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Medicine Technology

Paging Dr. MacGyver: Maker Movement Comes To Medical Gear 61

Posted by samzenpus
from the get-me-an-avocado-an-ice-pick-and-my-snorkel dept.
eggboard writes "The maker movement has started to rapidly turn to medical gear, especially in developing nations. The early results are quite marvelous, but there are a ton of concerns, too. The pace of change is incredibly fast. From the article: '[Many people] without any without any formal medical training—can take advantage of access to global supply chains, cutting-edge medical knowledge, and recent leaps in design and fabrication technology that have made the prototyping process faster, cheaper, and simpler than ever before. Even as concerns about safety and liability are only starting to be addressed, medical inventors and other technical tinkerers are already improving and saving lives—sometimes their own.'"
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Paging Dr. MacGyver: Maker Movement Comes To Medical Gear

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  • From the summary (Score:3, Insightful)

    by codeButcher (223668) on Thursday January 16, 2014 @09:27AM (#45975167)

    From the article: '[Many people] without any without any formal medical training—can take advantage of access to global supply chains, cutting-edge medical knowledge, and recent leaps in design and fabrication technology that have made the prototyping process faster, cheaper, and simpler than ever before.

    And Many people without any formal language training -- can take advantage of access to global electronic publishing media etc.

    • Yeah, and look how that turned out [slashdot.org].

      I'm not saying you're wrong. I'm certain that giving everyone the ability to make anything in the way that only expensive fabrication factories could before will be as revolutionary in it's own way as the Internet has been for language, publishing, news reporting, etc.

  • by Anonymous Coward on Thursday January 16, 2014 @09:30AM (#45975183)
    The cause is a very noble one but one can see it being only applicable to countries where people are far less litigious and the red tape required to get a product to market is not inversely proportional to your bank balance. It is a sad fact that there are now so many no go zones for inventors there is little wonder that innovation is beginning to stagnate. People can't play with nuclear materials or even the most basic of chemistry sets without arousing the suspicion of the ever more paranoid security apparatus. There needs to be some sort of national exemption for the real tinkers that affords them some protection from litigation and without fear, it is in my opinion can only then real advances be made.
    • Re: (Score:3, Interesting)

      by TWX (665546)
      "Makers" in my view are predominately a bunch of wannabes; excited and enthusiastic but lacking in real capabilities. They may have an idea for something, but often they have no idea how to go about designing and building it, have to rely on the manufacturing expertise and trades of others, and yet think that they're really accomplishing something.

      This is only going to be worse in medical spheres. "People" shouldn't play with nuclear materials, if they're serious about it then once they've received f
      • I don't get your hatred of Makers (as long as they don't bust into your workshop and enthusiastically destroy your tools), can't you just avoid them?

        Sometimes, people "playing" with new materials/techniques actually make big breakthroughs. I doubt that Pierre and Marie Curie would have discovered so much about radioactivity if they had to go through all of your red tape. Conversely, they may have lived longer, but how are we supposed to learn these things without experience?

        If someone is prepared to ta
        • I doubt that Pierre and Marie Curie would have discovered so much about radioactivity if they had to go through all of your red tape.

          Probably not. But their original papers are still too radioactive to touch without wearing protective equipment.

      • by AthanasiusKircher (1333179) on Thursday January 16, 2014 @01:02PM (#45977223)

        First, let me be clear that I do not consider myself associated with the "maker" movement. When I first read about it (mostly in skewed media accounts), I too had a negative impression -- since the media reports I happened upon tended to focus on people who get a lot of attention for ambitious and overly broad goals, but little practical results or expertise. But I don't think that's a fair characterization of the whole idea.

        "Makers" in my view are predominately a bunch of wannabes; excited and enthusiastic but lacking in real capabilities. They may have an idea for something, but often they have no idea how to go about designing and building it,

        I think you're talking about idealist idiots who don't actually do anything, rather than people who actually participate in making things. Sure, there are plenty of the former in the world, but the main driving force of the "maker" movement (as I understand it) is to transition more people into the latter category.

        have to rely on the manufacturing expertise and trades of others, and yet think that they're really accomplishing something.

        There's nothing wrong with people collaborating, or even relying on pre-existing manufactured goods which are combined or tweaked in some way. Or would you have everyone all go out and mine their own ore with their bare hands and build a forge so they can act as blacksmiths to make tools that would then allow them to start producing things? We all relying on expertise and labors of others in civilized society. If you can add some value by doing something more with the work of others, what is wrong with that?

        This is only going to be worse in medical spheres. "People" shouldn't play with nuclear materials

        Okay, I know the GP mentioned nuclear materials, but I don't think that's at all a fair comparison for the kinds of medical devices primarily mentioned in TFA. Go read it. The examples they give are things like modified construction helmets with added electronics that work as a kind of "hearing aid" for people with particular auditory problems. Otherwise, these people would have to buy ridiculously expensive devices or have surgery. Also from TFA -- some prosthetics... which are just as effective (or more so) compared to expensive standard "medical" ones. Some of the things mentioned in TFA have even been approved by government organizations because they proved to be better than or useful in different ways from existing technology.

