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.

Comments

FDA + Wheelchair

[SKPhoton]

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

Re:FDA + Wheelchair

[91degrees]

Administrative convenience, probably. It means that hospitals only need to deal with one organisation to determine whether the things they use are safe.

Re:FDA + Wheelchair

[SKPhoton]

The wheelchair rides around on 2 wheels like the segway as seen in this article. Since this is designed for disabled people, would it be able to keep its balance when a person with constant siezures was placed in it? Even when the wheelchair climbed stairs?

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.

Re:FDA + Wheelchair

[SKPhoton]

Not necessarily. You still have medicare, medicaid, HMO's, etc, but those are for insurance. I'm sure there has to be some better group to test it such as the organization that tests vehicle safety.

Re:FDA + Wheelchair

[trikberg]

As always Google found what I was looking for here.

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 + Wheelchair

[91degrees]

Probably the FDA subcontract the testing to an agency that specialises in vehicle testing. As for insurance, it's a lot easier for them to say that they cover anything approved by the FDA, rather than any drugs approved by the FDA, mobility devices approved by the agency for those, prosthetics approved by the prosthetics people, pacemakers approved by another agency, and so on...

It's just a case a feature creep for the FDA. Someone needs to approve these things. They assign it to the agency that's already known to those who want approval.

Re:FDA + Wheelchair

[Anonymous Coward]

Each person who wants to market Class I, II and some III devices intended for human use in the U.S. must submit a 510(k) notice to FDA at least 90 days before marketing unless the device is exempt from 510(k) requirements.

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.

Re:FDA + Wheelchair

[91degrees]

The question isn't why aren't they expempt. The question is why is it a department of the FDA who deals with it? They are meant to be testing food and drugs, which presumably involves animal testing.

The original post was asking why doesn't a department of conumer safety, or perhaps a branch of the agency that regulated motor vehichles deal with this isntead.

Re:FDA + Wheelchair

[Anonymous Coward]

Keep this mod'd low. It answers
a stupid question.

Also, keep the stupid question
mod'd up at +4 or +5.

"Since when does the Food and Drug Administration have to approve advanced wheelchairs?"

What a fscking dumb question. I mean,
just google for "FDA medical device regulation"
and you'll learn something.

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?

Re:FDA + Wheelchair

[SoSueMe]

would it be able to keep its balance when a person with constant siezures was placed in it?

Probably not.
From the article:

To climb up stairs, the occupant backs up to the first step and holds onto the stair railing. Then he shifts his weight over the rear wheels, causing the chair to begin rotation of the front wheels up over the rear wheels and then down onto the first step.

It also would not be appropriate for quadriplegics as the weight shift would be a problem.

Re:FDA + Wheelchair

[Anonymous Coward]

Do you have some ideological problems with FDA or what?

Re:FDA + Wheelchair

[91degrees]

Why indeed. This is another very similar question. What is the answer?

Re:FDA + Wheelchair

[Eustace Tilley]

The FDA does not do any testing. It establishes the rules for testing and reviews the test results. Here's how Annabelle Rajaseharan explained it to in the Journal fo the Indian Medical Association:

The Federal Food, Drug, and Cosmetic Act requires FDA to ensure that the new drugs developed by pharmaceutical companies are safe and effective. It does not give the agency responsibility to develop new drugs itself. So, FDA physicians, scientists and other staff review test results submitted by drug developers. The purpose : To determine whether the drug is safe enough to test in humans and, if so - after all human testing is completed - to decide whether the drug can be sold to the public and what its label should say about directions for use, side-effects, warnings, and the like. FDA first becomes involved when a drug company has completed its testing in animals and is ready to test a drug on humans. (Actually, some animal testing continues after human tests begin to learn whether long-term use of the drug may cause cancer or birth defects. Also, more animal data may be needed if human tests turn up unexpected effects. And new therapeutic uses may be found by continued animal studies). Although FDA usually does not tell drug companies what specific laboratory or animal tests to run, the agency does have regulations and guidelines on the kinds of results FDA expects to see in any request to conduct human testing.

In the U.S., you may tie balloons to a lawnchair 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:FDA + Wheelchair

[Anonymous Coward]

Because some time after being founded, the FDA also assumed the approval process and categorization on medical devices -- of which this is one.

Why do you think implants also have to be FDA approved?

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:FDA + Wheelchair

[Aesculapius]

The FDA has responsibility to assure safety and efficacy for medicine AND medical devices. This includes devices that are implanted and ones that are not. Some examples include diagnostic equipment (MRI, CT, PET), implantable devices (joints, pacemakers, breast implants), and assistance type equipment.

Look at it this way, what would happen if this company sold their product and it failed....often? Many people could be injured or killed. It's the job of the FDA to try and prevent these incidents by reviewing and "approving" medicine and medical devices.

Re:FDA + Wheelchair

[Anonymous Coward]

They have the authority to (dis)approve a lot of stuff. Stair lifts, for example.

Re:FDA + Wheelchair

[Anonymous Coward]

just dropped acid taking this baby down the mall.

fda approval = 10, 10 & 10

Re:FDA + Wheelchair

[Anonymous Coward]

I hear that. Real men solder off their tear ducts.

Re:FDA + Wheelchair

[HeyLaughingBoy]

Probably the FDA subcontract the testing to an agency that specialises in vehicle testing

The FDA does not test devices. The manufacturer develops the device using a documented process and then tests it. The results of the tests are submitted to the FDA for approval. The FDA can (and do: but we usually have warning) show up and audit any aspect of the development or testing that they feel like, so it behooves the mfr to not cut corners or say they do things that they actually don't.

Re:FDA + Wheelchair

[Mikeytsi]

I think you could figure out that it wouldn't work well for quadriplegics by the controls.

Re:FDA + Wheelchair

[Anonymous Coward]

The iBot is a Class III medical device. Which means that a malfunction can result in death for the user. This is the highest class of medical devices useualy reserved for implantable devices like pacemakers. The reason for this classification is because the whelchair can climb stairs, which if the chair malfunctioned, could cause death to the user.

Re:FDA + Wheelchair

[91degrees]

Fair enough.

It's nice when I'm wrong. I learn so much more than when I'm right:)

Re:FDA + Wheelchair

[reboot246]

My main complaint about the FDA is that they move at a snail's pace. Devices and treatments that have been available for years in other countries still take forever to be approved here.

Case in point: I have avascular necrosis in my left hip joint. There is a treatment called shockwave therapy that works in the early stages of the disease. It has been used successfully in Europe for years, but is still in trials here in the good ole USA.

By the time it's approved I'll have already had my hip replaced. If anybody knows of a treatment that will work now, I'm all ears.

Re:FDA + Wheelchair

[jcr]

FDA is one of the most power-hungry bureaucracies you can possibly imagine. They assert jurisdiction over anything they can possibly describe as having a medical use.

Always remember: Thalidomide kills thousands of people every year, because it was the Thalidomide debacle gave the FDA the power to withold treatments, with fatal consequences.

Frankly, I'm disgusted that the people who want this device have to wait for years until some petty tyrant deigns to let them to use it.

-jcr

Re:FDA + Wheelchair

[jcr]

If you think they should be exempt, then you're insane.

That you, Dr. Kessler?

If you think that a government bureacrat should decide what moblilty devices a person may use, then you're the crazy one.

Look, this isn't a beach chair we're talking
about here.

Exactly. It's a device that can make a vast difference in a person's quality of life, people who have been forcibly deprived of the product for the years that it took for FDA to condescend to give a shit.

-jcr

And here I am

[some damn guy]

using my legs like a sucker.

Re:And here I am

[Anonymous Coward]

"And here I am using my legs like a sucker."

Yes, well you are a giant octopus.

Re:And here I am

[Night0wl]

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

I'll be sitting here flipping you off, like an asshole.

Re:And here I am

[muirhead]

You be a bigger sucker if you'd bought a Segway.

Re:And here I am

[Anonymous Coward]

Dude, seriously.

Just get a real sucker.

They taste better and you won't be risking a dislocated pelvis.

Re:And here I am

[Anonymous Coward]

using my legs like a sucker.

Loser. All the coolest people are on wheels. Skateboarders, inline skaters, those mini-scooter things, Segways, and don't forget Professor Stephen Hawking! I'm going to cut off a leg just so I can ride around in one of these puppies. Woop!

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:And here I am

[Anonymous Coward]

To some degree, you're right about the exercise--but on the other hand, it's not "optional" excercise; on a day when you're exhausted (for what ever reason) the prospect of a required exertion just to more around can be daunting... One of the most common problems for manual wheelchair users (especially as they get older) is rotator cuff injuries--there are many folks for whom manual chairs become a fairly painful machine---for them, this may be a god-send

Re:And here I am

[Night0wl]

The thing is with electric wheelchairs they're a sort of double edged sword.

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, 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 ;p

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

[Lurker]

It's not his fault you're crippled

Get over it, retard

Are you suggesting that people who use wheelchairs are retarded? I ask for information purposes only, as I am confined to a wheelchair and wasn't aware I was a "retard".

Re:And here I am

[karnal]

This may be a silly question, but do you have to go with a new chair because of wear?

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 chock this post up to stupidity, but curiousity.

