iBot Self-Balancing Mobility Device FDA Approved

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

[SKPhoton]

Since when does the Food and Drug Administration have to approve advanced wheelchairs? Maybe if it was a big vitamin wheelchair.

FDA?

[jasoncart]

Excuse my ignorance, but why is electronic device this being approved by the "Food & Drugs Administration"?

Re:FDA + Wheelchair

[trikberg]

It was a long time since I read about it, but it was something about it being a lot cheaper to buy once it was classified as an aid for disabled people. I don't remember the reason, could have been either related to insurance or to tax deductability I guess.

Compare this to the Segway

[Max Romantschuk]

It's interresting to note that this wheelchair also has served as the technology-cradle (if you will) for the Segway. Yet, the Segway has been around for quite some time already, and the wheelchair only just got approved by the FDA.

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:FDA?

[ratfynk]

Good question, if you build wheel chairs they need approval. Any device that the medical insurance industry might need to pay for has to be approved. It does not matter if it is a tech creation. The FDA is there to look after the well being of industry. "The business of Government is business" You will not be able to sue if you have an accident using this device, unless you can prove neglagence on the part of the maker. Same thing goes for the cost of practice insurance for doctors, it costs a fortune because Americans love litigation so much nowadays. There are hords Lawyers who do nothing but take cases against medical companies and doctors on spec because it has become so lucurative. I just hope this bullshit continues to stay south of the Canadian border where it belongs.

Re:FDA approval

[lovebyte]

Drugs companies actually spend far more on marketing than they do on R&D, which includes approvals. How much of that marketing is really necessary - unless, of course, the drugs aren't really as effective as they claim?

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:Hefty price tag

[ArsonPanda]

One of the major points of getting FDA approval on something like this is so that the feds (medicare/aid) will likely pick up a large portion, or in some cases, all of the cost.

Re:FDA + Wheelchair

[Anonymous Coward]

Well done on totally missing the point.

A wheelchair is not food.

A wheelchair is not a drug.

Why does it fall under the FDA's remit to test it then, rather than the federal Wheelchair agency or whatever?

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[account_deleted]

Comment removed based on user account deletion

Perhaps this is off topic but

[dodell]

I saw this thing on Discovery once about Dean Kamen. He's a great guy. This class of like 3rd grade students all wrote him to see if he'd donate one to their science teacher who was disabled. So Dean came personally and brought one of these things to the guy and he was soooooooooooooooooooooooooooooooooooooo happy. He could even do dances and stuff with the thing; his wife was there too and they did like a waltz or something, and it actually worked.

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.

Re:FYI on FDA

[evilviper]

Why do they place so much power in one agency is beyond comprehension. Can you imagine the type of abuse someone can put another company through.

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:FDA approval

[panurge]

It is true that the results of the tests are open to scrutiny. However, as I am sure you realise, in many cases it is extremely difficult if not impossible to weight the levels of benefit versus harm across the entire population. It is probably better for a marginally effective drug to be approved than to be rejected because, once it moves beyond clinical trials into general use, it may prove to be particularly effective in certain cases or in combination. The outcome can be that insurance companies and, in the countries that have them, government health agencies, can be very unsure of the need actually to prescribe certain drugs given the cost/effectiveness benefits. There seems to be something of a vicious circle: drugs are expensive, there is resistance to their use, more has to be spent on marketing to get them sold, so they get more expensive. The drug companies have to function in a very difficult environment, because most drugs are not as effective as penicillin or AZT.

The reason I know anything about this at all is that the guy who taught me statistics was a specialist in the area of clinical trials. He was also brilliant, and I guess you have to be to be able to navigate your way around such a difficult area.

Re:And here I am

[Suidae]

as someone who has been sitting in a wheelchair for 13 years of his life

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 some time, but if it's successful I can imagine that it has the potential to almost completely take over the powered wheelchair market. If it does, the price point will come down, possibly bringing it down far enough to be a sane purchase for people who otherwise would not get a powered chair.

Is there a potential problem there regarding physical fitness? Even the minimal walking that most people do elevates heart rates enough to maintain some basic (albeit pathetic) fitness levels. Are people who would otherwise be using their upper body to provide locomotive power going to now have to do little more than wiggle their wrist for nearly every sort of movement?

It seems like most powered wheelchairs would not be worth the price for the limited mobility they provide for otherwise healthy people, but this one does stairs, and can raise the user to eye level with up-right folks. Seems that people who haven't really needed a powered chair before might decide they need this one.

In a nutshell, I'm curious if use of a powered chair has more severe physical fitness impact even than a typical persons sedentary lifestyle, and if this will effect people who would otherwise get excersize from daily locomotion.

Re:FDA + Wheelchair

[2Flower]

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:Any videos?

[erasmus_]

NBC's Dateline Videos http://www.msnbc.com/news/950639.asp"

Can't believe this isn't moderated higher - that's a really great 2 part video of it.

Re:Videos of it in use

[nounderscores]

Having two wheels on a rotating arm like that means that the robot can climb a bigger step than a larger diameter wheel can. You could try just driving up such a step if you were in a humvee, but this wheelchair has to run 3 CPUs and who knows how many motors off the onboard batteries....

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 Automatic Weapon mounted securely to the seat? Add a wireless video camera to the picitinny rail on the top of the machine gun, and maybe a bulletproof riotshield bolted to the front and you have the utimate solution for those pesky barricaded hostage situations in tight urban areas.

Wait, urban areas, poor radio reception... maybe make it cable controlled? Or maybe put a laptop and a thermal camera in the seat and let it make its own decisions. you get the picture.

And the insurance companies don't pay that price

[anomaly]

Because when they get a $30K charge, they "approve" only a small portion of that amount - 50% or so and the hospital writes off the rest.

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 of time. If she had not asked, she would have been paying much more than the fair market value for the rendered services.