What class of device are you talking about? Even if you clear FDA, commercialization is incredibly difficult. I think you're pish-poshing how hard it is to get regulatory clearance, btw. The regulatory approvals in US and ROW are incredibly difficult, costly, and time consuming to meet all the requirements imposed by the various regional authorities. Sounds like you are severely underestimating the costs, work and length of time to generate data and create an approval submission. You won't obtain labeling without funding and running clinical trials. It can take 5-10 years of development and clinical studies and $50-$100 million for PMA approval.

Then if you hit the market you are going up against the most connected, cutthrough, organized and entrenched sales forces from the large device companies who make tech b2b sales look like kindergarteners on the playground. The medical offices, site staff and hospitals all try to block access to your sales force so you are probably going to need to fund and deploy an MSL and RSL force as well and present at all the industry conferences to get any leads and traction.

Then even if you have customers who want your device it won't matter unless you develop a patient access team, lobby to secure reimbursement from insurers otherwise all your previous efforts are wasted. So now you need a market access team and you're probably $200 million in the hole, and you're dead in the water if CMS won't get onboard for reimbursement because all the private insurers generally wait and see what CMS does. Meanwhile any time any of your suppliers change you'll need to run more trials to show validation for safety and efficacy.

With average time to market is 12 years, 75% of new device companies fail for a reason.

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.

Because hardware is very different from software, one does not just switch like that

They do but the industry and regulations are such that this is usually led by people who have medical degrees or, say, phds in relevant fields. A "software guy" can then be up to VP level and lead the software aspect. This makes a lot of sense considering the credibility and expert knowledge required.