Re:And here I am

[Night0wl]

You didn't say you were sitting around like a sucker, so it's all good. I'm rather open about my disability, It's the only existance I know. So I can deny the obvious truth that I'm in a chair, or run with it.
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:And here I am

[Johnny130]

There is one thing that needs to be mentioned that I haven't seen anywhere in the article. My father works in the wheelchair industry as a salesmen and has seen one of these devices in action before. Yes, the may be able to scale stairs to a point, but in doing so they have to sacrifice some other aspects. The ability to travel outdoors across any difficult terrain is limited. Also, at least with all the past generations (yes, this isn't the first wheelchair like this), they had a problem with breaking down very easily due to some of the moving parts that wheelchairs don't usually have to deal with. Just my two cents.

Re:And here I am

[CrazyGringo]

Just curious, not trolling, but did you know that the "using my legs like a sucker" comment was a reference to a Simpsons episode?

Re:And here I am

[Anonymous Coward]

I *think* the poster was referring to a Simpson's episode where Homer said that.

http://members.tripod.com/~preTender_316/homer6.ht ml (tripod.com)

You know, one of those moronic things that Homer always says, where you just have to smack your head at the ridiculousness of the statement. I don't think he was trying to be an asshole.

Re:And here I am

[Xerithane]

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.


It's good you can do that. I had a friend I used to work with that was hit by a car and broke his back. He then got hit 2 years later, in his wheel chair, and broke his back again. After the second reconstruction surgery, he actually had increased mobility. He could walk around for limited times, albeit very slowly.

He came over to my apartment, and was using his walker, so when he got up stairs I immediately offered him a seat. His response, "No thanks, I've been sitting all day."

Keep the humor up (I'm guessing from the thread you are in your early twenties) and keep running with it.

Re:And here I am

[Night0wl]

21. :)

Thanks for your kind words. It saddens me to see some of the negative replies around here when this topic comes up as it is an issue I'm forcefully involved in.

I go to a camp, funded by MDA, once a year for a week. And have been doign so since I was 5 years old. It's one of the greatest things in my life, I get to make friends with people who are no different from me and the only reason I am weird or different is because of my personality.
This was my last year however as the age limit is 21. In my later years when I wasn't being more of a kid, I'd come to realize how fragile life is. Fellow campers who I had known for years, suddenly weren't there. Bright faces and wonderful people who's lives where cut short due to there diseases.

Along with that knowledge that some of these campers will die all to soon, it hurts to see the young kids in wheelchairs and to know that they too might not escape that burdon.

I was diagnosed at 3 months of age, The doctors announced I wouldn't live beyond 3 years, at 21 I'm going strong. So I am grateful that I have what I have, and like any one I certainly do yearn for more, but you can only live life one day at a time.

Re:And here I am

[Night0wl]

Nope, I didn't.
But now I know, And knowing is half the battle! ...

G.I. Joe any one?

Re:And here I am

[some damn guy]

Yeah, I love that show...I thaught people would remember the line

FDA?

[jasoncart]

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

Re:FDA?

[Anonymous Coward]

They are marketing it as a medical device which requires a doctor's order so that insurance will help people buy them. Therefore it is considered a medical device and needs fda approval. THey could have marketed it directly to consumers and avoid the FDA hassel but then insurance could not help pay for them.

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?

[mabhatter654]

The approve other pesky "electronic" things like heart monitors, pulmonary relectrocution units, and artifical hearts too...get the idea...

Re:FDA?

[Anonymous Coward]

FDA approval has nothing to do with getting insurance to cover the cost of a device. It has to do with ensuring a medical device is safe and effective. The favorite industry horror story concerns a radiation therapy device made in Canada. Two software errors killed several people (I believe 2 were cooked, and one was crushed when the table he lay on was lifted past its limit into the emitter head).

Many FDA approved medications and devices are not covered by insurance, or Medicare.

Is the FDA approval too much of a hazzle?

[NKJensen]

Sometimes I wonder if the FDA approval is too difficult to obtain. It's always a balance between getting the products onto the market and keeping them safe. It's said to cost near one billion US$ to get a new drug on the market - not many companies can afford someting even remotely as expensive for a mechanical aid.

Re:Is the FDA approval too much of a hazzle?

[Anonymous Coward]

Well the chair retails for $300,000 ;)

Re:Is the FDA approval too much of a hazzle?

[NKJensen]

I guess you mean that the approval IS to much of a hazzle since it pushes prices that high?

Re:Is the FDA approval too much of a hazzle?

[Anonymous Coward]

Why does a piece of tech require `food and/or drug` administration approval? Just develop it outside the US then. Sell it for entertainment use only, or make it a kit you have to make yourself (even if that just involves assembling some macro components).

Re:Is the FDA approval too much of a hazzle?

[Anonymous Coward]

" Well the chair retails for $300,000"

Did you just make that up? The figure I saw wa $29,000.

Re:Is the FDA approval too much of a hazzle?

[Anonymous Coward]

No, it is not "hard" per se, if we're talking about devices. There may be a million and one requirements your device have to comply with, but there isn't much red tape.

Howto:

1. Go to the FDA 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:Is the FDA approval too much of a hazzle?

[rlawley]

It may cost $1B to get a drug to market, but it strikes me that it would be a lot cheaper to test an electronic device than a drug- and the testing process shouldn't take as long either (I doubt there are many long term side-effects of using an electric wheelchair!)

Re:Is the FDA approval too much of a hazzle?

[amabbi]

It's said to cost near one billion US$ to get a new drug on the market...

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?

[maxume]

If they do that, they don't get to compete in thier target market - people with insurance. Insurance companies will only pay for something if they have to. They have managed to make 'fda approved' something that everything they pay for is considered...

Re:Is the FDA approval too much of a hazzle?

[barryfandango]

I work in aviation, another "over-regulated" industry. In the case of Food and Drugs, as with aircraft, Too Much Regulation is a Good Thing. Sometimes it's astonishing the amount of paperwork involved for my company to repair, for example, a tiny composite step panel - 90% of the manhours relate to paperwork, not the repair itself.

If i'm going to be climbing into an aircraft that flies 30,000 feet in the air, or swallowing a pill that is going to be interacting with my body, I want to be damn sure that it has been tested more times than it has to be, certified and re-certified by several panels of experts. I want a paper trail telling me everywhere it's been, what went into it, and the middle name of the guy who screwed the lid on the bottle in the factory where it was made.

This is life and death, after all. There's a reason you don't see public beta versions of new drugs for sale.

Re:Is the FDA approval too much of a hazzle?

[jcr]

Sometimes I wonder if the FDA approval is too difficult to obtain. It's always a balance between getting the products onto the market andkeeping them safe.

I lost the last remnant of respect I had for FDA when that pack of raving quacks actually *approved* injecting a solution of botulism toxin into your face to treat wrinkles, for Christ's sake! What's next, arsenic to treat acne?

So, they can keep anti-clotting drugs off the market for a decade or more (letting heart-attack victims die for the misfortune of living in the USA, instead of Denmark or any of the other, saner countries), but they go right ahead and say "have fun", when those quacks in the Cosmetic Surgery business come up with something even MORE asinine than stuffing a woman's chest with bags of silicone gel!

-jcr

nice

[Anonymous Coward]

really nice. good to see they've got this approved. now if they could get the thing to look a bit better. maybe some gofaster stripes or alloy wheels on it would do ;]

Re:Ahem... and in some more important news:

[Anonymous Coward]

with brides worth an estimated $5 million

Damn, those are some expensive women. Apparently Microsoft is "diversifying" their business quite a bit.

iBot is the first step.

[Cappy Red]

This is but the first step on the way to making giant robot anime a reality.

I wonder if I can mod this thing into a gundam... or better yet a megadeus.

*honk*

Re:iBot is the first step.

[Mark Programmer]

It's a good first step... ... next, it would have to know kung fu.

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:Compare this to the Segway

[Frambooz]

"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."

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

[cscx]

Actually the wheelchair has been around for quite a while, but it was just pending FDA approval. I got to see a demo of this wheelchair... pretty neat stuff.

Re:Compare this to the Segway

[thejuggler]

I personally saw a demonstration of this wheel chair in 1999 at Epcot Center. iBot could not be tipped over. The guy doing the demonstration gave the iBot a full on body check, knocking it almost 10 feet across the stage, but it never losts its balance. It is a real invention with a real use. This is where the Segway came from. The FDA has been dragging its feet in approving the iBot for use. My guess is the Segway was created to get public attention about the self balancing technology and to light a fire under the FDA. The Segway is nothing more than a segway from wheel chairs to the iBot.


I wanted to get a cool signature to put here, but they where out.

Re:Compare this to the Segway

[ckaminski]

Yeah, but was someone sitting in it at the time? Quite a bit more difficult, I'd expect, than an empty chair.

Re:Compare this to the Segway

[Anonymous Coward]

Wait a minute, how often do disabled people receive full on body checks anyway?

Re:Compare this to the Segway

[Anonymous Coward]

The guy doing the demonstration gave the iBot a full on body check, knocking it almost 10 feet across the stage, but it never losts its balance.

Did it fall of the stage? There are plenty of situations were it would be impossible for it to keep it's balance. You just saw a staged test.

