In the United States, any ventilator must fulfill:
- Safety and
requirements as set forth in Medical Device Standards.
Sales of medical devices are regulated by the FDA: a lengthy (data intensive) and paperwork intensive process. FDA ventilator specific guidance within the context of COVID respirator demand
I would suggest that you identify testable system requirements. The quickest way to learn is to operate an existing device: if you have access to a healthcare professional (Anesthesiologist or Respiratory Therapist), he / she would be the best functional resource. A good starting point (do your homework before talking to anyone) is this functional explanation on youTube.
Challenges for hacking a ventilator for the COVID crisis comprises:
- A design where parts (Bill of Materials) are readily available (100K to 1M devices needed)
- A testbed to demonstrate Safety and Efficacy testing + any required regulatory approval
- Skilled labor to manufacture assemble and test
April 8 2020: Medtronic is sharing its portable ventilator design specifications and code for free to all That being said, a 510K and all the document would be required by the FDA ensure requirements discussed above are met.