Wii Balance Board Gives $18,000 Medical Device a Run For Its Money
Gizmodo highlights a very cool repurposing effort for the Wii's Balance Board accessory. Rather than the specialized force platforms used to quantify patients' ability to balance after a trauma like stroke, doctors at the University of Melbourne thought that a Balance Board might serve as well. Says the article: "When doctors disassembled the board, they found the accelerometers and strain gauges to be of 'excellent' quality. 'I was shocked given the price: it was an extremely impressive strain gauge set-up.'" Games controllers you'd expect to be durable and at least fairly accurate; what's surprising is just how much comparable, purpose-built devices cost. In this case, the Balance Board (just under $100) was compared favorably with a test platform that costs just a shade less than $18,000.
What determines the price of a scale is not just its equipment or accuracy.. but also the insurance the manufacturer has to carry in case something goes wrong. That's why medical devices are more expensive... you're also paying for the liability of somebody being misdiagnosed by a technical malfunction. Highly unlikely, but the money that has to be paid when that happens and gets proven is huge.
It says a lot about the wastefulness of institutions when it comes to buying hardware. I bet you the Defense Department could find lots of savings by sourcing their parts from Nintendo, too!
Juln
Wii parts replacing 18,000 dollar medical equipment... PS3s replacing 10,000 dollar supercomputers... clearly the video game industry knows something we don't.
Ah, I see you have the machine that goes ping. This is my favorite. You see we lease it back from the company we sold it to and that way it comes under the monthly current budget and not the capital account.
When It Counts.
Hospitals charge so much. Someone along the way decided to jack up a price and its been flowing downhill to the consumers ever since.
Only the State obtains its revenue by coercion. - Murray Rothbard
These "test platforms" are not just a slab of plastic a few inches in size: they are usually about two feet or more square, can handle up to 400 pounds of static force (and often a ton or more impact for jumping), and more importantly, come with a full diagnostic software package that can track patient history and results. Show me ANY medical office outfit that can develop this level of software for $18,000 or less, let alone support it, and hack up the proper interface to the WII board.
Is it due to the Wii's balance board being terribly cheap or is it due to the the price of the "medical-grade" device being extremely over-inflated? Some of the prices practised by medical equipment and even drug distributors are insane and they always hide behind the mysterious "it's fantastic, medical-grade stuff" and that quite possibly is plain bullshit to increase their profit.
Slashdot, fix your code or at least hire someone who is competent at it to do it for you.
With price comes respectability. That's why Christian Science practitioners always make a point of charging for their prayers roughly as much as a real doctor would charge for treatment: They know that something given away will not be percieved as effective.
Same thing here. Stick a patient on a wii board, and they'll regard it as quack rubbish. Stick them on an $18,000 purpose-built and impressive piece of diagnostic equipment with the logo of a respected medical equipment manufacturer (ie, not nintendo) and they'll feel far more confident, even if they do exactly the same thing equally well.
Customers who feel they arn't being given an expensive enough service are more likely to sue the hospital.
It is all just people's perception. A videogame can't be too expensive, but it damn well better work so the market pushes high quality at low prices. In the medical world we expect devices to cost out of the ass and be complex. That is the exact opposite of the videogame, or rather, the general technology world. It is about time there is direct market competition with the medical device manufactures who rip us off and overcharge for clunky hard to use equipment that doesn't work that well in the first place.
I had been prescribed a medical device to assist in night time breathing... after asking the clinic person to show me an itemized list of parts and costs, I was shocked at the bill - over $2,200 (USD). She was annoyed that I wanted this list printed out because my insurance was "going to pay for it anyway..."
A few months later, my insurance no longer wishes to pay the rental costs - so I have to return it or pay $250/month. Found online for $700 new and delivered with three years of support.
Only when you put medical care in a truly competitive market is when you'll actually see competitive prices.
Actually, it's more a matter of volume manufacturing. If you have to spread out your fixed manufacturing costs among only a few hundred of something for some hospitals, they're going to be very high per item, thus resulting in a very high price. If you mass market millions of them, those same costs might only be a few pennies per item.
Before the Wii, there wasn't much demand for mass producing these kinds of components.
The eyetoy from the PS3 is also de best camera in the market and it costs less than 40€. It has 75 degree wide lenses and can reach 125 fps. This is much more than what most cameras do. Even the 200€ ones.
"When doctors disassembled the board, they found the accelerometers..."
