Save the IBot Update: the FDA Gives Us Some Good News

You might call it an early Christmas present.

As I indicated in my previous iBot update, the FDA held a hearing on December 12 to consider DEKA’s petition to change the iBot medical classification. As I wrote in that post:

“…The iBot needs a new manufacturer. But first, the regulatory environment must be improved. DEKA initiated an application to have the FDA modify the status of the iBot from a Class III medical device to Class II medical device. This would significantly reduce the regulatory burden on the product…On December 12 a team from DEKA will meet with the FDA Medical Devices Advisory Committee (it would have been sooner but for the government shutdown)…If (the application) is eventually approved, DEKA will be in a stronger position to recruit new manufacturing partners.”

Now we have this news from the Department of Health and Human Services meeting notes: 

“…the panelists recommended a Class II designation for stair-climbing wheelchairs...”

Perfect!

There were two major regulatory impediments making it difficult for the iBot to be commercially viable. First, there was the Class III to Class II issue, which is apparently behind us. Second, there is the fact that Medicare will not reimburse patients for the iBot wheelchair. I don’t hold out much hope for changing the Medicare issue in the near future, but maybe I'm wrong. 

By changing the iBot from a Class III device to Class II Device, a potential manufacturing partner could relatively easily improve the iBot in a number of ways, and make it more marketable to more users. Perhaps these improvements could eventually make it so that Medicare would reimburse patients.

I know that DEKA, with an assist from Huey 091, is recruiting potential manufacturing partners, and what happened on December 12 in Washington can only make the iBot a more appealing venture. Hopefully, this will be enough to lure in somebody. Maybe there was a group waiting in the wings and they will come forward soon because of this decision. It's more likely that DEKA still has a lot of work to do, but they now have a better case to make with these companies.

How big of a deal is this decision? That remains to be seen. Perhaps it was too little too late, or perhaps it was just what the doctor ordered. Only time will tell which of these two clichés will apply.

Here’s a video of Alan Brown’s public testimony before the panel. Alan is an iBot user and a member of the Board of Directors for the Christopher and Dana Reeve Foundation. He is a strong advocate for the iBot and for wheelchair users in general, and a gifted public speaker. Please watch and enjoy.

If you're reading this through email click here to watch the video at YouTube.

Memories: The Ghosts of Christmas Past

From time to time I will post Memories, where I describe some facet of my life before MS. I hope you enjoy these digressions.

Growing up, our Christmases were right out of Currier and Ives: cold and snowy weather, traditional holiday treats, family, gifts, mistletoe.  I remember those Decembers fondly and miss them terribly.

In grade school, on the last day before Christmas vacation, a local radio station would record each homeroom class singing a different Christmas carol, often of the religious variety – it was a nonissue in those days. On Christmas Eve, at the appointed time, we would huddle around the radio at home and listen for our song. It was played only once, so you had to be ready.

My parents hosted what they called an Open House on Christmas Eve. To me, it was just a big party that started in the afternoon and lasted until late at night. My mother, a quadriplegic, was universally loved in our town. She had been through so much pain, yet had endured it with uncommon grace and good spirit. I think a major reason we had such a strong turnout each year was because people just wanted to be around Vernice, especially at Christmastime.

The guests would enter our house amid great fanfare. Most would bring something delicious and homemade. But the favorite visitors were the ones who placed a fifth or half-gallon of Jack Daniels under the tree for Dad. My father was a social, happy drinker. I never considered that he had a drinking problem, and looking back I still don’t. In fact, I enjoyed being around Dad when he was into the Jack and water. He was a purist in this regard. If you insisted on soda or some other mixer, you were served Jim Beam, a lesser grade of bourbon.

When I was a young boy the adults would shuffle me off to bed at a decent hour, employing the old adage, “The sooner you get to bed and to sleep, the sooner Santa will come.” But, in fact, although I may have gone to bed I would often lay awake for hours listening to the loud, alcohol-fueled conversations drifting down the hallway from the kitchen and living room. I loved to eavesdrop on the stories that I was otherwise not allowed to hear. Christmas Eve was the most educational day of the year for me.

When I was in high school, and Kim was my girlfriend, there was another aspect of Christmas Eve that worked out very well for us. Danny and Darlene, neighbors from across the street, would come over to the party for a couple of hours. During that time Kim and I would babysit their two sleeping children. Danny and Darlene had a water bed. Enough said?

When I was in college, my brothers and other people my age became the late-night partiers, staying up long after my aging parents. I wonder if Mom and Dad eavesdropped on our loud conversations and became educated about things that they otherwise wouldn’t have.

Then one year, out of the blue, my mother told me that there would be no more Christmas Eve open houses for the next seven years. I was incredulous. “Why?” 

My father was a shift foreman at the paper mill. He worked a rotating schedule called the southern swing. They knew that for the next seven Christmas Eves he would be working the 3 PM to 11 PM shift, and so there would be no parties. I was heartbroken. That tradition was my favorite part of Christmas. Sadly, everyone in town moved on and developed new Christmas Eve traditions, and my parents grew old. The Christmas Eve open houses never resumed.

