[rvz]

Because just like in the legal profession, finance and the defense industry, medicine is a heavily regulated and protected field (as it should) which is meant to gatekeep against low quality or harmful "medical" devices that could be built by anyone.

The costs itself to enter already makes it close to impossible without outside funding which is why you see less startups in this and more vibe-coded toys that are at best experiments.

No-one would be happy to hear that they are using a "vibe coded" medical device instead of the established solutions.

[piratesAndSons]

I am talking about class 2 medical devices. It takes you maybe $200k at the high end to clear FDA and trials. High enough that all these bottom feeder LLM providers will drop out but low enough small burners can thrive.

There are two enemies. Chinese manufacturers who will dump a cheaper alternative the second you find success. With FDA and trials gates, they are out. The second is LLM guys who sit in the middle vulture state. They are ok with violating every law, every established norm except industries that are more powerful than them: healthcare and banking.

By forcing them to invest at minimum $200k-250k per product, they will be a lot more hesitant. It is easier to violate some poor author's copyright, but in this case each time they try to compete with you they have to jump this high gate.

I am not saying this is easy money. There are established corps already looking to expand their business, but $10M-15M won't move the needle for them, and for those it does, you can compete.

[mionhe]

I work in this field, and I've never seen a device that isn't dead simple be able to clear the FDA for $200k. I've definitely never seen a medical device with software anywhere near this.

The reason people don't switch to medical devices is because even a fairly simple device without software or electronics can still take between $750k and $1.2M to develop and clear the FDA. Adding software is a cost & time multiplier.