The Complicated Reality of 3D Printed Prosthetics
A decade ago, fantastic media coverage of 3D printing dramatically increased expectations for the technology. One of the favorites of this media coverage was the use of 3D printing for prosthetic limbs: for example, Iin 2015, The New York Times celebrated 3D-printed prosthetic hands, worth $15 to $20, facilitated by the nonprofit E-nable, which matched amateur 3D printer owners with children with limb differences. The magic seemed undeniable: disabled children could get cheap, freely accessible mechanical hands, made by a neighbor with an unusual hobby. Similar stories about prosthetics abounded, painting a picture of an emerging high-tech utopia made possible by technology straight out of Star Trek.
But as often happens, the Gartner Hype Cycle was in full swing. In the mid-2010s, 3D printing was in the “peak inflated expectations” phase, and prosthetics were no exception. Those LEGO-style hands that were getting media attention didn’t have the strength needed for a handheld device, the prints themselves had too many inaccuracies, and the designs were – as you might imagine an entirely plastic object – deeply uncomfortable.
Quorum’s 3D printed prosthetic socket.Quorum
What follows is what we call the “trough of disillusionment”. Joe Johnson, CEO of Quorum Prosthetics in Windsor, Colorado, has seen prosthetists shy away from 3D printing technologies for years. Johnson held on, however, waiting for technology and bureaucracy to catch up with his ambition. A milestone occurred last year when U.S. medical insurers issued an “L code” specifically for adjustable sockets for prosthetic limbs. An L code allows durable medical equipment, such as prosthetics, to be processed for billing within the U.S. insurance system. Quorum engineers responded with a sophisticated, adjustable socket using 3D printing. Quorum’s design can adjust both volume and compression on residual limbs, for a better fit, like tightening your shoe laces.
Despite its high-tech and sleek appearance, Johnson says his take could be manufactured using traditional methods. But 3D printing makes things “a little better and easier.” “When you look at the overall cost of labor,” says Johnson, “it keeps going up. To make one of our sockets it would take a technician 12 to 16 hours. [using traditional methods].” Using 3D printing, he says, “we can make five of them overnight.” As a result, Quorum spends less on technical labor.
However, new costs are emerging. Quorum must pay for subscriptions and software licenses in addition to the overhead costs of running a nearly $1 million Hewlett-Packard 3D printer. “We have to spend $50,000 on the air conditioning unit just to control the humidity,” Johnson says. Ultimately, it costs over $1000 to print each socket, even when printing multiple sockets together. Costs are now higher than if Quorum didn’t use 3D printing to make prosthetics, but Johnson believes the quality is higher. “You can see more patients. [3D printing] is so precise and fewer adjustments need to be made. This means fewer follow-up visits for patients and, for many, better adjustments.
Operation Namaste uses 3D printing to standardize coatings for prosthetic limb sockets.Operation Namaste
Why hasn’t 3D printing reduced costs?
When I asked Jeff Erenstone, a prosthetist for more than two decades and founder of the nonprofit Operation Namaste, why 3D printed designs haven’t reduced costs, he replied that Quorum is “able to make a socket that wasn’t possible before 3D printing – a much greater socket and sophistication. What they’re making doesn’t cut costs any more than Ferrari cuts costs. They make the Ferrari of sockets.
But Erenstone says technology is finally getting closer to doing some of the things everyone thought possible a decade ago. Namely, the ability to share designs across the globe and increase communication among practitioners has been life-changing. Ernestone aimed to crack the code for prosthetic liners, the flexible silicone socks that prosthetic users wrap over their residual limb before inserting it into the prosthetic socket. Liners from one of the most common brands, Ossur, sell for several hundred dollars a piece, but are essential for making a denture comfortable enough to wear all day. To provide high-quality inserts to prosthesis users in low-resource countries, Operation Namaste standardizes molds to make silicone inserts. Clinicians around the world can print the mold using inexpensive 3D printers and around $22 worth of materials and local labor to produce a high-quality silicone coating. “3D printing has value in low-income countries because accessibility is much more difficult,” says Erenstone. “I didn’t see him [have as much value] in urban areas where prosthetic care is adequate.
