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Keep in mind that TuringNYC did not even MENTION the main issue that trips up most startups... ie - they are unfamiliar with how to secure, (and KEEP), FDA app
by bilbo0s 10y ago
Keep in mind that TuringNYC did not even MENTION the main issue that trips up most startups...
ie - they are unfamiliar with how to secure, (and KEEP), FDA approval for their products. It actually comes as a surprise to many of them that they even NEED FDA Approval. Then they are further shocked by how invasive the process is, and how long it can take. And don't even get me started about the look on their faces when they realize that, despite all of that, you're still held CRIMINALLY accountable for any bugs in your software. (Stay away from anything that might injure anyone if you are unsure of the ability of your process to reliably prevent bugs. Things like RTP are no-go areas for all but the most meticulous medical software developers.)
Don't get into medical software unless you have an extremely long, and very well funded, runway. This is not an industry where 2 guys in a garage can innovate and side-step the regulations. And whatever you do, stay away from anything that could actually harm the patient if it is wrong.
- mhb 10y agoChina Creates Special Economic Zone for Medical Tourism: https://news.ycombinator.com/item?id=14022383 https://news.ycombinator.com/item?id=14022383
- TuringNYC 10y agoVery good point @bilbo0s and thank you for bringing this up. I didn't mention it as we focused on a non-clinical diagnostic (thus not subject to FDA), decided to entirely avoid the US market (focus on more less risk averse economies open to innovation and aligned via ACO-style systems.) FDA is definitely the biggest hurdle of them all. I'd shudder if we had to deal with that 600 pound gorilla.