Jeff on Portfolio12 wrote:
This gets to be quite a bit more complicated. The devil is literally in the details. Not only do you have to worry about sterilizing air going out but also coming in. You don’t want to have mold, bacteria, fungus, etc going into peoples lungs that could be forming in the lines. I’m not sure PVC is appropriate for that. There are certain materials that you have to use for medical applications and in the medical device industry they are well known. The functional requirements are a good start, but they would need to be further expanded upon. From an electrical standpoint you have to design a robust circuit in combination with software that has to be verified and validated. You need to verify that the system will not only perform but won’t fail to work or kill your patient when the software or hardware reaches fault conditions. You are going to have to perform some level of environmental qualification testing to ensure you electronics, fittings, tubing maintain functionality, sealing, and structural integrity. Then you need to make sure your design can actually be manufactured without defects, within a reasonable timeframe, and for a cheap enough cost. Of course there’s FDA approval.
This is not everything, but you can begin to see why medical equipment development and production is so pricey and wrought with risk.
Maybe other countries might be more relaxed about what I mentioned above. Obviously FDA approval doesn’t matter in that case, but you still need a reliable, safe, easy to manufacture design.
FYI, I don’t personally work in medical devices, but my wife does as a quality engineer. I am an Electrical engineer but design test equipment in a different industry.