3D printing has proven particularly useful in war zones like Ukraine and Sudan, where it can be dangerous for prosthetists to come from abroad and resources are very scarce. Canada-based Victoria Hand Project identifies prosthetics and orthotics clinics around the world, sets them up with a 3D printing lab, and trains clinicians in 3D printing software. Where 3D printing has made a difference is in increasing knowledge sharing among practitioners and increasing the availability of low-cost designs. It is unclear, however, whether prosthetics printed with cheaper 3D printers hold up to proven, body-powered, inexpensive conventional designs. Quorum Prosthetics runs a nonprofit called One Leg at a Time in Tanzania, where they train local people in 3D scanning and measuring residual limbs, but those scans are sent back to Colorado, where an industrial multi-jet fusion printer prints the hands. Local Tanzanians can be trained to use the new technology, but the best equipment to accomplish the task is still beyond their reach.
Unlimited TrueLimb of tomorrowUnlimited tomorrow
Can 3D printed prosthetics be cheaper?
The goal of using 3D printing to make prosthetics less expensive is still being pursued, but non-technical issues pose significant obstacles.. Easton LaChapelle, founder of Unlimited Tomorrow, sought to leverage 3D printing, a technology he fell in love with as a teenager, to create an inexpensive, high-performance hand that could compete with the bulky multi-jointed prosthetic hands on the market. The result was the TrueLimb, a $7,000 prosthetic hand so intricate in its appearance that it appears to have been carved from wood. The TrueLimb was sold directly to consumers in an effort to avoid issues with medical insurance, but even at $7,000, about 1/10th the cost of other multi-joint myoelectric hands, the hand proved too expensive for many. Customers contacted LaChapelle and asked them to take out insurance. Unlimited Tomorrow then began working with prosthetists who had to choose between billing insurance companies for (for example) a prosthetic hand made in Germany for tens of thousands of dollars or the TrueLimb. “Prosthetists were hesitant to work with us because our price was so low they couldn’t match it to what they’re used to,” says LaChapelle. “It doesn’t matter what technology is used in these circumstances. Unlimited Tomorrow could have produced the best device, but clinicians are asking ‘why should I bill for a TrueLimb when I could bill for a Bebionic?'” As a result, the cost of TrueLimb has skyrocketed.
Very quickly, LaChapelle says, “We became exactly the problem we were trying to solve. We were just another fancy weapon that cost a lot of money and for the consumer it was always an out-of-pocket expense.” LaChapelle decided it was unethical to continue this and put Unlimited Tomorrow “on pause.” In the meantime, he’s working to commercialize some of the innovations he and his team of engineers stumbled upon, like their haptic glove system, which they hope will catch on in virtual reality applications. “The United States [prosthetics] “The market is not going to change,” he says with dismay. With the profits from their glove, he hopes to focus on developing a “badass body-powered”. [prosthetic] device” to be distributed through a non-profit organization.
Insurance companies are also innovating, but not in useful ways. While 3D printed devices now have official, codified L codes that prosthetists across the United States can bill for, Joe Johnson says insurance companies don’t care about the benefits of 3D printed devices. “Lawyers have reached a level of sophistication in writing policies that they can write around mandates. [that should guarantee coverage]”, says Johnson. “We have certain coverage mandates for prosthetics, but insurance companies have become very sophisticated. They’re betting on you giving up. Insurance companies still refuse to cover even knees equipped with microprocessors, Johnson says, a technology that has been around for twenty-five years. He and his team considered the possibility of trying to repurpose microprocessor knees to make them more affordable for many patients. In the not-so-distant future, they imagined, insurance companies would find new ways to thwart their efforts. Johnson says: “They would totally break those knees. »
This article was supported by the IEEE Foundation and a John C. Taenzer Fellowship.
