12-Lead Clinical ECG Design Open Sourced; Supports Tablets, Too

New submitter isza writes "MobilECG is probably the first open source clinical-grade electrocardiograph with simultaneous 12-lead recording and Android support. It has been designed to meet all the relevant medical standards (ISO 60601-1, etc.). Manufacturing cost @ 1000 pieces: ~$110. I had worked at a medical device company designing clinical electrocardiographs for three years. Fed up with the unreasonably high price, cumbersome design, and dishonest distribution practices of clinical ECG machines, I started working on a high-quality ECG that is different. After a couple of failed attempts to get funding for the expensive certification process and completely running out of funds, I decided to publish everything under a license that allows others to finalize and manufacture it or reuse parts of it in other projects." From the project page linked: "The software is licensed under WTFPL, the hardware under CERN OHL 1.2," and a few words of disclaimer: "Note: the design is functional but unfinished, it needs additional work before it can be certified. There are also some known bugs in it. Most of the software is unimplemented." Conventional crowdfunding may have fallen short, but Isza has proposed an interesting bargain for working on the project again himself: that will happen if he raises via donation half the amount of his original $22,000 investment.

Comments

Why isn't all medical equipment open source?

[The123king]

Seriously, why? The study of medicine has only one goal. Improve the life expectancy of human beings. Surely any profession in which proactively benefits the human race should be patent and royalty-free to allow other human beings to improve and advance the technology. Why should we pay $1000's for clunky and out-dated machinery when computerisation has allowed us to minaturise, improve and cheapen, the manufacturing of medical devices.

I'm glad there's some people in this world who see sense rather than paychecks.

Re:Why isn't all medical equipment open source?

[Okian Warrior]

The study of medicine has only one goal. Improve the life expectancy of human beings.

I believe the flaw in your argument is in this statement.

Re:Why isn't all medical equipment open source?

[laird]

In the US "maximize the revenue of medical providers and vendors" is how we roll.

That's why in the US there's almost no money spent educating people on basic health and nutrition, minimal regulation to protect our food supplies, and $billions spent marketing fast food that's causing massive health problems and early deaths for millions of Americans. But businesses in the healthcare business are making record profits. Yay!

Re:Why isn't all medical equipment open source?

[Okian Warrior]

A cynic would point out that the cost to develop these devices is very high, and companies must recoup their losses.

A mathematician would point out that, from a game-theory point of view, having one group of people come up with safety requirements without any burden of cost for the implementation of those requirements leads to stifling over-regulation.

Specifically, this leads to "safety at any cost", when in reality the cost of safety should be compared to other costs.

Re:Why isn't all medical equipment open source?

[Anonymous Coward]

Actually profits are down. LOTS of medical practices have sold out or gone bankrupt over the past 5 years.

Computers have not made your medical care cheaper. FDA approval for medical devices are not a walk in the park. Vendors take on a HUGE risk selling these devices and don't want to go to jail over a $10.00 device and neither does your doctor. EMR software for medical practices can be a pain and they are expensive. I suggest that anyone interested should, read Hacking Healthcare. It is a lot more complex than you would think.

Yes, fast food and bad eating habits are going to kill us all. I fight the habit off daily. But if you try to regulate or educate people on it you are labeled a socialist or something else. City of New York and now some place in Cali? Can't say I care if someone is eating badly or not until I think about the health care system we are going to now. Then I think about how I am actually paying for their bad choice as well as mine.

Now it is great that someone is working on an open source solution to lower the cost. But if it doesn't get certification, It will probably not get used. At least not in the U.S. no one wants to fight that battle in court when a mistake is made.

This has only reminded me of a recent court case.
http://www.huffingtonpost.com/2012/06/01/william-martinez-threesome-death-family-medical-malpractice-sreenivasulu-gangasani_n_1563247.html

Re:Why isn't all medical equipment open source?

[girlintraining]

In the US "maximize the revenue of medical providers and vendors" is how we roll.

