stay safe. i’m getting the war stories from my sister, who is an ER nurse at Vanderbilt—whose narrative has informed this post since i know fuck all about the application of medicine.

Ventilators are useful, but now that we have more experience, we've learned that you don't need to intubate as early as originally thought, so the original concern that we will run out of ventilators is much less. In my experience, the biggest bottleneck for care has been nursing staff, especially critical care trained nurses.

They should just go for markets that aren't made up of lawyers that want to sue everyone and medical companies that want to rip everyone off. So somewhere outside the US. The EU would likely be a more welcoming market for open source.

The EU is about as hostile to open source as the US is, and it's also considerably anti-business compared to the US, which manifests e. g. as extremely complicated regulatory requirements, which is not really what open source shines at.

> it's also considerably anti-business [...] extremely complicated regulatory requirements

Do you have any personal experience with starting a business in the EU and receiving hostility or dealing with complicated requirements? (asking emteycz here, no one else)

I've started multiple businesses in different EU countries and never hit any "extremely complicated regulatory requirements" when I've done it. Basically sign some papers, pay the necessary fees (if even needed, not always a requirement) and make sure the company reports accurate numbers each quarter and you're basically good to go. Is it any easier in the US?

Or are you simply echoing other peoples opinions here?

IDK if "cz" means Czechia in the name of OP, but yes, once you employ somebody and are a VAT payer, your paperwork goes way up. You can outsource it to your accountant, though.

AFAIK employment is bureaucratically easier in the US and none of the US states even has VAT.

But other barriers have fallen recently. If you wanted to start a Ltd company here in Czechia around 2005, all the necessary paperwork took about 100 days to complete. This has been optimized, now it takes just several days and the fees have been cut in half.

I ran a business in California - there sales tax is incredibly more difficult to manage than the VAT (GST) here in New Zealand. Imagine having to charge someone a different sales tax rate depending on which county they live in .....

Only five US States don't have Sales Tax, and most counties and cities have their own, too.

I was born in, live, work and do business in the EU.

Perhaps you're talking about one of the 'free' sectors? My IT services business is as easy as you say, even being a VAT payer is not that bad to me (but is to others in different sectors).

Medical devices, or e. g. people transportation (which I have experience with) are the polar opposite.

Medical devices and transportation sound like exactly the kind of areas that should be heavily regulated (and are in the USA as well as the EU).

No, transportation definitely is not as regulated in the USA as it is in the EU. I'm not against regulation, and you're right that medical devices should be regulated more than less, but tranportation is overregulated for nothing.