That's awesome! At least in my limited experience developing health care hardware is much more challenging when there isn't a clear "regulatory path" that has been done before. Which makes it harder for completely novel devices (eg versus making an improved pacemaker which already has been approved)
The good thing for us is that artificial pancreases are regulated not as one device, but as three separate (interoperable) devices: the pumps, the sensors, and the control software. Only our control software is under a de-novo pathway ("totally new thing" pathway), everything else is 510k ("we know what this thing is" pathway). We also have Breakthrough Device designation, which really accelerates the regulatory timeline