And now having written this piece, I realize how very much I miss my parents, all of my friends and relatives who are no longer with us, and this simpler time in our lives. The ghosts of Christmas past do indeed haunt me. 

Wheelchair Winters

note: click on any of the photos to enlarge

Snowfall in this part of Maine begins in December and can linger through early April – a full third of the year. Before I was diagnosed with MS I had no sympathy for the snow haters. My mantra was, “If you don’t enjoy the winters in Maine, then you shouldn’t live here.”

Those of us from northern climates have fond childhood memories of the snow. If you want to witness joy in its purest form, take some children with lots of energy and imagination (which is almost every child), gently toss them into a fluffy, white snowbank, and watch what happens.

From grade school through college, winter was all about downhill skiing for me. There were no major ski areas near our house in Lincoln, but we were a short drive from a short mountain, called Mount Jefferson. There were maybe eight trails; one clunky, old T-bar; and one rope tow. We didn’t care. We had a lot of fun anyway. Unlike at the large ski areas that most people frequent, skiing here was a very intimate experience. We kept running into the same people all day long, and all winter long. Naturally, Mount Jefferson became the setting for much of my clumsy romantic maneuvering, almost always for naught.

In college, Kim and I purchased season’s passes to Sugarloaf Mountain, a major resort in Western Maine, about two hours away from the University of Maine. We paid $110 for the discounted student pass. During one winter I was completing an internship at a paper mill not far from Sugarloaf, so Kim hitched rides there with Cookie and Shostak, my fraternity brothers, and we would meet for the weekend.

After college, we moved to Ohio and Vermont for a few years and continued skiing sporadically. Soon after we moved back to Maine I took up snowmobiling, and my skis only gathered dust in the basement from that point forward.

Driving my snowmobile down a freshly-groomed trail on a cold, crisp morning was the closest experience I ever had to flying. I don’t mean flying like a plane. I mean flying like a bird.

When I was in that zone, crafting seamless turns at the maximum safe speed, or just slightly above, there was nothing like it. Puttering along at a slower pace and taking in the scenery was nice too, but that was not the experience I craved. My ideal ride was at once sublime and exhilarating: reading poetry while hanging on the edge of a cliff…eating crème brûlée in a hurricane.

I was hopelessly addicted to the endorphin rush of high-performance, cross-country snowmobiling. But it ended in 2008, when I could no longer operate a snowmobile because of my MS. This may have been for the best anyway. Being a husband and father, I didn’t need to wrap myself around a tree in the Maine wilderness at 100 mph. And so I became one of those people who I had pitied and scorned for most of my life. I no longer had any use for the snow, yet I continued to live in Maine.

I’m quite sure Kim and I won’t follow my own advice and live elsewhere. Reason #1 is that summers here are perfect for a person with MS – nice and cool because of ocean breezes. Reason #2 is that Kim’s career is here. Reasons #3 through #100 are the family and friends who we live among. We’re not going anywhere.

Two winters ago the weather was freakishly warm, and it rained when it should have snowed. I was free to cruise the neighborhood in my wheelchairs, with no ice patches or snow banks in my way. If this is global warming, I thought, then bring it on. Last winter turned out to be unusually cold and snowy, including one storm where we received 32 inches of snow. If this is global warming, I thought, then no thank you. The picture to the left is what poor Phoebe woke up to that morning. How was she supposed to go pee?

I understand that the implications from global warming are not straightforward. Climate change may have been more responsible for the cold and snowy winter than it was for the freakishly warm one. Who knows? However, if our trend is toward more winters like two years ago, and there are fewer fluffy, white snowbanks and frigid temperatures in my future, I’m not going to complain.

Don’t worry. I’ll still do my part to save the planet by voting for alternative energy projects, reduced carbon emissions, etc. But at the same time, I’ll be secretly hoping for rainy winter days.

Save the IBot Update and My Trip to DEKA

This picture shows Bill Clinton and Dean Kamen in the office of the president. Kamen is on his iBot. (Photo credit: Wikipedia)

The story of the iBot is a potentially heartbreaking one. This exceptional wheelchair, which can climb stairs, navigate difficult terrain in four-wheel-drive mode, and elevate its user up to eye level with standing people, is no longer being manufactured or sold. In fact, if nothing changes, maintenance and parts for the iBot will only be available through March of 2014. After that date, I don't know if my iBot will run 10 minutes or 10 years before a fatal malfunction occurs. Yet, not all hope is lost. Some very talented and dedicated people are still trying to save the iBot.

Through my affiliation with Huey 091 and SavetheiBot.org I was introduced to Joe, the Special Projects Officer at DEKA Research and Development. DEKA is the company founded by entrepreneur and inventor Dean Kamen. They are responsible for such innovative products as the Segway transporter, the iBot wheelchair, and countless other devices that help people lead better lives.

I asked Joe if he could give me a tour of the DEKA facility, and he agreed. One day in early November Kim and I made the hour and half drive from South Portland, Maine to Manchester, New Hampshire.

