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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.
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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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
...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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