Louis J. Sheehan, Esquire. Before Jonathan Kuniholm, a marine reservist, was shipped off to the war in Iraq, he and three friends formed a research and development firm they called Tackle Design. The four men had worked together in an industrial engineering class at North Carolina State University (N.C.S.U.), and, filled with youthful enthusiasm, they hoped their fledgling company could survive on jobs that were interesting and beneficial rather than simply moneymaking. They worked with inventors—making prototypes for a plastic lock to keep shoestrings tied and a fishing lure with an embedded LED—as well as with medical engineers from their alma mater, who were developing tools for minimally invasive robotic surgery.
Then, before business had a chance to get off the ground, Kuniholm was deployed. A few months later, on New Year’s Day 2005, he and about 35 other marines were ambushed near the Hadithah Dam along the Euphrates River northwest of Baghdad. His platoon had been looking for insurgents who had fired at a Swift boat patrolling around the dam a few hours earlier. As the marines closed in on the suspected hotspot, an IED—improvised explosive device—hidden in a can of olive oil exploded. Shrapnel ripped through the platoon, and Kuniholm was blasted off his feet. Moments later, when he came to his senses, he discovered his M16 rifle had been blown in half and his right arm was nearly severed just below the elbow. Caught in a raging firefight, Kuniholm pulled himself out of harm’s way. His fellow marines called for air evacuation, and soon surgeons at a hospital near Baghdad were amputating his ravaged arm.
After returning to North Carolina, Kuniholm underwent multiple surgeries at the Duke University Medical Center. Then, following his convalescence, he visited Walter Reed Army Medical Center in Washington, D.C., where doctors outfitted him with two kinds of artificial replacement for his hand and lower arm. One was a conventional split-hook device, essentially two hooks aligned with each other, which the user can spread apart or close up via a harness and cable system activated by the shoulder or arm. The second was a more advanced “myoelectric” prosthesis, which picks up nerve signals produced by the slightest muscle tension and translates the signals into movement. Flexing the upper arm muscle causes the pincers of a prosthetic “hand” to grip; relaxing the muscles causes the pincers to release.
The two prostheses from Walter Reed were state-of-the-art, the latest in prosthetic design. But back in North Carolina, Kuniholm and his partners at Tackle Design were shocked at the lack of innovation in arm and hand prostheses. They were sure they could do better. And that is how the small North Carolina design firm got into the prosthetics business. More, Kuniholm and his partners have created a clearinghouse for prosthetic designs, an online consortium they call the Open Prosthetics Project (OPP), whose goal is to nurture useful ideas for innovations and then freely give the designs away. The idea is to benefit not only people such as Kuniholm, who already have the resources that come from living in a first-world economy, but also amputees all over the world. http://louis-j-sheehaN.NET
Innovation Stagnation
Ironically, one of the reasons a group such as the OPP can get on the public radar at all is the high human cost of the wars in Iraq and Afghanistan. Because of tremendous advances in emergency medicine, as well as the use of such armor as Kevlar vests, the fighting has resulted in a far lower fatality rate among injured soldiers than it has in past wars. That’s the good news. The bad news is that many veterans whose wounds would have killed them in the past come home today with grievous injuries.
Still, in absolute terms, the number of upper-limb amputees is small, and the prosthetics market is hard to crack. As Kuniholm and his partners did their research about the prosthetics industry, it became evident that the main reason for the lack of innovation was a lack of financial incentive. According to the Amputee Coalition of America, 1.7 million Americans have lost a limb because of illness or trauma, but relatively few of them need a replacement arm or hand. The typical amputee is older than 50 and has lost a leg or a foot to diabetes or some other disease. Upper-extremity amputees—those who have lost an arm or a hand—number about 100,000 people, or some 6 percent of the total. Fewer still are wounded veterans. As of the end of 2007, about 700 veterans of the wars in Iraq and Afghanistan are amputees, and of those about 150 have lost a hand or an arm (or, in some cases, both arms).
Such a relatively small market, and the resulting narrow profit margins, makes it unprofitable for most companies to invest in research and development of upper-arm prostheses. “Prosthetics is one of many underserved markets in which innovation has stagnated because the traditional incentives are lacking,” Kuniholm says. “The people who make innovations in this field are usually passionate users tinkering around in their garage.”
