I completely agree with you. This does have a restriction on engineers, creating new innovative ideas. Medical devices basically have to be pre-existing. This week in the lecture we learned about CDRH. The goal of CDRH is to bring innovative technologies to market, by insuring that the medical devices out in the market will advance and continue to be safe and effective. Therefore, regulation does put a cap on the new innovative ideas which is very unfortunate. I believe this is due to safety. The FDA wants to make sure all devices out in the market are safe for the public. I think companies do this so they don’t face legal actions from the customers. Another issue is time and the amount of research needed for new ideas. This could take years before it could go out in the market.

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/default.htm