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Biotech Medicine

More Medical Devices Should Be Open Source, Like This ECG (github.com) 79

isza writes: This is a follow-up to the Slashdot story about mobilECG, a 12-lead, clinical-grade ECG being open sourced. We have not given up on our goal to get rid of the high-profit-margin and dishonest distribution practices of diagnostic ECGs, and make a certified open source version of this important diagnostic device. After many months of hard work, there is now a working prototype of a much more capable device than the first version, with its sources available on GitHub. MobilECG now has a Holter function, changeable lead-configurations and Bluetooth. Here's a video of the prototype working.
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More Medical Devices Should Be Open Source, Like This ECG

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  • Hearing aids (Score:2, Insightful)

    by Anonymous Coward

    Hearing aids are another great example of nonsensical medical equipment price gouging.

  • by psergiu ( 67614 ) on Friday February 26, 2016 @01:57PM (#51592549)

    Also check the guy's business card.

    https://www.youtube.com/watch?... [youtube.com]

    The card is measuring the real Einthoven Lead I ECG curve between the two hands - sampled at 50Hz.

  • Because certification of medical or any other equipment with the potential to affect life safety is as much about the manufacturing process and QC as it is about the design.

    The more likely a device is to injure or kill someone, or produce false reading which may lead to incorrect diagnoses, the more its entire life cycle needs to be regulated (design, manufacturing, repair). Stuff like ECGs, regulate them. Hearing aids, maybe. Touch screen speech synthesis devices which can easily be replaced by an iPad ap

  • by OverlordQ ( 264228 ) on Friday February 26, 2016 @02:07PM (#51592617) Journal

    So, who is going to pay for the FDA certification?

    • by sbaker ( 47485 )

      Yep...exactly. That's the reason simple electronic gadgets that are ridiculously easy to make cost an ungodly amount of money if they're used for medical purposes.

      The FDA regulates "medical devices" in the same way it regulates drugs...you have to demonstrate efficacy, safety, do human trials...then there is liability insurance...it's ungodly expensive.

      • The FDA regulates "medical devices" in the same way it regulates drugs...you have to demonstrate efficacy, safety, do human trials...then there is liability insurance...it's ungodly expensive.

        But to be fair, the alternative is being able to buy thorium toothpaste over-the-counter.

      • The devices I worked on were extremely expensive on their own. None of these were "gadgets".

    • There's more than that too. Often the software is a part of the purchase price. New features are added and customers are willing to pay for those features. Businesses are not going to readily change their business model into one where the machine is purchased and all software upgrades and features after that are free. I recall a case where a Russian distributor refused to sell our machines unless we added security features to block pirating the licenses.

      And don't forget that there are often rational and

  • by Fencepost ( 107992 ) on Friday February 26, 2016 @02:09PM (#51592627) Journal
    I'm not directly involved with medical product design or certification, but while this looks fascinating I think they're going to have a difficult time with selling it, at least in the USA and I suspect in many other countries as well. That's because they're going to have a very hard time getting required certifications / FDA approval, and it'd be really hard to try to argue that this isn't a medical device.

    I'll give a couple of related examples: DICOM viewing software, which has a wide variety of open source and free low-end versions of commercial software, most or all of which are careful to note that they are "Not For Clinical Use" because they haven't been through a certification process. You can get them an use them (for example for reviewing your own medical imaging data), but physician's offices that actually use them for clinical purposes are running significant risks not so much of being sued but of having insurance complications on the off chance that they do get sued (or if the company somehow found out about it).

    The other example I'll offer is Cefaly, a device for treating migraines with low-level electrical stimulation. They were available for quite some time (including over the counter I believe) in Canada and Europe, but it took a couple of years before the FDA approved their marketing and sale in the USA (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm388765.htm). The version approved for the US market was also simplified from the international version, having only a single level rather than the 3 modes found on international models. Cefaly was also reviewed through "the de novo premarket review pathway, a regulatory pathway for generally low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device." That's not something that will be available for mobilECG which will likely get a variety of industry pushback noting that it's substantially similar to existing ECG and Holter devices.