        I absolutely agree with you that there are many medical devices which should NOT be a DIY job. If you need a tool during surgery, or you need diagnostic equipment that gives reliable results, people's lives will be on the line when something fails. But a specialized DIY hearing aid?? What's the worst that's going to happen if it malfunctions? The person just takes the thing off. It's probably no worse than some sort of "approved" device having its battery go dead or something.

        TFA for the most part outlines a lot of situations for medical devices that won't be likely to kill or even significantly harm someone if they malfunction. Instead, the choice for these people often is -- live without hearing or a hand or whatever because they can't afford the "approved" device, or get the DIY one for a tiny fraction of the cost.

        You really think this is that bad? We're not talking about people playing around with nuclear materials in their basement.

        I'm not deluding myself that somehow my tinkering or puttering around will affect anyone besides myself. Applying a label besides "hobbyist" is stupid.

        Yeah, see I think you're missing a critical distinction. I associate the term "hobbyist" with exactly the kind of thing you describe: someone who works on stuff that doesn't really provide a significant benefit to anyone, other than perhaps entertainment or a sense of "accomplishment" for the individual doin

        • by TWX (665546)
          I needed an air compressor shack. I like Doctor Who. I built an air compressor shack in the shape of an 85%-scale TARDIS over several weeks, starting with raw lumber and only the most rudimentary of plans.

          I needed an enclosure to protect my outdoor bench grinder from the elements while it's not in use. I disassembled an old barbecue grille, installed a worktop, and put the grinder inside under the lid.

          I needed a cover for my outdoor-stored hydraulic press. I went through my piles of scrap lumber a
      • by sjames (1099)

        Because nothing speeds up innovation and invention like lawyers and their fees. Because everyone has the cash for that shooting out of their backsides. I agree that people who are going to play with nuclear materials should learn enough to do it safely. I also agree they need to know enough to avoid exposing the neighbors to harm.

        If you shared the results of what you're doing freely on the net, you would be a maker.

    • by Shavano (2541114)

      You mean, only in countries where people are far less concerned about the safety of medical devices.

      • by sjames (1099)

        Not really, no. The regulations in the U.S. are SUPPOSED to be just what's needed to assure safety and efficacy, but it doesn't always work out that way. Far too often, no risk analysis is applied at all. Yes, the EKG in the E.R. has to work right every time, but the one used in a doctor's office for routine followup SHOULD be much more affordable because all it needs to do is not shock anyone and read correctly, obviously incorrectly, or not at all in order to be safe. Not doing that actually increases ris

    • by Anonymous Coward

      There needs to be some sort of national exemption for the real tinkers that affords them some protection from litigation and without fear

      What does this even mean?

      I read it as, "Anyone with good intentions(*) should be immune to the consequences of doing anything without sufficient knowledge or experience, because while the majority will waste time at best and cause serious harm at worst, a tiny minority may help."

      There needs to be some sort of elimination of the rockstar-hero-I-don't-need-no-educashun attitude that the Internet has fostered, where mediocre thinkers assume that all they need is a few pages from Wikipedia and a couple of tutor

  • "Concerns" (Score:5, Insightful)

    by Azghoul (25786) on Thursday January 16, 2014 @09:55AM (#45975303) Homepage

    You can always tell the entrenched interests are getting worried about their bottom line when "concerns" start appearing.

    "How DARE they build a prosthetic with a cheap 3D printer!?" "But it might be DANGEROUS!"

    No, you are just scared that your ridiculous profit margins might get a haircut, and use regulation and FUD to increase the barrier to entry into "your" market. This is a great story and should be lauded by all, not tainted by the fishy smell of the concern trolls.

    • by Anonymous Coward

      Actually, it might be dangerous. But where there's a genuine medical emergency (as opposed to frivolous cosmetic augmentation), it's worth the risk.

    • by Shavano (2541114)

      I for one am happy to buy a cheap prosthetic leg that will snap within a month.

      • by thelexx (237096)

        robohand.net

        I for one am happy to have the chance to produce a working set of fingers for my daughter, while waiting for pediatric i-limb digits type devices to a) exist and b) cost less than $100K. Currently available prosthetic devices are also crazy expensive for what they are and have less functionality than the robohand. It can be scaled to grow with her, I can make improvements as they come from the community, use custom colors, etc. So yeah...bite it haters. Hard.

      • by sjames (1099)

        If the other option is hop, you might be. Even better, reinforce it so it holds up a bit better.