Re:Compare this to the Segway

[fm6]

The Segway doesn't have to be Bush- *cough* fool-proof...

Actually it does. If the Segway made it too easy to fall over or run people down, it'd have no chance of selling.

Although I suppose it really has no chance anyway. Too expensive, no serious applications. (And of course there's the "save the planet from the Segway!" crowd...) The only thing it has going for it is the techno-cool factor.

Corrected Statement

[Anonymous Coward]

...but it's good to see it officially approved and available for those who need it.

Read: those who can afford it.

Re:Corrected Statement

[jez_f]

Read: those who can afford it.

read other peoples posts concerning FDA approval and health insurance.

Re:Corrected Statement

[toybuilder]

...but it's good to see it officially approved and available for those who need it.

Read: those who can afford it.

Yeah? Most technological improvements start out that way. The rich essnetially sponsors new technology (and tolerate the limitations of early generation products) which, if the technology is truly good, eventually drop down in price and becomes accessible to the general population.

You *do* use a telephone, right? And a personal computer? And drive a car (presumably with antilock brakes, and air bags)? And watch movies on DVD's? And should you ever get in an accident, MRI's are much more accurate and affordable...

*sheesh*

Re:Corrected Statement

[silvwolf]

I'm pretty sure it was the IBOT that was featured on one of the tv news magazine shows the other night.. 60 Minutes or Dateline, I forget. They said the cost will be in the $30,000 neighborhood... I was floored by that figure!

But you shoulda seen the guy that was testing it.. Paraplegic who hadn't walked in years after an injury (didn't catch the details, if they reported them). He was able to play catch with his kids, order a drink from a somewhat high lunch counter, and pick up a book from the top shelf at a bookstore. The dude was in tears over being able to do such simple, to the rest of us, things. If the "wheelchair" enables more people to do more everyday things that the rest of us take for granted, I'd say it's worth every penny.

Any videos?

[Khad]

Ok that's cool. But aren't there any videos for us to see what it really can do?

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.

FDA approval

[panurge]

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?
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

[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:FDA approval

[RMH101]

this applies to software development and implementation too. i do this for a living for a major drug company, and we're putting in a new data capture system for use in a clinical trials department. it's very, very time consuming and difficult to do this to the level of detail and accountability that the FDA requires - but this is a good thing. it *should* be difficult to get approval as you're dealing with things that have a direct impact on people - whether thru drug efficacy, or though a medical aid that could cause harm if misued.

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:FDA approval

[lovebyte]

You are right. It is a very difficult thing to know if a drug will work for everyone or for only a few people and how well it works. On top of this there is also the problem of testing combinations of drugs as some cocktails can be lethal.

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

[batemanm]

Since I'd never seen this thing in use I dug up some videos of it in use. The first two are quite low quality, the final one is a good quality.

• Movie 1 1.8MB
• Movie 2 1.8MB
• Movie 3 20 MB

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

[batemanm]

Here is a news report which has even better info + an interview with the guy that made it.

Re:Videos of it in use

[Anonymous Coward]

I can't tell you how pissed I get when someone only posts for karma whoring.

Re:Videos of it in use

[gilesjuk]

Going up stairs looks tedious and cumbersome, why can't the wheels just drive it up somehow?

Re:Videos of it in use

[Josh Booth]

Does this mean that businesses won't have to be handicapped-accessable once these get cheap enough?

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.

Re:Videos of it in use

[R2.0]

"utimate solution for those pesky barricaded hostage situations in tight urban areas"

Or mount the toys on a regular manned model. Just the thing for taking care of cars illegally parked in a HC spot.

Re:Videos of it in use

[gilesjuk]

If it had three sets of wheel with a variable spacing it could climb quite easily. Two of the sets of wheels could be on the horizontal keeping the device steady while one is on the vertical.

Re:Videos of it in use

[Anonymous Coward]

Don't get your panties in a wad because he thought of it first. I was happy to see that videos were available without having to dig through the 'net to find them.

Fun

[LiquidCoooled]

Remote Function
The remote function allows you to detach the joystick, and via cable wire connection, drive the empty iBOT(TM) Mobility System into the back of a vehicle for easy transporting.

I sense a few comedy moments exploiting THAT feature.

From a serious side, I saw a documentery a while ago about these, and the only thing about them that would make me nervous is the stair climbing and descent.

Cool

[tsa]

What an enormously cool thing! It's like a Segway on steroids. I'd almost chop off a leg for one of these!

Hefty price tag

[Florian Weimer]

According to this article, the iBot costs $29,000. Most people who would benefit from this technology cannot afford it, unfortunately.

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:Hefty price tag

[Anonymous Coward]

An unpowered wheelchair can be had for $150; an ordinary electric wheelchair is about $5500, and paid for by many insurance policies. If the insurance co's can be convinced that the increased quality of life is worth the 5x cost in the same way that power is worth the 35x cost, they'll pay.

Of course, this leaves the uninsured and HMO-bound in the cold. At some point, though, one has to admit that not everyone can have the highest quality medical care. "Good enough" has to be enough sometimes.

Re:Hefty price tag

[Tsu Dho Nimh]

"the iBot costs $29,000. Most people who would benefit from this technology cannot afford it, unfortunately."

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:Hefty price tag

[cprincipe]

Because of its ability to climb stairs, drive over rough terrian and raise a person to a standing height, it also eliminates the need for some house modifications that need to be made when someone becomes wheelchair-bound, such as building a wheelchair ramp into the house or creating a lift between floors.

Re:Hefty price tag

[jpellino]

On balance (sic) look at the cost of retrofitting a house to accommodate a typical wheelchair- stair elevators, ramps and decks, standard electric wheelchair... it's better and not much more expensive, and now it'll get paid for too.

Re:Hefty price tag

[Nick Watkins]

I actually had the pleasure of seeing Mr. Kamen do a keynote speech. He did the entire speech from an iBot. It was an amazing thing to see. He had no problems climbing the stairs up to the stage and climbing back down when done. Besides the ability to lift the user up to the equivalent of a 6 foot person, the iBot can also fit through normal doorways. As a result, it should be possible to not have to do any modifications to houses for people with wheel chairs. I would think that insurance companies would much rather spend $30,000 on an iBot than $70,000 on house modifications that will basically prevent the house from being sold to anyone else.

Re:Hefty price tag

[PONA-Boy]

This is a good point, actually. I watched an article about the iBot on 60 Minutes this past weekend and it looks pretty impressive.

Once I got over the "gee-whiz" factor of it all, I started wondering about ADA requirements and how the iBot might circumvent some of them. I mean, no ramps are needed for this wheelchair. No special accommodations (other than some extra patience to navigate with it) are honestly necessary in order to get around and live a very functional life.

Once it has proliferated into the masses, I think that technology like this will take quite a bit of bite out current legislation for the disabled. A shop owner could justify his lack of ramps and guardrails by saying, "why don't people just get those iBot thingies?".

-PONA-

Re:Hefty price tag

[timeOday]

How much do those vans retrofitted with lifting platforms cost? I see a lot of those around. I think they must be subsidized.

Re:Hefty price tag

[druske]

How much do those vans retrofitted with lifting platforms cost? I see a lot of those around. I think they must be subsidized.

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 understand that Ford is an acronym for Found On the Road Dead. So my wife and I are looking at a converted Toyota Sienna from Independent Mobility Systems. We're hoping that'll be a bit more reliable, but it'll set us back around US$40,000. Toyota's mobility program is also good for about US$1,000. Beyond that, well, I'm just hoping to keep my day job.

Stay healthy. It's way cheaper. :)

Re:Hefty price tag

[Anonymous Coward]

To keep things in perspective, that's not a whole lot more than a lot of people are paying for cars/SUV's, etc. As far as I'm concerned, if it works as advertised, people will make financial sacrifices to buy them, and I don't see why anyone would have to come up with the whole 29K up front. Also to consider is that this eliminates much of the need to remodel/revamp entire houses (or move) after someone loses the use of their legs & that can save an enormous amount of money. As far as I'm concerned, this is an amazing engineering achievement.

Re:Hefty price tag

[haut]

I have a couple friends in wheelchairs and I always forget that they can't stand up. One of my roommates is and I constantly put stuff on the top shelf in the pantry just because I forget. My neighbor is in a chair too and she doesn't use any of her upper cabinets in the kitchen. The ability to stand up will open up tons of possibilities for people that need chairs and will greatly reduce the amount of modifications a house needs. Too bad its purely electric, most the people I know have straight mechanical chairs and would never use an electric. If they could make something that climbs stairs and stands up that also can be pushed like normal (I have ZERO idea how they would though) they could help many more.

Sounds like something Apple should market...

[Zemran]

Well you can listen to music on your iPod while working on your iBook and sitting in your iBot whilst invading iRaq.

Re:Sounds like something Apple should market...

[LordSah]

And get iRate over the overuse of 'i' in marketing. I find it annoying to the X-Treme.

Re:Sounds like something Apple should market...

[dcw3]

Well you can listen to music on your iPod while working on your iBook and sitting in your iBot whilst invading iRaq.

i'Ve gotta go iNto iSolation to get away from all these iDiots before i go iNsane.

Re:Sounds like something Apple should market...

