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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.

70 comments

  1. Fluffy the feel good piece by ColdWetDog · · Score: 1

    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!
    1. Re:Fluffy the feel good piece by Anonymous Coward · · Score: 0

      Yeah they also design ebola diagnostics dude http://pubs.rsc.org/en/Content/ArticleLanding/2015/LC/c5lc00055f#!divAbstract

    2. Re:Fluffy the feel good piece by thesupraman · · Score: 1

      Boy, the FUD on this one is going to be impressive.

      Tell me, if its your baby who cannot get treatment with a nebulizer because multi-thousand dollar 'certified' equipment is not
      affordable, when $50 of parts would do the job perfectly well, will you feel the same? Welcome to the lives of a good proportion
      of the worlds population.

      Of course that doesnt apply to YOU right? to fuck em.. let them watch their children die.
      MIT should convert themselves to another business school and turn out more MBAs!

    3. Re:Fluffy the feel good piece by gl4ss · · Score: 1

      well how would you feel if you got something nasty because the doctor in the village was being creative with sharing needles?

      the multi million dollare equipment isn't usually used to "keep healthy", it's used for getting healthy after getting something that would kill you.

      --
      world was created 5 seconds before this post as it is.
    4. Re:Fluffy the feel good piece by Anonymous Coward · · Score: 0

      There is no 'multi thousand dollar certified equipment' here so hold on to your angst. It's a low pressure air pump and some cheap plastic. So cheap, that even here in the land of hundred dollar aspirins we only pay $2.50 for it (I'm sure that the patient charge is higher but nowhere near the hysterical figure you quote). So this particular example of Sterling Do-Goodedness is kinda silly. If that is the best he can come up with, I have to wonder just how he plans on taking down the Medical Industrial Complex.

      There are lots of overpriced bits of equipment and treatment that might benefit from this approach, but I'm not seeing it here. And the other example cited had absolutely nothing to do with the MIT lab (and, actually, represents a potentially significant device).

      So work on the reading comprehension and tone down the rhetoric.

    5. Re:Fluffy the feel good piece by jandersen · · Score: 1

      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.

      It is obvious that you find it all too easy to sneer, but the big point he is making, as far as I can see, is that a serious lot can be achieved with relatively simply means, if you have the necessary insight and a bit of creativity. Nowadays too many people are blikered into thinking that we can only ever do anything at all with high technology; one of my favourite examples of the idiocy of this sort of viewpoint comes from the simple act of shaving. Not long ago people would use a straight razor - basically a knife with a core of high-carbon steel that could keep a sharp edge. You would probably only ever buy one in your life, and you could pass it down to your son for generations. Now, however, people are sold the idea that you need a contraption with 5 very thin platinum coated blades, which you can use only a few times, and which costs something like, what, $25 for a packet of 5? Something ridiculouos, any way. And the amazing thing is - the result is not actually better, you are just being taken for a ride.

      So, back to this issue: this is not about your local hospital saving money, although thigh maight well benefit as well; this is about helping poor nations achieve a better standard of health without having hundreds of billions to splurge out on luxury equipment. And who knows, it might end up saving you money on the tax or insurance bill, if your health service gets a lot cheaper. Isn't that worth doing?

    6. Re:Fluffy the feel good piece by Cytotoxic · · Score: 1

      The example of the nebulizer was ridiculous. You can buy a full nebulizer for home use for under $25. As others have stated here, the pump is just an aquarium pump. The bit that makes it a nebulizer is the little plastic parts that pump the air through the medicine. The "DIY inventor" didn't replace that bit, he just replaced the air pump.

    7. Re:Fluffy the feel good piece by Jose+Gomez-Marquez · · Score: 1

      Hi ColdWetDog, You're right, the nebulizer is a like the facepalm example of simplicity. We're not claiming this is the technical glory. For that I can go down the street and hang out with my friends that work on plasma fusion. A major point of our work is to show that this is often *not* rocket science. (In the case of the actual nebulization cup that you can buy here http://www.directhomemedical.c... or lots of other places, there IS some cool fluid dynamics going on that some engineer way back when considered and designed before our time). What happens to us is a lot of people think the compressor is the nebulizer (it isn't). It's just a compressor. By giving people lots of choices of how to push air, they can understand that's what's going on. Of course, you have to test these things and validate that what you are doing isn't causing harm. So we shoot lasers through the mist using something called a Spraytech diffraction system that shows us that the size of the particles coming out of the DIY pumps (bike, fish tank, bike tire, etc) are just as good as the ones out of a Pari LC (the 510k FDA proxy). So the next time a nurse tells us the "nebulizer is broken" and points to the big beige box, he can be more knowledgeable about what's going on. And the next time the hospital tries to bill a ridiculous amount for some of the consumables, patients can be more informed. I do appreciate your perspective and I'm also hear to learn what people out there think and want to do themselves. Jose

