iBot Self-Balancing Mobility Device FDA Approved 274
ptorrone writes "In November of 2002, I was able to see the self-balancing iBot mobility device, which can go up and down stairs and travel/balance on two wheels, in person. It literally brought tears to my eyes seeing what it will mean for millions of disabled people around the world. Today, the FDA has approved its use, after years of approval processes and testing." We've mentioned this Dean Kamen-created product previously, but it's good to see it officially approved and available for those who need it.
Re:FDA + Wheelchair (Score:5, Informative)
As always Google found what I was looking for here [wired.com].
Johnson & Johnson wants to market the IBot as a physician-prescribed device, instead of a consumer device, so that it can be covered under many medical insurance plans, according to development information provided by the company.
Re:FDA? (Score:5, Informative)
FDA approval (Score:3, Informative)
This thing needs approval because in confined spaces it could to terrible damage to other people as well as the occupant. Stair climbing and standing up is all very well, but suppose it fell over with someone else under it? The approval costs must be a tiny fraction of the potential liability if it was shown an insufficiently tested thing like this was released on the market.
But then, many people with only minor disability - reduced leg movement for instance - could well get away with a Segway. Perhaps they will go on to develop a whole range of these devices for different levels of disability, using the work done on approving "everything" to make subsequent approval much easier for the less functional versions.
Videos of it in use (Score:5, Informative)
Hefty price tag (Score:4, Informative)
Re:FDA + Wheelchair (Score:2, Informative)
Wheel chairs are classified devices and not
exempt.
If you think they should be exempt, then
you're insane. Surely you'd want some
testing and standards to apply to devices
being sold to the disabled. Or would you
rather have a purely market-driven lowest-
cost-wins approach to medical equipment,
particularly when there's a risk of greater
injury.
Look, this isn't a beach chair we're talking
about here. If it breaks, people (who are
already disabled) can get hurt.
FYI on FDA (Score:5, Informative)
Now say employee John Foofxr decides he wants someone to pay him some serious moolah to have this drug approved. Either the company pays or it doesn't. Too much power for one gov agency, and bear in mind they have no oversight agency.
Congressional Institute's page on the FDA [conginst.org]
Re:Videos of it in use (Score:3, Informative)
More on FDA (Score:3, Informative)
(source for this doc [ncsu.edu])
Ethical Issues Involving Medical Devices
Rick Chen
Introduction
In a society where new technology is constantly being invented, medical devices are evolving at a fast pace. The use of complex and sophisticated equipment to monitor patient and diagnose disease are more and more routine in hospitals and clinics. New discoveries in the material science field have led to the improvement in implant devices such as pacemakers, artificial grafts, and artificial organs. Armed with these technological advances, physicians and engineers are able to save more lives and improve the quality of living. However, these new technologies have raised new debates and discussions on morality and ethical issues. Approval and regulation of medical devices, as well as patient's rights and informed consents are just a few of the many issues stirred up by these new developments. This section discusses some of the issues and concerns dealing with medical ethics as well as regulation of medical devices. It also talks about some cases that involved medical device failure, and some of the government's attempts to reduce failure.
Issues and Concerns
As most people know, putting new medical technologies on the market requires repeated clinical tests follow by animal and human tests. Finally the device is approved by the government agency such as the Food and Drug Administration (FDA). In order to fully test the effectiveness of these devices, animal and human testing is necessary at some point. Due to sheer increases in the volume of biomedical research, problems associated with human experimentation gain in importance. This need raises very complicated questions about balancing the patient's right against the overall benefits. On the one hand, human life is precious and needs to be considered a high priority. On the other hand, the new technology could potentially have large social benefits.
In order to ensure the risks of physical and emotional injuries are at a minimum, every clinical study is required to meet comprehensive guidelines and regulations before moving to human experimentations. In addition to the regulations, a patient's rights during a human trial study should be properly protected. The concept of "informed consent" has emerged as a way to control this issue. Under informed consent, patients need to be informed of every aspect of the study, as well as the potential risks involved. This topic is discussed in detail in the informed consent section.
