Someone I know is working on a platform to help startups with FDA compliance (specifically the quality systems requirements), who I think would be complementary to this effort. Mind emailing me at brandon@cardiogr.am if you'd like to be put in touch?
This would be me. @koji, I think this is fantastic, as my startup's mission is precisely to demystify the process of getting (and maintaining) regulatory clearance/approval. Would love to connect. Just reached out over email.
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.
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.
Have you thought about including redacted copies of 510(k) submissions available from the CDRH FOIA Electronic Reading Room [1]? You could probably just provide a list of links to the PDFs.
Here's an example of one for a powered laser surgical instrument (warning: 57MB PDF):
We had downloaded several 510(k)s early in our process, but found them so heavily redacted that they didn't really give the overview we needed. That's why we worked so hard to redact as little as possible in our own docs. I'll dig deeper into that set of links to see if there are some that have more info in them. Thanks!
