Hi Ron, and welcome!

Ideas that help people are wonderful. You are correct that they may require special approvals and testing to see production. In the case of my prosthetic hand, and possibly your idea, there is a grandfather clause that makes it easier since my idea is a replacement for an existing device. I need to show basic equivalence to the existing device relative to what the patient feels.
Other considerations include whether or not you need to go through human testing. Questions like this are the main reasons I felt licensing was my best choice. By licensing to a company in the appropriate field, you team up with someone who already knows what approvals are required, already has contacts needed, and already has a distribution system. These are huge advantages.
I am a big fan of EN, so I would recommend using their medical innovation search.
Good luck. Let’s make the world a better place.

Welcome Ronald!

There will be another Innovation search soon and medical is one of the catagories that your product might fit in. Use the search button above and wander the threads. Check out Mark Stark, he made something special and it was chosen for development by EN.

Check this out: http://www.edisonnation.com/prosthetic-hand

Good Luck.