They did? I couldn't find any information stating that the balance board had motion sensing. Everything I've read says it just has four pressure sensors, one for each corner and that's it.
When the Wii Fit first came out... there were several modes of operation that the experts thought should be in the software. Nintendo's first response was to say such people were welcome to develop their own games, then when realizing they were so simple to program the $20 new disk called "Wii Fit Plus" (which now replaces the original disk in the new package for new users) was Nintendo's make good.
That's part of it, but much of the "cost" is the fact that they can charge that much because it's medical. In other words, they charge that much because they can.
I can build you 100 medical test platforms at 18000 a piece or 18000 wii balance boards at a 100 a piece...
What determines the price of a scale is not just its equipment or accuracy.. but also the insurance the manufacturer has to carry in case something goes wrong. That's why medical devices are more expensive... you're also paying for the liability of somebody being misdiagnosed by a technical malfunction. Highly unlikely, but the money that has to be paid when that happens and gets proven is huge.
So they system is "protecting" patients right out of being able to afford treatment, and people are still willing to stand up and defend this insanity. With these sorts of controls, many, many patients go without treatment, or worse go for alternative Voodoo treatment that do harm because they simply can't afford the real thing. It's a sure sign that the medical system is itself quite ill and probably clinically insane.
What needs to happen is companies need to be held accountable for gross negligence and willful malice, but permitted to release a medical device with a disclaimer about the level of testing that has been done. If the overhead for adhering to medical standards is literally an 180 fold increase in the price, clearly there is something very wrong with the efficiency of the system.
These posts express my own personal views, not those of my employer
Nintendo should work on a fMRI-based game interface that can translate your thoughts into game actions. That should get the price of fMRI scanners down to a few hundred dollars each and immensely benefit medical research.
Once they are done with that, they can work on a DNA sequencing controller that customizes your on-screen avatar to look and act like you based on your genetic sequence.
And so forth, until all medical equipment and tests costs a few hundred dollars each.
I could see some folks using this a first stage "cut out" instrument sort of like the difference between
most road side BAC tests and a real live blood test or as a "backup" device.
Any person using FTFY or editing my postings agrees to a US$50.00 charge
Ads that tell selfish old geezers that they can get an overpriced motorized wheelchair "for free" is what keeps health care costs high.
That selfish old geezer who now has mobility can continue to live at home.
Where he will remain more active and engaged. Healthier. Less dependent on others.
That saves the system a lot of money.
Have you priced the nursing home bed or "assisted living" for your parents or grandparents?
Young kids being duped into thinking that their doctor visits are "for free" is what keeps health costs high.
Keeping kids healthy keeps health costs low.
Everyone has rightly pointed out that the cost of this sort of device is inflated by regulatory headaches and liability concerns. Let's not forget simple economies of scale here. A video game controller will likely sell millions if not tens of millions of units before it's eventually retired from the market. A medical balance board, on the other hand, is at best a niche device whose sales will likely be at least an order of magnitude (or two!) smaller. The costs of designing, testing and building this device are borne by a comparatively tiny number of sales, hence the higher price.
Medicare and many insurance companies won't pay for Wii because it is dual-purpose device
NYTimes had a story when they refused to pay for iPhone-based speech synthesizer for a paralyzed patient but had no problems paying $5000 for a desktop based one because the desktop-based device was not able to do anything but synthesize voice
I know in my professional industry, there may be many a cool technology or device that i want to use, but may not be able to, despite the fact it looks good and can handle what i throw at it. However, i may not technically be able to use it because it has not been tested against specific guidelines or a part of the product was not tested against particular standards with the right amount of traceability.
I believe that’s why some particular product may cost more than any other. I.e a device to be used in a medical institute for diagnosis of any kind would probably require quite a lot of process in it's accreditation that the Wii probably didn't have to go through to be used as a game machine.
Giving IE users a taste of their own medicine since 2005 - http://pods.-is-a-geek.net/
did you figure out what frys itself after one use so that you could maybe replace it??
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If they did something like that, they wouldn't be allowed to call their stuff USB (which they do), since it's a trademark held by USB Implementers Forum Inc. and licensed only under agreement of compatibility.
Apple makes bank from people who don't know any better. Scrounging a few bucks from geeks isn't worth this kind of danger.
"They were pure niggers." – Noam Chomsky
What the heck do (medical) doctors know about quality of accelerometers and strain gauges? Thats why health care cost are so damn high because doctors and hospitals pay $18000 for things that should cost $100. (Remind you of the military?) Of course there is economy in scale but not 18000%.
