I think a physician who wants to create their own medical device would face a lot of challenges, even though their medical expertise would give them a strong starting point. One major obstacle is the gap between knowing what patients need and actually designing a safe, functional device. Physicians aren't usually well versed in engineering, regulatory affairs, or business development to my knowledge, all of which are essential for getting a device from just an idea to the market. Another big obstacle as others have mentioned is the price tag as prototyping, testing, and navigating FDA approval all take significant resources. To overcome these hurdles, I'd say the physicians best bet is to put together a team of experts in each of the fields I mentioned above. Partnering with universities, medical device companies, or even startups could also help with this endeavor to provide technical or financial support. It would be up to the physician to decide on whether to license their ideas to companies with resources or continue to try to lead the development process themselves.

In my experience, the difficulty of an individual to create their own device doesn't come from the creation of the device itself. I believe it comes from the ability to have the device fulfill FDA requirements to either allow them to use the device in this setting or to sell to other companies in the event they want this to be a commercial product. The creativity is always there and it should always drive the individual if they desire to have this project completed in a way complimentary to their practice, however the FDA regulations will always be there. With this frame, it is always easier and more intellectually beneficial to find creative ways to surpass the "roadblock" that the FDA could be than to change or decrease the FDA regulations. What are your thoughts?