A biomedical engineer is developing a clinical-grade open-source 12-lead ECG. The device includes support for Android devices and is designed to meet all relevant medical device manufacturing standards, like ISO 60601-1. According to early pricing estimates, the per-unit cost of a device will be approximately $110 in batches of 1000.
ECGs are used to measure the regularity and rate of a patient's heartbeat. In addition, ECGs can measure the position and size of a patient's heart chambers. ECGs can reveal valuable clinical data on ischemic heart disease, the impact of drugs on the body and how devices (like pacemakers) interact with a patient's cardiovascular system.
The developer of the device, Péter Isza, worked for three years at an undisclosed medical device company, manufacturing and designing clinical-grade ECGs. According to Isza, several aspects of the medical device industry helped push him towards the open-source movement. In particular, Isla lamented unfair distribution practices, cumbersome designs and excessively high prices of commercial devices.
In February, Isza began the development of the MobilECG open-source device. In total, he has invested $22,000 of his personal savings in the device. According to estimates from him, landing FDA and CE Mark approval for the device (plus manufacture of the first 1000 units) will cost at least $230,000.
In an effort to raise funds for his project, Isza launched a crowfunding campaign on Indiegogo, a site that allows users to raise funds for a vairety of initiatives. On the crowdfunding site, Isza offered the device for $299 (with future delivery).
In comparison, most traditional ECG systems from medical device manufacturers carry a price tag of $3,000.
Unfortunately for Isza, funding for the project fell short at less than $10,000.
On Slashdot, a discussion of the device revealed a variety of different opinions. User The123king writes,Why isn't all medical equipment open source? 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 miniaturise, improve and cheapen, the manufacturing of medical devices.
An anonymous poster responded to this comment, stating,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.
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.
The anonymous poster also mentioned a recent court case (via Huffington Post), showing how litigation can drive up the cost of care.
User sjames joins the discussion, stating,Profits are down for medical 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.
A copy of Hacking Healthcare can be found on Amazon.