    8. Re:Fluffy the feel good piece by ceoyoyo · · Score: 1

      The safety razor was a rather important invention (invented quite a while ago). Shaving with a straight razor requires skill, is more dangerous, and keeping that razor sharp requires more skill, time, and equipment. Safety razors took over pretty quickly because they're a lot more convenient. I don't know whether the modern multi bladed ones are better than single bladed ones, but I wouldn't call that "technology." It's just marketing.

    9. Re:Fluffy the feel good piece by pnutjam · · Score: 1

      I actually bought a nebulizer for my daughter, several years ago. I don't remember the exact cost, but it was definitely over $100.

    10. Re:Fluffy the feel good piece by BranMan · · Score: 1

      I got fed up with the 4 and 5 blade contraptions as well, and went back 'old school' with a safety razor, soap, and boars-hair brush. Didn't go full old school with the straight razor - that does take too much time to keep sharp, and some time to get skilled with it. The safety razor though is great - blades are maybe 4 cents a piece - I can buy 'em in hundred packs.

      Try it - you won't look back.

      The one advantage modern razors have though is that you have to really really try hard to cut yourself. The safety I have is not bad (and blades last around 2 weeks it seems), but takes a little care. Straight razor - forget about it.

  2. For many it's already like this! by Anonymous Coward · · Score: 0

    Carrot juice to treat cancer, etc.

    I guess it's gonna be the same thing but more sophisticated.

    1. Re:For many it's already like this! by Anonymous Coward · · Score: 3, Funny

      I've had cancer and I've drank carrot juice - it's a close call which is worse.

  3. Home brewed? by Anonymous Coward · · Score: 0

    Woo, I'll start on the cough medicine!

  4. Yes!! by koan · · Score: 1

    This is something I could totally support.

    --
    "If any question why we died, Tell them because our fathers lied."
  5. "Home-brewed"? by Anonymous Coward · · Score: 0

    Who submitted this story? My Dad?

    It's Maker 3D-printed game-changing crowd-funded disruptive tech!

    1. Re:"Home-brewed"? by Adriax · · Score: 1

      On a Computer, Online, In the Cloud!
      Synergy!

      Ok, I'm all buzzworded out...

      --
      I don't suffer from insanity, I enjoy every minute of it!
    2. Re:"Home-brewed"? by ceoyoyo · · Score: 1

      You both forgot "open."

  6. He's partially right by Anonymous Coward · · Score: 5, Informative

    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.

    1. Re:He's partially right by Anonymous Coward · · Score: 0

      And lots of extra apostrophes too, apparently.

    2. Re:He's partially right by Falos · · Score: 1

      > If you're willing to dump the beak-wetters
      Reminds me of the Zuckerburg Evaporation. "Everyone gets paid but Tyrone still can't read."

    3. Re:He's partially right by currently_awake · · Score: 1

      meaning this should catch on in the third world. When most people never get to see a doctor, let alone have access to a modern hospital, expectations are much lower for reliability and liability.

    4. Re:He's partially right by Anonymous Coward · · Score: 0

      If you're willing to dump the safety requirements corporations must follow, you can do things a lot cheaper.

      Until the 3rd world gets shyster lawyers and discovers they can file lawsuits after the device injures them or has lasting consequences, or heck, even if it doesn't, and potentially win $millions of dollars in a settlement because it's cheaper than the court battle. Heck, even a $20K settlement is a lot for someone living on $2/day.

    5. Re:He's partially right by ColdWetDog · · Score: 1

      So if they can't see a doctor or get to a clinic, just what do you plan on putting in the little chamber? Tea? (actually might work with the xanthenes being bronchodilators). You just don't treat asthma by waving the nebulizer around.

