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?

[K. S. Kyosuke]

That doesn't even matter. What is the safety of not visiting a physician because of financial constraints? At one point, the diminishings returns on "safety at any cost" will mean that the outcome for the society at large will start declining.

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?

[gweihir]

The goal of medicine is to make tons of money. Human suffering is only a concern for a tiny fraction of the people in that field.

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

[K. S. Kyosuke]

But a society may decide that even if mathematically they got the odds of a medical device causing harm to be perfectly equal to the odds of doing nothing, that morally one may be preferable to the other.

I think that "many people are short-sighted morons" would be a shorter, yet semantically identical expression of what you've just elaborated.

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

[dmexs]

I'm actually on the residency interview trail right now. Judging by your post you must already be well entrenched in a residency you loathe. Sorry. When I read quote however I read providers to mean hospital CEO's and insurance companies. Certainly not doctors and nurses, at least based on the relative return on time and education invested.

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

[Teun]

I don't always agree with your posts but the three above are severely insightful, so much I'll bookmark them.

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.

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

[gweihir]

You misunderstand the system. These high costs of becoming a doctor serve as indoctrination, making it very clear to any prospective doctor that this is not primarily about helping people, but primarily about making money. Sure, a few idealists that manage to keep their personal ethics intact remain, but the majority of prospective doctors gets the message loud and clear.

I do completely agree about your last statement though. The US population has become so anti-knowledge that even solid, well-researched and dependable information sitting in plain sight gets ignored by most. As to the money question in education, it is not a cost issue. Other countries manage to give children far better educations at significantly lower cost. That is why "shoveling piles of cash by the dump truck load into our public schools" would have no effect whatsoever. It is not a problem of funding. The problem is that the US does not understand what a good education is at this time. Not that it ever did, from what I can tell, indoctrination was always paramount over independent thinking, at least below the PhD level. And PhD students are (or were until recently) mostly imported, at least in the STEM area. The reason is that US educated students just do not cut it, except for a small minority. As far as I can tell, it is not a question of "recovering" either, more a question of starting to import all that foreign talent again. But with the reputation the US has these days, and with it becoming worse daily, I do not see that getting fixed for a long, long time, if ever. Your 70 years might be entirely realistic, but possibly with an economic crash in there as well.

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

[gweihir]

Indeed. It leads to people dying without need, as treating them would be far too risky or rather far too costly once the risk-cost (insurance) has been included. Another case of those that want security at any cost not getting it despite the high price they pay.

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

[sjames]

Currently, doctors are being squeezed, but the equipment manufacturers, hospitals, pharmaceutical companies, and universities standing behind the doctors are making a killing (sometimes literally).

However, $80k/year after taxes ain't bad. It's a lot more than most of the doctors patients will ever make.

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

[sjames]

Safety at any cost endangers all of us when it comes to healthcare because it drives people to avoid any sort of healthcare until it's too late.

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

[Trax]

You do realize that a part of that $80K needs to go into 401K for retirement and don't forget that for the last 7 to 12 years of training that the physician did not earn enough money to put into their retirement account while still accumulating debt. From my own perspective, I now have > $300K in debt that needs to be paid off and I have not a single piece of wealth to show for it. I don't have a car, home, retirement account, stocks / bond, or anything that I can hang my hat onto if the proverbial shit hits the fan. It's folks like you that don't understand the amount of time that we put into medicine, lose out on opportunities during training, and come out the other end with significant debt load. You despise us for the incomes we make but fail to gauge the above.

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

[Anonymous Coward]

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.

The definitions of IMR are different in the different countries, genius.

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

[Anonymous Coward]

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

I'm gonna stop you right there. I live in Europe, idiot, and there's plenty of private medical practices, private insurance, and your myth of how life is here is laughable. Also electricity is privately run (though effectively by a monopoly), internet and telecommunications are certainly run in a very capitalistic way ... basically, I have no idea what the fuck you're talking about.

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

[nurb432]

Because it often costs obscene amounts money to develop it and people want a return on their investment.

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

[Anonymous Coward]

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.

Wrong it's 8 years for a doctor, it's 4 years just to become an LVN (Licensed Vocational Nurse) while to become an RN/NP (Registered - Nurse Practicioner) or a PA (Physicians Assistant) Takes 6 years. As The main difference between the RN/NP/PA is the 2 years residency requirement for that Coveted MD (Doctor) title. The $150,000 is for a Nurse/PA. A Doctor has over a quarter million dollars in debt by the time they graduate (don't forget Malpractice Insurance is part of that debt).

Tack on another 4 years for specialty school (Orthepedic/Neurology) and you're now talking a full Million Dollars in debt along with 12 years of schooling before you even begin making the money needed to repay that debt. Now there are several programs that can and do make it feasible for folks to become doctors but they're either the Militay or offer to discharge a full year of debt for every year served in an under-served region (rural) and let me tell you, docs in those programs don't make nearly as much as private practice in New York, San Francisco, D.C.. and other large metro areas.