I lost all the balance function in my ears more than 5 years ago. At that time only one center in the Phoenix area had the testing equipment. It took me 3 months to get in for testing and the testing ended up costing me close to $500. Oh and that was out of pocket as the testing center wasn't covered on my insurance plan. I would love to see something as inexpensive as this as a first round of testing. Would have saved me months of stress over not knowing what the hell was going on.
1. The US legal system and congress are hopelessly broken, see SCO v IBM ... and the Health Care Debate, which gave no account od single payer or honest insurance.
2. You are dimwits who have regulated yourself in to the worst mobile phone system and 37th in the Western World, just above Cuba; and failed to regulate your Financial System into the 2008 Drepresion.
3. You need, urgently, to get a grip, and grow some common sense, the $18000 is blatant price gauging, nothing else.
.... is the most awesomist console ever. :D
I have Wii Fit and board. When you do the balance test and balance games you can tell it's a very sensitive and accurate board. It's also an accurate weight scale. It's also very heavy and dense for its dimensions. Much stronger than you think a chunk of plastic would be.
Camping on quad since 1996.
The reason medical devices are so expensive has little to do with lawsuits when compared with the number one reason: the market for health care is distorted because the decision maker (doctor) is not the person paying for the decision (the patient or insurance). Medical device companies just market directly to doctors. Medical conferences are like industry paid vacations for doctors. Even if you tell your doctor that your Wii balance board does the same thing as the $18,000 device, he's still not going to prescribe it because he has no incentive to. He doesn't bear the cost of paying for it. You do or most likely your insurance do. You see the exact same thing in the textbook industry. The professors make the decision and the students pay for it. When the two entities are not the same, you have a market that's distorted and normal mechanisms of capitalism don't lead to lower costs and greater efficiency like they do in other areas. Of course FDA approval definitely plays into this by making it easier for doctors to have support for their decisions.
EvilCON - Made Famous by
If the price difference was 500 to 100, there would not be too much spleen, even if they made 200% profit. $18000 is an obvious obscene rip off and is indefensible.
... and all the other nonsense the could simply tie it inside a stout sterile plastic bag, cost $0.05, or in your mad world $50 at a 17850 saving.
As to sterile, pee blood
This reminds me of the $800 hammer that defense contractors sold to the US government back in the 80's. It was an ordinary hammer.
More evidence health care costs are through the roof for no good reason. $18K for a board that is no better than one I'd get with my kids gaming system?? Next time my doc wants to send me for physical therapy, I'm going to say "No thanks, I have Tony Hawk's Downhill Jam at home. Thats just as good".
There is no justification for an $18,000 price difference for what amounts to the same fundamental technology. I don't need a formula, or theories as to why this is. The medical industry is full of a bunch of crooked greedy bastards........
I think your missing the point here.
It's not how much it costs or if there ripping us off .
"The how much it costs" argument is irrelevant.
Its the fact that we are now getting devices, which are used to play games, in our homes which are comparable to highly sensitive medical devices.
WOW !!!
The doctors in this melbourne hospital should also be congratulated for looking at alternative ways of doing things.
Behold: economies of scale.
For every problem, there is at least one solution that is simple, neat, and wrong.
Want to make a mint selling ordinary hardware?
All you need to do is either
A. Get it FDA certified for use in medicine.
Or
B. Get it FAA approved for use in aviation.
You can pretty much guarantee a 100x price premium in the former case or perhaps 10-20x in the latter case.
Of course, requiring government certification for things upon which the general public relies for life safety is not necessarily a bad thing, but the price premium that comes from the certification requirement probably is proportional to the square of the cost of doing whatever is necessary to obtain said certification.
I have worked for both doctors and surgeons, and currently work for a work insurance company and the main reason behind the costs of these equipments is support and insurance. Like people have stated, if someone gets mis-diagnosed then that patient can sure them for a lot more then what they could sue Nintendo because they hurt themselves playing on their wii fit board. If someone gets wrongly diagnosed then the doctor can be looking at $100k's of thousands of dollars of damages alone, and then there is the private practise/ hospital that would also then be sued for a shitload. The device most probably links in with some set of software applications that will then let the doctor send it off to a specialist to look at who can then send it back to the doctor. If something malfunctions with the device or of the doctor has any questions, then they can get support for it straight away.
