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Paging Dr. MacGyver: Maker Movement Comes To Medical Gear

Posted by samzenpus on 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.'"

61 comments

  1. Fire up the Makerbot by Anonymous Coward · · Score: 0

    I need a new tibia.

    1. Re:Fire up the Makerbot by jellomizer · · Score: 2

      Perhaps not for bones, but you can make custom sized casts, that are lighter than plaster. Custom sized tools for surgery. Heck just be able to have a supply of medical equipment in storage so you don't need a huge inventory, allowing smaller surgical areas.

      --
      If something is so important that you feel the need to post it on the internet... It probably isn't that important.
  2. From the summary by codeButcher · · Score: 2, Insightful

    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.

    --
    Free, as in your money being freed from the confines of your account.
    1. Re:From the summary by Bacon+Bits · · Score: 1

      Yeah, and look how that turned out.

      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.

      --
      The road to tyranny has always been paved with claims of necessity.
  3. Hard to see this flourishing in USA by Anonymous Coward · · Score: 4, Insightful

    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.

    1. Re:Hard to see this flourishing in USA by TWX · · Score: 2, Interesting

      "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 formal training they should form a legal entity in the form of a company, follow basic handling and exposure rules, and conduct thoughtfully designed experiments to determine the outcomes. We learned about playing with nuclear materials in the form of deaths of many, many people that didn't know about the dangers; I expect any random untrained person to be just as bad today.

      As for myself, I'm not a "Maker". I have a workshop, I work on things. Sometimes my friends come over and help, sometimes I go over to their workshops to help them. I know that I'm not saving the world when I work on something, and very likely what I'm working on will only benefit me or my household. I'm not deluding myself that somehow my tinkering or puttering around will affect anyone besides myself. Applying a label besides "hobbyist" is stupid. If people want to learn how to build or modify things, then start by tinkering and don't throw stupid labels on it like it actually means something, it doesn't mean squat.

      --
      Do not look into laser with remaining eye.
    2. Re:Hard to see this flourishing in USA by __aaltlg1547 · · Score: 1

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

    3. Re:Hard to see this flourishing in USA by Anonymous Coward · · Score: 1

      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 tutorials to save the world.

      Hard work is hard. Apply your knowledge to gain qualifications and experience, then you'll be a net contributor rather than net liability.

      (*) And I don't even think this "maker" movement is altruistic - just as the OLPC project was just a bunch of geeks wanting to feel good about having fun with some geeky endeavour. This is just the 21st century White Man's Burden, where the developed world rush in and assume they know what's best, because, well, they're in the dirt and we're not or something, so all of us must surely know better.

    4. Re:Hard to see this flourishing in USA by Anonymous Coward · · Score: 0

      I've always considered "Maker" to mean something roughly equivalent to "hobbyist".

    5. Re:Hard to see this flourishing in USA by TWX · · Score: 1

      I've always considered "Maker" to mean something roughly equivalent to "hobbyist".

      Look at the way that you write it. "Maker" with a capital letter, "hobbyist" without.

      "I'm a hobbyist" expresses that one is not a professional.

      "I'm a Maker" implies that there's something more than being a hobbyist, and is something of a title. Worse, it's borderline doublespeak in that most "Makers" couldn't actually make something to save their lives.

      I suppose that when it comes down to it, the very term itself is what I find offensive, as I'm offended by serious pretend that things are better or more capable than they are. In the same sense that it's not necessarily the tools that Harbor Freight sells that are offensive (cheap tools are cheap tools, after all), but selling them with brands like "Pittsburgh" and "Chicago" and "US General" offends me when traditional tools named after an American city or town were called that because that town was where they were made.

      --
      Do not look into laser with remaining eye.
    6. Re:Hard to see this flourishing in USA by Anonymous Coward · · Score: 0

      that innovation is beginning to stagnate.

      It is?

    7. Re:Hard to see this flourishing in USA by hawkinspeter · · Score: 2

      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 take the risk of performing home surgery (maybe they can't afford professional care), then I don't see why they should be criminalised for doing so. Yes, some people will make mistakes, but the sooner people learn about the mistakes, the better.

      --
      You're a temporary arrangement of matter sliding towards oblivion in a cold, uncaring universe
    8. Re:Hard to see this flourishing in USA by AthanasiusKircher · · Score: 4, Insightful

      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

    9. Re:Hard to see this flourishing in USA by mcgrew · · Score: 1

      I've always considered "Maker" to mean something roughly equivalent to "hobbyist".

      GM is an auto maker. Does that make them hobbyists? I write for a hobby, and do it a lot better than many professionals. I know musicians with day jobs who are better than most major label musicians. "Professional" doesn't guarantee quality or talent, it denotes that the person is earning money for their craft (and there's no guarantee that he's the least bit dedicated or even competent), while the hobbyist does it for the love of the craft itself.