    • Re:"Concerns" (Score:4, Interesting)

      by Ihlosi (895663) on Thursday January 16, 2014 @10:14AM (#45975457)
      "How DARE they build a prosthetic with a cheap 3D printer!?" "But it might be DANGEROUS!"

      I'm sure if those "entrenched interests" weren't familiar with multi-million dollar lawsuits, they'd use cheap 3D printers to build prosthetics, too.

      Oh, and might I interest you in a used Therac-25?

      • by sjames (1099)

        Oh, and might I interest you in a used Therac-25?

        You mean that fantastically overpriced machine that passed all regulatory requirements even though there are high school programmers who could have written less brittle software?

        • by Ihlosi (895663)
          You mean that fantastically overpriced machine that passed all regulatory requirements even though there are high school programmers who could have written less brittle software?

          It's what happens when you have insufficient measures for product quality in place. As far as I'm aware, some of the newer regulations were partially due to these incidents.

          Working without these measures will increase the frequency of such incidents again.

          • by sjames (1099)

            There are ways to assure safety and I'm not suggesting they be skipped. I am suggesting a rational risk benefit analysis.

            For example, it is not rational to treat an amplifier that replaces a fantastically expensive hearing aid the same way you treat a machine that by design dispenses a near lethal dose of radiation. It is not rational to leave someone to surely die because otherwise they might get hurt. It i not rational to treat every single medical device as if it will be used in a trauma bay.

    • Re:"Concerns" (Score:4, Insightful)

      by Anonymous Coward on Thursday January 16, 2014 @11:18AM (#45976051)

      Your ignorance is scary.

      You damn well should be concerned about random medical devices made in someone's garage. You're ridiculously stupid if you aren't.

      If you're living in Rwanda, your concern may be outweighed by the NEED for medical equipment of some form. If you're in America, you can drive to proper medical equipment faster than you can print it.

      There is a REASON that medical device approval takes time. There is absolutely no way you can test for 'long term' effects without taking 'long term' into it. Just because you test a million switches for a million button presses and they all pass because you did it in the course of a week and none of them had any time to corrode doesn't mean they'll last for 1 billion years since they only get pressed a couple times a day.

      Worse still ... Joe, over in his garage, doesn't likely have any of the knowledge about WHY some of the things he is doing is dangerous, or won't work. Like he's unaware of the fact that putting a small bump in the middle of where the prosthetic attaches to the body significantly lowers discomfort (totally made up statement), and again, thats find for the poor guy stuck in Rwanda who is going to die if he can't walk reasonably well and has no way to seek proper medical treatment.

      But he should still be concerned about what it might change.

      I for one, with a wife who is a lab animal vet ... know damn well how many CRAZY side effect can happen in research where people know ALL ABOUT the subject.

      You're an idiot of the Prosthetic arm from Joes RepRap in his garage doesn't concern you. That doesn't mean its 'bad', but you're an idiot for not being concerned about the possible unforeseen effects.

      These effects in other engineering practices are less important, when someones life is on the line, its another story entirely. If I print a part for my RC car and it brakes during a race, I just print another one and race again tomorrow. If I print a leg and it breaks while someone is walking, its very likely they'll break another bone when they fall due to lack of support from the broken plastic leg.

      I have a 3D Printer, a desktop CNC machine, and make devices and gadgets all the time with my equipment, am an advocate of the idea of the maker movement ...

      No one in the maker movement should be doing medical stuff, unless they happened to already be engineers or in medicine. Anyone in the maker movement who is qualified and thinks they have sufficient skills is MORE than qualified to get a job somewhere that makes their work safe. That means pretty much anyone who has the money to buy a 3d printer

      And lets be clear, there is no 'cheap 3d printed prosthetic'. The materials of required strength that can be 3d printed are not cheap in the first place. The printer types required to use said resin are not yet cheap (though there is a $10 prototype/hack that is mind numbingly impressive, its resin is ridiculously expensive).

      3D printing is for prototyping. There is nothing you can't make better, cheaper in other ways if its going to be more than a one off production.

      • by jpschaaf (313847)

        You damn well should be concerned about random medical devices made in someone's garage.

        It's really not that simple. Almost anyone on slashdot is unbelievably wealthy by comparison to the the average denizen of our world. Risks that are unacceptable for a wealthy person are very acceptable for someone who has nothing. Think about it: if your choice is between certain death due to heart failure or using a pacemaker assembled by a tinkerer in his/her garage, a rational person would be willing to accept ad

      • You damn well should be concerned about random medical devices made in someone's garage. You're ridiculously stupid if you aren't.

        Or you can read TFA, and see some examples of devices which likely won't kill someone or even significantly harm them if they malfunction, yet they help people in need, who otherwise could not afford standard medical devices.

