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.
If coming up with a cheap nebulizer - which costs a hospital $2.50 for the plastic bits, is the best he can do, then this isn't going to get us far. Sure, the battery powered pump costs a couple of hundred dollars retail but anyone with more than a slotted head screwdriver for a brain is going to realize that it's an aquarium pump. This is hardly the earth shattering breakthrough that TFA insinuates it to be.
The other mentioned device, a better way to extract babies from the birth canal is certainly interesting but it represents the efforts of a single clever person (not associated with the MIT lab in any way). I don't think anyone has decided that there are no more smart people amongst the 7 billion humans on the planet.
Hopefully, this isn't reflecting where MIT is going but I'm beginning towonder. They seem to be in the news for all manner of Silly Little Things associated with important sounding laboratories.
Faster! Faster! Faster would be better!
Carrot juice to treat cancer, etc.
I guess it's gonna be the same thing but more sophisticated.
Woo, I'll start on the cough medicine!
This is something I could totally support.
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It's Maker 3D-printed game-changing crowd-funded disruptive tech!
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.
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.
When I go on WebMD or wikipedia, I always apparently have a rare jungle disease or cancer based on my symptoms :P In reality it's usually lack of sleep or too many tacos. So self-diagnosis isn't usually great, but they are true that people charging 10 million for an MRI device is RIDICULOUS. It's all insurance money so nobody cares, which messes with the supply and demand system.
When someone's computer breaks, they bring it in to my shop with a list of symptoms, error codes, etc and then I fix it. That actually does work. So I could see self diagnostic cheap equipment working.
I'd hate for the crapfest that is forked software patches to intersect with modern medicine.
"Quick! Install the patch for OpenSSL before your pacemaker crashes and YOU DIE."
"Nah, you need version V1.2.003, Barney patched it last night."
"It doesn't work on HealthSmart devices, for that you need the unapproved fork from SuplexNet, there's a binary from three months ago that might be compatible with your web frontend but it might break the audio. There's a few issues there. Don't mind the corruption on the graphics though, that's a known issue, one of the contributors is working on it after he gets back from the Himalayas. As long as he gets back before the other devs get too wirey because there's talk they're going to fork that tree off for a rewrite within a few months. What's that? This is for your toe-nail clippers? Yeah...the toenail clippers."
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?
When your facilities and equipment are free, your materials and labor are heavily subsidized, and you don't factor in legal or accounting overhead, it's really easy make cheap stuff!
How expensive would it be to attract the talent an MIT lab attracts for free? How much would it cost to build similar facilities, hire the same quality of administrative staff, hire equivalent IP lawyers, have the same legal and insurance freedom to operate, have the same quality accounting tools...
If it's at MIT (or some place like it), it starts off VERY expensive. When those guys can go off campus and do this with an independent funding stream, THEN it will matter.
Modern hearing aids cost a hell lot more than it should have cost - resulting in hundreds of millions of hearing impaired patients worldwide don't get to be equipped with hearing aids
If a DIY version of the hearing aids could be had, then many more people would benefit without having to lose their limbs to those blood-suckers
"staying healthy requires extraordinarily expensive, sophisticated equipment"
Not all the time, but for the most part 'staying healthy' requires eating sensibly and exercising.
And, yes, that can be 'home-brewed'.
It often doesn't take expensive equipment, it however takes deep pockets to insure against the blood sucking parasites called lawyers who have infested our courts and society!
Someone I know had to go in for basic hernia surgery. However this person was an avid flint knapper. He asked his surgeon if he could furnish obsidian blades for his scalpels since obsidian, when fractured properly, creates a edge just a few atoms thick, far thinner than the sharpest steel blade. The result is a perfect cut that leaves very little scar tissue, and no perceivable scar.
I don't know why there isn't a bigger obsidian scalpel industry.
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As a physician, his nebulizer kit raises some issues.
First, I'm not entirely sure why it has a solderless breadboard. Sure, many of us would have no trouble wiring up a simple circuit. However, the goal of this project is accessibility, and it just isn't going to work to hand a breadboard and a schematic to the general public and expect them to build something.
Second, how much will the product liability be? Asthma can be fatal. It can be fatal even with the very best treatments in place. It's simply a matter of time until someone dies while using this nebulizer, and it's only a matter of time until someone sues.
Finally, you can find nebulizers with cash prices of well under $100 right now. If it gets billed to insurance, the price will be listed at $1000, but in the end about $100 will actually change hands. How much of a savings is this version?
The one advantage I see in his nebulizer is the lack of an electrical plug. There are parts of the world without reliable electricity, but this isn't an issue in the US.
Just some thoughts. I wish them well, but they really need to find the right niche for their efforts.