      --
      Free Martian Whores!
    10. Re:Hard to see this flourishing in USA by sjames · · Score: 1

      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.

    11. Re:Hard to see this flourishing in USA by semi-extrinsic · · Score: 1

      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.

      --
      for i in `facebook friends "=bday" 2>/dev/null | cut -d " " -f 3-`; do facebook wallpost $i "Happy birthday!"; done
    12. Re:Hard to see this flourishing in USA by sjames · · Score: 1

      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 risk because it means more people skip it entirely.

      Having a cheap hearing aid (actually cheap, not just relatively cheap) fail during the day is NOT worse than never having one at all because it costs $3000.

      With any luck, the makers will force some of the gold plated medical gear come down to more reasonable prices.

    13. Re:Hard to see this flourishing in USA by TWX · · Score: 1

      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 and put one together.

      Your citations for things like building furniture for personal use don't really help me appreciate the term "Maker", as building things at home is what normal non-wealthy people often did until the developments of the Industrial Revolution and Consumer Culture. People switched to buying prefinished goods because they liked the simplicity of not having to work to put these things together themselves.

      Building a table, however noble, probably doesn't save the environment or the economy any more than sourcing a table from somewhere else. It's probably a lesser table than buying a craftsman-made table built by hand in your area, and given the benefits of mass-production, it might actually be better for the environment to produce tens of thousands of tables in a factory that can better handle its waste products than you'll get at home. So don't kid yourself, you built your table at home because you wanted to.

      Personally, I buy or scavenge a lot of used things. The aforementioned compressor was used. The grille that became the grinder enclosure was being thrown out by a neighbor, it was in the bulk-pickup pile in the alley. The wood used for the cover on the hydraulic press was a remnant from building a garden shed. Many of the computers at home were from the local college surplus or from other used sources. I could probably make the argument that reusing things is even better for the environment than building new things.

      --
      Do not look into laser with remaining eye.
  4. Re:fuck everything by mwvdlee · · Score: 3, Funny

    I'm not sure medical rapid prototyping is advanced enough to offer the replacement parts you need.

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  5. you mean Doctor McCoy by Anonymous Coward · · Score: 0

    McCoy was improvising to save lives two decades before MacGyver existed.

    "I'm a doctor, not a bricklayer!"
    "You're a healer, there's a patient. That's an order."

    1. Re:you mean Doctor McCoy by nitehawk214 · · Score: 1

      McCoy was improvising to save lives two decades before MacGyver existed.

      "I'm a doctor, not a bricklayer!"
      "You're a healer, there's a patient. That's an order."

      "I'm a doctor, not an inventor."

      --
      I'm a good cook. I'm a fantastic eater. - Steven Brust
    2. Re:you mean Doctor McCoy by mcgrew · · Score: 1

      "I'm a doctor, not an inventor."

      What episode or movie did he say that in? The AC's quote is from "The Devil In The Dark".

      --
      Free Martian Whores!
  6. "Concerns" by Azghoul · · Score: 5, Insightful

    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.

    1. Re:"Concerns" by Anonymous Coward · · Score: 1

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

    2. Re:"Concerns" by __aaltlg1547 · · Score: 1

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

    3. Re:"Concerns" by __aaltlg1547 · · Score: 1

      Depends on whether the frivolous cosmetic augmentation is under the skin.

    4. Re:"Concerns" by Ihlosi · · Score: 3, Interesting
      "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?

    5. Re:"Concerns" by Anonymous Coward · · Score: 4, Insightful

      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.

    6. Re:"Concerns" by Anonymous Coward · · Score: 0

      Real world examples were the idea that paralyzed people could be made to walk again by inserting metal electrodes into their muscles and running some processed motion capture data into those electrodes. Sure those people could walk again, but the high voltages made their muscles melt and the electrodes disintegrate. Now they are stuck with bits of decomposing metal all inside their legs.

      Then there was the time that the doctors thought that they could weld titanium pins into the bones so that prosthetics could be attached directly. They didn't figure out how skin would heal around the metal, so they are stuck with skin infections. Later research using deer antlers showed that by making lots of little holes in the titanium, skin tissue (collagen) would form a seal around that metal.

      Another example was when a biotechnology company did some trial runs with immune system boosting drugs, got their units wrong by two decimal places and now five volunteers are walking around with no immune system.
      http://www.nature.com/news/2006/060814/full/news060814-2.html

    7. Re:"Concerns" by jpschaaf · · Score: 2

      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 additional and substantial risks. Admittedly, I don't want a pressure cooker in somebody's kitchen to sterilize medical devices that I will be using, but I can certainly understand why someone else would.