    So overall this looks like a great way to improve cardiac care in second- and third-world hospitals lacking access to or priced out of purchasing equipment, but I think their market is a lot smaller than their video implies.
    • I think you are correct. In a CYA world, you need proof of the most stringent testing and accuracy people will demand when something goes wrong. It is one of the reasons I think that some limits to medical liability would help lower costs, and improve access in the USA. I think people forget that doctors, nurses, and other associated professions are people. And that having anyone, no matter how well trained or educated, perform operations that involved cutting you open and probing around can and will go

  • by mykepredko ( 40154 ) on Friday February 26, 2016 @02:15PM (#51592673) Homepage

    This reminds me of an entrepreneur who approached me to help him design and code flat panel instrument panels for light aircraft. He felt that $25k+ for a panel and instruments was ridiculous when he could buy the parts for just a couple of hundred dollars. Then he looked into certifications (which included environmental testing) along with liability insurance and type certificates and suddenly that $25k wasn't so outrageous. This was around ten years ago - doing a quick check, it looks like Aspen Avionics has a fairly inexpensive PFD ($5k for a basic display).

    Now that I'm over 50, my doctor has an ECG he rolls out every couple of years and doesn't seem to regard it as anything other than a piece of equipment like a stethoscope. It has a simple LCD display and it connects via WiFi to the office network where it sends jpgs of the waveforms.

    So, how outrageous are the profits for ECGs and what are the dishonest distribution practices?

    • by GuB-42 ( 2483988 )

      That's why some light aircraft pilots use iPads for navigation instead of certified equipment.
      They don't have the right to use it but who's gonna check when they are flying. And should they get controlled after landing there is no problem as long as they have the proper paper maps. As for the iPad, it is just a personal mobile device so it doesn't have to pass the certification.

    • There's an advantage here I've noticed over a lot of consumer products. It's that because of the high cost up front that you can sometimes afford to actually spend time designing it right in the first place. And just the fact that it has to be examined in detail by third party agencies will cause some developers to not create their usual half assed crap. When you have to sit in front of a grumpy panel to explain why your software crashed and what you will do to ensure it never happens again then maybe yo

  • Trouble is... (Score:5, Interesting)

    by sbaker ( 47485 ) on Friday February 26, 2016 @02:18PM (#51592693) Homepage

    ...medical devices have to be certified by the FDA (or someone big and scary like that)...and that costs an off-the-charts amount.

    I built a gizmo for some sorts of diabetics who have to be careful about standing still for a long time because it can destroy their feet, There are a truly ghastly number of amputations each year because of this. So - pressure sensors in shoes, bluetooth gizmo, cellphone app that goes BEEEEP! If you're standing badly for too long. Cost to make - about $100...maybe $50 in quantity.

    Sure - any idiot with an arduino and some old-school hacking skills could do that - right? Sure - I don't claim to be all that clever!

    So I go to doctors who specialize in this stuff - they say that the current solution costs $12,000 and mine is just as good. In fact, I could trivially get it to log data, text or email it to the doctor, log it to the cloud...whatever...the $12k gizmo's don't do that.

    Oh - but FDA approval is needed. Human trials. Yadda yadda yadda. Cost of doing that is $500,000. Add product liability insurance, you name it.

    Estimated sales...oh darn. My $50 gizmo will have to sell for $15,000.

    So - 70,000 people who we could EASILY help for very low $$$ are still getting their feet amputated for absolutely no good reason every single year.

    Go figure.

    • Re: (Score:2, Interesting)

      by Anonymous Coward

      This is another case of Snake Oil Salesmen ruined it for the rest of us. The problem is that as a layman I can't tell if what you just sold me is garbage or a very useful product.

      We could make the process a lot less inexpensive but then how are the big corps going to pay for their upper management perks?

    • by Anonymous Coward

      There is nothing about the firmware being open sourced that means it cannot be a FDA certified device.

      But you know, FUD FUD FUD.

      • Re:Trouble is... (Score:5, Interesting)

        by sbaker ( 47485 ) on Friday February 26, 2016 @02:39PM (#51592869) Homepage

        In my case, it didn't matter whether the firmware was opensourced or not...the cost of the certification made it impossible for a small business to do...the cost of liability insurance was insane. There are requirements to certify the manufacturing process (so no $6 Arduino clone) and a requirement to offer a repair service (Really? Just throw the old one away and buy a new one!)...it's crazy.

        When you consider the cost of amputation (surgery - not being able to walk afterwards, loss of quality of life, etc) - even this device doesn't have to be anywhere near 100% reliable to do a lot of people a lot of good. But if just one person were to lose a foot because the gizmo failed to warn them - the resulting lawsuit would bankrupt any small business just like that.

        So, 70,000 people per year suffer one of the worst things that can happen to anyone as a direct consequence of a broken system.

    • by pr0t0 ( 216378 )

      Sell it in the Middle East. I was surprised to learn they have the highest incidence of diabetes in the world.

      • by sbaker ( 47485 )

        Probably my best chance is to sell it to Walmart who use pressure pads to make sure that their "greeters" are actually doing something! (But that would be evil...so, no).

