Agreed. We'd like to expand fom just FDA specifically (and 510k specific), and get into maintaining quality standards. There are numerous different segments you can expand to as well.

Can you explain why?

It seems to me the big chunk of the problem is that my local hospital doesn't really have to compete with anyone and has rather free reign in setting prices.

There is also a very high overhead required for simply getting products to market. When the easiest way to proceed is by hiring high-priced consultants who hold all the keys, it makes it very difficult for new ideas to become available. Only established players really have the pockets deep enough to navigate the regulatory process.

There are numerous costs that you can't avoid, such as lab testing, clinical trials, and fees for acquiring certifications, but being able to do more on your own as far as documentation is a big first step.

> It seems to me the big chunk of the problem is that my local hospital doesn't really have to compete with anyone and has rather free reign in setting prices.

Yes, there is definitely lack of competition at the provider level which has gotten worse post-ACA. But in this context I'm talking about lack of competition among technology manufacturers. Really easy to set high prices for things when competitors can't enter your market without going through several hoops. That's how you get guys like Martin Shkreli.