    8. Re:"Concerns" by AthanasiusKircher · · Score: 2

      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 than an "approved" medical hearing aid with a failing battery or something?

      And contrast that against the upside: without the DIY hack, the person would either have potentially shell out tens of thousands of dollars which is not reimbursed by insurance. Or, they could just not hear. Is this really such a terrible third choice -- to pay a few hundreds dollars and be able to hear again, with little downside?

      I absolutely agree with you that there are a lot of medical devices that should NOT be made by random DIYers. You need a reliable tool for surgery or a piece of diagnostic equipment to look for life-threatening conditions... obviously, you need it to work or people could die or be severely injured. But there are also plenty of things that could be hugely beneficial, and they are unlikely to have terrible consequences even if they fail. Yet they could mean the difference for some people between hearing or not hearing.

      TFA has a number of examples that fall into this category -- "medical devices" that provide significant benefit but would be unlikely to cause dangerous results if they failed. What's wrong with investigating such things for potential DIY applications?

    9. Re:"Concerns" by fermion · · Score: 1
      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 allows others, who may not be able to support a commercial venture, to access these innovations. And it is not just outside the US. If someone want, for instance a new tool, maybe they can make it. What is to stop someone to make a brace and use it themselves to support their knee?

      Yes, the vested interests are fighting this, but these type of things are not going to really cause any revolution in medicine. If someone wants a cheap prosthetic, one can already go to another country and get it. Same part, good doctors, just without the US markup.

      --
      "She's a scientist and a lesbian. She's not going to let it slide." Orphan Black
    10. Re:"Concerns" by Anonymous Coward · · Score: 0

      Is it really going to be armageddon if someone builds a hearing aid? Even if it malfunctions, what is the likely downside?

      It's actually really easy to damage your ears with earbuds you can pick up at radio-shack provided the audio output doesn't limit it's volume to safe ranges.

      A home-made hearing aid could easily be making your hearing worse over time, which is exactly the sort of thing the FDA approval screens out by making the manufacture do all those long term studies.

    11. Re:"Concerns" by thelexx · · Score: 1

      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.

      --
      "Gold still represents the ultimate form of payment in the world." - Alan Greenspan, 1999
    12. Re:"Concerns" by TubeSteak · · Score: 1

      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, 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]

      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]

      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.

      --
      [Fuck Beta]
      o0t!
    13. Re:"Concerns" by sjames · · Score: 1

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

    14. Re:"Concerns" by sjames · · Score: 1

      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?

    15. Re:"Concerns" by sjames · · Score: 1

      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!

    16. Re:"Concerns" by sjames · · Score: 1

      So they did everything the heavily regulated corporate way and it went to hell. So what's the advantage of that approach again?

      The maker way would have tested on people who were going to die without an effective treatment first.

    17. Re:"Concerns" by sjames · · Score: 1

      And yet the earbuds are available dirt cheap for anyone who wants them, as long as they don't actually need them.

      Would you prefer that the people who need them and can't afford them just never hear again? How is that an improvement?

    18. Re:"Concerns" by stymy · · Score: 1

      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.

    19. Re:"Concerns" by Ihlosi · · Score: 1
      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.

    20. Re:"Concerns" by sjames · · Score: 1

      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.

  7. Medicine without safety and liability concerns ... by Ihlosi · · Score: 1
    ... 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.

  8. MEDICAL GEAR IS ALREADY ACTIVE?! by Anonymous Coward · · Score: 0


  9. 'Maker movement' by Anonymous Coward · · Score: 0

    Fucking hipsters

  10. Re: fuck everything by Anonymous Coward · · Score: 0

    Of course you can. It wouldn't be functional just like the original part. He wouldn't even notice the difference.

  11. MakerBot to Mechanic's Bay 3 by LifesABeach · · Score: 1

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

    1. Re:MakerBot to Mechanic's Bay 3 by chaim79 · · Score: 1

      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 machining instead of 3D printing.

      An engine part often has very very tight tolerances, down to 1/1000th of an inch for mounting surfaces and alignments, something I don't see 3D printing replicating anytime soon, then to add to the fun engine parts have to hold up under stress from the combustion process, lots of heat and vibration.

      Now, that's not to say it will never happen, there may be a 3D printer capable of laying down metal with strength comparable to cast or forged counterparts, with an accuracy capable of a mirror finish, but I'm not expecting it anytime soon or for a price that's less than the value of the entire car.

      However, if you want to print cosmetic components of a car (rear-view mirror mountings, gauge faces, handles, etc) that is very likely possible now.

      --
      DEMETRIUS: Villain, what hast thou done?
      AARON: Villain, I have done thy mother.
      Shakespeare invents 'your mom'
    2. Re:MakerBot to Mechanic's Bay 3 by LifesABeach · · Score: 1

      It begins. I wonder if conversions to elecrtic motors would side step the requirements of building useable internal combustion engines?