Medical Device Regulation
The first step in medical device regulation is to clearly define all the related terms and categories. A medical device is defined as any equipment used to treat, diagnose, or prevent disease (Jefferys, 2001). It can range from very basic equipment such as needles and syringes to complex devices such as X-ray machines and MRI scanners. In the case of clinical studies where the device has not yet been approved, a series of steps needs to be taken. In the US, the Food and Drug Administration (FDA) is responsible for the regulation of these devices. For the new device to be used on human subjects, first an investigational device exemption (IDE), which allows an unapproved device to be used in a research study, needs to be approved by the FDA. After the approval, the devices are then divided into two categories: significant risk and insignificant risk. Devices that pose significant risks include implants and artificial organs. Devices such as glasses and teeth-braces are qualified as insignificant risk devices. Research study that involves devices with significant risk cannot process until the procedure is approved by an institutional review board (IRB) and the FDA, which is based on the informed consent forms (Enderle et al., 2000).
In the UK and Europe, the devices are divided up into three categories: low risk (category I)
Re:Cost... (Score:2, Informative)
Re:Exercise (Score:5, Informative)
They simply provide feedback to an onboard computer that controls the servo motors that power them.
About 100 times a second, the motors make corrections either backward or forward based upon the data the gyros provide.
So no, there is no way of making a Segway a push scooter since it can't balance at all without power.
From the pictures, the iBot looks like the motor might be able to be disengaged to allow it to be pushed in four wheel mode. I don't think it can be manually self-propelled however.
USA only, why? (Score:4, Informative)
But the whole site has a little note saying it is for USA people only, and there dosn't seem to be an international site. It seems strange that they are not interested in the rest of the world.
Anyone know why this is?
Reading through the comments (Score:5, Informative)
As to answer peoples' questions regarding to Dean's interest in the medical sector: Dean's first invention was something to make IV injections smaller/easier around the time of the 70's (sorry, I don't remember exactly what it was or where more information is). He's been working on advancements for disabled and sick people for many years. I think it's due to commend him for his work.
Re:Is the FDA approval too much of a hazzle? (Score:2, Informative)
Howto:
1. Go to the FDA [fda.gov] and download the requirement specs for your device. Sometimes the specs point to other standards, e.g ISO standards, which you will have to find elsewhere.
2. Test your device according to the specs.
If you're to lazy or too much in a hurry to do 1 and 2, talk to an independent testing lab and they will help you from start to finish, for lots of $$$.
3 When you see that your device passes all requirements, send the results (aka premarket notification) to the FDA and 90 days later you can start marketing.
Re:Hefty price tag (Score:5, Informative)
Not true. As an approved "medical device", some to all of the cost can be paid for by insurance. And this avoids having to do extensive modifications to a home: the ramps, stair lifts, kitchen modifications, etc. can quickly add up to tens of thousands of dollars. Just its ability to go over a small curb, such as is often found between a garage and house or front entry walk and house eliminates two ramps. Standing up means the top half of a kitchen and closet is no longer useless.
The ability to 'stand up' and reach things makes much more of the world and home available to a paraplegic, and can probably give a proportion of them the ability to live without attendants or to expand their career opportunities.
Re:FDA + Wheelchair (Score:3, Informative)
In the U.S., you may tie balloons to a lawnchair [darwinawards.com] and run ads saying "buy this and fly!" without filing with the FDA. If you want to run ads saying "Now the disabled can fly," well, that is a medical claim, and the FDA will require you to submit proof that your claim is valid and that the device can be used without serious side-effects.