Excuse me, but you're wrong. Very. Wrong. You think your doctors, nurses, etc., have an easy time of it? Let me break it down for you:

Wanna be a doctor? You're going to need four years of medical school. Cha-ching: $156,000 was the average student loan debt for a graduate. In 2009. You may have heard; tuition has been showing double-digit percentage gains every year since. But let's ignore that. Now you'll need another five years of surgical residency training. Yay! You get to start making money here! Er, $56,000 a year average. Great, right? Nope. That average salary comes with the expectation of up to eighty hours a week. Rumor has it the government plans on putting restrictions on this; if that happens, your 5 years just became about 7. Fun fact: Most residents defer their student loans during this time period (did you say compound interest? Oh yeah baby!). There's another cost too: Medical malpractice insurance. It's quite a bit higher for residents, but let's say you make it all the way out into the field. Yay! You're a doctor! A prestigious position where you make so much money even Tony Stark would nod his head approvingly. Well... actually, no. For all this work; you can now earn $156,000 a year as a pediatrician or family practitioner. Nice, huh? Not so fast there, sunshine: The government wants its due: Your takehome is now about $4022 biweekly, or a take home of $104,572 per year. Om nom nom! And don't even think about trying to get a specialist job for another 4-8 years.

Oh, and now that you can pay those student loans you might have forgotten about? on a 10 year repayment plan, your monthly loan payment will be $1,795.25 or thereabouts. That's $21,543 per year. Sooo now your take home is down to $83,029. But wait, there's more: Medical malpractice insurance to the tune of around $3,000 per year. Burp. $80k.

So after 11 years of hard work, maybe more, you can finally sit back and enjoy your first year's wages. You probably won't reach parity with your non-college educated peers that are making median income for another 7 years, but hey -- it's a prestigious line of work. Oh, I should mention one more thing: Thanks to the medicare crisis, your salary's probably going to drop by 15-20% over the next 7 years because of all those old people that are going to no longer be contributing anything to the economy except racking up medical bills and passing on their massive consumer debt (which eclipses the national debt, by the way -- you think the government is bad at managing their checkbook, wait until you see what the Boomers did with theirs) to those still able to work. And you can bet the top earners -- of which you are now in that category despite your own high debt load, are going to be paying for.

And to use your own words, "That's why in the US there's almost no money spent educating people on basic health and nutrition" ... except that's a lie. We do educate them, they just don't listen. Not that it would matter much at this point even if we shovelled piles of cash by the dump truck load into our public schools... because the Boomers bled us dry, and there's nobody investing in infrastructure or anything anymore. They lived beyond their means, and I sincerely doubt America will recover, at least not in our lifetimes. Get used to each generation earning less than the previous for the next 70 years or so.

Re:Why isn't all medical equipment open source?

[girlintraining]

The study of medicine has only one goal. Improve the life expectancy of human beings.

I believe the flaw in your argument is in this statement.

You're both wrong. That's not why our health care system went to hell. It's insurance companies. They're turning a profit on human misery. But ignoring that side of the equation, there's also excessive regulation. This article talks about how low-cost it is to actually make the equipment. And they're right. Meeting the standards is pretty easy. But that's not where the costs are. As I'm sure the designers know, or will soon discover, it's getting certification for their equipment. Certification is the reason why a table-side bed in a hospital costs $500, but you can pick up the exact same item, for home use, off Amazon for about $35 plus S&H.

If you want to fix the health care system, you're going to have to do something you don't want to do: You're going to have to give up on capitalism. Private-run insurance, private-run health care, private-run... kill it. Burn it all to the ground. Europeans figured out a long time ago that capitalism is good with non-essential commodities, but it's absolute shit with natural resources or essential goods and services that have a non-trivial cost. Electricity. Telecommunications. Gas. Internet. Health care. Transportation. These are not things that capitalism has done well with; The owners of these key resources make a fuckton of money, but the rest of us are enslaved to poverty to do so. Capitalism only works when there's a natural tendancy towards competition, and there isn't any in those areas. The invisible hand can kiss my invisible ass, because it doesn't work the way people have been led to believe. It works well much of the time. It works very well when the cost of entry into the market is low and there's no natural monopoly (like land, to use the quintessential example). But to say it always works, or to try and shoehorn it into markets and situations that it has a poor history with, is stupid. Nothing always works. Ever. Capitalism is no different -- put it to good use where it is efficient and effective, but it's not a "spray on all surfaces" sort of ideology. In fact, no such ideology has ever been created.

