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More Medical Devices Should Be Open Source, Like This ECG (github.com)
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 are another great example of nonsensical medical equipment price gouging.
Also check the guy's business card.
https://www.youtube.com/watch?...
The card is measuring the real Einthoven Lead I ECG curve between the two hands - sampled at 50Hz.
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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 app. Screw it. Go for the open source solution.
Have gnu, will travel.
So, who is going to pay for the FDA certification?
Your hair look like poop, Bob! - Wanker.
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.
fencepost
just a little off
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?
Mimetics Inc. Twitter
...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.
www.sjbaker.org
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 pain pill instead of having surgery to fix the underlying problem. Hey, and if your employer sponsored plan is too good, we'll penalize that too. Imagine that, the federal government punishing people having plans that are too good. WTF.
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 something that affects so many lives..
"Imagination is more important than knowledge" - Einstein
Hey, and if your employer sponsored plan is too good, we'll penalize that too.
The tax is only 40% on plans with annual premiums exceeding $10,200 for individuals or $27,500 for a family. It isn't a very large burden if you're wealthy enough to be able to afford over ten thousand dollars a year in health insurance! The people that have that much cash to blow are obviously not paying their fair share.
The tax is only 40%...
It's actually not quite that ridiculously and stupidly low. The amount over that Cadillac amount is not a deductible business expense so corporations will have to pay income tax on the excise tax thus significantly increasing the tiny 40% tax. It's not perfect, but it's better than the tiny 40% tax rate that the Republicans keep spouting due to the common sense double taxation.
> common sense double taxation.
Found the Democrat.
The medical device tax is only 2.3% so you're full of crap. Those health insurance corporations can easily afford that.
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.
Can you please block greenwow's posts? The guy is a nutcase.
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 can tweak the design, build and sell the devices. Essentially, MobileECG's open source hardware would be a reference architecture that other companies could use and provide feedback to. * Would be great to see a scientific study comparing the safety and efficacy of 'open source' vs 'closed source' medical devices. Since ECG devices are so common, this seems like a great opportunity with a relatively low-risk device.
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 medical professionals in my country but that isn't the target market.
I have to get an ECG done shortly, as part of a regular check up with a range of other tests, and that will be using a certified device under the control of a medical professional.
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.
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?
What kind of sick fuck goes after health insurance costs in order to penalize people?