And as one of those folks who has to have that education, where is it? I've never seen one lick of it and I've been insulin dependent for the last 5 years. Education? Depends on where in hell you're at. I live in a rural area and the medical offerings are slim to fucking hours in the ER if you're sick. We've got 100k people in the region but spread out over an area of 200 square miles (50x4) Yea, we have lots of doctors here. Like hell, it's a god damn 60+ mile drive from where I live to the nearest metro region that has plenty of docs and that's only got a population of half a million (5x what we have).

If we do have docs, then it takes a week to get an appointment that means wasting at least 3 hours on due to the backlog and it isn't getting any better.

Posting AC to preserve Mods
Fast Turtle

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

[theshowmecanuck]

Correct me if I'm wrong, but I believe in many countries in Europe (France, Austria, and Germany is where I'm thinking specifically), health insurance goes by a means test. If you have the means (the income) you must buy private insurance. If you can't afford it, you get public insurance. And the kicker is that you should receive the same level of treatment, including wait times regardless of whether you have public or private insurance. Or something like that. Yes? No?

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

[Interfacer]

Because all distributors of medical equipment are liable for the damages in case of malfunction. Doesn't matter if you package it up and distribute for free. Your ass is on the line if something goes wrong. That is why there are expensive certifications, regulations, and oversight watchdogs such as the FDA and FAGG (Europe). If you create an ECG appliance, then you had better hope nothing ever goes wrong, because someone dies due to a malfunction, you're bankrupt. That is why even your development and QA processes are subject to severe regulatory requirements.

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

[girlintraining]

You misunderstand the system. These high costs of becoming a doctor serve as indoctrination,

What the fuck man? Seriously... you're signing up to pull parts of cars out of people. You're gonna tell someone they have cancer and 3 months to live. You're gonna be explaining to someone the surgery didn't go well and they're going to be leaking shit out of their ass for the rest of their life. Or that you have to amputate their leg. Or that they have AIDS. You think people sign up for that so they can be indoctrinated? And you think I don't understand? Fuck you man. Fuck you and the horse you rode in on! These people bust their asses for long hours for years, dealing with blood, guts, shit, and gore, out of a genuine conviction that life is sacred. And you come here and you shit on that to serve your own political needs? FUCK. YOU.

The high costs are because they need to be highly trained, there is no margin for error, because unlike your job, when they fuck up, they have to bury their mistakes. So don't you dare twist around a profession that sooner or later, you're gonna need because that's what they do. They don't judge. They heal drug dealers and terrorists, and saints and grade school teachers. That's their job. That's what they do. No politics. No bullshit. Just the job. The job of saving lives.

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

[PPH]

You're both wrong. That's not why our health care system went to hell. It's insurance companies.

This.

But one aspect of the insurance industry many people are overlooking: There is a quiet move afoot to securitize insurance. This means holding a policy (life, for example) on someone you do not have an "insurable interest" in. Essentially, a CDS against someone else's life. The problem the insurance companies face (Besides getting the above legislation. That's trivial. Just slip Congress some cash and its a done deal.) is that medical breakthroughs which affect mortality rates will affect the value of these securities. And that means risk and uncertainty, which discounts their value.

God forbid that Obamacare should suddenly decide to fund some lifesaving procedure (or demand insurance coverage for it) which would add years to the life of the insured. The rich folks holding your grandpa's policy will be pissed if he hangs on for another 10 years.

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

[lakeland]

It's hardly fair to compare a doctor's take home pay to the median income in the US. People going to med school are both smart and hard working, try comparing the income of smart, hard-working non-doctors to doctors and I think you'll find the difference is far smaller.

Yeah, $80k after applicable deductions is a good income. Approximately 12% of Americans make that much or more.

I tried to find some data on the median income of people with similar work ethic and IQ to doctors but couldn't find anything sorry.

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

[gweihir]

Ah, those with a simple model of the world... And those that think screaming and swearing makes them right...

Bit of a simplistic approach to discussion you have there. Not all bow to open aggressiveness and it certainly does not make you right. In fact it gives a high incidence score to the assumption of you being wrong, because otherwise you would not have to resort to an approach this primitive and transparent.

And a bit of reading comprehension would help as well. I never claimed the people going into medicine _want_ this. It is just what happens to them in the US. Hint: In other countries people do not come out of medical education deep in debt. The doctors in many of them are not worse then US doctors. This begs the question what the US is doing differently. I just pointed out the obvious.

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

[fatphil]

No. In every European country where I've lived (3 of them) essential public healthcare is free. Non-essential healthcare (e.g. having a wart removed, 4 15 minute slots, say) costs almost nothing, and everyone is treated equally. Different countries cost different levels, but they're roughly on a par PPP-wise. There is also the option of private health care, and you'll be treated by the same doctors, just queue less.

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

[knarf]

While there is some truth to what you write, said truth would be conveyed in a much stronger way by refraining from referring to copulation every third word. Capice?

Apart from that you don't manage to explain why health care in the USA is so much more expensive than it is in the rest of the world. I assume you do know the reasons? Doctors in France or Sweden or the Netherlands or Finland are just as much into their jobs as their North American counterparts, yet they manage to do their jobs within a much smaller budget. Ask yourself why if needed.

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

[penix1]

I am not going to comment on the OP's asinine ramblings but will ask you a few different questions...

