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.
Hearing aids (Score:2, Insightful)
Hearing aids are another great example of nonsensical medical equipment price gouging.
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They are custom-fitted, high precision medical devices that as such are also subjected to intense regulatory and lawsuit considerations. If you want to stick a cone of paper in your ear and save a few bucks go ahead, but you'll look like a moron. There is also a lot of testing that is involved with selecting an appropriate hearing assist device.
None of those factors prevent them from being open source.
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If a filter in GIMP doens't work quite correctly no one really cares
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Re:Hearing aids (Score:4, Informative)
"They are custom-fitted, high precision medical devices..."
Which contain perhaps a hundred bucks worth of electronics and have a history of seldom working to the satisfaction of the patient. My town is full of high-end retirees, and every one I have spoken to has a drawerful of expensive hearing aids that suck. This area of medicine is overripe for disruption by some Silicon Valley company that can make a device that performs more like a natural ear.
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Problem is getting the FDA to approve it. Not because of corruption, but just sheer bureaucracy.
The thing is, once something is considered a medical device, and pretty much just because of that fact alone, the price suddenly goes way up.
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Do you suppose the hearing loss is due to wax buildup and to dryness? I am a senior. I noted that seniors are more prone to be limiting their water intake. They cut water consumption to the minimum so as to not pee at night or have a "pee urge" that does not give them enough time to reach a toilet to void before ....
Body dryness may contribute to hearing loss and possibly some eye problems.
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Being careful about wax is part of the standard instruction that patients get.
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What's the down side of a hearing aid failing? Most often, the patient can't hear. Which is pretty much the same as a dead battery. Rarely, I suppose they could do further damage if they failed in a high decibel output mode. But I've never heard of that happening (yuk, yuk).
So, if the hearing aid turns out to be a piece of shit, that's a problem between the patient and their audiologist. They made a deal to fit a patient with something that works. It doesn't. So fix it or give them a better model. I mean i
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They are custom-fitted, high precision medical devices that as such are also subjected to intense regulatory and lawsuit considerations. If you want to stick a cone of paper in your ear and save a few bucks go ahead, but you'll look like a moron. There is also a lot of testing that is involved with selecting an appropriate hearing assist device.
The fact is, that hearing aids are simple audio amplifiers with a filter after the microphone. The filter is designed to allow the audio frequencies that the user finds weak. Typically there is a boost of the midrange and treble. In newer earphones, this boost or cut is programmable.
Better hearing aids use silver oxide or lithium batteries for long life. Some earphones are in-ear, while others are at the earlobe with a fine sound tube to transfer the sound to the eardrum. From what I have seen, three ty
Mobile ECG Business card (Score:5, Interesting)
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.
Yes, no, maybe (Score:1)
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
FDA (Score:5)
So, who is going to pay for the FDA certification?
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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.
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Your co-worker's dog won't sue the manufacturer if the hip doesn't work.
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But to be fair, the alternative is being able to buy thorium toothpaste over-the-counter.
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The devices I worked on were extremely expensive on their own. None of these were "gadgets".
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But Open Source doesn't add anything. Sure I have the source, but if I actually use it and make my own, it wont be covered by the same certification so there's no way I could use it without leaving myself wide open.
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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
Unlikely to be usable in the USA (Score:5, Interesting)
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.
Re:Unlikely to be usable in the USA (Score:4, Informative)
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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
Where is the proof of the rip-off ECGs? (Score:4)
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?
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According to the ECG, your left ventricle has severe artifacting, and your right valve is macroblocking. I'm sorry to have to break it to you like this, but you've got about 38 seconds to live.
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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.
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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)
...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.
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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?
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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)
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.
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Sell it in the Middle East. I was surprised to learn they have the highest incidence of diabetes in the world.
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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).
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Gaming the system. (Score:3)
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.
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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.
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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]
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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.
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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.
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is the approval of government agency in a corporate fascist state worth anything?
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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
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It's the dems who are ruining health care. Hey, let's tax medical equipment. It's already obscenely expensive, who will even notice? Let's make insurance so expensive that even large employers will drop PPO plans for less expensive disaster plans. Let's promote health saving accounts and ignore the fact that it screws the middle aged worker who hasn't been putting money into one their whole adult life. Remember Obama on the campaign trail? He told some lady in NH that she should just be happy with the
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Yep. Because they're going to pay it out of their own pockets and not pass it on. FFS.
What planet do you people come from?
THAT'S innovation (Score:1)
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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.
it's got potential (Score:1)
Congress can't have that (Score:2)
Forget the FDA (Score:1)
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
Certification (Score:1)