Do we need any more evidence than this that there isn't a free market in medical care... and that there should be?
"And the reason my friend was willing to let me tear it apart? It can only be used once! It is designed to permanently disable itself after one period of treatment."
An electrical engineer who's stymied by $5 worth of parts. Macgyver could bring it back.
What determinds the price is production, and demand.
The principle of economics doesn't apply when it comes to medical equipments.
The jack up the price so high ($18K) simply because they CAN !
Now you know why they charge patients hundreds of dollars for a painkiller?
Depending on the client you most certainly could the first time, it's the next time it breaks they'll go somewhere else. And with any luck they'll tell their friends :)
-Matt
--- Need web hosting?
This reminds me of what happened to Rober Ebert. He lost his voice, and this is what happened:
"I am one of those you write about who uses a computer voice after losing the power of speech as a result of cancer surgery. After trying an $8,000 custom device with little computing power and a small, dim screen, I tried the built-in speech software on my MacBook and found it much more practical.".
http://www.nytimes.com/2009/09/19/opinion/l19speech.html?_r=3
Not only was the "official" solution crap, it was also a lot more expensive than the consumer-device was, which was not even designed for this particular task.
Lesbian Nazi Hookers Abducted by UFOs and Forced Into Weight Loss Programs - -all next week on Town Talk.
Well said. Any health reform that does not change this won't contain costs. What you are wrong about is the idea that a one-payer system can't change this. It may not - I can think of several plausible national health care systems that wouldn't - but some in Europe do. That said, I am not in favor of a national health care system.
A systen where deductibles were $10,000 minimum with 50-90% of costs (depending on price etc) were covered after that, would do wonders for keeping costs down and improving medical tech (that last bit national health care tends to be rather poor at)
T
Laws are horrible moral guides, moral guides make even worse laws.
Funny that I should read this today. A couple of days ago, someone told me about the Wii gadgets for balance etc.
I had a Jiu-Jitsu-related ankle injury that needs boring and expensive physiotherapy and I had pondered whether the Wii boards wouldn't allow me to ditch my sessions (basically balancing acts throughout the whole session).
Main difference between the BSD license and the GPL license: one is from California and the other is from Massachusetts
They are just now starting to realize how overpriced everything is being sold to the medical profession, on purpose....when they come out with a wii, and that same device they can use is sold at 1/1000 the price, it makes you wonder, no?
There will always be mafia types everywhere, trying to make as much money go into their own pockets, instead of letting the hospitals
be able to have more for less. Then when budget time comes, they get the government telling them they cant be given more....
and like a little kid that did not save up properly in such situations, cries that its not fair.
I hope this will shed more light on other like minded situations in the hospitals...and maybe get them to review properly what they are buying....
They did not charge 6k for the HDD.
Yes they did. There are other things rolled into that cost to be sure (insurance, etc) but don't kid yourself. There is also a hefty profit margin there too. Medical equipment companies aren't doing this stuff out of the goodness of their hearts. If they can get away with charging $6000 to swap a hard drive, they will.
If they were going to charge you 6k, why even bother about the warranty?
Because this isn't the PC on your desk. If there was a lawsuit any lawyer worth his retainer would stand up and ask the defendant "why did you think it was acceptable to tinker with the equipment in a way you knew would void the warranty when your tinkering resulted in the death/injury of my client?" Shortly thereafter the lawyers for the hospital would settle for a large sum of money MUCH larger than $6000. The decimal would move three or maybe four places to the right I would guess. Never underestimate the fear of lawyers.
That's not to say the medical equipment company wasn't ripping off the purchasers of the equipment. I suspect there was a very healthy profit margin in there.
From my point of view, if the machine was under warranty, the repair should have been free of charge.
Only if you agreed to that when you purchased it. Shady I'll agree but not unusual.
What would happen if the liability was removed or limited?
Then you have the problem of snake oil salesmen. Liability is not always a bad thing. It protects all of us from unscrupulous vendors every day. You can either regulate heavily or allow liability but you have to have at least one of the two and preferably some of both.
Getting several million "liability" for essentially nothing is insane.
Are you seriously claiming that a video game is the same as diagnosing a neurological condition? In medicine we are literally talking life and death. Permanent injuries can result from momentary lapses of judgment or faulty equipment. It might be that a medical equipment provider is ripping off the buyer but that doesn't mean the liability cost isn't still very real.
