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That hasn't been the case with artificial limbs, which have long required wearers to put a lot of thought and effort into a simple stride. Now, though, a newer generation of prosthetic devices is making use of chip technology to make walking a more natural act for amputees.
One such device is the C-Leg, from Otto Bock HealthCare, a German company that got its start working with war victims in the first years after World War I. The C-Leg is a decidedly 21st-century device, with a microprocessor in the knee that reads data 50 times a second--from real-time sensor data--to help the wearer negotiate changing terrain. The company also provides upper-body devices such as a new "dynamic arm" that for the first time has power-assist technology in elbow.
Bert Harman, president and CEO of Otto Bock's Americas region, recently spoke with CNET News.com about R&D challenges, getting nerves to talk to prosthetics and the current state of bionics.Q: How big a business is high-tech prosthetics, and what is Otto Bock's part of that business?
Harman: Well, if you start as high-tech prosthetics, it's relatively small. In fact the whole prosthetics industry is a small industry. In United States alone, there are about 1.2 million people that are amputees.
What is the state of the collaboration between the medical and scientific community?
Harman: There is a fair amount of collaboration in centers (such as) the Mayo Clinic, the Cleveland Clinic, Johns Hopkins, Stanford...There are a number of people who are interested, and have established gait labs as an example, to study the gait and how prosthetics impact that. That's adequate. I think what we're missing is the ability to develop good clinical claims...because again there aren't that many people. In a traditional drug study, a drug company might study 5,000 patients or more, and if we do a C-Leg study, we're lucky to get 20 patients.
What percentage of that 1.2 million amputees would go high tech, would have devices like the C-Leg?
Harman: In total, it's probably less than 10 percent of the population that would receive high-tech componentry. To give you an example, the C-Leg in the United States is a product that is generally recommended for mid- to high-active patients, and there are only about 8,000 of those a year that would be an above-the-knee, active amputee.
And we are taking about products that, from what I've read, are in the $40,000 to $60,000 price range?
Harman: That's a bit misleading. The products themselves are only a percentage of that. A $40,000 device would include all the components; the socket, which has the interface between the residual (limb) and the componentry; and the prosthetist's time. They can be that expensive, but it's a part of a total package.
Are we still in the first generation, or we are in a second generation of chip-based technology for the prosthetics?
Harman: As far as lower extremity is concerned, we're moving into the second generation. Now in upper extremity, which doesn't get a lot of press...myoelectric upper-extremity componentry has been around a long time. While (those devices) didn't use chip technology, they did use micro motors and batteries and power supplies and electrodes, so that was kind of a frontrunner. Actually, upper extremity really started the whole high-tech push.
Harman: Much like just about anything else where chip technology is applied today, it's basically making decisions faster. In this case what chip technology has allowed us to do is...very quickly monitor the terrain and the speed of the wearer and make adjustments, so that in essence the patient is in a much safer mode. Prior to chip technology, just to go down the stairs, typically an amputee takes one step at a time, and it would be good leg first and then they'd drag the prosthetic device behind them. With chip technology, an amputee goes down the steps one foot after another much like you or I would. The decision process is taken out of it (for the amputee), and it's made in the leg itself.
What are the limitations of something like the C-Leg and these higher-end devices? How reliable are they, what is their life span?
Harman: I don't think that the technology has a limitation. I think it's cost-return, cost-benefit that's the limiter at this point, because again we are not producing that many units. It's not like we're making cell phones or calculators where you just continue to drop the price down because of volume.
What's the next big step?
Harman: The next big step is probably going to be motorized or power-assist (additions). Today you're under your own power--there's a battery that drives the electronics, but it's your leg that powers the movement of the device. In the future there's some technology around
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