Slashdot Mirror
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.
Hi! Medical equipment designer here for several companies. He's partially right. It often doesn't take expensive equipment. Soap is a good example. And EMT's can do wonders with a 14ga needle.
However, to sell equipment in the USA and many other countries takes extraordinary amounts of validation testing. Lot's of documentation and proof. I won't even bother with the list, but check out CFR 21 for a taste. That extra work takes time and money. And that's where the first layer of expense comes from in our medical system.
If you're willing to dump the safety requirements corporations must follow, you can do things a lot cheaper.
I've had cancer and I've drank carrot juice - it's a close call which is worse.
A lot of tools in medicine are initially built as one offs, effectively home built. However, when dealing with medicine the controls are simply not good enough. When we build and test a medical device, it takes rigorous testing to know how it will interact with patients and other devices/ medicines. Home built devices simply are not consistent enough to be able to keep things within allowable guidelines. It is bad enough that unrelated symptoms get reported under current practices, but homebuilt would make it thousands of times worse. Even little differences like acrylic vs paper tape can lead to large repercussions and few are going to take on that liability.
Of course the party you either fail to appreciate, or dont want to mention is that the regulations are strongly supported by the incumbents.
It created a very artificially high gateway to entry for competitors, while the cost of maintaining it is well covered for the current manufacturers
who use it as a way to charge artificially high profit margins in the name of 'safety'. Many of the regulatory requirements have been actively
created BY the manufacturers..
This is of course how almost all of the medical industry operates, certainly not just the manufacturers.
The natural reaction to this is of course a black market in affordable 'medicine' for people who just cannot afford to take that ride. Unfortunately
the US has just taken the opposite tack by trying to 'spread the load' instead, continuing to fuel its insane medical inefficiencies, and to continue
to maximise profitability for medical related companies. What a surprise.
If you really think that top quality medicine costs that much, then I suggest you visit South Korea... Their private medical services are very high
grade, and cost much, much less. Their fault rates are also lower..
The fact is that a lot of diagnosis (and other) equipment is cheap to make these days, and is not directly a safety threat to patients. The medical
system however does not want large price drops in one area, as they are worried at all levels that it may tip the scales and their own gravy trains
may get tipped..
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?