Hmmm, let’s see here, one device, marketed as a medical device, is made in a heavily government controlled environment where there is much need of tort reform. The other is a repurposed game device with similar components of equal quality where tort reform is not an issue
Sure, a lot has to do with the fact that there is much more demand for the Wii balance board than the Medical Scale, but because of all the bureaucracy and litigation involved in the medical field the price of the medical scale includes not only the equipment’s accuracy and the quality of its components or the demand for such a device, but also the insurance the manufacturer has to carry in case something goes wrong. Hospitals and doctors are paying the manufacturer high prices so that the company who makes the device can cover for the likely case that somebody who may have been misdiagnosed and had used the device may try to make a case against the company based on the theory that the improper diagnosis could have been due to a “technical malfunction”. The money that has to be paid when the company gets sued all the time is huge. This cost is passed on to the doctors and hospitals and the cost that the doctors and hospitals incur for the device is passed on to the patient. This contributes to the higher cost of health care which has caused a heavy reliance on health insurance as opposed to people being able to save money for healthcare as they need it and for making health insurance much more expensive.
What is amazing to me is that people who advocate more market tampering and control would have failed to notice that the free market Gaming sector of the economy would be able to generate enough demand to bring down the price for what would otherwise be an obscure piece of medical equipment.
In a controlled market the idea of investing money and resources in gaming devices would have been deemed wasteful and there would never have been this possibility for an incredible price drop.
laissez-faire FTW.
Yes, but all of what you just said further illustrates why govt. bureaucracy is causing our medical expenses to spiral out of control. It's not sustainable. The only people who really "win" in this mess are the attorneys, and all the talk of medical reform in the USA right now conveniently skips changes in THAT area.
Not long ago, I was reading about a heart surgeon in India who among other things, got tired of the high cost of medical sutures. Apparently, the only supplier of the ones he needed was the Johnson & Johnson company, and they kept increasing prices each year. He finally got some investors together, who opened their OWN manufacturing facility to produce the sutures in India at a far lower cost, so he can now buy from them and cut at least 35% off of his annual expenses for them. (Since he's running huge clinics doing nothing but heart surgeries there, he benefits more than most would from "economy of scale".)
It seems to me, that's exactly the type of change the medical field needs to see. Unfortunately, government legislation often seems to stand in the way of progress here in America. (A doctor my friend knows heard this story about the medical sutures and angrily protested, "But I'm not even legally ALLOWED to invest in such a thing as a surgeon in the US!")
As it stands now, doesn't it bother you at least a LITTLE bit that you had to fork out upwards of $250,000 in *lawyer fees* just to prove that it was ok for a hospital to start using what's really just a touch-screen PC in a hardened metal frame?
Supply and demand aside, when it comes to medical devices (or any special purpose device or package, for that matter), you often pay a premium for intangible features--specific certifications or backings, regulatory approval, availability through an authorized source, etc.
A friend of a friend is in the business of selling supply packages for a specific law enforcement function via government contract. He's repackaging and selling items anyone could get at retail for a fraction of the cost. In fact, it was my friend who suggested to his associate that the supplies included in the packages not be the ones embossed the with house-brand label of the supplier from which he was getting them, since it wouldn't take too long for the end-user to realize that they could purchase the same items on their own.
Or, look at medical fast drying adhesives (e.g. "super glue"). Boxers were using glues they bought at hardware stores for years before the medical community considered a medical use. Now doctors and clinics can order supplies of "medical grade" superglue that cost many times more than their non-medical versions. According to my physician, there really was no difference between the two products. The medical one was simply something billable at a higher price, and it carried the implied benefit of being somehow more sterile than the other product. I don't know if there is any real difference in how the lots are produced, but our doctor recommended "super glue" for quick at-home fix ups of cuts and gouges that might otherwise might require a stitch (or staple) or two.
Just give it some time and you'll likely see lawyers and lobbyists from medical device manufacturers fighting to stop the practice of using "non-approved" devices for patient diagnosis, therapy, or prevention.
I use irony whenever I can, but my shirts are still wrinkled...
the cost of malpractice insurance at every level of healthcare is a major driver of the enormous cost
Take a read Tom Baker's The Medical Malpractice Myth.
Ezra Klein also has a highlight/review of the book.
Tweet, tweet.
I see one idiot babbles in the comments to this article about "heavily regulated industry needing tort reform".
