Their main line of business isn't in medical equipment. What resources are out there to help companies re-tool?
I'm aware of MIT's Emergency ventilator design toolbox:
https://e-vent.mit.edu/
...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.
Making this process easier for companies will greatly increase the chance of workable ventilator production, shipment and actual use -- and thus fewer grieving families.
Any thoughts? Thank you!
Harry
University of Florida: https://simulation.health.ufl.edu/technology-development/ope...
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.