      --
      Faster! Faster! Faster would be better!
    6. Re:He's partially right by Dr_Barnowl · · Score: 1

      The drug most often used, salbutamol, is a dirt cheap generic, you can get get 20 x 2.5 mg nebuliser vials for around £2 ($3)

    7. Re:He's partially right by Dr_Barnowl · · Score: 1

      Incidentally, if there are any Yanks reading : the British National Formulary is an excellent reference for just how hard you're being shafted by your medical industry ; the prices listed are what the NHS pays for these drugs.

      A 200-dose inhaler of that stuff costs £1.50 ($2.30) - I hear it's more like $100 in the states.

      These are the prices you can get if you have a single-payer healthcare system negotiating on your behalf. Socialized medicine, the great evil!

    8. Re:He's partially right by Anonymous Coward · · Score: 0

      Lots of people wanted caps on drug prices when the ACA was being written, but the drug lobby wouldn't hear of it.

    9. Re:He's partially right by Dr_Barnowl · · Score: 1

      Too true.

      We don't have legislation capping drug prices AFAIK - our relatively cheap prices come from the power of having that single payer. If you have to choose between serving a market of 65 million people in one of the richest nations on Earth, and not serving that market, you're prepared to compromise a little on price.

      It also helps that we have a blanket policy of using generic vs brand named drugs where possible, and we also have a body who's job it is to rate the effectiveness of treatments - we don't have the same pressure to use branded drugs just because they are newer and possibly-maybe marginally more effective (but 10x the price because they moved an atom to put it back on patent).

    10. Re:He's partially right by Anonymous Coward · · Score: 0

      NO, you can't. Americans are subsidizing your health care. It will be paid, you're just hoping someone's else taxes takes care of yourself.

    11. Re:He's partially right by ceoyoyo · · Score: 1

      Many companies sell, either of their own volition or through government encouragement, to the third world for steep discounts already because there's less risk of being sued and for humanitarian reasons. It's naive to look at what a hospital in the US charges their customers (er, patients) and think that's what someone in the third world has to pay.

    12. Re:He's partially right by ceoyoyo · · Score: 1

      Yeah. Good thing you guys talked yourselves out of public health care. Keep up the good work!

    13. Re:He's partially right by pnutjam · · Score: 1

      Keep drinking that kool-aid, this argument is just not true. Please provide a citation to back up your assertion.

  7. Medical devices are not going to be routinely HB by Anonymous Coward · · Score: 2, Insightful

    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.

  8. that sort of works by slashmydots · · Score: 1

    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.

    1. Re:that sort of works by Dutch+Gun · · Score: 1

      When I go on WebMD or wikipedia, I always apparently have a rare jungle disease or cancer based on my symptoms

      Well, yeah, a huge number of illnesses include symptoms like elevated temperature, sore throat, muscle aches, fatigue, etc, since that's how the body reacts to nearly anything that goes wrong internally. I'm hopeful that expert medical diagnostic systems will eventually be able to improve on patient diagnosis.

      --
      Irony: Agile development has too much intertia to be abandoned now.
    2. Re:that sort of works by Bing+Tsher+E · · Score: 1

      What amuses me is that most medical conditions and illnesses that laymen are told that they have are just Latin language translations of the symptoms. Once you understand that, when a doctor pronounces that somebody has a particular 'illness' you just say 'duh, yeah, tell me more than the symptoms.'

    3. Re:that sort of works by ColdWetDog · · Score: 1, Insightful

      Too bad that MRIs don't cost $10 million. More like $1 million. That is a lot but they are very, very complex devices.

      And yes, people care. And yes, there is graft, greed, avarice, blackjack and hookers but it's a pretty complicated problem. So complicated that even the vaunted European social democracies (the ones with the 'free' healthcare' are scratching their heads trying to figure out how to afford everything.

      Blow into a paper bag for a while and quit hyperventilating.

      --
      Faster! Faster! Faster would be better!
    4. Re:that sort of works by Dr_Barnowl · · Score: 1

      even the vaunted European social democracies (the ones with the 'free' healthcare' are scratching their heads trying to figure out how to afford everything

      As a citizen of the democracy with the "best healthcare system in the world", (the UK NHS) we already worked out how to afford everything - have a single-payer system that can negotiate a sensible price, and don't waste money on all that insurance bureaucracy.

      We spend less than half what the USA does, and get better outcomes.