[Anonymous Coward]

Don't worry; most of it is only iCandy

FYI on FDA

[segment]

For those wondering why the FDA would have to approve the device, figured this would help. Also in Europe they have the Medical Device Directive, and the UK Medical Devices Agency

Who is watching your food to make sure it is safe? Who should be? Well, for almost ninety years the Food and Drug Administration has been charged with the task of protecting and promoting the public health. Laws including the Nutrition Labeling Education Act, Pure Food and Drugs Act, and the Food, Drug, and Cosmetics Act have shaped the way the FDA operates, outlining an agency which has jurisdiction over the approval of food additives (Delaney clause), biologics (prescription drugs), medical devices, and cosmetics produced by manufacturers for the United States market

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. IE, say XFOO Corp. has some Cancer drug that works and the developers spent some couple million on it.

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

Re:FYI on FDA

[HBI]

Corruption is almost unknown in the US Government. Yes, I work there. Why is it unknown?

Fear.

There are just too many people watching in most instances, and corruption *will* get you a long trip to an ass-ramming federal pen. Besides, government workers are dweebs. Anyone with enough smarts to pull off a good extortion racket wouldn't take the job, the pay is too low.

And before you ask, i'm a contractor.

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:FYI on FDA

[bjelkeman]

Corruption is almost unknown in the US Government.
You mean "direct corruption" such as money paid under the table to some anonymous official to get something passed through the a legal process. That is probably because the people who really need to corrupt the government in the US has invested in the highest level of government instead. They own the president and the congress, legally. Why would they bother with bribing people then? Much better to fire of another million to the appropriate lobbyist.

Watch the results: Clinton's public health care bill killed in the cradle, gas guzzler tax on SUVs abandoned, healthy eating habits information from the government suppressed. The list goes on.

It's institutionalised corruption.

(And yes, it is off-topic. :) )

Re:FYI on FDA

[hey!]

Why do they place so much power i none agency is beyond comprehension

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 that make it possible to provide government services without corruption. </clue>

Re:FYI on FDA

[Anonymous Coward]

Why does they entrust so much power in the FDA? Because the FDA has been trustable. It has one purpose and does it well. It may be the premier medical approval board in the world, as it's surely one of the most conservative. Basically, if you can get FDA approval, you're golden.

Re:FYI on FDA

[MarkGriz]

"Well, for almost ninety years the Food and Drug Administration has been charged with the task of protecting and promoting the public health."

Now if only they would start regulating herbal supplements, maybe we'd see a reduction in the herbal viagra/penis enlargement spams.

Re:FYI on FDA

[gobbo]

No, it's actually relevant to the topic to mention that the FDA's approval process, while unlikely to be influenced by direct corruption (e.g. bribery), is likely infected with institutionalized corruption in the far subtler but far-reaching form of golfing-buddy favours and the old game of hiring the right people.

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 found wherever there is employee movement between industry management and government. "It's no longer a conflict of interest if they don't work there, is it?"

The current administration's foreign policy seems to circle around oil-rich regions. Any surprise that they're almost all former oil execs?

Re:FYI on FDA

[hellfire]

Corruption is almost unknown in the US Government.

HAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHA!!!!!

*wipes the tears from his eyes and gasps for breath*

Thank you... I needed a good laugh today.

Re:FYI on FDA

[RealAlaskan]

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. IE, say XFOO Corp. has some Cancer drug that works and the developers spent some couple million on it.

Now say employee John Foofxr decides he wants someone to pay him some serious moolah to have this drug approved.

That's awfully blatent, and would get old John a long vacation at club fed. That kind of thing just isn't going to happen.

THIS is how the ``bribes'' happen. If you are a high-level bureaucrat, you can have a little talk with the executives at a company whose new drug you are tasked with approving. You mention that you'll be retiring soon, perhaps in a year or so after you've concluded their case. They reply that they really need someone who's experienced with dealing with FDA bureaucrats, to act as liasion with the agency (or experienced at dealing with Congress, to lobby for them, or ...), and would be interested in hiring you. You reply that you will certainly contact them when you retire. No money ever changes hands, but if you really want that cushy job, you make sure their drug gets approved.

There are some very real problems, with the FDA and government agencies in general, and you've missed them all. Two examples:

A real problem is that the FDA bureaucrats have nothing to gain by approving a drug, but a great deal to lose. If an FDA bureaucrat approves a drug and it turns out to be another thalidomide, he's in BIG trouble. If he approves a drug, and it turns out to be a side-effect-free cure for cancer and the common cold, he gets absolutely nothing. Thus, the bureaucrats always want one more round of tests, and people die waiting for safe, effective medicines.

Another big problem is regulatory capture, a natural process in which the regulated and the regulator talk only to each other, and the regulator eventually winds up siding with the regulated. We see this in action in US government when industry insiders are appointed to head the watchdog agencies for their industries, and when upper-level bureaucrats retire from Civil Service to take very high paying, low stress jobs in the industry they regulated. The result is that the FDA protects the pharmacutical industry at least as effectively as it protects us.

One example of how the FDA protects the industry is their enforcement of monopolies. No drug can go to market unless it is patented, because no drug can go to market unless someone has spent tens of millions getting the FDA's blessing. If someone were to find that an unpatentable combination of eye of newt, hair of bat and toe of frog cured cancer, the FDA would never approve it, since no company would fund the tests. Doctors would never hear about it from the drug company salesmen, so most of them would continue prescribing the current slash-and-burn therapies, which are sometimes worse than the disease. This hypothetical free, safe and effective therapy would never become available to most Americans, even if the research were published in JAMA and Lancet.

Cost...

[md81544]

Does anyone know how much one of these costs, approximately?

Re:Cost...

[batemanm]

It is expected to be around $29,000.

Millions?

[EnglishTim]

At the kind of price it'll be going for, I think the number is probably closer to a few thousand...

Tranny?

[Anonymous Coward]

Does anyone else think the guy in the wheelchair on the iBot page (linked in the article above) is the same person as the women to the left on the iBot page? Their faces are strikingly similiar...is it just a coincidence?

Re:Tranny?

[louferd]

Yes, the first thought that crossed my mind was "for the amount they're charging for it, you'd think they could pay more than one model."

boxing?

[hangingonwords]

Maybe if Rocky had one of these way back when he wouldn't have had to run up all those stairs.

More on FDA

[segment]

(source for this doc)

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

[mothrathegreat]

Now all that remains is for George w Bush to fall off it and the federal government's work here is done

Re: Presidential Testing

[Jackdaw Rookery]

Oh c'mon, be serious. The President is a person of dignity and intelligence; they would have the common sense NOT to hop onto some weird device and make an ass of themselves.

*cough*
http://www.usatoday.com/money/industrie s/technolog y/maney/2003-06-17-segway_x.htm
*cough*

Exercise

[RupW]

Could you redesign this with a manual push mechanism? Neat though this is, if I were disabled I'd prefer to push myself. Mostly for exercise - I'm young, why let the rest of me rot? But also in case of mechanical / battery failure, etc.

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

[mikeophile]

The gyro technology that is used in both the iBot and the Segway don't keep the device balanced directly.

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

[YrWrstNtmr]

Here's a novel twist on a wheelchair that provides a little muscle movement. Some future iteration of the iBot could be pedal powered when on level ground, and go into gyro mode for more strenuous movements.
EZ-Chair

Re:Exercise

[jandrese]

Uh, I think there might be a problem making a pedal powered wheelchair... If you're thinking it might have something to do with the owners not having use of their legs you're on the right track.

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 (I'd rather not get caught in the middle of a long staircase with no power for instance).

Re:Exercise

[Mistah Blue]

My son's power chair (not an iBot) has two levers at the front wheels that can be used to disengage the drive train so you can push it. However, that is not something you are going to want do for long distances as his chair weighs 200 lbs. I would imagine the iBot's weight is in this neighborhood. I only manually push it to park it (sometimes).

On a lighter note, when we got his chair we were playing with it. It has a joystick on the back for adults to tilt it/drive it. We also have a remote control to shut it down if he gets in trouble or is acting up (let's driving for a wall). I'm the only one who can drive the joystick (all those hours playing video games pay off in the real world :-)). My wife and her parents have trouble using the joystick.

Re:Exercise

[YrWrstNtmr]

A pedal wheelchair might be valuable for a variety of reasons. People that cannot walk/stand for long periods of time, people with balance problems, people in recovery.

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 functionality.

Re:Exercise

[xerx]

Some type of hand operated recharger could be added to recharge the battery adding an exercise benefit. It could even be used while the chair is not moving. Could also be an add-on allowing for different devices designed for specific abilities.

I for one welcome our new Dalek masters....

[Channard]

.. because if they ever get their hands on this technology, we're up poo creek without a paddle - no longer will stairs be an adequate Dalek defence.

Re:I for one welcome our new Dalek masters....

[Anonymous Coward]

In Remembrance of the Daleks they have a levitation feature that lets them glide up stairs.

OK up to a point

[R.Caley]

But it looks to me that if you had battery probems you would be fucked. Any of us who ever had a laptop battery unexpectedly die will know how the unierse punishes reliance on that kind of technology.

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.