Why is it that the same procedure in the same town at different hospitals have costs that vary widely as much as thousands of dollars? The training required to provide that service isn't any different and is often preformed by the same doctor. So why the huge disparity in costs?

The one true constant in this world is everyone is going to get sick and die. I put forward that hospitals in particular take advantage of the pain and grief to make the most money possible. People rarely have a choice of which hospital to go to in the ambulance. And when they are in pain, unconscious or otherwise not in a frame of mind to make financial decisions, they are slapped with bills that destroy their lives or the lives of their successors. This is the number one reason many won't even consider going to the hospital usually until it is too late and the costs are far worse.

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

[gweihir]

Well, whatever the subject, you have just demonstrated that you are incapable of rational discourse. And blind to things that are glaringly obvious. Pathetic.

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

[AlphaWolf_HK]

That's not true at all - regulation is extremely tight. You can't so much as sell fruit off of your own tree without a food handler's permit in most states.

Fast food isn't causing health problems btw (in fact, fast food is actually shockingly well documented, especially McDonalds which is one of the few fast food joints I'll eat at because unlike most places I can know exactly what's in it) what's causing problems is people eating lots of calories with minimal nourishment included. You don't have to eat fast food to do that. Fresh foods tend to be cheaper, but nobody buys them because most people don't know how to cook.

Regulation is both holding back profits AND better health. I need to get corneal crosslinking done on both of my eyes to prevent my corneas from eventually becoming useless. I'd be happy to pay for the operation (costs around $5,000 if you're lucky enough to get into a clinical trial) but the FDA won't approve it yet in the US, even though it's been done safely everywhere else around the world since 1998. You know why I can't get it? Because people like you tell the US government that doctors are too greedy and profit driven, therefore we must put up with 15+ years of red tape before the government deems it safe, even though it is already well known throughout most of the world to be perfectly safe.

Thanks to these glorious regulations of yours, I have to sit helplessly as my eyesight continues to deteriorate rapidly (irreversibly I might add, as crosslinking usually only halts the progression) until the FDA can get its head out of its ass.

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

[Anonymous Coward]

Medicine amounts to a custom job performed by a highly trained specialist. Prices will vary based on geography, supplier contracts, predominant payer (e.g. specific insurer or medicare). and how the individual doctor practices (e.g. some prefer expensive new drugs/devices, others are more conservative, and still others are downright paranoid with tests). A simple coke will vary in price by an order of magnitude between stores, so why is it surprising that one hospital charges $1,000 for an MRI while another charges $3,000? Something like a cholecystectomy will vary a heck of a lot more, given how complicated the case was and what equipment the surgeon prefers to use.

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

[girlintraining]

I am not going to comment on the OP's asinine ramblings but will ask you a few different questions...

Thank you for that small courtesy.

Why is it that the same procedure in the same town at different hospitals have costs that vary widely as much as thousands of dollars?

Long story short: The same reason Coca-cola is rolling out machines that change the price depending on how hot it is. It's not just about how much it costs, or what the profit margin is... it's also about how much you're willing to pay. And when it's pay up or die, unsurprisingly, they charge infinity.

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

[Darinbob]

There are other issues involved. Ie, where practical the end user needs to be prevented from making the device malfunction, sometimes there are laws that require this. Thus software can not be modified by the end users. And the users do attempt to subvert their own machines; with radiation therapy machines which can kill someone in a variety of ways of not used correctly, operators still attempt to bypass safeguards.

Another reason is that some of the software is third party licensed. Even non medical stuff like Image processing libraries, RTOS, network stacks, etc. The manufacturer can't make that code available and so is prohibited from using some common licenses, like GPL.

Finally, everyone cheats. Seriously. People will steal devices and designs and resell them, sometimes with no legal recourse if it happens in a country with lax laws. Thus the companies creating new technology can be hurt financially, unable to afford research and development. No one will want to spend 10 million dollars turning some academic theory into a real product if in the end there is no revenue. Are you willing to work a full decade with no paycheck at all?

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

[Darinbob]

Profits are way down for many device makers. Don't let a few success stories fool you into thinking medical devices is a good business plan.

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

[Darinbob]

The regulation isn't about safety at any cost, it's about safety at a reasonable cost. The alternative before regulations were enacted was to completely ignore safety.

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

[laird]

