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.
FDA + Wheelchair (Score:3, Interesting)
Re:FDA + Wheelchair (Score:3, Interesting)
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.
This was the real purpose of the Segway (Score:5, Insightful)
This is a the real revolutionary device and it will make lots of money. I still have my doubts about whether the Segway itself will be a sucess in the next few years. That doesn't matter though, it paved the way for IBot in the court of public opinion. Imagine the reaction of people to IBot if they had never seen the Segway, "You're going to give a wheelchair-bound person what?!?" Now, with the public acclimated to the balancing technology, the reaction will be one of amazement instead of concern.
Re:This was the real purpose of the Segway (Score:5, Insightful)
The other thing that will limit the iBot adoption is that it takes an extra amount of coordination to control it safely in its enhanced modes... mostly fine for people with lower spinal cord injuries or spina bifida, but probably less useful in general for cerebral palsy or the later stages of muscular dystrophy or multiple sclerosis. The people best equipped to make full use of the iBot are also those who can often get by with a manual wheelchair.
Finally, there's the "fear factor"... my wife watched a video of this thing going down stairs and declared that there was no way in hell she'd trust the machine. Her chair weighs in at around 220 pounds; a tumble with such a machine could very easily be fatal.
I do think that advanced machines like the iBot have a future, but I think that future will be a long time in arriving. Meantime, accessibility is improving all the time, and stairs aren't the obstacle they were even ten years ago. By the time a stair climbing wheelchair is widely available, cost effective, and trusted, the problem it solves will have greatly diminished.
Re:FDA + Wheelchair (Score:5, Interesting)
Actually, the FDA regulates all manners of medical devices; there's an entire branch of the org which deals with them, the Center for Devices and Radiological Health. That means everything from syringes to x-ray machines to wheelchairs.
I work as a webmaster over there (All Opinions Expressed Are Mine And Have Nothing To Do With My Employer) and got to post the happy news of this thing to the CDRH website (http://www.fda.gov/cdrh) today. Whee! ...please don't slashdot our database server, we're a little understaffed today...
Re:FDA + Wheelchair (Score:2, Insightful)
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 equipm
Re:FDA + Wheelchair (Score:3, Informative)
And here I am (Score:5, Funny)
Re:And here I am (Score:3, Interesting)
Since you are in a position to have an opinion, what do you think of the physical fitness aspects of this?
The most excerise many of us geeks get is walking to and from the car and possibly up the stairs. I see a number of wheelchair-bound people that, judging by their upper body development, get more of a workout moving themselves around than the rest of us.
Obviously the price of this thing is going to prevent very wide use for som
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"?
Re:And here I am (Score:2)
I know it's a little more near and dear to you than I, but I kind of think of a poor analogy... I repair my cars all the time, constantly replacing broken parts.... what would keep someone from replacing worn parts on a wheelchair? Is there a certification process from the FDA that would limit that?
Of course, if you're in a wheelchair to begin with, you may not have the mobility to actually do the work yourself.
Just ch
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.
FDA? (Score:4, Interesting)
Re:FDA? (Score:5, Informative)
Re:FDA? (Score:5, Interesting)
Re:FDA? (Score:2)
Is the FDA approval too much of a hazzle? (Score:5, Insightful)
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
Re:Is the FDA approval too much of a hazzle? (Score:2, Insightful)
Keep in mind, that figure includes the cost of research and development on the drug being approved, as well as previous drugs that have failed for various reasons (ineffective, toxic, etc). Neglecting the cost of failed drug research, the cost for each drug would probably cost a factor of 4 or 5 times cheaper than $1B. Still a lot of money, but hey, who said pharma was easy?
Re:Is the FDA approval too much of a hazzle? (Score:2)
$29,000 is the cost (Score:3, Informative)
nice (Score:2, Funny)
iBot is the first step. (Score:3, Funny)
I wonder if I can mod this thing into a gundam... or better yet a megadeus.
*honk*
Compare this to the Segway (Score:4, Interesting)
The whole approval thing makes it possible to get part of the (very costly) wheelchair price covered by medical insurances and the like, as I've understood things correctly anyway.
Re:Compare this to the Segway (Score:2, Insightful)
Yes, and what about safety? The Segway doesn't have to be Bush- *cough* fool-proof, the wheelchair has to be.
Any fast, unexpected motion (losing balance, falling, a quick jerk forward or backward) can have far-reaching consequences for the person using the device (think about neck and back strain).
Re:Compare this to the Segway-3 Wheeled? (Score:2)
Re:Compare this to the Segway (Score:2)
Corrected Statement (Score:5, Insightful)
Read: those who can afford it.
Re:Corrected Statement (Score:2)
oh, please (Score:2)
however, the patent system will probably keep it expensive for longer than it should be..
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.
Re:FDA approval (Score:4, Interesting)
The thing people usually misunderstand about drug approval is that the results of the clinical tests are open to scrutiny. If the drugs are not effective, the FDA can (and does) not approve them.