Re:OK up to a point

[MikeD83]

If you'll notice in the video posted above the user should always hold the stair rail. Or have another person hold the handle next to the head restraint.

As far as losing power while going down the stairs. If you notice the person leans very far back. I bet the motors are so geared down that the machine will slowly creep down the stairs on it's own. At that point you may be lying on your back while going down the stairs- but at least you didn't fall down the stairs.

Of course, there is also a battery indicator right next to the joystick. If it was telling me I'm extremely low on battery power, I wouldn't want to attempt the stairs anyway.

Re:OK up to a point

[R.Caley]

Of course, there is also a battery indicator right next to the joystick. If it was telling me I'm extremely low on battery power, I wouldn't want to attempt the stairs anyway.

And those things never lie:-)

As I said, I presume the thing is failsafe, what would worry me if I needed and used one would ending up stuck somewhere with a low/empty battery. Not dangerous, just embarassing and/or inconvinient. Such things are important in what is intended to be an enabling device.

To some extent a traditional wheelchair allows someone to use their arms in place of their legs. This device however in some sense replaces their legs. This means the user is much more technology-dependent.

All I was really saying was that it would be nice if there was some way in which (some of) the good features of this could be available without the total reliance on technology.

Same Chips as the Segway (FYI)

[polyp2000]

In the UK we have something called the "Tommorows World" roadshow, kinda like a since exhibition on wheels!
They were showcasing this thing . Apparently it uses the same "Silicon" gyroscope technology as the Segway!

Re:Same Chips as the Segway (FYI)

[TapTapTheChisler]

Not surprising, considering the Segway and iBot were invented by the same person.

Re:Same Chips as the Segway (FYI)

[polyp2000]

This might be knowledge to you, but is it common knowledge to everyone else :)

This device is truely amazing

[jeffkjo1]

The iBot is a truely amazing piece of equipment (and its self balancing device is borrowed by the Segway Scooter.)

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.

Videos from NBC's Dateline

[Anonymous Coward]

http://www.msnbc.com/news/950639.asp

Wasted of time, it will be out of reach ...

[Anonymous Coward]

the people that need these wont be able to get them anyway on state healthcare, NHS is a joke, dont expect to get one of these anytime soon as they will be overpriced like all the other machines.. Think MRI, unless yer dying forget it.

Its priced out of reach of those that need it.

Re:Wasted of time, it will be out of reach ...

[chiph]

Its priced out of reach of those that need it.

I'll probably marked as a troll, but in the interest of getting this predictable sub-topic out of the way:

Why don't you save your money up and buy one for a handicapped person or two? That way they won't have to wait for Medicare/Medicaid or their private insurance to buy it for them.

You'll get a really nice tax deduction for charitable donations, too.

Chip H.

NBC's Dateline Videos

[Anonymous Coward]

Dateline Videos

This was the real purpose of the Segway

[John Harrison]

IBot will be a huge seller. The government will bear much of the cost as doctors will prescribe them and they will be covered by Medicaid. The approval process has been long and slow. The Segway served to generate public interest in the technology and get people used to it. If it weren't for awareness of the Segway and how safe it is touted to be it would have been harder to get approval of the IBot. You think the Segway is expensive, wait until you see the sticker price on these things.

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

[Anonymous Coward]

I doubt it. Are you implying that Kamen spent millions developing the Segway only to promote the already-invented iBot? That's ridiculous. What did the Segway show that the iBot didn't? I've seen demonstrations of both, and in my mind the iBot was way more amazing than the Segway.

Re:This was the real purpose of the Segway

[druske]

"IBot will be a huge seller. The government will bear much of the cost as doctors will prescribe them and they will be covered by Medicaid..."

That'd be nice, but I rather doubt it'll be easy to get these expensive monsters approved. My wife has a rather simple electric wheelchair with a joystick control, and even that cost US$8,000. It took me a good bit of arguing with our HMO to get it covered, too, back in the days when my employer's health plan was worth something... these days I'd end up paying most of it out-of-pocket. With luck, it should be another two years or so before it needs to be replaced.

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:This was the real purpose of the Segway

[Anonymous Coward]

no it will not be that popular. This is only for rich folk, not for the masses. The easier solution would be to make places more accesible.

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.

Just Curious..

[dirtydiaper]

Has anyone been on a segway or one of these.. I am curious as to what the feeling is like? Is it really weird to start? Or is it really comfortable of the get go?

Re:Just Curious..

[Monty67]

I have not but I did see the Dateline/20-20/Can't remember show. A number of people where choosen for testing and the reporter, also in a wheel chair, where followed around while they tested and got used to it. One of the testers, a father of two boys raised the chair up on two wheels to play catch with his sons, you could see it in his eyes how much this new chair meant to him.

As to how it felt, I'm guessing very empowering. The guy couldn't thank Dean K. enough. A from the look in Dean's eyes, he just got paid in a way money could never match.

Re:Tears

[Anonymous Coward]

So, you take off someone's trousers in a public toilet and then bask in a warm "glow". I don't know, but that paints a pretty disturbing picture to me *shudder*

USA only, why?

[jez_f]

Just a bit curious, I live in the UK and know someone who may be able to make good use of one of these.
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?

Re:USA only, why?

[g_attrill]

There's a nice review by a fan in the UK here - he read about it and got a director of the company brought one to round for him to play with.

We can hope that the mass-production of Segway (it it ever happens!) will help reduce the production part of the price tag.

Gareth

Re:USA only, why?

[babyrat]

it would likely have to be approved by the equivalent of the FDA in other countries as they are marketing it as a medical aid.

Does the iBot incorporate a video camera...

[PiscoX]

... so that grandpa falling down the stairs in his new mobility device can be sent to funniest home videos?

Tears?

[bigboard]

It literally brought tears to my eyes

Perhaps you should try adjusting the seat properly.

Re:Tears?

[sharkey]

Perhaps you should try adjusting the seat properly.

Maybe it's like the seat in Mr. Garrison's radical new personal transport.

Re:Tears

[i_zarf]

Your words cry out with pain that I cannot imagine. Many of the replies here do not fathom the wonderous achievement this medical device gives the disabled, and yet it would be simpler if we all just, "Loved thy fellow man" to find the joy it brings in helping another.

Reading through the comments

[dodell]

I see that many people are concerned about what happens when this thing falls down. This is not a new invention. It's been tested thoroughly for the past several years and has not fallen once yet. This is not to say that faulty manufacturing could not contribute to this happening, but to give you an idea, I saw a program where someone sat in one of these things and wiggled around like a madman. It stayed up.

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.

Where do I sit?

[PygmySurfer]

My iBot doesn't have a seat.

And in other knews

[Anonymous Coward]

Apple sues to have the device removed from the market due to the use of 'i' in front of Bot, which might confuse consumers into believing it to be an Apple productt.

You jump to conclusions, grasshopper...

[Mark Programmer]

They're quite interested in the rest of the world. You can find the European-targeted website describing the device here. I am quite surprised that this website claims it is not yet available in Europe, however; I was under the impression that the iBot had already been cleared for the European market. It's on its way as soon as the FDA-equivalent organizations clear it, I would surmise.

I will echo your concern about the design of the website though. C'mon, if you're going to put an American flag at the bottom of your site, and you have a European site, make the flag hyperlinked!

iBot

[DeepDarkSky]

If Dean Kamen were to keep up this line of naming and also keep up the pricing on the product he produced, Steve Jobs will have to buy him out one day just to have the whole collection of high-cost iThings(tm). To bad he didn't name the Segway something like iWalk/iRide/iRoll.

Nothing yet..

[tprime]

Sorry, this really isn't a big deal yet. When the insurance companies, ESPECIALLY MEDICARE, pay for this under their coverage I will be impressed. For now, it is a great tool with incredible potential for helping disabled people. Most people who will need this will not be able to foot the expense to use them.

Where have you been?

[Illserve]

Obviously you haven't been out in the real world for a few years.

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.

Re:Where have you been?

[TMLink]

Obviously you didn't read the previous post.

His concern was not the wheelchair losing power at any old random time...he was concerned of it losing power while it was balancing on only 2 wheels, causing it to topple over and throwing the user into the ground. Valid concern, though I seriously doubt it would have gained FDA approval without having failsafes preventing that from happening.

Good investment for society

[bjelkeman]

If you have someone who seriously needs one of these to be able to work, then it is a good investment for society to give them outright to the person. You will easily make back that money in tax revenue from the person as well as increase the person's self esteem enough that social problems in the family etc. induced by depression are much less likely to happen.

Amortizing fixed vs. variable costs

[hey!]

I wonder whether the hefty price tag is based on short production runs recovering the hefty $150mil R&D price tag. The unit costs might not be so bad, especially if the production run could be made enormous.

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 not be much more expensive to simply buy one of these devices for every paraplegic in the country. This would afford them mobility everywhere, not just on non-exempt buildings.

Also it would be fairer to business owners, since it would not discriminate against those who happened to buy buildings before ADA that wouldn't meet the future regulations.

iBot? iMac?

[axxackall]

Does iBot require an account on iMac as many other iApps?

In the end, more significant than the Segway

[NecrosisLabs]

Although Kamen had been working on this since before the Segway, I think this will have a greater impact. The Segway, let's face it, it an interesting toy that targets a pretty narrow niche. The iBot, on the other hand, will vastly improve the quality of life for a large number of people.

