Ask HN: Why don't software developers make medical devices?

As software development becomes a commodity thanks to LLM, I wonder why more software developers don't switch to building medical devices to make their careers more secure. Here's why I picked medical devices in particular.

1. Natural Moat

Since human body hardware is more or less immutable in its most essential parts, you don't have to worry about some LLM hype cycle replacing you. Once you build the product and clear FDA or local certifications, you're set. Unlike Uber destroying the taxi medallion business, healthcare is a beast — no tech startup dares to bypass all the regulations and gatekeeping.

2. Regulatory Moat

The medical devices I'm talking about require around $50K–$200K for FDA clearance — low enough that any small business can manage it, but high enough to discourage bottom-feeders and Chinese product dumpers. It also lets you avoid the big established healthcare corporations, because this market segment is too small for them to care about, yet large enough for you to pull in $10M–$15M a year in revenue.

Medical device manufacturing sidesteps the two fatal flaws of software development: the lack of a moat and static, almost never-changing hardware margins. LLM companies don't care about copyright, IP, or the health of the broader economy — but they can't go head-to-head with the healthcare industry, so you don't have to worry about them at all.

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

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.

I think it is protected by many moats. Personally I don't mind building and using devices by and for myself, but to commercialize them? It's going to be a huge headache, and you can bet that many companies sit on the moats for their lunch. You and I will never know which of the moats really make sense and which ones are simply BS for barriers. It's too much hassle.