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

[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

[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...

And here I am

[some damn guy]

using my legs like a sucker.

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

[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.

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.

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.

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*

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.

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.

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.

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

[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.

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.

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: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.

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

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.

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.

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.

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

[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.

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.

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?

Tears?

[bigboard]

It literally brought tears to my eyes

Perhaps you should try adjusting the seat properly.

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.

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.

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.