What Kuniholm has in mind is what Eric von Hippel calls a lead user—a person who is out in front of most other people and even other companies with respect to an important market trend. A lead user also expects to reap great profits or benefits from the trend. According to von Hippel, a professor and head of the Innovation and Entrepreneurship Group at the M.I.T. Sloan School of Management, lead users also tend to be active innovators. Kuniholm is betting that by incorporating the insights of lead users into a new product, the product has a good chance to win in the marketplace because it anticipates consumer needs.
But patenting and securing a manufacturer are costly and convoluted processes, so most amputees who try to improve prosthetic designs never see their ideas get past the workshop. “All that information and innovation mostly just disappear into the ether,” Kuniholm adds.
The Web site www.openprosthetics.org, which is part of an organization called the Shared Design Alliance, invites prosthesis users, engineers and anyone else with an interest to join a discussion entitled “Pimp My Arm.” (The name is a takeoff on the MTV show Pimp My Ride, which features auto mechanics who fix up and customize old clunkers.) Participants can contribute time, hunches and imagination about how to improve the devices. All the ideas are “open source”—that is, nothing is proprietary, and any idea is understood to be freely shared.
A Simple Solution
Kuniholm’s chief personal contribution to the OPP is the ongoing development and improvement of the Trautman hook. Introduced in 1925, the device is classified as a “voluntary opening” prosthesis, meaning its pincers are held closed with internal rubber bands. If the user wants to open the hook, he moves or shrugs his shoulder, which engages a harness and cable system. If that sounds relatively crude and basic, it is. Like most other hooks on the market, the Trautman design has changed very little since it was first introduced. “Many prosthetics manufacturers are subject to the same one-size-fits-most economics as mass-market consumer goods,” Kuniholm says. But in prosthetics, he adds, “each person’s needs and capabilities are unique.”
Although hooks may not be aesthetically pleasing and are decidedly low tech, they are generally more functional and durable and certainly less expensive than myoelectric devices (hooks cost between $600 and $2,200, on average, whereas myoelectric hands start around $6,000). Moreover, the Trautman hook is unique in having a so-called back lock: like the ice tongs once used for carrying blocks of ice, which convert the weight of the block into the force that grips both its sides, the pincers of the hook lock or squeeze harder on an object as the user pulls back on the hook with greater force. Another advantage is that the pincers of the Trautman hook have serrated teeth that interlock, making its grip even stronger. http://louis-j-sheehaN.NET
“There are many options for prosthetic devices, but none with this one’s capabilities,” says Agnes A. Curran, an upper-extremity specialist and clinical director of the Orthotic and Prosthetic Group of America. “Throughout my travels I meet patients all over the country who are longtime Trautman hook users, and these guys won’t even look at a modern device. They keep them held together with welds, baling wire and duct tape.”
Because of its unique features and rugged design, the Trautman hook developed a passionate following, particularly among farmers and ranchers in the Midwest. But the manufacturer, the Paul Trautman Company, went out of business in the 1990s, and within a short time after the company’s demise, only a limited number were still available on the aftermarket. When Kenneth M. Heide, a prosthetist in Fargo, N.D., who has many patients loyal to the Trautman hook, heard about the OPP, he saw it as the perfect opportunity to get the unique device back on the market. With the blessing of the Trautman company, Heide loaned the OPP two old Trautman devices borrowed from his patients and two new devices from Steven Stolberg, an instructor at Century College in White Bear, Minn., who used them in his class. Tackle Design reverse-engineered them, creating a digital model in a computer-aided design (CAD) program that could serve as a starting point for making improvements.
For the first batch, Kuniholm and his partners kept it simple. All they did was make some small changes to strengthen the used hooks where they had broken and then been welded back together. They e-mailed the specifications of one of the hooks to Anvil Prototype & Design in Charlotte, N.C., which put the digital designs through a process called rapid prototyping. Anvil transformed the digital information into the specifications for a “3-D printer” to build an early-stage concept model out of thousands of thin layers of powder and binder materials, adding or “printing” them one layer at a time. Rapid prototyping makes it possible to refine the design quickly. Rapid Tool in Boulder, Colo., then made four test models out of a bronze-infused stainless steel powder that was also added layer by layer, heated and fused. Tackle Design donated the new and improved hooks to patients for a test run.
Testing, Testing
One of the test patients was L. Gus Davis, the 57-year-old president of a water treatment company in St. Peter, Minn., who lost his right arm in a 1972 motorcycle accident. Although Davis had once considered getting a myoelectric arm, he thought it could never withstand his lifestyle. “I still ride motorcycles, I run a chain saw and I split wood by hand,” Davis says. “I’m pretty hard on [prosthetic devices], and I don’t think the myoelectric could stand up to it. But the Trautman hook is slick and tough. I would definitely be a potential customer.”