Having said that, pharmaceutical companies spend way too much money on "lobbying" doctors. The usual budget rundown is: 1/3 R&D, 1/3 infrastructure, 1/3 Marketing and sales. Of the 1/3 R&D, 1/3 goes to research, which makes the pharmaceutical industry the industry that spends the most in research.
Re:FDA approval (Score:2)
Re:FDA approval (Score:3, Interesting)
Re:FDA approval (Score:2)
Let's hope that with the advances in human genomics, doctors will be able to DNA-test the efficacy of drugs on patients before giving them the drugs. We are not so far away from that, I'd say 5 years.
Videos of it in use (Score:5, Informative)
- Movie 1 1.8MB [fsnet.co.uk]
- Movie 2 1.8MB [fsnet.co.uk]
- Movie 3 20 MB [freeserve.co.uk]
It still looks a little unstable on stairs but it does mean that a person in a wheelchair can go up and down stairs by themselves, which is definetly a good thing.Re:Videos of it in use (Score:3, Informative)
Re:Videos of it in use (Score:2)
Re:Videos of it in use (Score:3, Interesting)
hmm speaking of humvees, what would happen if you got an ordinary good quality remote control aeroplane, stripped out all the servos and put two servos on an iBot's joystick and one servo on the trigger of a M249 Squad Aut
Cool (Score:2)
Hefty price tag (Score:4, Informative)
Re:Hefty price tag (Score:4, Interesting)
Re:Hefty price tag (Score:2)
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.
Amortizing fixed vs. variable costs (Score:2)
Compare this to the cost of retrofitting buildings to apply with the Americans with Disabilities Act. The fixed cost of saying this will be done is zero, but it costs tens of thousands per unit just in construction costs, not to mention the cost inspection, planning and legal efforts. It might n
Re:Hefty price tag (Score:2)
Re:Hefty price tag (Score:2)
Re:Hefty price tag (Score:2)
Well, I have a Ford van with a Ricon 6000 wheelchair lift. I bought the van new in 1992 and had it converted; it came it around US$28,000. Subsidized? Well, like most manufacturers, Ford had a US$1,000 credit towards the installation of such equipment, but the rest was out of my paycheck.
Unfortunately, with 150,000 miles on the van its second transmission is now going, and I under
Sounds like something Apple should market... (Score:3, Funny)
Re:Sounds like something Apple should market... (Score:3, Funny)
Re:Sounds like something Apple should market... (Score:2, Funny)
i'Ve gotta go iNto iSolation to get away from all these iDiots before i go iNsane.
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]
Comment removed (Score:5, Interesting)
Re:FYI on FDA (Score:3, Funny)
HAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHA!!!!!
*wipes the tears from his eyes and gasps for breath*
Thank you... I needed a good laugh today.
Re:FYI on FDA (Score:2)
Examine the history of Aspartame, and correlate that with the employment osmosis between FDA officials and Monsanto's management, for example. Similar forms of failure of 'due process' can be fou
Re:FYI on FDA (Score:4, Interesting)
I think your mistrust is unfounded. I admit I don't know how the FDA is operated, who has direct/indirect oversight, etc., but why worry about the FDA (which has an incredible record) while there are plenty of other agencies that have numerous and ongoing cases of blatant corruption and abuses?
Re:FYI on FDA (Score:2)
Yeah, and while we're at it let's talk about the military. They've got government employees who run around with guns for chrissakes. Can you imagine the type of abuse they could put people through. IE say Sgt Foofxr wants some money, he could just make you fork it over at gunpoint.
<clue>Government agencies are given power because they have a job to do. This is inherently dangerous. It's the structures ensuring accountability
Millions? (Score:2)
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)
Presidential Testing (Score:5, Funny)
Re: Presidential Testing (Score:2, Funny)
*cough*
http://www.usatoday.com/money/industri
*cough*
Exercise (Score:5, Insightful)
Does this gyro technology work at any speed or is it kept it on a smooth motor to avoid overstretching it? Could you make a push-scooter Segway?
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.
Re:Exercise (Score:2)
EZ-Chair [ezchair.com]
Re:Exercise (Score:3, Insightful)
Although it's kinda lame, you could stick a couple of handcrank generators on the sides of the wheelchair to let the rider keep the batteries charged longer. Does the wheelchair have a remaining running time display or something similar? I didn't see one in the demo, but it seems like a rather important feature
Re:Exercise (Score:2)
For instance, if you have Parkinson's, one of these may let you get around without the fear of falling.
Plus, I don't think the pedal was meant to be the sole motive force. But as an add on, to provide some daily motion for the lower extremeties, it may well help prevent further atrophy.
Not all wheelchair users have lost complete leg functi
I for one welcome our new Dalek masters.... (Score:2)
I too welcome our new Dalek masters.... (Score:2, Funny)
OK up to a point (Score:5, Insightful)
I presume the FDA testing would mean that a failure going up stairs wouldn't result in it crashing to the bottom.
