The Complicated Reality of 3D Printed Prosthetics

About ten years ago, fantastic media coverage 3D printing Expectations from this technology have risen sharply. A special highlight of this report was the use of 3D printing to prosthetic limbs: For example, I2015, New York Times celebrated the creation of $15 to $20 3D printed prosthetic arms supported by a non-profit organization Give opportunitywhich brought together amateur owners of 3D printers and children with limb differences. The magic seemed undeniable: disabled children could receive cheap, freely available mechanical arms 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 from outer space. Star Trek.

But, as often happens, Gartner Hype Cycle was in full force. By the mid-2010s, 3D printing was at its “Peak of Inflated Expectations” stage, and prosthetics was no exception. The LEGO-style arms that attracted media attention didn't have the strength needed for a wearable device, the prints themselves had too many inaccuracies, and the design was – as you can imagine, an all-plastic object – extremely awkward.

Close-up of a 3D printed Quorum denture socket. 3D printed Quorum denture socket.Quorum

What followed was the so-called “trough of disappointment.” Joe Johnsongeneral manager Whose prosthetics In Windsor, Colorado, prosthetists have shied away from 3D printing technology for years. Johnson persevered, however, waiting for technology and bureaucracy to catch up with his ambitions. An important milestone occurred last year when U.S. health insurers issued an “L-Code” specifically for adjustable sockets for prosthetic limbs. The L-code allows you to bill durable medical equipment, such as prosthetics, under the US insurance system. Quorum engineers responded with a sophisticated, adjustable socket using 3D printing. The Quorum design allows you to adjust both the volume and compression of the stump, providing a better fit, for example, by tightening your shoe laces.

Despite its high-tech and sleek appearance, Johnson says his plug could produced using traditional methods. But 3D printing makes it “a little better and easier.” “When you look at the total labor cost,” Johnson says, “it continues to go up. It would take a technician 12 or 16 hours to make one of our outlets.” [using traditional methods]” Using 3D printing, he says, “we can make five in one night.” As a result, Quorum spends less money on paying technical specialists.

However, new costs arise. Quorum needs to pay for software subscriptions and licenses on top of the overhead costs required to operate the nearly million-dollar Hewlett-Packard 3D printer. “We have to spend $50,000 on air conditioning just to control the humidity,” Johnson says. After all, it costs over $1000 to print each socket, even if they print multiple sockets together. Costs are actually higher now than if Quorum had not used 3D printing to produce prosthetics, but Johnson believes the quality will be higher. “You will be able to see more patients. [3D printing] so accurate that fewer adjustments are required.” This meant fewer follow-up patient visits and, for many, better compliance.

The doctor adjusts the prosthesis on the leg of a sitting patient. Operation Namaste uses 3D printing to standardize prosthetic limb inserts.Operation Namaste

Why hasn't 3D printing reduced costs?

When I asked Jeff Erenston a prosthetist with over two decades of experience and founder of a non-profit organization for limb prosthetics. Operation Namaste, Why 3D printed designs haven't brought down costs, he said Quorum “is able to create a rosette that wasn't possible before 3D printing – a rosette of a whole new level and complexity. What they're doing doesn't reduce costs any more than Ferrari reduces costs. They're making a Ferrari out of rosettes.”

But Erenston says technology is finally getting closer to achieving some of the things everyone thought possible a decade ago. Namely, the ability to share developments around the world and increase communication between practitioners has been life-changing. Earnestone set out to crack the code on prosthetic inserts, the flexible silicone sock that prosthetic users wrap around the stump before inserting it into the socket of the prosthesis. Earbuds from one of the most common brands, Ossursell for many hundreds of dollars each, but are vital to making the prosthesis comfortable enough to wear all day. To provide prosthetic users in low-resource countries with high-quality inserts, Operation Namaste is standardizing molds for making silicone inserts. Clinicians anywhere in the world can print an impression using low-cost 3D printers, spending about $22 in materials and local labor to produce a high-quality silicone liner. “3D printing has value in low-income countries because accessibility is much more difficult,” explains Erenston. “I didn't see it [have as much value] in urban areas where adequate orthopedic care is available.”