Re:Why isn't all medical equipment open source?

[girlintraining]

P.S. I can already hear the heads bubbling over of certain people because I mentioned regulation as being a problem, yet am suggesting institutionalizing health care. This is not the paradox you think it is: Much of our regulation is due to private interests demanding it. Just ask Tesla Motor Co. Canada, Spain, the UK, they've all done quite well at providing decent health care in an institutional capacity... though the UK system is showing signs of needing some attention due to neglect of late.

And yes, I know you can probably demonstrate any one of fifty different angles and case studies on how those systems are sub-optimal compared to ours. I answer with two statistics: Infant mortality in the United States, and current life expectancy. In those countries, they're going down, and up, respectively. In ours, the reverse is currently true. It's generally true that if you have money here and get sick, this is the best place to be. But in those countries, you don't get sick as often, because there's a focus on preventative care, not treatment. Here, specialists outnumber general practitioners about 3 to 1. There, the reverse is true.

If we look at it from a macro-perspective; At the societal level, their system is beating ours on both costs, and quality of life. And if the overall health of the general public, while maintaining reasonable costs, are your priorities, you cannot support our current privatized system.

Re:Why isn't all medical equipment open source?

[sjames]

Profits are down for medial practices. They've skyrocketed for device manufacturers and the pharmaceutical industry. It's a mixed bag for hospitals.

Computers and electronics have brought costs down everywhere they've been applied except medicine. There they have boosted profits but haven't benefited the consumer.

There is no reason equipment used in non-emergency practice needs to be built (and paid for) like lives hang in the balance. You could afford to throw away a LOT of failed ECGs that cost hundreds before reaching the price of a single current model. It's not as if a malfunction will cause it to display a normal ECG when the patient isn't normal.

Regulations and lawsuits are a popular excuse for gouging but it just doesn't hold water.

As for the link you provided, if the equipment had been less expensive, the man might have gotten his test sooner and tragedy avoided. Otherwise the problem had nothing to do with the quality of equipment at all. It's down to medical judgement and dumb luck.

Really internet?

[Anonymous Coward]

We can come up with a million dollars to make a sequel to one of the worst games of all time, Myst, and we can't come up with $22,000 to actually change the world?

Re:umm, ok...?

[jd]

Modern medicine works on the basis that dead people rarely sue. The same goes for other mission-critical systems like fly-by-wire avionics. To be fair (me? fair? well, it was bound to happen eventually), a lot of companies put in a lot of effort to do a good job. The problem is, if you're on life-support or flying at 20,000 feet, there is every probability that a software crash will be followed by a crash of another sort. There have been very close calls of this nature in the past.

But what would happen in the event of a fatal incident? In virtually all industries that use mission-critical systems, there are disclaimers and waivers that prohibit lawsuits.

Even in non-critical systems, EULAs invariably state the manufacturer/developer is not at fault, no matter what, even if they admit they are, and to use the system you have to agree to that. You aren't given a choice.

Open Source licenses often say the same, but Open Source allows you to validate the system to your satisfaction. You are prohibited from any code analysis and certain forms of runtime analysis with closed systems. Thus, although neither provide any form of warranty or fitness for use guarantees, you are capable of at least certifying open source as fit for use. No commercial product using computers will provide anything remotely close.

A good start

[jd]

But only a start. Researchers using - it was either 48 or 64 leads - were able to identify specific muscles that were showing abnormalities long before those abnormalities turned into organ failure. Isolating problems to that degree just by collecting more of the same data would seem a great way to help prevent problems serious enough to show up on a conventional system ever developing in the first place.

In other words, why not turn thus from being open source medicine into an open source debugger? Why let things get to the point where medicine, rather than our own creativity is needed?

Re:12-lead?

[Anonymous Coward]

Okay, this may be a stupid question, but I only count 10 leads in the pictures of the device, so where/what are the other two? Grounds?

lead != wire in this context, it refers to the electrical paths through the body between various parings of the 10 wires.