I’m an engineer, and DEKA is all about that. They have almost 500 technical people on staff in Manchester. Kim is a Middle School Guidance Counselor, and she had only a passing interest in this tour. In fact, she was participating only as a favor for me, which was nothing unusual. Kim is a very generous person.

Joe greeted us when we arrived at DEKA, and introduced our tour guide, Sarah, who is Dean Kamen’s Chief of Staff. Joe indicated that Dean had wanted to meet us, but unfortunately he was out of the office on this day. (Did I mention that a couple of years ago I was almost personally introduced to another great inventor, Steve Wozniak?)

I asked if we were allowed to take pictures, even though I was pretty sure of the answer. Indeed, DEKA works on many top secret projects, and they don’t allow photography inside their facility. I get that.

First, Sarah shared the background story about Dean Kamen and DEKA, showing off a few of the early products he developed. This included a drug delivery system that later became the first insulin pump for diabetics, and a portable dialysis machine.

(Photo credit: Wikipedia)

We were then guided to the machine shop area of the facility, where they have a rare 3-D printer that works with metals. DEKA also operates a bank of more traditional 3-D printers that work with plastics (if any version of these machines can yet be considered traditional). A collection of products that come off of these devices was on display, and they were amazing. If you’re not familiar with 3-D printers, and why every home will have one in the coming years, read this article.

Sarah and Joe then introduced us to some of their more recent projects. Dean is concerned about the availability of potable water in Third World countries, so they developed a pair of products to address this issue. The Slingshot is a self-contained, highly efficient water purification unit that can be easily deployed anywhere in the world. DEKA is partnering with Coca-Cola to make these units available where they are most needed. The Stirling Engine is a self-contained generator appliance that can power a Slingshot and satisfy other local electricity needs using a variety of nonconventional fuels.

The Slingshot and the Stirling Engine are very cool, but the most impressive product we saw was DEKA’s prosthetic arm, called the Luke Arm. Development is being funded by the Department of Defense (DARPA). We met up with the Manager of Engineering, Stewart, who explained the project to us. It’s heartwarming to watch an amputee pick up grapes and place them in his mouth, or drink a bottle of water without crushing or spilling it. The goal is to make this technology available to war veterans with arm amputations, and eventually anyone who can benefit from this prosthetic device.

Our last stop on the tour was the iBot testing facility. Years ago DEKA created a series of indoor obstacles for the purpose of putting the iBot through its paces during development. There are ramps, curbs, stairs, and your worst nightmare of a bumpy walking path. But now it all sits idle, frozen in time while the fate of the iBot is determined. I’m glad we were shown this area, although I was slightly unnerved by its resemblance to a museum exhibit.   Yet, I find it telling that DEKA has not decommissioned this testing facility and reallocated the space to active projects. They obviously haven’t given up, and so neither should we.

After the tour was complete, we enjoyed a lunch with Joe and discussed the future of the iBot. Joe’s number one priority is to facilitate its rebirth. After DEKA developed the iBot in the early 2000’s they licensed the technology to Johnson & Johnson, who created a subsidiary called Independence Technology for the production, sales, and service of the iBot. Five years ago, about six months after I purchased my own iBot, Independence Technology announced that they were discontinuing production. This was due to low sales volume and, I can only assume, business unit losses.

(Photo credit: Esthr)

The primary reason for this product’s commercial failure was its onerous regulatory burden. For one thing, the iBot is categorized as a Class III medical device by the FDA, which means that extraordinary effort is required to obtain approval for any product modifications or enhancements. This places an undue burden on the development team and slows down or prevents improvements that consumers rightfully expect. For this and other reasons, the product underperformed in the marketplace, even though it has been a life-changing success for any individual lucky enough to own one, myself included.

The iBot needs a new manufacturer. But first, the regulatory environment must be improved. DEKA initiated an application to have the FDA modify the status of the iBot from a Class III medical device to Class II medical device. This would significantly reduce the regulatory burden on the product. The FDA received over 280 letters in support of this change, including one from me. On December 12 a team from DEKA will meet with the FDA Medical Devices Advisory Committee (it would have been sooner but for the government shutdown). After the meeting, we should have a much better idea of the viability of this petition. If it is eventually approved, DEKA will be in a stronger position to recruit new manufacturing partners.

I’ll let you know what I hear from the December 12 meeting.

The people at DEKA were extremely friendly and gracious. More than one of them commented about how much they enjoy seeing people like me benefiting from their invention – the iBot. I envy them in that sense. I never worked for a company where I felt I was making such a positive impact in the world (few people do). Also, their affection for Dean Kamen is palpable and infectious. He’s one of my personal heroes.

I can’t thank Joe, Sarah, and Stewart enough for taking the time to share their knowledge and their passion with us. In the end, Kim admitted to me that this trip was much more rewarding than she thought it was going to be. Although the tools employed at DEKA may be highly technical, the folks there are motivated by compassion for others, and it doesn’t take an engineer to appreciate that.

Note: for more information on the effort to save the iBot, please visit these sites:

America’s Huey 091 Foundation

SavetheiBot.org

Save the iBot (Facebook Page)

My iBot Videos