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

[Capt_Troy]

I totally agree. Using the tech prototyped in the Segway for something that can actually provide a meaningful use rather than a symbol of vanity and dorkyness (IMHO).

My faith has been partially restored. now let's see if we can get that price down so people can buy it...

cnn

[arban]

This was a short CNN news blurb on the tube this morning. What I found interesting was that they did not even mention Dean Kamen or Deka Research, nor did they even say "from the creator of the Segway".

Watch out for Bananas

[digitaltraveller]

This is a great invention by a cool guy. It does have it's engineering flaws though. To work it must rely on friction that may not always be available. I doubt that it has a rocket and parachute ejector system in case the balance system fails. I am sure that Dean did his best to mitigate the risks though.
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 solution that served us well but was quickly obsoleted.

Re:Watch out for Bananas

[kleine18]

also, dont forget it requires gravity to work to.

Re:Compare this to the Segway-3 Wheeled?

[DrWho520]

I thought I saw a three wheeled version of this device that climbed stairs, but held the user in an upright manner. The three wheels were arranged in triangle and I do not remember the device needing any interaction with the user to fascilitate stair climbing. Anyone else see this?

Before you start weeping uncontrolably....

[tbase]

It literally brought tears to my eyes seeing what it will mean for millions of disabled people around the world.

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....

[CharlieG]

As MANY other folks pointed out - the reason for the approval process, and the MD prescription is simple:

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, it cost us $10

Re:Before you start weeping uncontrolably....

[Mistah Blue]

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....

[tbase]

Yes, and therein lies one of the major problems with Healthcare in the U.S. My neice had 2 identical proceedures done over the course of a little over a year. The first time she had insurance, and the second time she didn't. You would be amazed at the difference in the bills when they know they're getting paid by an insurance company. When you consider the insurance premiums, the out of pocket was actually less without insurance.

As long as the insurance companies blame the overpriced hospitals, hospitals blame the uninsured and malpractice suits, and everyone blames the lawyers, it's the consumers who are left holding the bag.

People who have insurance don't mind getting billed $30k-$40k for something that should cost maybe $10k, because they think the insurance company is paying for it, when in fact it's the consumers who pay for it with their outrageous premiums. You don't see a lot of insurance companies filing Chapter 11, no matter how much they pay for an asprin.

Re:Before you start weeping uncontrolably....

[CharlieG]

I agree - your right, but that's the "system" - so when you see $35k for a wheelchair, remember we are talking "the system"

Re:Before you start weeping uncontrolably....

[tbase]

I seriously doubt that your son's chair costs any more to manufacture or has any more expesive parts than this chair (I know it's probably a totally different design, but I'm sure it uses the same motors and controls), which lists for just over $6000, and sells for under $6k. It's certainly not your fault, you don't have a choice in the matter. But if there was a cap of say 300% or even 400% profit on products paid for by insurance companies, maybe our premiums would go down. Or maybe insurance companies would just make more money. I'm just saying this chair sounds just like a $20 asprin at the hospital. But then again you could argue that people wouldn't come out with innovative products like this if there wasn't such a huge profit potential. Ok, now I'm debating myself, so I'll just stop now :-)

Re:Before you start weeping uncontrolably....

[tbase]

Yeah, you're right. The scary part it's the same system that makes treatments more profitable than cures. And those profits buy a lot of really good lobbyists, and really bad politicians.

Re:Before you start weeping uncontrolably....

[Mistah Blue]

Not arguing with you, but I think the costs start to ramp up on the accessories (seats, headrests, footplates). So, depending on your muscle control (which my son has little of - he has low tone) determines what you need. We are getting a new seat for his manual chair and that is costing around $1400.

I agree on the costs though. This stuff is very expensive. I don't know if that is because of insurance (my gut says it is, you price for what the market will pay), low volume (however, I don't think wheel chairs are a low volume business), government, or what. All I know is that it is very expensive to have a physical disability that requires equipment to help overcome (e.g. wheel chairs, standing frames, bath seats, etc.).

Apple Law Suit

[suckass]

Okay, so how long will it be unitl Apple sends them cease and desist letters for trademark infringment because they used the "i" at the beginning of the product's name?

"What walks downstairs, alone or in pairs..."

[Insightfill]

"and makes a slinkety sound?"

My 3 year old just got one of those and we're all still singing the song. Love that song.

(No, not an iBot.)

That will happen

[Anonymous Coward]

In a couple years when the iBot Type R is introduced.

You insensitive clod!!!

[tundog]

You insensitive clod!!! I 'dont have legs!

Segway

[tundog]

Is it just me, or is anyone else experiencing segway sightings? I saw two here in town within a two week time frame. (1 looked like a knock-off tho).

I saw Dean give a talk at MIT about a year ago and he did the whole thing while standing on a segway. Seemed like the most natural thing in the world.

Re:Compare this to the Segway-3 Wheeled?

[atrizzah]

I'm pretty sure this is the same device. The 3rd set of wheels is on the front of the thing, and the back 2 are used for climbing

Wired Remote? Why?

[alta]

They mentioned using the wired remote to navigate the chair into the back of your vehical. Now this sounds kinda stupid because since it's wired, what do you have to do after you get it back there? Walk to the back and do something with the remote. Am I not reading this correctly. The feature sounds like, 1. I ride up to my door, 2. Climb in the seat, 3. Reach down and grab the WIRED REMOTE, 4. Navigate the chair to the lift at the back, then what do I do then? I'm stuck with a joystick that's wired to the backof my vehical??? Am I supposed to walk back there and put it up? Get a friend to do it? Not even use that feature?

Re:FDA Scope

[brokeninside]

Chapter 5 of the federal food, drug, and cosmetic act gives jurisdiction over enforcing regulations concerning medical devices to the Secretary of Health and Human Services. The Secretary of Health and Human Services originally decided to combine enforcement of these regulations with the FDA. This decision was cemented in the FDA Modernization Act of 1997 which define the mission of the FDA in part as (emphasis is mine):

With respect to such products, protect the public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labeled, and; public health and safety are protected from electronic product radiation.

Perhaps the real question should be: why is the agency named the FDA instead of being given a broader name that more accurately reflects its mission?

Kind of defangs the ADA

[russotto]

Businesses being sued on the one hand to do $30 zillion in renovation to accomodate handicapped employees and on the other by the preservation commission not to modify their facade could just buy these and provide them to any handicapped employees during the term of their employment.

oh, please

[Jeppe Salvesen]

this is not an inherently super-expensive product. it will eventually become somewhat reasonable.

however, the patent system will probably keep it expensive for longer than it should be..

Re:oh, please

[HiThere]

This is actually the kind of device for which patents are probably reasonable. The cost of development is not small, especially when you factor in the additional cost of getting FDA approval (which also cuts down the amount of time when the patent is valuable).

The patent system is so broken that we would be better off without it, but this is one case where it appears to be being used as it should be.

$29,000 is the cost

[spineboy]

Actually, that's cheaper than many other existing wheelchairs (WC) that are out there already which cost around 35K. But these are often, but not always, the one's that are usable by people with upper extremety disabilities - joystick, sip and puff controls by your mouth... Medical devisec aren't cheap.

Portable infusion pumps

[spineboy]

That's how he started, by inventing a small easy to use/cary infusion pump. Good for people on chemo, who need insulin infusion, etc.

I too welcome our new Dalek masters....

[mikeee]

...and I'd like to take this opportunity to point at that, with my excellent slashdot karma, I'll be invaluble in rounding up geeks to work in their code mines.

I have a much cheaper solution

[teamhasnoi]

I prefer to have a MSCE carry me around. Their minds are quite malleable and are easy to train and control. Best yet, they can bring me a beer, which is the test of any fine robot.

Drug/Device approval costs ALOT of $$$

[spineboy]

Don't forget that alot of countries have their own version of the FDA. Japan has their own and can tend to be isolationist. Europe is moving towards a unified agency. Many small countries save cost and just approve/disapprove whatever the USA or other large nearby country has already reviewed.

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.

mod parent up

[dodell]

This is a more accurate description :) Thanks for correcting the technicality, I couldn't remember exactly what it had to do with. The deal was at the time a whole ton of equipment was needed for this and it wasn't practical for patients to leave the hospital while undergoing this sort of treatment. He was a huge pioneer in this feild.

If only...

[piyamaradus]

If only the Daleks had been built like this...the universe wouldn't have been saved by a flight of stairs.

I doubt the battery endurance

[mnmn]

Considering the size of the motor+battery on that thing, I doubt the battery on that thing lasts more than a toshiba Athlon laptop. After all beside moving the person around, it can lift him/her up a flight of stairs, heavy on the battery.

With a different view, if that battery lasts more than 10 hours with that kind of work, why arent laptop manufacturers using it?

Possible trademark infringement?

