@jonny wow this is awesome! Do you think it could get through clinical validation?

we tried for a long time, but couldn't find a way through the US process, even with an EUA, without a corporate liability sponsor which required us to sacrifice the IP being fully copyleft. you need to have someone to sue in this system, so someone has to be making money. so we meet the FDA benchmarks, but would never be approved by a regulator. this is a vent of last resort, a "foundation" monolith, and a research vent for now.

like the model of open source being inspectable and less error prone than just throwing proprietary engineering time at it is something that structurally works better for most problems, but the stakes are too high to use it to save a life if you have any other option that's legal without years of battle testing.

so the hope is that by being as meticulously open as we could about the hardware and software design as we could that we leave something that can be used by people shut out of the western medical profit system but nonetheless have need for invasive ventilation, and can serve as a plausible basis for design in the future (as most COVID vent projects didn't attempt or didn't make it to full pressure control, most were volume control)


@jonny that makes sense, thank you for the explanation :)

· · Web · 0 · 0 · 1
Sign in to participate in the conversation

kanoa.de - eine freie unabhängige Mastodon Instanz. Poste Links, Bilder, Videos und Texte. Folge Freunden und finde neue Freunde.