The reality is that the medical industry needs more regulation, since their mission statement isn't providing goods and/or services, and making a reasonable profit, it's 1. ROI, 2. ROI, 3. See #1, sell something that the customers will buy, and that we can get a deal with the health insurance companies so that we both make out like bandits, and Did I mention ROI?
Another example: why do hearing aids cost $1k and up... and a cellphone well under a hundred, or any music player under? Why can't one be produced with the sound quality of any headphone set, with microphone and one-chip amplifier, and sold at commodity prices for under $100, and cheap ones under $50?
As I said, because the REAL cause of massively rising healthcare costs is how the industry, not even necessarily doctors, can make out like bandits.
Oh, and about tort reform as some sort of answer? Go pay the $36 for the report from that company in PA that's the *ONLY* one who collects such stats. Last time that report made the news, maybe 5-6 years ago, it was a tiny amount of malpractice awards that were over $1M, and something like well under 10% of the doctors who were responsible for 90% of the malpractice awards.
But self-regulation works *so* well... that these incompetent scum stay in business after lawsuit after lawsuit.
mark
Snake oil salesmen would get criminal punishment, as they do nowadays.
That's quite irresponsible because someone (usually) has to get hurt before you act. Lawsuits (civil and criminal) are a useful deterrent but hardly a foolproof one especially when there is money to be made. There is a reason we have regulatory controls and approvals on dangerous medications and devices.
There would just not be lottery-kind incentive to sue anybody
I think you overestimate the actual cost and probability of success of medical tort lawsuits. Despite all the noise about them, they are nowhere near the biggest source of cost in medicine. They're a little like plane crashes - spectacular sometimes but rare and mostly not that big a deal on a day to day basis. My wife is a doctor so I'm more than a little familiar with this personally.
Yes, a video game can give valuable information whether someone has a neurological condition.
No one has claimed otherwise to my knowledge. But if the equipment is not designed and approved for that use by the FDA, the physician using it IS exposing him/herself to liability. Medications and devices get used for "off label" purposes all the time but the physician does so at their own risk, especially if there is no informed consent and/or if it is not within standard of care.
AFAIK no equipment can do that without a doctor and no (sane) doctor would ever rely on one positive output alone.
Quite right. But it does provide data and sometimes test data is misleading. Don't get me wrong, I think it is terrific that they are using cheaper technology - I'm just pointing out that there are sometimes risks in doing so.
Spot on. Most people have no idea what drives medical costs, and their experiences with the legal system are as culturally foreign as IT is to the average layman (at a minimum; it's likely enough they're gratingly adversarial as well as foreign), so it's easy to make the legal system into a bugaboo. And, bonus! The cost problem becomes simple! One easy factor you can blame!
Thing is, medical malpractice is a genuine problem, and when practitioners screw up, the resulting costs to a patient can be astounding. And as adversarial as the legal system can be, dealing with medical practitioners and organizations is often just as bad. Ever tried discussing billing mistakes with a hospital or doctor's office?
If you want a good overview of the various drivers behind medical costs, take a listen to what's available here.
Libertarianism is rich wolves and poor sheep playing gambler's ruin for dinner.
But other posters will point out, "you can't put a price on your health"
Seems to me this is quite probably the larger reason over regulation that prices don't behave like an efficient market. Regulatory burden may mean an upward pressure on costs, but in a competition/choice driven market, there's downward pressure on prices, which encourages participants to find more efficient ways to provide goods or services within the regulatory framework.
But consumers don't treat health care like they treat electronics or restaurants.
people will cough up to $3200 for a simple abdominal X-Ray that takes, literally, 45 seconds of device time. The same X-Ray costs (I'm told) around $800 in Japan, and less in France or the UK. But in France and the UK, you turn up for your appointment, fill out no extra paperwork, but wait for maybe 90 to 120 minutes to go under the device, because it is utilised at 90% to 100% of the time.
So unless your time is worth over $1000 an hour (and you can't find a way to gain utility out of waiting time), the French and the English have come up with a more efficient system.
Seems
Libertarianism is rich wolves and poor sheep playing gambler's ruin for dinner.
I think the "IT'S DA GOBBERMENT!!"" arguments are unhelpful. It may seem unreasonable to the layperson to require entrepreneurs to spend countless thousands on documentation and quality control,but we have to remember why we have these protections in place; the drive to lower cost in order to maximize profits is exploitable by unscrupulous companies. Hucksters to this day are trying to dupe the public into buying all kinds of "medical" crap on late night teevee, and that is with "govt. bureaucracy". You have to enforce QC on anyone who makes a medical claim about their product to ensure that they are responsible for their product and don't just take you money and run... with your life.