3D printing has proven particularly useful in war zones such as Ukraine and Sudan, where it may be unsafe for prosthetists to travel from overseas and resources are few and far between. Canada Victoria's hand project identifies prosthetics and orthotics clinics around the world, equips them with 3D printing laboratories, and trains doctors in 3D printing software. 3D printing has changed this by increasing knowledge sharing among practitioners and increasing the availability of low-cost designs. However, it is unclear whether prosthetics printed on cheaper 3D printers can compare with traditional, time-tested, low-cost body-powered designs. Quorum Prosthetics operates a non-profit organization called One leg at a time in Tanzania, where locals are trained to 3D scan and measure residual limbs, but those scans are sent back to Colorado, where an industrial multi-jet fusion printer actually prints the arms. Local Tanzanians can be trained to use the new technology, but the best equipment for the task is still beyond their reach.

A close-up of the Unlimited Tomorrow prosthetic arm, with complex joints reminiscent of the bony structure of a human arm. TrueLimb of unlimited tomorrowUnlimited tomorrow

Could 3D printed prosthetics be cheaper?

The goal of using 3D printing to make prosthetics cheaper is still being pursued, but non-technical issues pose significant obstacles.. Easton LaChapellefounder Unlimited tomorrow sought to use 3D printing—a technology he fell in love with as a teenager—to create a highly functional, low-cost hand that could compete with the clunky multi-joint prosthetic hands on the market. The result is TrueLimb, a $7,000 prosthetic arm so intricate in appearance it appears to be carved from wood. The TrueLimb was sold directly to consumers to avoid the headaches of health insurance, but even at $7,000, it's about 1/10th the cost of other multi-joint models. myoelectric arms— the hand turned out to be too expensive for many. Clients approached LaChapelle and asked for insurance. Then Unlimited Tomorrow began working with prosthetists who had to choose between billing insurance companies for (for example) a tens of thousands of dollars worth of German-made prosthetic arm or a TrueLimb. “Prosthetics were hesitant to work with us because our price was so low that they couldn’t raise it to the level they were used to,” LaChapelle explains. “Under these circumstances, it doesn't matter what the technology is. Unlimited Tomorrow could make a better device, but doctors say, 'Why should I bill for TrueLimb when I can bill for Bebionic?’” As a result, the cost of TrueLimb has skyrocketed.

Soon enough, LaChapelle says, “we became exactly the problem we were trying to solve. We were just another fancy tool that cost a ton of money and still left an out-of-pocket expense for the consumer.” LaChapelle decided that it was unethical to continue in the same spirit, and put Unlimited Tomorrow on pause. In the meantime, he's working to commercialize some of the innovations he and his team of engineers have stumbled upon along the way, such as a haptic glove system that they hope will find use in virtual reality applications. “USA [prosthetics] the market won't change,” he says anxiously. With profits from their gloves, he hopes to focus on developing a “cool body-powered car.” [prosthetic] device” for distribution through a non-profit organization.

Insurance companies are also innovating, but not in a useful way. Although 3D-printed devices now have official, codified L-codes that can be billed by prosthetists across the U.S., Joe Johnson says insurance companies don't care about the benefits of 3D-printed devices. “Lawyers have reached such a level of sophistication in policy writing that they can write around mandates. [that should guarantee coverage]”,” explains Johnson. “We have certain requirements for prosthetic insurance, but insurance companies have become very sophisticated. They are betting on you to give up. Insurance companies still refuse to cover even microprocessor-equipped knees, Johnson said. This technology is already twenty-five years old. He and his team were considering trying to redesign microprocessor-controlled knee joints to make them more accessible to many patients. They assumed that in the not too distant future, insurance companies would find new ways to thwart their efforts. Says Johnson: “They would just lock those knees.”

This article was supported by the IEEE Foundation and a John C. Tenzer Fellowship Grant.

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