News that a new iBOT is in the works has generated a lot of excitement among wheelchair users. A May 22 press release explained that Toyota North America is joining forces with DEKA Research and Development, the company founded by iBOT inventor Dean Kamen, to help complete the development and launch of the next iBOT power wheelchair. The announcement has created a great deal of anticipation and a myriad of questions from fans of the chair, ranging from what kind of advances the new machine will have to whether it will be covered by insurance. For answers I turned to the man himself, Dean Kamen.
For those not familiar with the iBOT, it is a revolutionary four-wheel-drive wheelchair that can climb up and down stairs and curbs, roll across varied terrain, raise a seated user to eye-level-standing height by rising up and balancing on two wheels, and travel in this mode — all while relying on sophisticated sensors and gyroscopes to maintain the chair’s balance. The original iBOTs were manufactured and sold through Johnson & Johnson’s Independence Technology division starting in 2003. It discontinued the chair in 2009 because of slow sales due to lack of insurance coverage for the $24,000 cost. Additional challenges included only one available seating option and only one control mechanism, a joystick.
Many wheelers who did get iBOTs loved them, and many are still driving theirs to this day — something that is becoming increasingly difficult because repair support is extremely hard to find. To its credit, Johnson & Johnson continued to service the original iBOT fleet for five years after the 2009 discontinuation.
To say Kamen is excited about the next generation iBOT is an understatement. “The new iBOT will blow away the performance of the original — it has every benefit of the original but with advances similar to comparing a cell phone from 15 years ago to a smartphone of today,” says Kamen. He offers a glimpse of improvements starting with lighter chair weight — in some configurations the entire chair weighs less than 200 pounds. The original NiCad (nickel-cadmium) batteries have been replaced by two stacks of lithium ion batteries (three on each side). They are much lighter, easily swapped in and out, produce more power, more energy, longer battery life and have onboard charging — no external battery charger is required. The chair can also be plugged directly into a wall socket. In addition, charging is fast — a 50 percent increase in battery power takes about two hours.
Kamen cites the battery advances as emblematic of the product-wide improvements. “Another example is the gyro systems. The previous ones were the size of half a shoebox. The new gyros are the size of a sugar cube, are digital solid state and they sit inside totally new electronics.”
Perhaps of equal importance to the improvements in technology is the FDA’s reclassification of the iBot from a Class III medical device to a Class II medical device. “Being a Class III device meant we couldn’t change anything about the original iBOT, from seating system to joystick controller, without starting the FDA approval process all over again — from submittals to clinical trials — for any change,” says Kamen. With the Class II rating, Kamen plans on making the iBOT as a power base so it can work with a variety of seating systems, from pediatric to custom. The change also means that the new iBOT can be fitted with different types of controllers under the same FDA process as other power wheelchairs on the market.
Class III devices are considered the highest risk and subject to the highest amount of FDA control. Class II devices (power wheelchairs are in this class) are considered to have less risk. “The FDA was great,” says Kamen. “I explained to the FDA that they were appropriately cautious with the Class III rating when the chair was introduced, but now the original fleet of iBOTs have delivered 10-million-hours of operation, and electronics and sensors are more sophisticated, so we would like a reclassification to Class II. They looked at all of our data and in 2014 granted the iBOT a Class II rating.”
Funding for the next generation iBOT is another reason reclassifying to a Class II medical device is important, explains Kamen. The change to a Class II device should open the door for the Centers for Medicare and Medicaid Services to fund the iBOT, and most insurance carriers tend to follow CMS’s lead.
The new iBOTs will be designed by DEKA and commercialized by Mobius Mobility LLC, a new company in Manchester, New Hampshire, with the support of Toyota. “We are excited to be backed by Toyota, the largest transportation company the world has ever seen,” says Kamen. He adds that the future potential for this collaboration is exciting because each company could bring a lot to the table in terms of advanced control, sensors, and technology. Some of the technology for the iBOTS can be used in Toyota robotic devices, and there are lots of things Toyota robotics is working on, like motors and batteries, that could potentially be used in iBOTs in the future. In addition, the connection to Toyota’s supply chain and management and service organization around the world could be invaluable for sourcing iBOT components from electronics to tires.
When will the new iBOT be available to consumers? Kamen says he is aiming to supply the next generation iBOT sometime in 2017. “DEKA is working really hard to be ready to submit a new iBOT for the FDA testing, and approval of all power wheelchairs submitted as medical devices must go through in early 2017, as close to January 1 as possible,” says Kamen. “Since it is a predicate (similar) device and the FDA has moved it from Class III to Class II, we are hoping that it will get a quick review and approval.”
As far as retail cost of the next generation iBOT, Kamen says at this time he has no idea. However, he feels he can reduce the price considerably and provides three reasons this can happen:
1. Advanced technology is much less expensive than it was when the original iBOT was built.
2. DEKA’s design for manufacturing and supply chain capability has advanced.
3. Support from Toyota’s world-class supply chain.
At the moment an unknown in regards to retail cost is how to get the chairs to consumers — which has a significant effect on wheelchair price.
What about service and repair options for wheelers still using the original iBOT? Support for the original machines is difficult because replacement parts are no longer made, explains Kamen, but the nonprofit Operation Onward
“I explained the idea of a trade-in program to Toyota and they said, ‘Let’s try to come up with a plan like that. It will be fantastic to show that we are supporting all the people who are depending on this machine for their independence and their lifestyle,’” says Kamen. And although Johnson & Johnson is no longer involved in the iBOT in any way and has no plans to be involved, the company has been extremely supportive of the efforts to re-launch the iBOT. “I went to J&J and said, ‘I know you left the business and I know it cost you a fortune, and you continued to support iBOTs because it was the right thing to do. But now I need your help again.’ And the chairman and CEO of Johnson & Johnson said, ‘You’ve got it, Dean, we are turning over the keys to the kingdom. We will transfer everything you need.’”
It is clear that Kamen’s enthusiasm goes beyond building the next generation iBOT. His goal is to make it attainable. “We understand we need to make these available. There are so many ways to justify building this device. It is like building a high performance hybrid of a robot and a car. We understand we have to find ways to make this available to people that need it, and we will do that.”
• FDA Medical Device explanation: www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm
• iBOT Press Release: pressroom.toyota.com/releases/toyota-deka-research-partnership-may21.htm
• Operation Onward, www.operationonward.org
• Still Dreaming of an iBOT, www.newmobility.com/2009/04/still-dreaming-of-an-ibot/