This looks like an awesome product. Buy the rights and open the source code so we can have hundreds of eyeballs on it. I am sure lots of improvements can be built around it including better regression testing, monitoring, finding existing bugs, etc.
If the choice is no FDA approved ventilator vs one that is not approved I think the second option is the better one. Emergencies will change the landscape rapidly to the point where such luxuries as FDA approval will no longer matter as much as they did before.