A quick example from a non-medical industry, my friend works in the laser safety equipment industry. He was recently complaining that a batch of frames they received for protective lenses were complete crap and broke at the lightest pressure. In looking for a cheaper supplier, his company's SUPPLIER had gone to a less reputable manufacturer without telling him, and passed off the junk component as quality. Though they had no control over what manufacturers his supplier chose to use, my friend's company took the hit in the end, if they hadn't, someone could have been seriously injured. The natural drive to cut costs often leads to cutting corners, and someone is always left holding the bag.
Even if you do the right thing, there is always someone scamming, and you have to protect the public somehow. Could the regs be smarter? Probably. But because the response of anti-government forces is simply to remove protections whole cloth to "spur innovation", we get nowhere.
Just imagine you are the head of the tech dept in that hospital. Given the prices of all medical grade stuff, if the guy charged say $200, you'd think that he just plugged in a consumer HD. If he asked for $1000 you'd suppose he used a non-genuine or even used HD. With $6000 you can't think of anything - you just trust the man with the additional benefit in case of a court trial (assuming that e.g. the PC caused a patient death) you'd say that you did all that was humanly possible to make sure that no consumer grade, used or non-genuine parts were used on that PC.
The only problem with this kind of story, is the amount the end worker is payed for working for company X isn't taken into account. The company that makes that $18,000 piece of equipment probably pays their employees building the thing a lot more than Nintendo pays its line labour.
Medical devices, like drugs, cost money because the company has to prove to the FDA that their device does what it says it does and that the risk the device presents is less than the benefit derived from the device. It's not uncommon for a device to take up to 5 years to get through the design/validation process. If Nintendo decides to offer the Wii balance board as a medical device, you can bet your bippy it'll cost more than $100.
So here's the rub. If 'the government' backs off and lets device and drug companies be less rigorous and more nimble in their work, whoo whoo...more change in less time, innovation, costs drop, new products stream onto the market...yeah.....happy day....
Until someone gets hurt because the company didn't do the things you should do when designing products that are supposed to save lives. A couple of years back the FDA did exactly this to a company making...ohhh flu vaccine. Seems they cut the company a bit too much slack and the entire batch was crap, had to be recalled, and people didn't get flu shots. Guess who spent time sitting in front of a congressional committee explaining what happened? YOU want to explain the congress why companies are killing people?
I work in the industry and as much as I chafe under the paperwork, I have to admit that the only thing the FDA is doing is making us do what we SHOULD be doing. Is it expensive? You betcha. But I, for one, don't want MY health damaged because someone wanted to get product x to market just a bit faster and for a lower cost.
Your family does not deserve to eat.
You do not deserve to be employed.
Your company does not 'deserve' to be registered as a 'company' or be allowed to do business.
You fail.
Get used to this fact.
1. Load up Google. That's http://google.com
2. Research ITIL
3. Do some reading on ITIL
4. Book yourself on the Foundation ITIL course
5. Research Configuration Management
6. Do some reading on the subject
7. Book yourself on Configuration Management Level 1 (and, preferably Level 2 - I'm guessing from your post that you should be more than capable)
8. LEARN SOMETHING ABOUT WHY IT IS EXACTLY THAT YOUR GOVERNMENT IS DEMANDING THAT YOU PROVE THAT WHAT YOU SAY IS WHAT YOU DO
Your post pretty much says it all. You fail to see why it is that an auditor can not simply ask a question and you can provide an answer in a short amount of time with assurance that the answer matches the question.
Yes, you work in an area that can be 'highly dodgy'.
Yes, it can be very easy to disguise what has / has not been done.
Yes, your processes can be improved.
Yes, your documentation can be improved (go on, shock me, say that your documentation is 'up to scratch' and can withstand scrutiny)
Yes, and even then, when from end to end you can prove what happened when, who and what changed what and where and reality aligns with plans with documentation with change control.. even then you will still find yourself in the same position .. paying millions to prove and audit and show.. because not everyone has the same level of change control and audit systems in place.. and hence you will be tarred with the same shovel as they.
Sad, isn't it.
Where I am, if you can prove that your audit, change and control systems are on board, that release management and change management guard the gates and you can prove that your world is round.. then you don't get slugged to prove that you are not lying.
I will see you here, in heaven, when you throw off your 'oppressors' ( ha ha - yes, that is a joke ) and join us.
