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The Next Generation of Medical Tools May Be Home-brewed
An anonymous reader writes: In the Little Devices Lab at MIT, Jose Gomez-Marquez builds medical tools using a DIY mindset. He's designing cheap alternatives to existing hospital equipment to help spread high-quality medical care around the world. Gomez-Marquez is at the forefront of a large and often-unrecognized group of DIY medical tool builders. Together they are challenging the idea that staying healthy requires extraordinarily expensive, sophisticated equipment built by massive corporations. Harnessing this inventive energy, he argues, could improve the health of thousands of people around the world.
Aircraft instrument designer here, I've got a quick question for you.
Avionics certification require a lot of paperwork and documentation as well (DO-178B), but my impression is that it's mostly "paperwork for the sake of paperwork".
The FAA makes a big deal about things which have no impact on safety, make a big deal about things that have little impact on safety (coverage analysis), and leave the device testing completely in the hands of the manufacturer.
In short, if you have a process and paper trail, you can get certification. The aircraft manufacturer is the one that actually requires safe design practices, and this is lateral to the certification process.
Is it the same in the medical world? Are the requirements mostly about paper trails and accountability, or are there some actual safety regs there? What proportion is about safety?
For example, we hear all the time how medical devices have no security, that they can be easily hacked, pacemakers can be reset in the wild by a hacker, and so on. Is device security not part of the regs?
(I complained about the lack of common-sense safety regs in the FAA, and was told that it's bureaucratic safety, not human safety. The FAA people want deniability of blame, so they worry about procedure and regulation rather than actual safety.)
I wonder how much of the effort actually goes into making a safe device. The FAA system is still stuck with 1970's guidelines for software safety, for instance, and has never updated with modern theory. (I could give you a list...)
So... how much of the medical certification process actually keeps us safe?