      The problem is that the medical-industrial complex has worked out that obviously, people are willing to spend a lot more, and have contrived with our politicians to try and destroy the NHS so that they can profit.

  9. As long as we're not talking firmware by Anonymous Coward · · Score: 1

    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."

  10. No, you are wrong.. by thesupraman · · Score: 4, Insightful

    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..

    1. Re:No, you are wrong.. by Goldsmith · · Score: 1

      Have you tried to meet with the FDA and get a medical device approval started? It's not hard. It's free to meet with the FDA and there is a ton of grant funding out there for exactly the kinds of clinical trials required here. The barrier of entry argument is an illusion if you actually know what you're doing. The FDA isn't going to do your study design for you, and the NIH isn't going to give money for a poorly defined set of experiments. In my experience, very few people even try to do this. That's just laziness, not a real barrier to entry.

      Who is responsible if there's a mistake with a device an someone dies? No matter how well intentioned you are, or how many warning labels you slap onto something, we live in a very litigious society and you will get sued out of existence. Our system for dealing with this is very bad, but it would be far better to reform the system than just scrap the idea of independent medical oversight. We live in a society getting less sophisticated about general understanding of medical technology; most people are not equipped to make good decisions in this area without help.

      You bring up South Korea. Why are things so much cheaper and better in other places? Part of it is regulatory, but there are many other factors. We in the US do not have the raw materials, IP, or facilities to completely manufacture high end medical tools. Medical device companies from Asia and Europe hunt for acquisitions in the US. They're hungry and they pay for patents, value, ideas, and people here. The best medical tech coming out of the US is not making it through to big VC backed companies, but going overseas at a very early stage.

    2. Re:No, you are wrong.. by Anonymous Coward · · Score: 0

      No matter how well intentioned you are, or how many warning labels you slap onto something, we live in a very litigious
      society and you will get sued out of existence.

      This is the real root of the problem. In comparison, in New Zealand, we have a high quality, efficient and cheap public health care system and a very high quality private health care system, but it is impossible to sue a licensed medical practitioner. We have a medical malpractice board that takes itself very seriously, but rather than being a profit seeking enterprise, the point of it is to strike off negligent or incompetent practitioners.

      In fact this is the root of many of America's problems. If you add it up, all the IP law, liability law, compliance law and so on, costs more than the rest of the US economy. Sure it contributes to GDP, sure the US would still be the largest industrial economy regardless, but the cost of all this blame gaming and doing intentionally stupid shit because regulations make that more profitable than doing things well has to add up.

  11. Quick question by Okian+Warrior · · Score: 3, Interesting

    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?

    1. Re:Quick question by fustakrakich · · Score: 1

      Well, we can complain about the FAA all we want, but I can't remember the last last time there was a serious airline wreck in the States. As for medical tools, it's too bad the Snap On truck doesn't have any.

      --
      “He’s not deformed, he’s just drunk!”
    2. Re:Quick question by Okian+Warrior · · Score: 3, Insightful

      Well, we can complain about the FAA all we want, but I can't remember the last last time there was a serious airline wreck in the States.

      I think that's a false association. You might just as well say "well, my anti-tiger rock seems to be working".

      I've already noted that it's the aircraft manufacturers who ensure safety, at great expense and effort in addition to the certification process.

      Considering the expense of certification and that it's largely needless, don't you think the expense and effort should be directed towards a more useful goal? At the least, don't you think the regs should be changed to encourage safety?

      And from a completely economic perspective, since the cost of compliance is so high, are useful solutions which would make us safer being ignored because the price of entry is so high? (For the longest time there were no updated Cessna designs because they couldn't afford the certifications. The older designs went for *decades* without modern updated electronics.)

      I complain about the FAA because their system is worthless. You support them because their pointless system hasn't caused an accident.

      Your anti-tiger rock could be put to better use.

    3. Re:Quick question by fustakrakich · · Score: 1

      You support them because their pointless system hasn't caused an accident.

      Their 'pointless' system has prevented many accidents. You, as a direct beneficiary, don't know what you are babbling about. Their 'pointless' system has made flying safer than going upstairs to take a piss.

      --
      “He’s not deformed, he’s just drunk!”
    4. Re:Quick question by Anonymous Coward · · Score: 1

      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?