Until then: Pay to prove that what you say is what you have done, or get out.
Go fuck yourself and your redneck imitation.
I had back surgery about 18 months ago and the Wii Fit helped me regain my sense of balance. Two disks had intruded into the spinal column, crushing the nerves running to my feet. It had been about a decade since I had feeling in my feet, so I was extremely clumsy after the operation - The new signals just confused the heck out of me, so I was constantly off balance.
Physical therapy was slow, so we started looking for alternatives. They were just exploring the Wii for the sports modules to get folks moving in a very fun way. The Wii fit was fairly new at the time, so I bought it as well.
In less than two weeks, I was walking normally, thanks to twice daily sessions with the Fit's balance games. My physical therapist said it would have taken me about two months using traditional twice weekly visits. (Based on my progress before the Wii Fit.) They quickly added the Wii Fit to their many machines.
It truly is a powerful little gizmo!
Basically I think some of the above posters have it right, I work in the medical software industry. Now unlike hardware there is absolutely no component cost to software, so why is our medical software so much more expensive then comparable non-medical software, hell why isn't it free?
Well, first of all there's the development costs. But that could be said for any other industry so we'll rule that out as a base cost for all similar software packages.
Then there's QC cost and support cost, unlike other industries if something goes wrong with our medical software someone could get seriously hurt. We have to perform a lot of QC and make sure we offer 24 hour support. The support also needs to be more trained and in some cases have a medical background, so that adds on to costs.
Then there is also liability. If our software files information into the wrong patient file someone could get seriously hurt. That means we have to assume liability for a malfunction, which is a huge incentive to buy from us despite the high costs. These things raise the price significantly. Now the software is still basically the same as it's non-medical counter part but our price tag is much higher. This means that people that don't need to worry about high QC standards and great support won't buy our product, which means we now have to target a limited marketplace. To make up for the limited market place we have to raise the price even more.
It's not that medical equipment or software manufacturers are greedy people that are trying to rip everyone off, that money that the product brings in is actually distributed amongst a lot more channels than a non-medical device. It's necessary to help assure quality and accountability.
Same thing goes for the $18,000 dollar piece of equipment vs. the $100 one. If a patient is miss-diagnosed on the $100 device, who is going to be accountable? Is it the doctor that probably should have double checked the results but didn't because he was busy with other patients? Is it Nintendo? Is it the hospital? The answer is it's sure as hell not Nintendo, they'll say they're not responsible for users miss using the device. And it probably should be the doctor but the doctor doesn't want that, nor does the hospital. In fact the doctor and the hospital would both gladly pay $18,000 dollars for the same device just so that they can off load their liabilities on someone else.
"Yes, but all of what you just said further illustrates why govt. bureaucracy is causing our medical expenses to spiral out of control"
So you'd like us to de-regulate medical devices. How about meat as well? We can go back to eating rotten meat.... Cause hey, if only a few hundred die each year, it is well worth the 50% cheaper meat....
The regulation of the industry does add cost, but that cost is directly tied to the overall health system as a whole. And the largest factor in the cost of all aspects of health care, is insurance costs. Both for physicians and patients.
There's a reason why health care costs in the USA are more than twice any other modern nation, and it certainly isn't government regulation. Feel free to read about the health care of every modern nation on Earth (except the USA) and see how their health care is the same quality or higher while at the same time much less costly.
But hey, don't let facts get in the way of your Fox News talking point about regulation being bad....
In support, I offer these two anecdotes. I might be remembering wrong because of all the morphine, but I'm pretty close.
1) I was offered some chemical that takes off the gummy black stuff left behind after they take tape off you. The kind of tape that holds an IV in, or a naso-gastric tube in place. My doctor intervened and said basically: don't do that, it will charge you $40. Wait till you get home and get acetone, nail polish remover for a dollar. That's all it is, they just added on costs for profit and liability.
2) To illustrate the point, my doctor told me about the chemotherapy drug that costs $10,000 per dose. It works in horses as well. Doctors would tell their patients that they could order some, or they could provide their own, hint hint. Patients would go to the veterinary supply store and get the same thing for a few hundred dollars, claiming a sick horse, and then take the bag to the infusion clinic. The cost was because they can, and for liability and insurance due to it being a newly patented drug.
Doesn't matter if your insurance pays, your copay amount is probably going to be higher with the "for humans" version than full price "alternative" sources.