  12. Yeah, I'm sure there is a "ton of concerns" by Applehu+Akbar · · Score: 1

    From a monopolistic, overpriced medical device industry that is about to get 'Ubered," like the medallion cabdrivers.

  13. Re:Medicine without safety and liability concerns by Anonymous Coward · · Score: 1

    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 sue.

  14. The problem, and the solution: by Anonymous Coward · · Score: 0

    The problem is the holy war on "drugs." If "prescription" medication was available over the Internet, from the lowest priced seller, without any more red tape than is necessary to make sure it is what it claims to be....prices for medical care would plummet.

    Of course, this would destroy the careers of most doctors, who make their livings prescribing a few medications for a few conditions. My pulminologist started muttering "oh no...oh no...oh no" when I shower her proof that Nasacort was going OTC.

    Let's think about the price of a bottle of antibiotics (the same ones dumped into a chicken's feed)
    $220 for an office visit,
    $150 for Your time off work to go in when it's convenient for the Doctor, not when it's convenient for You
    $25 for a trip to the pharmacy (time + gas)
    $25 for another trip to the pharmacy, because they were closed the first time (time + gas)
    $4 for the pills, which includes a pharmacist handing them to You,
    $50 for Your time calling in for a refill (3 to 5 calls, more than an hour on hold)
    (of course, it does not get refilled in time because of the red tape)
    $4 for the next round of pills (which would have cured You if they had been in time)
    $450 for 3 more days off work, as You get worse despite the refill that Your disease-causing micro-organisms are now resistant to
    $220 for another office visit
    $75 for another kind of antibiotic that finally cures it, but not before You pass this antibiotic resistant infection to 3 more people, who get to go through the same expense.
    TOTAL: $1,223

    All of this could have been handled as easily as someone picking up a $1.95 bottle of pills at a convenience store if the government were to get out of the way and allow it.

    The Rx system costs money, causes antibiotic resistant infections, and costs lives.

    I have a friend (a former EMT) who recently developed a heart murmur because he often goes without his blood pressure medication because he can not afford the doctor's visits to get the scripts to get the medication.

    I should have added a cost for the political wrangling that surrounds all this, and forces me to buy health "insurance," but that cost is incalculable. I've looked for a precedent for one person forcing another to buy something. The closest I can come is: In the days of slavery in the Old South, a master could dictate how a slave spent his money. All of us f*cking Amis are now slaves.

    I just do not care about the lives of druggies enough to put up with all this. Let them OD and die. It will be painless.
    I do not care about the careers of those who can not earn a living in the free market. Let them retrain themselves. Transmission repair is a hot field.

    1. Re:The problem, and the solution: by Anonymous Coward · · Score: 0

      The prescription system is what prevents idiots from taking antibiotics to cure their cold (a viral infection), and ensures that someone with medical knowledge sets the dosage for medications that have tight tolerances on how much is helpful vs harmful.

      It's the insurance system that introduces the systematic inefficiencies that cause most fo the price hikes you're complaining about.

      The rest of it is due to patents, but patents are largely a correctional me sure to account for the fact that the expensive part of producing medicine isn't manufacturing the pills but the R&D that goes into figuring out what ingredients in what amounts are helpful (something it would be impractical to recover costs from without IP protection)

  15. developed vs undeveloped by tommyatomic · · Score: 2

    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 costs means there are a great number of things we take for granted in 1st world nations that people in the 3rd world have only seen photos of.

  16. Re:"developing nations" - LOL by Attila+Dimedici · · Score: 1

    Actually, they came up with the new term, "developing world", because the old terms were less informative, and to some degree obsolete. "third world country" was one of three categories. "First world countries" were those like the U.S. and most of Western Europe. "Second world countries" were part of the Soviet bloc (primarily those in parts of the Soviet bloc in Europe, although others may have been included). And that is why the terms are obsolete, there is no Soviet bloc any longer and the term "second world country" has lost all meaning.
    Dividing the world netween "developed nations" and "developing nations" may be incomplete, but it is more informative than "third world nations".

    --
    The truth is that all men having power ought to be mistrusted. James Madison
  17. A lot of assumptions by nobuddy · · Score: 2

    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.

  18. Re:"developing nations" - LOL by Anonymous Coward · · Score: 0

    The world has changed. The "three worlds" used to be the first world (Europe, North America, democratic free industrialized nations), the second world, which was the Communists (Russia, China, Cuba, etc) and the third world was everybody else, most of whom were undeveloped or underdeveloped or developing. Since Communism has collapsed, the three world paradigm no longer works.

  19. Re:Medicine without safety and liability concerns by Anonymous Coward · · Score: 0

    There is a solution - http://sti2.blogspot.com