The traditional big-wheeled wheelchair is (relatively) low tech, cheap and, for those who can use it, gives real independence of the `let me on with my own life damn it' variety.
Obviously there are classes of dissability for which a powered chair is neccesary, stick Stephen Hawking in one of these for instance. But I wonder if there is some way to bring some of this technology to a machine which wouldn't just be a oversized couch when deprived of power, and wouldn't reduce people who don't need to be to couch potatoes.
Where have you been? (Score:2)
Battery powered wheelchairs are EVERYWHERE.
So apparently the handicapped community doesn't share your outdated skepticism.
Hell, even people who don't *need* them are buying these battery powered carts for thousands of dollars.
This device is truely amazing (Score:5, Insightful)
On top of being able to go up stairs and balance on only 2 (one wheel raised on top of the other) (designed so that the disabled can effectively "stand" at eye level with a medium height adult) It also will fit through a standard size doorway. This means that if someone is to become disabled through an accident, that they do not need to retrofit their house (or move into a new one) to continue to be functional. The iBot allows a person to traverse stairs, travel on most all terrain (pneumatic tires), and due to its function to lift a person and self balance on only 2, a person can access higher kitchen cabinets, and shelves throughout their home.
This erases the massive price tag to retrofit a persons home, which is often paid for by workplace disability or the federal government. That is not to say that the iBot is not expensive ($20,000 at last count), but the cost of refitting a home can often be signifcantly more than that.
I've seen the device at FIRST competitions in the past (another Kamen brainchild), and it is revolutionary.
Perhaps this is off topic but (Score:5, Interesting)
This is a great invention by a great guy, and I genuinely hope it goes to people who really need and deserve it. Teachers may not be aware of the difference they make in a kids life; I hope these kids realize what a difference they've made to their teacher's life. It's amazing.
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?
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 countrie
Tears? (Score:3, Funny)
Perhaps you should try adjusting the seat properly.
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.
Portable infusion pumps (Score:3, Informative)
mod parent up (Score:2)
iBot (Score:2)
Nothing yet.. (Score:2, Insightful)
Good investment for society (Score:2, Insightful)
iBot? iMac? (Score:2)
In the end, more significant than the Segway (Score:4, Insightful)
Having assisted a number of people in various types of wheelchairs, the significance of this to the chair-bound cannot be overstated.
Re:In the end, more significant than the Segway (Score:2)
My faith has been partially restored. now let's see if we can get that price down so people can buy it...
Watch out for Bananas (Score:2)
I sincerely hope that in 20 years (or sooner) the disabled will be driving around in Dr. Xavier like chairs made by Harrier corporation and we will look back at this workhorse technology as a temporary sol
Before you start weeping uncontrolably.... (Score:3)
Are there really millions of disabled people who can afford a US$30k wheelchair? I saw this on the news last night, and that's about what they're charging for it, apparently. Now, if it weren't going to be covered by some insurance companies, do you think it would retail for that much, or would it be closer to the roughly US$5k that a Seqway goes for? It's more complicated, but is it 6x more complicated?
They also said it is very complicated to operate, and requires a doctor's prescription. The video they showed looked like it would be very easy for someone to get hurt if they didn't know what they were doing.
Re:Before you start weeping uncontrolably.... (Score:2)
Now that is no longer "experimental", but an FDA approved treatment, Many, if not most insurance companies will pay for it
Now, if you thing 20 or even 30k is expensive in the medical field, you haven't had to have surgery lately. If I remember right, the "Offical" bill for my Son's birth (totally normal - no C section, no complications) was in the 30k-40k range. Of course, with the deductable, etc, i
Re:Before you start weeping uncontrolably.... (Score:2)
As long as the insurance companies blame the overpriced hospitals, hospitals b
And the insurance companies don't pay that price (Score:3, Interesting)
It's a way around cost controls - the providers know that insurance will only pay a portion of the costs so they jack up the fees.
The down side is if you don't have insurance and you get billed the "insurance" price. My aunt recently needed treatments that were not covered by her insurance company and was able to negotiate the discounted prices from the providers ahead
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).
Re:Before you start weeping uncontrolably.... (Score:2)
I have a much cheaper solution (Score:4, Funny)
I doubt the battery endurance (Score:2)
With a different view, if that battery lasts more than 10 hours with that kind of work, why arent laptop manufacturers using it?
Remote control? (Score:2)
Name Collision (Score:2)
c'mon people. Google search before you name your product.
Re:Ahem... and in some more important news: (Score:2, Funny)
with brides worth an estimated $5 million
Damn, those are some expensive women. Apparently Microsoft is "diversifying" their business quite a bit.
Re:Cost... (Score:2, Informative)
Re:Any videos? (Score:2, Interesting)
Can't believe this isn't moderated higher - that's a really great 2 part video of it.