[the_d3f4ult]

I'm a physician and I've thought a lot about this in the context of the US healthcare system. Step foot in a hospital and the first thing you notice is that everything is single-use, thousand-dollar widgets. I've been into the idea of open-source medical hardware and software for a while. The unfortunate reality, however, is that the obscene cost of getting FDA approval for even the simplest medical device makes these types of initiatives a non-starter.

The way the marketplace is organizing, most local hospitals are being purchased and re-organized into large regional state-wide networks. At this scale I wonder if it might become economically feasible for a hospital system (or systems) to invest in getting open-source designs through the approval process and then have an in-house engineering department that could manufacture parts for the regional system.

[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.

[derbOac]

Some larger hospitals already have this, or had something like this. I know personally of one that had an in-house engineering team and it was slowly dismantled in a process of outsourcing, until the remainder of the team resigned as a group. It caused a certain amount of chaos.

EHR is sort of similar. To me, the roll-out of that was a disaster, and pushed what was in-house in most cases to being managed by EPIC and other EHRs out of the hospital. The mandates were a big mistake in my opinion, as it forced hospitals to scramble to use something being offered by outsiders, instead of collaborating to produce something open-source, or growing EHRs more organically from within the organization.

I personally blame the rise of hostageware in hospital settings partially on this trend.

My broader point is that although I think there's a lot of potential with open source hardware, software, and things like 3D printers, prevailing economic forces are pushing in the opposite direction. Consolidation and mergers, streamlining everything that doesn't contribute to increasingly dense profits as you go up the administrative chain. In this schema, better to outsource everything you can to trim costs. I don't agree with it, as I think it leads to a lot of hidden costs and hidden but lost benefits, but that's the idea.

Unfortunately, the combination of overregulation and profit-driven hierarchical management is creating pressures against in-house, from the bottom up creation of goods and medical services. The talent is there, it's just pushed out from the top.

Sometimes I feel like healthcare and the biomedical area is today driven more by the interests of profiteers than patients/clients/customers.

[wnkrshm]

This immediately made me think of a cyberpunk dystopia where there are shiny, pre-packaged widgets for the elite and open-source medicine for the poor masses. But then I immediately remembered that there may just be no medicine for the masses instead.

Open source tools could be a boon to civilization though, especially in developing countries - one problem is materials though. Some optics projects are really clever, like that visual microscope malaria diagnostic kit with the glass ball lens. But then again, you think: hey, are real microscopes really that unaffordable? I really have to read up on how that was financed and why that road was taken.