[Anonymous Coward]

http://www.orangemicro.com/ibot.html

Re:Exercise (iGlide)

[GarthSweet]

Check out the iGlide which is likely more what you are thinking of. Check out the videos of it in action (no sound).

http://www.independencenow.com/iglide/index.html

-- From the web site --
Get a boost

Imagine being able to go further and keep going
longer, all with the same effort. The
INDEPENDENCE iGLIDE Manual Assist
Wheelchair is a brand new category in high-
quality wheelchairs. The iGLIDE
Manual Assist Wheelchair is designed
to supplement your own natural effort with a
smooth, motorized motion. We call it "Manual
Assist" because it puts you in control of
your motion, and gives you a boost when you
need it. In this way, it assists your own
manual effort by gently propelling the chair
using a small, tucked-away power source and
a "smart" microprocessor.

Now you can enjoy amusement parks, long trips
on the boardwalk, and rolling hills... you can
move over grass and carpet...all with the same
effort. All thanks to the advances found only
in the INDEPENDENCE iGLIDE Manual Assist
Wheelchair.

Truly, not truely

[Anonymous Coward]

Duh

Remote control?

[Dexx]

Was anybody else wondering about the remote-control aspect of it? How does it link up? Can it be hijacked?

Re:Remote control?

[kleine18]

it is wired, not wireless.

Name Collision

[Soong]

A previous "iBot"

c'mon people. Google search before you name your product.

Nice

[SeJo]

This is indeed a very good device... I know some people close who would enjoy having the iBot... Hopefully they will be available outside US soon... great job

Money mis-spent on wheelchair ramps

[dzelenka]

You've pointed out something that I've thought about for years. What if all the money used to make our curbs and buildings wheelchair accessable was spent developing wheelchairs that could deal with curbs and stairs? We're talking about billions of dollars of curb cutouts, ramps, wheelchair lifts, etc. This chair could reverse the trend.

They have a few at Disneyland..

[delus10n0]

If you ever want to see this thing in action, go to Disneyland. Outside of Innovations they usually have a person standing there with the iBot, and showing off it's different modes. They won't let you ride in it, though, because it has to be specifically calibrated for the person riding on it. It was pretty slick, seeing it transform from a four wheel model, rising up a few feet higher and then balancing on two wheels, with a flick of a button.

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.

Cost

[Synn]

Assuming that anyone who uses a wheelchair could eventually make use of this technology, I wonder if it would be cheaper to society to just give everyone who needs a chair one of these things(or something like it) instead of trying to make all buildings/areas wheel chair accessible?

The next version

[Generic Guy]

I hear that the next upgraded version will automatically interface with ATMs and other electronic devices.

... It'll be known as the eBot!

(Okay, okay, I can't believe I actually typed that one in but enough already with the crazy Apple-based lemming naming conventions.)

Re:Pay for it YOURSELF.

[Anonymous Coward]

you are a twit that does not belong in a SOCIETY.

part of society involves taking care of those who are unable to. ie disabled people, the elderly etc.

get over it, get used to it. but hey maybe you could qualify. stupidity is a learning disorder isnt it?

It literally brought tears to my eyes..

[LifesABeach]

next time, step out of the way of the wheeles. :o)

Re:Pay for it YOURSELF.

[angus910]

While I typically feel the same way about a lot of things (welfare has always been my main beef), I feel that helping those with physical handicaps is a decent use of taxpayer dollars. Many people that have physical handicaps have difficulty getting jobs, and when they are able to find them you expect them to sink another 15-20k on a wheelchair. I don't know about you, but I know that my budget wouldn't allow for another expense like that. So, then if you don't have a job, and have difficulty getting one how are you supposed to pay for mobility? And if you can't be mobile, how can you get a job? It's a catch-22. This new chair, while expensive, should allow those who are fortunate enough to get them more mobility it will hopefully allow them to possibly even find better jobs which will put more money back into the tax system which eases the burdon on everybody else. Now, if we could only get Yoda's little hover chair...

Re:Pay for it YOURSELF.

[Night0wl]

Wow, this is one of the lowest posts I've ever seen on slashdot. It's a new record for me.

Tell me, how exactly am I supposed to save money for one of these things if I can't work a normal job? I can't flip burgers for McD's, I can't sweep floors at Safeway. And without a chair I couldn't get into some office building to type, being that I'm computer savvy.
Do you realize that the price of a manual chair is also not cheap? So the price of one of those is something I'd have to save up for as well.

Not to mention the fact that without an electric chair I have *NO* method of getting any where in my house let alone life.
Oh and sure, Mom and Dad can help you save up money, Easy right? Except for the whole aspect of daily living, and what about low income families? Families living from paycheck to paycheck, who are strugling to live in America? Disabilities have no money prerequisits, they'll cripple any one from the rich kid to the poor kid, to the homeless kid.

And it's not as if you're the one who's fronting the bill entirely, it's not a large some of money from your paycheck going to one crippled kid who has a hard time with the basic functions of life, like breathing.
There are far fewer disabled people then there are able people, every one pays taxes. A majority of your money isn't even reaching the disabled people, so trust me, you're not helping us one bit.

Yeah, I'm thankfull for my wheelchair, I'm glad there's a system out there that helps provide funding to cover these things. Because with out it I would be forced to live my life in a bed with only my mother to bring me food and help me live my life.
With out my chair I wouldn't know the things I do, I wouldn't have gone to school, I wouldn't have learned what I know about computers. I wouldn't be here for you to be a blind fool towards.

Yes this is a heated reply, but every time slashdot posts something about disabilites, cost will always come up, and there's always some asshole who thinks he shouldn't have to pay taxes and support his countries people.
A country which provides him freedom and safety, and the right to post on slashdot like a jerk. If you don't want to support your country, and your countries people, get the fuck out.

its actually pretty cheap.

[rebelcool]

Medical equipment is outrageously expensive - a similar discussion on FARK had one wheelchair bound participant in a fairly ordinary powerchair who had spent $17,000 on it, and then another $4,000 for a ventilator. There are powerchairs which retail for more than this one.

Legs vs. Wheels

[Anonymous Coward]

I just wanted to relate a story about my Dad.

My father contracted polio at the age of 9 and lost the use of his legs. Being a farm kid, he refused to accept a wheelchair, and instead used heavy iron leg braces and crutches to get around for his entire life. He never experienced many of the limits that wheelchair users do, and I admit, I was proud of the determination and sheer force of will he showed every day. He would use his entire upper body and propel himself up flights of stairs, step by step, sweating, straining, but never complaining. As a child, I sometimes would look at the occasional person in a wheelchair and think, "Why don't you just get up and use your muscles like my Dad? You must be lazy." Then I tried spending a day like my Dad, using only crutches to get around, get up from a sitting position, get up stairs. I was 17 and it was completely exhausting. I realized not everyone could do this.

Eventually, like all of us, my Dad got older. Using crutches all his life was very hard on his body. My family worried about him falling, but using a normal wheelchair was unthinkable to Dad. He wouldn't accept not being at face level with other people, he wouldn't accept not being able to walk through the woods or go hunting, and he wasn't going to remake his entire house just for a stupid wheelchair.

One day, our worst fears came true. Dad slipped, fell down, and the iron braces twisted his legs and tore into his skin. He didn't let on to the rest of us how badly injured he was until weeks later, when the pain and infection got so bad, he had to be rushed to the intensive care ward of the hospital. He had taken so many Advil for the pain that he'd destroyed his stomach lining, and was throwing up blood. The doctors tried to save him by operating on him, but his body was too weak to recover, and a month later... he died.

I know if Dad had had access to the iBot, he would still be around today. It would have given him the security and rest he needed, without sacrificing the freedom he treasured so much. Instead of feeling demeaned by sinking into a wheelchair, I know he'd have been charmed by the sheer gadgetry of it, and amazed by all the things he could do so much easier now. Kamen changed the fundamental nature of the wheelchair, and by doing so, he will end up changing -- and perhaps even saving -- the lives of thousands of people. The iBot is a Big Deal, and I only wish it'd been around a decade ago.

Re:Legs vs. Wheels

[Anonymous Coward]

Truly an American icon.

The battery is huge.

[rebelcool]

Both batteries weigh 10.5 kg. I don't think id want a laptop that uses that.

Good page with specs

6-legged walker...

[Anonymous Coward]

would be way more fun than clunky wheels!!!

Re:Pay for it YOURSELF.

[Xerithane]

I want the justification that I or any other person should pay for YOUR wheel chair, let alone one of these damn over expensive machines destined only to be viable businesswise at the expense of tax payers.

Her'es your justification: If anything happens to you, you get money to. Social Security, that's what it's there for.

Put yourself in a similar situation, wouldn't you like to have aid because you can't pay for it? Do you have any idea what actually goes into making a motorized wheelchair? Go down to an electronics store, and just start pricing out the controllers and motors, then stabilization, and design. Then try to make something that is comfortable enough to sit in for say, your entire fucking life.

The innovation is a great thing, its just that the "entitlement" process is so over blown in this country that I know I will be paying for many of these things, even though I have no use for one, and there is little or no justification for others to have one; especially when good old fashioned chairs work fine.

Hey sparky, unless you are making a six figure salary, your taxes barely cover your living expenses. Thank the rich folks for his wheel chair, otherwise you are just taking credit for what other people do. Ironically, that's what you are blaming him for.

Your a great example, oh your burden is so hard, having to go through that long drawn out process to take my money. So much easier than saving the money and paying for it yourself.