A few points:
- You're very right about the cost (cash, time and work) of getting devices certified. That swamps the actual development costs, by a wide margin. And that is the real reason that open source can't make any advances into the medical arena.
- Yes, it's expensive getting into the medical devices business, but when you win, you win HUGE. Device manufacturers are, in total, making fantastic fortunes in the US, because they sell the same devices here for far more than in other countries. That's not just because we are a rich country - Germany, Japan, France, etc., all run healthcare much more efficiently and effectively than we do, and they do that in part by using their purchasing power to negotiate aggressively for good pricing, and by choosing equipment based on medical value based on outcomes. In the US, the sellers have all of the leverage, so prices are unrestrained. And hospitals buy things for marketing/revenue value, not purely for medical outcomes, which is why they buy the latest expensive gizmos and advertise them to attract rich patients, while in other countries purchasing is based on medical outcomes so they use much cheaper but just as medically effective models, and thus provide much better medical care for the same budget.
- Other countries don't force doctors to go massively into debt to get trained. That's not true everywhere. For example, in France medical training is free (http://scopeblog.stanford.edu/2009/11/10/the_french_and/), so people become doctors based on talent and ability, not on ability to pay for training, and when they graduate doctors can focus on providing medical care rather than debt management, and doctors can afford to work for reasonable professional salaries rather than being forced to absolutely maximize revenue in order to repay loans and to hire an army of administrators to fight the insurance companies in order to be allowed to treat patients.
- Fast food's negative impact on health can't be pushed purely onto the buyers. The fast food companies spend $billions engineering food that targets our weak points, and $billions on marketing to pump it into the population, and they're quite willing to put things that are extremely bad for people into their food (salt and calories are the least of it) if it improves sales or reduces costs. Yes, McDonalds documents what they sell. That's due to government regulations requiring large chains to publish the nutritional data about their food - all chains do this now. What we need is more such regulation so that people can know what they're being fed, and to outlaw the most dangerous practices. The recent outlawing of hydrogenated oils is a good example of this - they're extremely bad for people but were at one point widely used in the industry because they're a bit cheaper than regular oils.
- Computers have actually improved some aspects of medical care. The rate of medical errors is much, much lower now that hospitals and medical records are computerized - at one point, 40% of all patient hospital stays had at least one medical error (wrong drug, wrong quantity, etc.) due to doctors scribbling on paper that couldn't be accurately read. And I don't know how you'd run a modern medical trial without computerized record keeping and data analysis. And of course most radiology devices such as MRI can't exist without computers, or are much faster/cheaper (X rays don't use film that has to be processed, for example, but are instant). But I'd agree - computers don't help with the basics - a well trained, experienced doctor uses the same diagnostic tools doctors have used for decades (i.e. talking with patients, checking blood pressure, weight, etc.) most of the time.

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

[sjames]

Then it's failed. The rest of the 1st world also has regulation but at nowhere near the cost in the U.S. The U.K. spends HALF per capita what we do in the U.S. and has better outcomes overall.

In the U.S. we have people die of preventable causes because they can''t afford healthcare until it's too late.

What's unclear is where the failures are exactly. On one have we regulate things that need no regulation beyoun normal consumer laws and at the same time we completely fail to regulate other things.

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

[sjames]

If profits are down it's because they've priced themselves out of the market. The prices are rapacious.

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

[laird]

No. Medical costs in different countries are vastly different because different countries are run differently.

For example, in the US doctors go wildly into debt, then charge a fortune to recover from that debt, then expect to make that kind of money their whole careers. In most other countries medical training is either free (e.g. France) or on the same scale as other professions, so doctors aren't stuck with a huge debt, and they get paid normal professional salaries.

Also in the US, we waste 15-20% of healthcare spending on insurance companies that do nothing of medical value. And we force people who do provide healthcare to waste 15-20% overhead dealing with the insurance companies, trying to be allowed to do their jobs and then get paid for the work.

Then you have Pharmaceutical companies who jack up prices in the US, so people buying the same drug from the same supplier in other wealthy countries pay far less than we do. In part this is because the Congress (Republicans) passed a law preventing the US government from using its purchasing power to negotiate discounts (thanks, Bush), while every other country does so, and thus pays much less than we do for the same product from the same supplier.

And we force millions of Americans to receive medical care only in the Emergency Room. That's fantastically expensive compared to preventative care. And it's far less effective, because all the ER does is stabilize people and kick them out, because emergency rooms don't provide medical care, they provide EMERGENCY CARE. And as soon as you're stabilized, it's not an emergency, they throw you out, and you're supposed to go to your doctor for ongoing care, preventative care, rehabilitation, etc. None of which millions of Americans get. This is largely fixed by "Obamacare", other than the few million Americans who had the misfortune of being poor in a state with Republican leadership.

Uninsured also inflate the cost of medical care in the US, because (since Reagan passed the mandate) hospital ERs are required to treat people even if they can't pay, so hospitals inflate their prices quite a bit so that those of us with insurance (or cash) end up over-paying by 10-12% to cover everyone else.

Interestingly, if you take out the 30-40% waste created by the insurance companies, US medical spending is still higher than any other country, but at least it's close. And that's a start.

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

[girlintraining]

Well, whatever the subject, you have just demonstrated that you are incapable of rational discourse. And blind to things that are glaringly obvious. Pathetic.

And with your original post on this claiming indocrination and all your tin foil hat non-sense, you demonstrated you're incapable of even rational thought. And blind to your own mental illness. Pathetic.

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

[XcepticZP]

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.

Lol, you say regulation is the problem but then you say we have to get rid of capitalism? As if capitalism is the cause of all the regulation. The level of WTF in your two posts is just outstanding. But I see you have behind you a regular contingency of slashdotters loving your posts, so that must make your right, right? Wrong.

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

[cusco]

So much cluelessness in such a short post . . .

If government intervention were the issue then countries with socialized government-run medical systems would automatically be more expensive. Instead we see the opposite, and our for-profit insurance industry-run medical system is far, far more expensive with much worse average treatment and far worse average outcomes. Eliminate the insurance leeches and 1/3 or more of the costs evaporate, eliminate the hospital chain (and they're almost all chains now) executive and marketing staff and the pharmaceutical companies' grotesque profits and we would be closer to the world average in cost and treatment.

