As soon as ANSM (french equivalent of US FDA) hears "linux", "wifi", "connected", they see a scary green monster...

And to be honnest, I understand their point. How can you certify Linux ? So much code behind... It is not a car multimedia center, it is a ventilator, a class III vital device.

In this project, what was really impressive is the gap between the bare minimum (a 4 lines lcd screen + a few buttons + a pressure sensor, and you can make people breath), and the doctors expectations (curves, flow meters, statistics, O2 sensors...).

This is the same for lots of activity: experts cannot work with basic tools anymore. Only High level experts still can.

Conclusion: do not work with high level experts to build your specifications. Also listen to normal experts and doctors that needs more UX assistance.