    • Is there a reason you can't market it as a general "activity" monitor like fitbit and similar items? So long as you don't state or imply that it's a form of treatment for diabetics (or any other specific condition), wouldn't you be ok? A little very carefully worded, targeted advertising that diabetics are likely to see would allow them to make their own judgement on whether it would/could help them manage their condition. If it's as good as you say and so much cheaper, word of mouth may be all you need.
      • A little very carefully worded, targeted advertising that diabetics are likely to see would allow them to make their own judgement on whether it would/could help them manage their condition.

        So easy, so tempting. So dangerous a precedent.

        What you suggest reminds me of the marketing of tobacco products, homeopathic remedies, etc.

        • Don't even dig that deep. It's a bit like Fitbit, or probiotic yoghurt, etc. I'm sure they'd love to be able to say it helps with your health but they can't.

    • Sure - any idiot with an arduino and some old-school hacking skills could do that - right? Sure - I don't claim to be all that clever!
      Go figure.

      The problem is that before the FDA (and its predecessors) the market was flooded with quack cures and worthless medical devices.

      It could happen again.

      By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products that had been ruled permissible under the 1906 law, including radioactive beverages, the mascara Lash lure, which caused blindness, and worthless "cures" for diabetes and tuberculosis. The resulting proposed law was unable to get through the Congress of the United States for five years, but was rapidly enacted into law following the public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent.

      However, in an indicator that the FDA may be too lax in their approval process, in particular for medical devices, a 2011 study by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovascular health purposes.

      Food and Drug Administration [wikipedia.org]

      • but we still have worse events than the 1937 elixir one with 100 people dead, even with the FDA. Over 2100 dead from Darvon and Darvocet as a fer instance. Those Sulfanilamide pushers were amateurs.

        • Except Davron and Darvocet were tested. Testing does not guarantee that harmful products are prevented from getting to market. But the lack of testing will guarantee that they'll get through.

    • If you are selling a medical device then yes the bar is very high, but do you need to sell this as a medical device. Walking is often prescribed to prevent heart disease, yet shoes are not regulated as a medical device. For that matter, you can buy heat rate monitors for exercise monitoring at the drug store that are not medical devices as far as the FDA is concerned. As long as you do not claim to treat or diagnose a medical condition you can sell your device with out any FDA approval. You might even b
    • You could give away the plans and such. However then you're still going to be liable if the product doesn't work right or the user was not properly advised on how to use it. Better to sell a consumer product designed for exercise, it warns you if you're being a couch potato or that it's time to stand up from your desk and walk around, but never ever mention diabetes. Let the diabetes part make the rounds by word of mouth.

      But because we've had a sad history of medical quackery leading to serious harm and

  • As for FDA (or whatever regulatory agencies exists world wide in using countries, the world isn't the USA after all and this product is from Hungary), I'm sure it would not be a huge deal for people to step up and get it certified with regulator agencies. This would truly put innovation in the medical industries instead of everybody spending a king's ransom developing/protect patents/exclusivity right.Image if we spent more time creating and cooperating than posturing and bidding for exclusive control over
    • Re: (Score:2, Troll)

      Why not try first marketing the device in some country where the registration requirements are not as ridiculous? If the device proves out over time, getting it registered in other countries will be easier.

  • As others have mentioned, the regulatory approval piece is big hurdle with something like this BUT there is still some good potential here... * Regulatory approval for 'me too' devices doesn't usually require clinical trials so the cost of regulatory approval would be less that some people have suggested. * The concept of 'open source' hardware is quite interesting. Rather than MobileECG design, build, and sell the devices all by themselves, perhaps they could focus on the design aspect so other companies
  • Look how long it's going to take our congress to shut that down. Can't be so unfair to the medical device manufacturers and eat into their large profit margins...
  • This is a low cost device that is being offered to the world and it not aimed at medical professionals in developed countries. Being one for personal use in your home would not require any certifications, although this wouldn't be a substitute for seeing a cardiologist. There are many parts of the world were basic medical equipment as simply unavailable due to the high cost. What we take for granted in a visit to our doctors or hospital simply isn't there. This would never be allowed to be used by medica

  • The device is going to have a CE mark (and hopefully FDA too, later). CE costs 50k USD, and you don't need human trials for such a standard device (you don't need to retest the efficiency of an electrocardiograph that does exactly the same as all the other ones, you just need to show that it does the same indeed). The investor is going to pay for it, and the business model is making money on the services instead of the device.

MESSAGE ACKNOWLEDGED -- The Pershing II missiles have been launched.