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

[cusco]

I take it you've never worked in a fast food place. Those of us who have are laughing at your statement.

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

[gweihir]

Not even original in your insults. But what can be expected of the likes of you....

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

[spectrumlogic]

This post is so full of double talk and half truth I almost don't have the energy to answer it...but it is the straight party line if I ever heard it. First, you ask us to believe the average student loan debt matches the average salary...check your numbers...not saying it is wrong, just highly unlikely. I assume one of those is a typo. Second, either your salary range is wrong or your hours a week are wrong. $156K gets you an 8 hr a day employee in every market I know of...otherwise the physician gets to bill independently for their work which earns them considerably more money. Third, Are we talking a surgeon here? Send me all the surgeons you can find for that salary...I can get at least double that in a variety of places and they can keep their billing. Fourth, as an employee, malpractice is commonly provided so it would not be a deduction from anything. Fifth, everyone pays taxes. Lastly, I don't mean to be disrespectful but this makes your parity argument complete bullshit. What could possess you to try to pass off this drivel? This "typical" surgeon would have to be the dumbest guy on the planet to be unable to negotiate a better deal than this. If he needs some help have him contact me...seriously, please do. The "unscalable" physician shortage is alive and well here in the US. This guy could be underperforming by as much as an order of magnitude with a little common sense management.

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

[mattack2]

minimal regulation to protect our food supplies

Really? Don't we have among the safest, if not the safest, food supply in the world?

(Compare to e.g. unregulated food carts in various places of the world.)

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

[mattack2]

The problem is that the US does not understand what a good education is at this time. Not that it ever did

Then why are tons of people from other countries coming to the U.S. for an education?

Why did U.S. residents invent the Internet, etc.?

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

[laird]

The US food supply is "safe" in terms of quantity, for example, and the FDA does a reasonably good job keeping deadly diseases out of the food supply (though it's far from perfect). The biggest problem is that the food industry, and in particular fast food, engineers and sells food that is quite unhealthy, making us literally sick. The human body is designed to crave things (e.g. sugar, salt, fat) that were needed but rare in the natural diet, but now modern food manufacturing provides in unlimited quantities. Add in that they flood food with chemicals and hormones and other processing that we don't understand the long term effects of, and the result is that modern man is in terrible health. And many countries (e.g. the EU. Japan) are much more conservative about what they allow in their food supply, and as a result have much better health.

To quote:

"The 3,000 annual deaths and 130,000 hospitalizations due to foodborne illness, though tragic, are miniscule compared with other deaths related to our diet. Every year at least 310,000 Americans go to an early grave and many more are sickened because of largely preventable diet-related conditions such as heart disease, diabetes, obesity, hypertension, strokes, and some cancers. The big problem with our food supply isn’t pathogens, it is processed food. We’re being killed not by E. coli, salmonella, or campylobacter, but by the nutritionally hollow contents of the bags, boxes, and fast-food clamshells that have managed to pass as nourishment in our society."

"Over the last century, our diet has undergone unprecedented change. Some 70 percent of the calories Americans consume now come from highly processed foods—loaded up with salt, sugar, fat, strange additives, and refined grains and bereft of naturally occurring nutrients and antioxidants. We’ve outsourced so much of our cooking to highly efficient food companies that “cook” very differently than we do in our home kitchens."

"The fact is that much of our food supply is not safe, and the FDA, despite its new powers of oversight, doesn’t have anywhere near the authority or the political will it needs to help change this. The agency has done nothing to set controls on the massive quantities of sodium going into processed food, especially restaurant food, and still allows trans fat, an acknowledged poison, into products. And its oversight of the vast number of ingredients going into our food is much less reassuring than we might hope."

"Of the roughly 5,000 substances that can be directly added to food, the FDA has no knowledge whatsoever of an estimated 1,000 of them. And more disturbingly, fewer than half of those 4,000 substances known to the FDA have ever gone through the sort of testing you might hope something you’re feeding yourself and your kids would be subjected to, namely toxicology tests on mice or rats. On top of that, a scant few additives have been tested according to the way they’re actually consumed—that is, in combination with a multitude of other additives."

http://www.thedailybeast.com/articles/2013/03/01/our-unsafe-food-supply-is-killing-us.html

umm, ok...?

[BringsApples]

"Here's a medical device that meets none of the standards of today, and it has bugs that need to be worked out. But, it's cheap!"

No one wants a medical device if they're not able to sue the pants off of someone, in the event that it fails.

Re:umm, ok...?

[Okian Warrior]

Here's a medical device that meets none of the standards of today, and it has bugs that need to be worked out.

There's a difference between "meets none of the standards" and "compliant, but untested".

Please don't sell something short by making unwarranted accusations.

Re:umm, ok...?

[BringsApples]

There's a difference between "meets none of the standards" and "compliant, but untested".

Yeah there's a difference in the meanings of the words as seen in a dictionary, but if it's "untested" then it meets none of the standards of the medical industry in America.

Re:umm, ok...?

[Maury Markowitz]

> There's a difference between "meets none of the standards" and "compliant, but untested".