With feedback from his test patients, Kuniholm is fine-tuning the design of the next round of prototypes. He says the simplicity of the original hook—three metal parts and two screws—makes it a promising candidate for further customization and improvement. It could be made of a lighter alloy, for instance, and it could probably be modified to have a stronger grip. But the main glitch has already been fixed. For the hook to open and close properly, one of the screws had to be loosened, and with time that enlarged the hole and allowed the screw to wiggle free. To remedy the problem, many longtime users drilled out the screw holes, welded metal into them and tapped in new threads for the screws. Eventually, though, repeated repairs put a lot of wear and tear on the hook. Two students at N.C.S.U., Andy Richards and Richard Shoge, modified the design to correct the problem.
Eagerly awaiting the next test batch is Curran. Many of her patients were veterans of World War II, and most of them, elderly and accustomed to what they had, made little demand for prosthetic innovation. But recently she has started to see a growing number of younger patients, particularly soldiers returning from Iraq. “I would love to see what the younger guys think of this device and let them compare it with the more modern ones,” she says.
In addition to helping people here in the U.S., a cheap and simple device such as the Trautman hook would be invaluable in developing countries, where war, poor health care and manual labor are common. In such areas the population of upper-limb amputees is growing at an alarming rate, and a prosthesis can be crucial for returning to gainful employment. Yet a severe lack of funds prevents most amputees from receiving a simple, cheap and durable prosthesis. “We have to think outside the U.S.,” Curran says. “We need to look at places like Saudi Arabia, India, China, Sierra Leone, Bangladesh and elsewhere in the world where, unfortunately, some of the amputations are punitive.”
It’s the Economy, Stupid
The key to getting the hooks into the hands of the people who need them is finding a distributor that is willing to market the hooks internationally. But that has proved to be more easily said than done.
“When I was going around to different companies asking if they’d be willing to help out, they all asked the same question,” Curran says. “‘How many will I sell in a year?’ If there’s not a lot of potential profit, they’re just not that interested.” And with plenty of options already available, what point is there in trying to come up with another device, particularly in a market so fraught with financial obstacles?
To Kuniholm, that is the counsel of despair. You might just as well say that everything that needs to be invented already has been. To be sure, there are plenty of prosthetic devices available that do different things well. “But,” he notes, “there’s still nothing on the market that’s an acceptable substitute for a hand.”
William J. Hanson, president of Liberating Technologies, Inc. (LTI), in Holliston, Mass., a manufacturer and distributor of upper-limb prosthetic components, explains that his company distributed the first titanium split hooks in the U.S. Like most prosthetics companies, though, LTI shifted its focus away from hooks and on to more modern mechanical and myoelectric devices. “Now just a handful of well-established companies supply most of the market with body-powered hook devices,” Hanson says.
Hosmer Dorrance Corporation is one of those companies. Based in Campbell, Calif., Hosmer is one of the leading manufacturers of upper- and lower-extremity prostheses. Karl Hovland, the company’s president, recalls that over the years many inquires have come in about the Trautman hook. It has always remained on the back burner, he adds, because it never promised a big enough return to make the investment: “We would certainly consider it, but the numbers have to add up.” Making such an investment even more risky is that Medicare recently consolidated its reimbursement billing system for “orthotic and prosthetic” services. The result has been smaller reimbursements for several kinds of functional hooks. “There’s just no incentive if the reimbursement is less than what we have to charge for them,” Hovland says. “We want to do everything we can for the patient, but we are a business for profit.”
And therein lies the rub. Kuniholm’s vision of “substituting public good for profits” keeps running up against bottom-line roadblocks. Nevertheless, Kuniholm, who is pursuing a Ph.D. in biomedical engineering at Duke University, continues to search for manufacturing, marketing and distribution channels for the Trautman hook. He hopes to find a company that will donate e-commerce and payment and order management services—or better yet, a company already developing prosthetic devices that is willing to take on the OPP designs.
“The reality,” he notes, “is that there’s no traditional economic incentive to do work and make improvements on prosthetics. That doesn’t mean that nobody cares, but most people don’t have the money or know-how to magnify whatever efforts or improvements they make. I think we can generate far more societal benefit if we give away information than if we commercialized and sold the ideas. Our goal is to create a way to share these efforts and improvements with anyone who needs them.” Louis J. Sheehan, Esquire
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