        Take, for example the woman from TFA who needed a special type of hearing aid for an unusual condition:

        The surgery costs from thousands to tens of thousands of dollars, and is not always covered by insurance. Insurers rarely, if ever, cover the snap-on hearing aid, which is fragile, has a price tag that can range from $4,000 to $7,000, and requires replacement every several years.

        âoeI realized it sounded like something I could build in my living room,â Marzec says, and thatâ(TM)s exactly what she did, attaching electronics from Radio Shack to a standard construction hardhat.

        Is it really going to be armageddon if someone builds a hearing aid? Even if it malfunctions, what is the likely downside? The person takes off the helmet. How is this any worse t

        • by stymy (1223496)
          Generally, hearing aids only raise the volume for very select frequencies. What she's done is probably just ramped up the volume for everything. So she could end up with far worse hearing loss.
      • by TubeSteak (669689)

        You're an idiot of the Prosthetic arm from Joes RepRap in his garage doesn't concern you. That doesn't mean its 'bad', but you're an idiot for not being concerned about the possible unforeseen effects.

        I posted this in a previous /. story about printed limbs [slashdot.org], so I'll just do a quick copy and paste:
        Prostheses are more or less exempt from any FDA regulation that would make them expensive.

        http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.3420 [fda.gov] [fda.gov]

        Sec. 890.3420 External limb prosthetic component.

        (b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.

        http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.9 [fda.gov] [fda.gov]

        Sec. 890.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

        The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. [...]

        [A list of reasons when your product is not exempt]

        There's someone, somewhere, who had to spend money for the FDA to approve the first [artificial limb], but after that, everyone gets a free ride.

      • by sjames (1099)

        If you're in America, you can drive to proper medical equipment faster than you can print it.

        And press your nose against the glass as you enviously watch people with a job benefitting from it's use.

        Are you under the impression that they just give away those 60K 'bionic' prosthetics?

        If I print a leg and it breaks while someone is walking, its very likely they'll break another bone when they fall due to lack of support from the broken plastic leg.

        So instead they hop, use a crutch, or a wheelchair? I'm sure those options will be consequence free. Meanwhile, guess what the socket for a prosthetic leg is made of!

    • by fermion (181285)
      Medical devices, AFAIK, have generally been made of those practicing the trade. Dr. Michael E. DeBakey hacked together blood vessels. Other doctors have taken general purpose tools and modified them for medical purposes.

      The question is how these tools get into the hands of other practitioners. Are they going to go to the hardware store and modify the tools? Some will but many will want a commercial application, which means developing, marketing, and training.

      The value of these ventures it that it al

  • ... is any researchers dream. Oh, and add ethical concerns to the list.

    I'm sure medical research can be accelerated tremendously if it doesn't matter that people get maimed or killed in the process. If they're consenting, informed volunteers, that's okay, but those are hard to find.

    Heck, not having to do all these bothersome safety tests would simplify my own work immensely. I could make "It compiled! Ship it! Ship it!" my new motto.

    • by Anonymous Coward

      I think the consenting informed volunteers are easily found when you have price points that don't include liablity coverage.

      It's the same in a lot of ways as the open source software. "Here it is, put it togethor yourself and if it breaks it's your problem" I've delt with enough vendors to know when it breaks it's my problem even if I have support or someone to sue.

      For something like a prosthetic that's external and easy enough to understand I'd much rather have the 5 figure discount than someone to s

  • Talk about a furtle field; the ability to actually obtain a "working" wiring harness for my '79 MGB. Or any other car part?
    • by chaim79 (898507)

      A wiring harness may just be easier to build yourself, there are places you can get the color coded wires and the wrap for bundling them together, and there are likely plenty of sources for wiring diagrams, worst case you can tear apart your old harness to make a diagram of your own. (speaking from the standpoint of someone who has looked into this for my '64 p1800)

      Making other car parts is a different issue entirely, at least for the engine... most likely one that will stay in the realm of casting and mach

      • It begins. I wonder if conversions to elecrtic motors would side step the requirements of building useable internal combustion engines?
  • From a monopolistic, overpriced medical device industry that is about to get 'Ubered," like the medallion cabdrivers.
  • Something to think about. Import/export controls, Taxes and Tarrifs.

    These exist for almost everything except software/information (non cryptological) and raw materials.

    Alot of the obsurd costs of bringing various products into another country are contrived but the useless bureaucracies in the sending or receiving countries.

    There are no such costs involved in 3d printing something onsite. In the 3rd world this is huge. When employed people might only make $10 a week, a 45% markup plus packaging and shipping

  • there are TONS of people taking the extreme stance here. No one can envision a 3d printed cast, or homemade oxygen concentrators. the bulk of the outrage is along the lines of "How DARE they 3D print a new heart in their garage!!11!!"

    There is a happy medium of non life-threatening tools and devices that can save people a lot of money. I seriously doubt these people are making implanted pacemakers or bluetooth retina replacements here.

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