[HeyLaughingBoy]

At least in OSH for Medical Devices, the limiting factor under current 21CFR regulations would probably be Manufacturing and the associated support operations. Design & Development is tedious but doable in an OSH/OSS fashion, and getting through 510k could probably be solved by people donating skills (and someone else donating cash). Don't quote me, but I don't think that the actual fees that the FDA charges to do a 510-k submission are not particularly high, it's just that the work that goes along with it is burdensome and people want to be paid. In an Open Source approach, this could largely go away as long as someone donates the fees.

That gives you a design that the FDA is happy with.

Now you have to build, distribute, service and support that device and no matter how you slice it, you're looking at substantial costs to comply with 21CFR across all these tasks. So this is where the creativity really has to come in: can we spread those costs across a "community" to make it worthwhile, or will we just end up right back at Square One with single use, $1,000 devices?

I don't think there's a path forward (at least in the US) without change to regulations.