      Yes, it is the same. The be all and end all is that you can point at a pile of documentation and you are all good. The actual regs are very light on details, and device security is simply not a consideration in most instances. When tasked as part of a team creating a new medical device I was extremely disappointed to discover that all that was necessary was to produce lots of documents that referenced at each other, ultimately pointing to a competitors device already on the market and saying "our is like theirs". Management soon realise they can avoid actually doing all the hard verification work if they just produce documents saying they have. FDA know this but still it goes on.

    5. Re:Quick question by DraconPern · · Score: 1

      I have worked on medical projects, and here's what I know. With medical, the medical related certification you need (in the US) is what's called a 510K pre-market approval from the FDA. Now, you only need the 510K if you are going to market and sell it. If you aren't doing that, then you don't need 510K approval. Part of the thinking is that experimental research devices (usually overseen by a MD) can be tested without going through lengthy review. Of course once you have the intention of marketing and selling, you would want to start filing for it. The FDA did put in new ruling for mobile apps recently though, basically it's an exemption for 510K for that category.

    6. Re:Quick question by Anonymous Coward · · Score: 0

      Well thank goods for that rebuttal, nothing like a firm assertion while ignoring all that came before. Fly safe now.

    7. Re:Quick question by Anonymous Coward · · Score: 0

      At least in my country (not US) it is like that for medical and some other categories of potentially harmful devices (such as gas burners).

      You need to produce a lot of documentation, but actual details about how it should be made safe are left for you to fill in. For some products an audit company has to check it, but normally they only verify the paper trail. The actual device can be inspected, but this is never done (maybe unless it caused some grave accident and you are suspected of faking documentation?)

    8. Re:Quick question by Anonymous Coward · · Score: 0

      How about comparing to countries outside of Europe and the US where there is less regulation? I think you'll find they crash a lot more.

    9. Re:Quick question by dunkelfalke · · Score: 1

      This paperwork for aircraft instruments is not just for the sake of paperwork. There is a huge market for counterfeit aircraft parts.

      --
      "It's such a fine line between stupid and clever" -- David St. Hubbins, Spinal Tap
    10. Re:Quick question by Anonymous Coward · · Score: 0

      I complain about the FAA because their system is worthless.
      You sounds like an anti-vaxxer complaining about vaccines. Since all the problems have gone away, the solutions that got us there must not have any value.

    11. Re:Quick question by Anonymous Coward · · Score: 0

      A lot of the medical regs is as you describe for the FAA.... IMHO, the FDA supplies a lot of rope in the regs; what you do with it....
      Much of it is like the TQM stuff -- have a Design History File that outlines the original purpose of testing, then tests, then did the thing solve those tests, then did the solution to the tests really apply to the problem at hand (which is why it's considered a new drug if a hear pill turns into viagra).

      But due to scrutiny, a lot of companies were going way overboard (eg, you should be able to verify incoming quality -- if you have a pipette, it should be a pipette and you should keep track of where you got them from so if you had a deviation along the line you could see if it's because you changed pipettes -- but what we did is assign an indlible serial number and asset tag to each disposable pipette).

    12. Re:Quick question by Jose+Gomez-Marquez · · Score: 1

      Hi Okian Warrior We're actually very interested in the avionics field---the FAA has a whole, what seems to be fairly mature department for home built aircraft https://www.faa.gov/aircraft/g... In the medical world, there's no such thing. Of course, if you are SELLING stuff, that's when things get FDA oversight discretion. However, when you are making your own (like the inventor of angioplasty balloons) there is no such things. We don't have all the answers, that's why we are learning, and opening up questions and technologies that allow us to explore these things. Jose

    13. Re:Quick question by ceoyoyo · · Score: 1

      The medical industry has both. There's a lot of paperwork for accountability and traceability, but most of the expense, at least for new things, is directly related to safety and efficacy. It's relatively easy to test whether airplanes fly or not, and you can test safety and reliability without exposing airliners worth of people to danger. You can't do that with drugs and medical devices - you have to test them for efficacy on lots of actual people.

      The regulatory agencies have a lot of catching up to do regarding the engineering bits like device security, but their regulations are usually fairly reasonable regarding safety and efficacy.

    14. Re: Quick question by Anonymous Coward · · Score: 0

      Technically they aren't 100% wrong. If the disease is completly eradicated stopping the vaccine eventually makes sense.