I'll tell you what. Let me break your break so that you have similar mobility to him, and then I'll see if you can make $15K on your own in 5 years. If you can, I'll give you $15K. Sound like a deal?

Ramps are expensive!

[Anonymous Coward]

I am in the process of buying or making a ramp to enable a disabled relative to more easily visit our house. Most portable ramps (aluminum) appear to cost around $100 per foot, and the ADA insists upon a maximum pitch of 1 on 12. For our 24" step, this is a $2400 dollar ramp. Even making it out of wood will cost hundreds of dollars & take a significant amount of time. Imagine redoing an entire house!

Total costs...

[Anonymous Coward]

Never mind the fact that this thing would be covered under health insurance...

This device would eliminate the need for wheelchair elevators in vans (simple stairs will do), ramps in the house, and numerous other modifications in a house that would have to be done to accomodate somebody who would otherwise need to access everything from a sitting position.

Now... do the math.

I agree

[Tharn]

I'm not even going to read the responses to this one as I am sure you are an "insensitive clod" or maybe even an "evil, right wing prick". Whether they like it or not, you are right (and especially about the "point of a gun" business. That is not to say that I would change the situation since I don't want the "disabled" any more disabled than they have to be (they can ALSO pay taxes!), but fundamentally, you are correct (in case solidarity means anything to you).

Physician prescribed saves costs??

[bl8n8r]

what a bunch of Horse##it.
The "companies" will rule this just
like any other "Physician Prescribed" consumer
product.

They will bilk the insurance companies for billions
of dollars for these things as disabled people
clamor to get their I-bot.


- The inventor will make his millions
- The "*.companies" will make their millions
- We will fund the whole thing through our health care costs every week.

Hate to rain on the parade, but ....

[Anonymous Coward]

Insurance and Medicare won't cover electric wheelchairs if you have full use of your upperbody. The Ibot requires that you have the use of at least one arm, and are able to shift and balance your body in the chair. If you are able enough to use the Ibot, you are not disabled enough to get it paid for.

Another problem (and the one the FDA was rightly concerned about) is the stair climbing. The Ibot assumes that when you lean in a direction, you want to move in that direction. I moves the base to keep under your moving center of gravity. You lean while climbing a stair, and the Ibot shoots off the step - ouch. If it doesn't, you tip over -ouch anyway. That's why you have to steady yourself on the banister - you have to balance the Ibot while climbing stairs. And that's more than most electric wheelchair users can cope with.

Re:Pay for it YOURSELF.

[ryanwright]

I want the justification that I or any other person should pay for YOUR wheel chair, let alone one of these damn over expensive machines destined only to be viable businesswise at the expense of tax payers.

You're obviously a stupid jackass, so I don't know why I'm wasting my time in replying...

There is a difference between an able bodied person who is just a lazy ass looking for a handout, and someone who is disabled. Quite frankly I wish we'd take all of the money from the filth who can work but refuse to and give it to people who would LOVE a normal job/life, but can't have one due to their disability.

You could get hit by a bus tomorrow and find yourself stuck in a wheel chair for the rest of your life with little ability to earn a living. Wouldn't it be nice if you could have an iBot to get around in? Or would you just prefer to drag yourself around because you can't afford shit after the half-million dollar hospital bill bankrupts your ass?

Have some compassion, for crying out loud. I've got no trouble with my tax dollars being spent to help out people who actually need the help.

Paraplegia is *so* funny!

[fm6]

The lack of mobility! The desperate search for a restroom you can use! The loss of bladder control! It's a laugh riot!

Not as funny as quadraplegia though. And don't even get me started on land mines....

Another ignorant jerk

[fm6]

The number of ignorant and stupid posts in this story is ridiculous. All the pronouncements about what the wheelchair-bound need by people who clearly don't know the first thing about physical disability.

You think people who use powered wheelchairs are lazy? John Hockenberry had to spend nine months in rehab before he learned to get by without his legs. And I understand that's pretty typical. Anybody who can deal with shit like that, with or without electrical assistance, has my respect.

And stop and consider all the practical things the wheelchair-bound can't do without assistance. Not just the obvious stuff like climbing stairs. But basic stuff like washing your car, reaching the top shelf at the store, cooking at a normal-height kitchen counter ... And imagine what it's like not to be able to hold a casual conversation in the hallway without craning your neck.

And you think battery life is the biggest problem for the paraplegic? Gawd I love these Slashdot "experts".

Re:Another ignorant jerk

[R.Caley]

The number of ignorant and stupid posts in this story is ridiculous. All the pronouncements about what the wheelchair-bound need by people who clearly don't know the first thing about physical disability. And your qualification to pontificate is? I know about why the traditional wheelchair is how it is because my father lost both his legs.

You think people who use powered wheelchairs are lazy?

Think some are, and some are stupid and some are ignorant and some a raving loonies and... In fact I think they are no different from any other randomly selected group of people.

But none of that is in any way relevent to what I wrote, which was simply that adding an extra single point of failure to someone's life is a big price to pay for the undoubted benefits of this device and it would be nice if that SPOF could be made less absolute.

Stability

[fm6]

One thing I found interesting about the iBot: some users report that it actually feels more stable in two-wheel mode. And indeed, ordinary wheelchairs do tip over. Possibly having a device that's actively resisting falling over is a more reliable safeguard than simple physical "stability". Hey, it works for bipeds!

This technology will be great for robots

[Anonymous Coward]

This should replace complicated mechanical legs on robots and finally make them affordable. All you need now are arms, brain, AI system, etc.

Dean Kamen understands disruptive technology

[mulp]

Take a look at The Innovator's Dilemma by Christensen.

He talks about the backhoe revolutionizing construction.

The backhoe fit a niche between steam shovels and human ditch diggers.

The Segway fits in between electric wheelchairs that are hugely expensive and ungainly and cheap wheelchairs with pushers and walkers (the four legged crutches).

The iBot is like a supercomputer compared to the mainframe electric wheel chair.

The Segway is like a PC compared to the calculator wheel chair and the paper and pencil walker.

A lot of people would like to have an electric wheel chair, or even better, an iBot, but those weren't available. And their problem isn't severe enough to mandate the more expensive solution. Those are the people who need to have the handicap parking space be empty so they can walk into the store and get to the store provided electric cart or wheelchair cart, or to the chairs placed around the store.

The Segway won't help the people who need the wheelchair all the time, but the people who can't walk due to weakness, joint problems, etc. are finding the Segway a great solution. So, its sort of like the IBM PC. Expensive, not able to handle many of the conventional computing needs.

But, all of a sudden, the PC found entirely new customers, customers who would never have gotten a PC. The Segway is finding lots of customers who would never buy an iBot or an electric wheelchair.

Manufacturing is about figuring out how to manufacturing goods for the lowest cost with the highest quality. As more PCs were sold, the cost of making a PC dropped and the PC got better, and that fueled the market for PCs and gave more people the opportunity to figure out how to use a PC resulting in more PC sales.

The Segway will improve, drop in price, find more customers with more uses, resulting in lower manufacturing costs. The people who need the aid of something like a Segway will gain the benefit of the improved technologies.

And just as the PC sales volume drove the PC technology cycle, the mini/mainframe market were forced to compete and they "stole" as much technology from the PC world as possible. Ethernet was a minicomputer technology, but once it was installed in just a small percent of PCs, the PC market represented most of the Ethernet product market and the mini/mainframes got Ethernet at such a low cost that it was practically free.

Dean Kamem understands that price/cost is critical to any successful technology. To develop a technology and then confine it to a low volume produce/market, the price is going to be too high to result in rapid success.

Back to the steam shovel and ditch digger, because the principle applies to clunking mechanical stuff and not just to microelectronics.

Backhoes were underpowered compared to steam shovels, but they could allow a couple of ditch diggers to run water and sewage to 5 homes a day instead of 1, even when the backhoe broke down.

But today, I doubt that many people have even seen a picture of a steam shovel because the pictures are so old that there are no women in the picture and thus it can't be used in textbooks (to have only men operating a steam shovel would imply that women aren't capable of operating a steam shovel). The backhoe has improved to the point where there are almost no jobs that require a steam shovel, almost, but not none.

The Segway will drive down the cost of the iBot. The iBot will drive down the costs of electric wheel chairs (really, what can justify a price of $15,000!!!?). The lower costs will allow more people to do things they can't do today.

Wheel chair technology has been dramatically improved by the people who race in marathons, etc. The Segway and iBot will be modified to allow athletes injured in accidents to resume play in sports they're excluded from today. Basketball? Field hockey? Soccer? But that will drive the technology and drive up demand and drive down costs.

Finding multiple uses for technology isn't win-win, it's
Win Win Win Win Win Win Win

Re:balance w/o seizures?

[fehlschlag]

The Segway couldn't even keep it's balance with the US president who does not have seizures.

Curbs are useful

[danila]

Curbs are not only used by disabled people, they can be used by people with bikes, people with carts, baby carriages, etc. Often I prefer to use a curb/ramp/etc. instead of stairs and I am perfectly healthy. Curbs are a good design, especially if you think about Segways, upcoming wheeled robots, etc. Wheelchair lifts, on the other hand, might have to go, once iBots are widespread and affordable.