No there isn't. You comply with the standard when the pass the tests. You comply with nothing before that point.

The long and short of it is that you don't get sued for false positives, but you DO get sued for false negatives.

Any device that can't pass testing and demonstrate that the balance is in the favour of false positives simply will not be used.

Period.

Re:umm, ok...?

[gmuslera]

In the other hand, a device that you can't buy or is not available probably will harm you more than not having it. Making devices/drugs/whatever that could be the difference between life and death for a lot of people, but have to have to add a "sue protection" price bump makes it not available for anyone,

Making it open source, and easy for anyone to build it also make people to decide which is the biggest risk, using it or not. Big companies could make the insured, high quality, throughly tested and expensive version, smallish/hobbyist could make the evaluate and take your risks cheap ones. They are not exclusive alternatives, and should not be neither.

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.

Re:umm, ok...?

[BringsApples]

All good points, no doubt. But I just think he'll have a hard time selling them.

Re:umm, ok...?

[BringsApples]

That's a good point. But would you rather use that device, or one that's been tested, and meets all of the requirements, paid for by your medical insurance?

Please don't try to pigeon-hole me into the health care issues of today argument...

Re:umm, ok...?

[jd]

Perfectly true. You seen the Open Source EEG at Radio Shack or Wal-Mart? Me neither. These sorts of devices don't sell in bulk and even the really good science tech out there rarely sells beyond the bare minimum needed to pay for development.

This device is good, but not that calibre.

Re:umm, ok...?

[gmuslera]

Not sure if everyone in US have and can afford a medical insurance, but you know, there is a rumour that there is a world outside US that exists too. And those medical devices use to have heavy patents/copyright issues usually forced by TPP-like agreements and trade embargos to make them pretty expensive or directly unavailable to others. Making them open source enables the entire world to decide to take the risk, or even to have responsible companies outside developing them.

Re:umm, ok...?

[Interfacer]

In meaning, there is a difference. But in reality there isn't. Medical applicances are subject to a lot of regulatory requirements that you cannot skip. If you have something that was not developed and released according to the applicable rules, it simply does not meet the standards and none in the medical field can use it for medical applications. You may think it is annoying or stupid or whatever, but it is law. Those regulations and mandatory QA processes exist to make sure that all bases are covered and that you don't get embarrassing 'oopsies' and people fall dead because you forgot to check for something.

Even today, problems still arise, but the goal is to minimize this as much as possible. And when it goes wrong, lawsuits are files for millions of dollars. Whether the distibutor made any money or not doesn't matter. Your well meaning open source project leader -assuming they somehow fullfilled all legal requirements to releasing something for medical use- would be bankrupted in court, even though he never made a penny.

Re:umm, ok...?

[BringsApples]

...there is a rumour that there is a world outside US that exists too.

You're talking about medical insurers, and you're right, they do exist. However they operate in the same manner as the ones in the US do. They're all middle-men that need a cut, so (medical) prices need to inflate in order to pay the people that process the bills.

Making them open source enables the entire world to decide to take the risk, or even to have responsible companies outside developing them.

Ok, stop right there. Because if the people are allowed to choose the risk, then why not remove the burden on the doctors to be right all the time, thus removing the ability of the people to sue them so easily?

Re:umm, ok...?

[tftp]

In the other hand, a device that you can't buy or is not available probably will harm you more than not having it.

I don't practice medicine; however I work with electrical test equipment every day. An instrument is all but useless if you cannot trust its readings.

Now, let's say this ECG shows something suspicious. What will you think? Is this a true abnormality, or it's a noise from the instrument? But here is a worse case: this ECG shows nothing wrong; you lead the patient out of the door, and he drops dead three yards from your office - because the ECG failed to detect a problem that was there all along.

Tools and equipment are cost of doing business, and as I understand these expenses are deducted from taxable income of your business. Why would you want to buy an uncertified device, risk huge, "open and shut" malpractice lawsuits, *and* give a third of the saved money to the government?

Re:umm, ok...?

[gmuslera]

In this particular case not sure how essential for life is, or not. But lets suppose that it is the difference between life and death to have it or not. Having a quality one improve your chances, but having none (for one of the reasons i posted above, and probably more, like not profitable to produce for some markets, delivery time, etc) is having no chances. And you don't want business to make decisions based on profits that cause deaths.

Re:umm, ok...?

[tftp]

In this particular case not sure how essential for life is, or not. But lets suppose that it is the difference between life and death to have it or not. Having a quality one improve your chances, but having none (for one of the reasons i posted above, and probably more, like not profitable to produce for some markets, delivery time, etc) is having no chances.

This problem should be restated as a different set of outcomes:

• The instrument produces true positive. This is correct, and the patient will be treated.
• The instrument produces false positive. This is not life-threatening, but will result in additional testing and additional expenses.
• The instrument produces true negative. This is correct, and the patient is healthy.
• The instrument produces false negative. The patient will not be treated; this is life-threatening.
• There is no instrument. The doctor is aware of the fact, and she will then either send the patient to a specialist who has an ECG, or will diagnose based on other symptoms, being aware that ECG is not available.

