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 le…
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…
Re: Ask HN: Why don't software developers make medical devices?
#21You’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.