
Ask HN: Helping companies re-tool to make ventilators. What do I need to know? - hdivider
I&#x27;m trying to help a number of manufacturing companies build ventilators -- and thus save lives.<p>Their main line of business isn&#x27;t in medical equipment. What resources are out there to help companies re-tool?<p>I&#x27;m aware of MIT&#x27;s Emergency ventilator design toolbox:<p>https:&#x2F;&#x2F;e-vent.mit.edu&#x2F;<p>...but what else is out there? Any insights or existing efforts I should be aware of? Basically I envision a significant amount of re-tooling needed, to be potentially funded by pre-orders.<p>Making this process easier for companies will greatly increase the chance of workable ventilator production, shipment and actual use -- and thus fewer grieving families.<p>Any thoughts? Thank you!<p>Harry
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davismwfl
I saw this from Medtronic earlier: [https://www.medtronic.com/us-en/e/open-
files.html](https://www.medtronic.com/us-en/e/open-files.html). It seems safer
in many ways than unproven designs IMO, but obviously doesn't mean it is best.

University of Florida: [https://simulation.health.ufl.edu/technology-
development/ope...](https://simulation.health.ufl.edu/technology-
development/open-source-ventilator-project/)

Just a couple of things I have seen.

I'd say pre-order funding for a non-medical device manufacturer is probably a
bit scary/unlikely for most commercial hospitals unless the government backs
it. A hospital won't feel comfortable pre-paying from a smaller non-medical
device manufacturer. Pre-orders funded by banks or private funds that are paid
on delivery would be more doable but obviously has different set of risks.

Additionally, right now the FDA isn't allowing any non-approved devices, only
allowing third party manufactures to work with existing device manufactures to
increase their capacity (usually a manufacturer has to be approved by the FDA
to even manufacture medical devices). So I'd start by looking to partner with
one of the larger med device manufacturers with an FDA approved device
already. Any of these open source designs would be required to go through at
minimum an emergency review at the FDA, which they said they are open to but
the obvious first move is manufacture more of what is already approved and has
testing already setup. Then use CE certified vents (EU based vents) since they
have similar standards to the FDA. Then as a last resort move to emergency
approval of these open source designs. I think they put out some guidance on
this exact issue last week, you might want to check with the FDA.

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hdivider
Great points, thank you. Yes, I saw those two designs. I wonder if there is an
effective effort to aggregate all open source designs.

Often engineers need to look at multiple designs to figure out how to most
effectively re-tool. Especially because lots of parts may become scarce soon.

Agree on those vents and partnering with existing device manufacturers. My
guess is we will see more applications of the Defense Production Act in the
coming weeks and months, and so we might have a list of large companies
scrambling to fulfill federal orders. Hence I think the FDA will attempt some
innovation to implement approvals at crisis speed. (Hard to know for sure, of
course. I have dealt personally with only the NIH in a limited capacity years
ago, not the FDA.)

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mtmail
I'm looking at [https://theinitiative.site/](https://theinitiative.site/) (in
your profile) and that is about vaccine development. Is the ventilator help
approach another website/newsletter to connect people? I guess I'm just
surprised somebody works on both.

~~~
hdivider
Thank you -- yes, this ventilator work is the modern equivalent of a side
project, as far as it's possible in the covid age. Advice and communications
work takes less of my time on the ventilator front since it's the companies
doing the actual manufacturing.