Now, what is safer for the patient: (a) the doctor knows that ECG is not available, but will request it if other symptoms indicate it; or (b) the doctor has the ECG, and it may be wrong.

You can see that in (b) the doctor may be convinced to dismiss other symptoms since the ECG shows no problem. In (a) the doctor does not have that bias, and the correct ECG will be ordered from someone else purely based on other symptoms. Positive bias is not life-threatening, and we set it aside. Negative bias is dangerous. This shows that (a) is better than (b) because (b) can only make things worse, but cannot make them better. The same applies to the first quad of outcomes (with this cheap ECG available) - it can help in #1, it cannot help in #2 and #3, and it can be fatal in #4. Sometimes not knowing something is safer than thinking that you know it and being wrong about that.

This works if the external ECG is available. However this instrument may be used in areas where no other ECG is available (somewhere in Africa, for example.) Then the calculations will be only dependent on instrument's own probability of error. In absence of better tools this ECG will be useful.

Re:umm, ok...?

[harlequinn]

"Any device that can't pass testing and demonstrate that the balance is in the favour of false positives simply will not be used. Period."

Except if you're in a third world country where they don't have standards and where even something that is only right even only half of the time is infinitely better than nothing.

"> There's a difference between "meets none of the standards" and "compliant, but untested".

No there isn't. You comply with the standard when the pass the tests. You comply with nothing before that point."

Yes, there is actually. You can run the test yourself and meet all the standards yet not get certified because you are not an official testing body. E.g. I can get NASA to test that the bicycle helmet I made meets the Australian Standards, and you can bet your arse that it'll be an accurate result, yet it still won't be certified since they aren't certified to test it.

Re:umm, ok...?

[harlequinn]

And the argument should not be pigeon holed to first world health.

Third world countries will be very interested in affordable ECG.

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:Really internet?

[girlintraining]

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?

$22,000 doesn't buy a lot of "world change". Sorry. And there's this other thing called quality of life: Our suck. We work 40, 50, even 60 hours a week doing stressful jobs, waking up at the butt crack of dawn, and dragging ourselves and our cars through miles of clogged roadways, etc., all for those few glorious hours on friday night and saturday where we can relax. And do you wanna know what I think of "world change" at 3pm on a Friday? Fuck. World. Change. I wanna go home, kick off my shoes, and forget that I'm just one of a couple hundred million other Americans grinding away their body and soul in thankless jobs. All I want, is some soothing, mind numbing entertainment. And alcohol. Over a third of Americans are alcoholics, and we have the highest incident rate of mental illness of any country on Earth. Three guesses as to why, and first two don't count.

So don't ask me about "world change". Nobody really cares about it once they get out of college and realize the next forty years of their life is going to be spent worrying about bills, about the car, about the kids, about whether the boss likes you, about... well, everything. Entertainment... and drugs... is what allows us to get by. Don't even think about trying to take either one away... it's all we have left besides over-priced coffee and status symbol cars to make us happy.

Re:Really internet?

[John.Banister]

Get with 11,000 small town mayors. I bet they'd each donate $5. There's lots of places where the volunteer ambulance service could use an ecg that doesn't rape the customer on price.

Re:Really internet?

[RedBear]

I think you meant to say, "Really, Internet?"

See, the Internet can be very helpful.

Some wrong assumptions made in comments thus far..

[Da_Biz]

I have been a certified/licensed EMT for over 10 years.

"Medical devices are expensive to make."
For many commonly-used devices (ECG, pulse oximeter, etc.), the level of technology implemented is magnitudes less than that of a decent smartphone. Sure, these aren't mass market items--but I'm also hard pressed to understand why it doesn't make sense to have an alternative to a LifePak which easily costs $15K+. Case in point: the AED you can easily buy from Costco in the neighborhood of $1K--and has lots of sophisticated logic. Just because the thing has blinky lights and makes "bing" noises doesn't mean it should be exorbitantly priced.

"People need a manufacturer big enough to sue."
Circular reasoning on the best of days. Does a commercial implementer of this device need a legal team? Yes. Is the pragmatic implementation of a device at lower cost that's reliable and lawsuit-resistant possible? Absolutely.

The fixer-upper.

[westlake]

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.

This tells me that no matter how promising your hardware design and software, I am going to be spending a lot of money before I have anything close to a commercially viable product.

Re:The fixer-upper.

[Okian Warrior]

This tells me that no matter how promising your hardware design and software, I am going to be spending a lot of money before I have anything close to a commercially viable product.

Apropos of nothing, I'm guessing that you have never started a business. Just a guess, mind you...

This is seriously awesome. I just donated $300!

[Anonymous Coward]

This will save many lives, all over the world. Wow.
I just donated $300 to the original Indiegogo campaign, and I'm contributing another $100 directly.

I'm someone who doesn't have much money, nor do I even know anyone with a heart condition, but this will do SERIOUS GOOD.

Re:WTFPL

[ArcRiley]

Its worse than that - of all the software I can imagine warranty disclaimer to be useful for, this would be one of them.

The authors could be easily sued if this ever got used for medical purposes and a bug they introduced led to harm or death. Not to say they couldn't be sued anyway, but the license would at least provide a bit of protection.

Seriously, if they wanted a permissive license use Apache.