Re:And here I am (Score:5, Informative)
Yes a number of disabled individuals in an electric wheelchair could push them selves around in a manual chair. In my own circumstance I could indeed push my self around. But due to my disability, Anterior spinal muscular atrophy, type 2 [mdausa.org], pushing my self around is very slow, tedious, and tiring work. Not to mention a simple low grade hill will bring me to a stop. Even if I did excersize extensively, the disease works harder then I do. Even others with more severe disabilities could push them selves in a manual chair, but the effort to do so or the lack of muscular control makes it too dificult. So the electric aspect of wheelchairs allows us to travel with speed, thus being more normal.
In a vague way once you begin using a manual wheelchair it's all down hill from there. Walking is indeed a baseline form of exercize, sitting and pushing your self around is less, and electric more so. That is more taylored to those with progressive diseases. I was a seemingly normal kid, just with a particular walk, up until I was 8. I'd fall down fairly often, more so the closer to 8 I got. Around 8 I got my first manual chair, I'd push my self any where I needed to go or my mother/friends would push me, how ever I could stand on my own for limited ammounts of time.
I don't remember exactly when I got my electric chair, it wasn't too long after my first manual.
Electric wheelchairs are more often then not a neccessaity, for those in them.
--
As a note to any one who mentions the cost of this thing, it isn't just the iBot. Wheelchairs, and medical equipment in general, are expensive. I use a rather plain/normal electric wheelchair, which when newly aquired was 15,000$
Which is well beyond the means of my family. Thankfully how ever, the government (yes, I know, taxpayers) has picked up the tab on that one. But they don't do it swiftly, the process of aquiring a new chair is a long and tedious one.
I my self am in need of a new chair, as mine is several years old (5+) and it's simply meeting the end of it's life. So we will consult with my numerous doctors, a medical equipment distributer, and start the process soon. Justification letters have to be written, any denials have to be resubbmitted, it can often take a year or more for it to come to an end.
This is true for all things medical that you aren't paying for out of pocket. It all needs justification, a prescription, and time. Some less then others of course.
--
If I some how manage to wind up in one of these, I'll be sure to submit something to slashdot about it
and to the trolls bickering at my previous post, can't you handle a counter-joke with a bit of insult tossed in?
Don't you think it was more flame bait then funny to joke about mobility as a "sucker"?
$29,000 is the cost (Score:3, Informative)
Portable infusion pumps (Score:3, Informative)
Drug/Device approval costs ALOT of $$$ (Score:3, Informative)
So while it costs nearly a BILLION dollars to get a new drug approved in the USA, a device is cheaper to get approved. But it still costs money. The USA will propbably be used as a test market and other countries will receive applications, once this initial reaction is judged.
Re:And here I am (Score:4, Informative)
I'm a bit of a comedian too, It was a handy tool to poke fun of your disability during highschool, thus disarming any one who would think they where the first in teasing you about it.
--
Any way, moving on...
Yes, they do get repaired, The most recent repair I had was to replace the motors on my chair. But there's more then just the mechanical and electrical aspect to maintain.
Chair's in general go through wear and tear. Arm rests begin to break down, seat backs begin to loose covering, the frame begins to woble.
Even a car comes to a point where you can continue to repair it at a larger hassle and expense, or just buy a new one.
And speaking of cars, I get my tires done at Les Schwab. Grey medical tires run ~60$ I can get black "wheelbarrow" tires for 12$ a piece, not to mention they're cooler.
I have neither the strength nor the know how to repair my own chair, there are plenty of places that do the work. But even then someone still has to pay, be it medical coverage of some sorts, or the person sitting in the chair.
That doesn't limit someone who does have the ability to do the work from doing it. But tell me, do you know where to aquire a wheelchair motor? Sure you can probably buy one from your favorite wheelchair supply company, but you're covering the bill your self then, and without their specific expertise.
--
If any one has any questions, feel free to ask, I'll do my best to reply.
Re:Before you start weeping uncontrolably.... (Score:2, Informative)
Power chairs are expensive. They cost as much as a car. My son's (he has Cerebral Palsy) chair officially cost around $22K. Having met his annual copay and deductible, it was 100% covered by my insurance (so the out of pocket cost to me was $0).