Yes. We spent as much time testing our alarm and monitoring system as we did doing gas delivery changes. And even on the gas delivery side, simple things like t

Yes. We spent as much time testing our alarm and monitoring system as we did doing gas delivery changes. And even on the gas delivery side, simple things like the patient changing positions while the ventilator delivered a breath could be damaging without following the standards explicitly. I think there are about 2 or 3 thousand different little functional requirements for building a ventilator. It took us about a year to get to first prototypes and then another year to get to the first passing of our system-level tests. Even just our alarm system was very complicated, with cross-checking alarms and even cross-checking that the audio was indeed playing back. Things like playback tones and frequencies and alarm indicator colors and flash frequencies are highly regulated with relevant standards. And nuisance alarms are almost more important to avoid than having enough actual alarms. No alarm is as useless as the one the clinician turns off because it's the 4th time this hour it's gone off and the patient has been fine every time. These are not easy devices to build, and selling something that doesn't meet the applicable standards and isn't substantially equivalent to something marketed today is unlikely to be particularly safe. You can easily do more harm than good by giving someone an untested ventilator.