WTFPL

[Quick Reply]

I doubt this was written by a lawyer. This might be an impediment to being picked up by a serious project because they can't take the risk that the WTFPL doesn't actually mean anything from a legal perspective.

12-lead?

[AJWM]

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?

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.

Re:12-lead?

[AJWM]

Ah, thanks.

I'd mod you up but I've already posted in this topic. ;-)

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:A good start

[Anonymous Coward]

Extend this to 32-leads will get you this, and by following the wave over time you visualise the heart as it beats:

http://www2.le.ac.uk/research/festival/meet/science/vanheusden/page-two

Note: the design is functional but unfinished

[Gothmolly]

The curse of Open Source. Good luck getting that last 10% finished.

Re:WTFPL

[Anonymous Coward]

It was not written by a lawyer. Or someone who knows business.

The first sentence is suspect "MobilECG is an USB-based open source 12-lead clinical electrocardiograph"

In the US, it is not a "clinical" electrocardiograph without FDA clearance to market (which is what you are doing), yet it is stated to be one. IANAL, but I recommend you get one. Now. Some people have an obligation to report this website to the FDA. If you're not in the US, fine, but statements like this will prevent you from ever getting clearance.

Citation: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073942.htm
Experience: Clinical portion of submission of several Class II and on Class III radiology and cardiac devices for FDA 510(k) and PMA.

Oh, and lastly, FDA "approval" (you would really be seeking clearance) does not come in for $230K. For this device, you are looking at $5MM minimum. And that does not count the attorney you're going to need to bail you out of the stupidly naive comments on your website.

Re:Really internet?... marketing

[anon mouse-cow-aard]

fwiw... It's 230 K, not 22 K$. but doesn't change your point. ECG is so nerdy... He should emphasize other uses, and try to market based on that. He could call it a "biorhythmic training device for understanding the crystals, and getting in touch with your aura. or talk up the "biofeedback" aspects of it, how it will help with meditation. That will sell to one crowd. Figure out how to use it as a kind of game controller, and the internet will fund in a (wait for it!) heartbeat.

Cost and profit in the medical industry ...

[Anonymous Coward]

Low cost, high profit: Perhaps commercial ECGs and other medical devices are built just like this power supply:
http://thedailywtf.com/Articles/Power-Supply.aspx

Re:Some wrong assumptions made in comments thus fa

[Interfacer]

There is no technical reason they should be so expensive, components wise I mean. But the development and QA processes, and regulatory filings, audits, and all the other crap to make it suitable for medical purposes, make it so. That is why a WII balance board costs peanuts, but a medical device with similar functionality costs 10K. If has to be developed according to FDA regulatiosn, there need to be mandatory QA controls in place, software needs to be developed according to medical use standards, there is a regular FDA audit to deal with, liability, studies and validations, etc.

The WII balance board just needs to work. For a while. Non calibrated, non validated, and if it doesn't do what is expected in some cases, you get to call tech support instead of file a million dollar lawsuit.

every gym should have one

[jclaer]

I lost a son, age 25, to sudden cardiac arrest. He left the gym, died a half hour later in his office. We thought he was the healthiest one in the family. Every gym should have an EKG machine as well as an AED. I hope you never learn what I know --- no loss exceeds losing a child. Search for Jos Claerbout

"dishonest distribution practices"?

[terryk29]

"...of clinical ECG machines" (summary). Does the submitter or anyone else care to elaborate?

Don't blame the boomers

[laird]

Now ask yourself why doctors in the US have to go vastly into debt, and then charge a fortune to recover from the debt. That's not how the rest of the planet runs. In France for example, which has much better medical service than the US, the training is free. This means that the best, most talented people get to become doctors regardless of wealth. And then they can work for a normal professional wage, without being forced to absolutely maximize revenue. So they can focus on providing medical care instead of dealing with financing.

As for the "there's no money for infrastructure", don't blame "boomers". Plenty of us were willing to pay the taxes to run the country, and we were paying down the debt and starting to save up for a rainy day. But one of the political parties became obsessed with dodging taxes while ramping up spending. But don't blame the rest of us for that!

Re:Don't blame the boomers

[cusco]

For many years Cuba offered to train doctors for free, as long as they spent the first five years of practice at poor and under-served areas (don't know if they still do, but that offer is good for med students in most of the rest of the world). The AMA refused to even consider allowing Cuban graduates to test in the US, much less practice.

Re:WTFPL

[gl4ss]

wtf is wrong with you guys? it has no official medical use before certification and he can't afford it. it has no implied warranty. there's no fucking way to sue 'em if you use it for something, if you want to use it for something go through certification first.

and as far as copyrights go yeah, it DOES have meaning: do what the fuck you want. besides, FSF agrees. it's as free as you can get. what the fuck is wrong with people who think it has no meaning in copyright? because it sure fucking does! why the fuck it wouldn't? because it has "fuck" in there in the name? it gives you explicit permission to do whatever the fuck you want with it.

you don't like it? well fuck, create your own fork and license it under gpl! or bsd! or apache!

(and I can think of a bunch of things more necessary to have warranty disclaimers like any heating system control systems like on every friggin 3d printer which may burn your house down)

http://www.wtfpl.net/about/