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by randycupertino·5mo ago·view on hn ↗
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.

1 comments
That is my point, though. You want something hard, something that requires actual money, effort, infrastructure, and lobbying. That in itself is the moat. As software developers, we have been lulled into this entirely unrealistic mode of thinking that extremely profitable products do not have to be expensive or high effort to bring to market.

That is exactly why vultures like LLM hustlers find their opening. There is a reason you do not see fly-by-night LLM hucksters selling medical insurance or devices, not because they cannot do the job of building the thing itself, but because the surrounding moat is too high for them to clear.

You’re defining a hustler as someone who can’t manage a small company or who is unwilling to do extroverted or operational tasks. I don’t think that’s helpful because there are plenty of hustlers oriented around those tasks, who now also can advance the software side and a lot of the paperwork with a smaller team, perhaps even with a semi-technical team or cofounder. The existence of these people means that to me, a person comfortable with thorny operations, marketing, and compliance issues, the existence of lazy vibe coders don’t affect my estimate of profitability of a medical device startup.