    15. Re: Quick question by Anonymous Coward · · Score: 0

      True, but my intent wasn't to compare the OP to a rational position. He sounds a bit more like the true nutters who claim smallpox wasn't eradicated by the vaccine (sadly they exist.)

    16. Re:Quick question by Anonymous Coward · · Score: 0

      This paperwork for aircraft instruments is not just for the sake of paperwork. There is a huge market for counterfeit aircraft parts.

      That is different paperwork, called traceability documents. I don't think anyone is arguing that traceability documents are retarding design of aircraft systems, that is simply a record of Vendor A sold part B serial 12985/batch 127 to distributor X, who sold to workshop Y, who got technician Z to install it on plane 124 on date 2015-12-11. This sort of traceability is low cost and easy to automate in computer systems. The cost is not in the traceability, but in the tracing when plane 124 falls out of the sky, and they have to recheck all the work by technician Z, all the work by workshop Y, the storage and handling at distributor X, the design of part B, and the batch 127 of that part to find out why that part failed. This trace work is expensive but measurably increases safety.

      The paperwork the GP was talking about is design certificates, which serve a similar purpose (allegedly), of tracing whether the design has been reviewed by the appropriate parties, who has handled the design documents, and declarations that the design and manufacture has been carried out according to the design documents. The problem with this is that it doesn't actually specify the tests required to verify that a part is suitable for purpose, only that it has been vouched for. In other words, it's a system for figuring out who to blame when shit falls apart, rather than to ensure that things are designed built correctly.

      I actually disagree with the GP. While he may be right that the required documents are insufficient or wrongly targeted, the value of traceability here is to make people accountable for their actions. If as an avionics designer, you have to put your signature to every design you send out, you are responsible for it being correct and safe, and you are protected if someone downline from you fails to implement it correctly. This level of traceability is necessary to create a culture of safety; it wouldn't be sufficient to just point the finger at vendor A or vendor B, and then they just shrug and say "we don't know who designed this part, we don't know who built it". The individual has to be accountable, and if they're not willing to stand behind their work, they have no business working in a safety critical industry.

      The basis of all of this is: The work isn't done until the paperwork is done.

    17. Re:Quick question by dunkelfalke · · Score: 1

      Ah, I see. Thank you for the explanation.
      I agree with you, for safety critical parts it is definitely important. Shoddy construction has often enough led to bad accidents.

      --
      "It's such a fine line between stupid and clever" -- David St. Hubbins, Spinal Tap
  12. made at MIT means it's not cheap by Anonymous Coward · · Score: 1

    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.

    1. Re:made at MIT means it's not cheap by Jose+Gomez-Marquez · · Score: 1

      MIT is actually one of the most expensive places to make anything! We have significant overhead. It would in fact be cheaper to go off campus. What we are trying to for a certain class of devices, is to create the tools so others can create things for themselves, safely, in a repeatable manner, and in a way that is tailored to their own needs. Sometimes that means that person can come up with something they can scale (and then they will then have to go through the normal FDA route). And sometimes that means they can solve the problem for their n=1 market.

  13. It's time to DIY a hearing aid by Anonymous Coward · · Score: 0

    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

    1. Re:It's time to DIY a hearing aid by Dr_Barnowl · · Score: 1

      The main reason hearing aids are expensive is twofold

      i) They need to be individually calibrated to the user's hearing loss spectrum

      This means skilled audiometric testing. Skilled labour costs money in any economy.

      ii) The miniaturization

      In 2 generations hearing aids have gone from a cumbersome box you carry around on a strap, to something that sits behind your ear, to something that sits in your ear.

      The box type could be built very cheaply now. You could probably write a smartphone app that did a reasonable job.

    2. Re: It's time to DIY a hearing aid by pruss · · Score: 1

      I would expect that you could also write an app that did the stereo hearing frequency response test (and I see a bunch are available). And you could combine the two apps.

  14. Staying Healthy by Livius · · Score: 1

    "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'.

  15. this is partial correct by Anonymous Coward · · Score: 0

    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!

  16. Obsidian Scalpels by scorp1us · · Score: 1

    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.

    --
    Slashdot's rate-of-post filter: Preventing you from posting too many great ideas at once.
  17. http://aazzhosting.com by Anonymous Coward · · Score: 0

    Free hosting and domain registration company.
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  18. His nebulizer doesn't seem like much of a deal by Anonymous Coward · · Score: 0

    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.