From Disruptor to Partner: 3D-printing Companies Take Their Place in the O&P Market

From industry disruptors to partnering with clinicians, manufacturers of 3D-printed orthoses and prostheses have made strides in recent years as they improve their devices and make them more accessible to patients.

Advances in printers, materials, and scanning technology mean that 3D printing is becoming mainstream in some areas of O&P, including fabrication. Device manufacturers are now partnering with clinicians and O&P professionals to help give patients the best possible experience and devices.

"3D printing is not something of the future; this is happening today. Right now," says Dr. Franziska Fuchs, LL.M.oec., CEDS, business development manager healthcare and humaneering at EOS, which produces industrial 3D printers and medically approved 3D-printing materials and is headquartered in Krailling, Germany. "The main point is to select the right technology and application for the patient."

The right application of this technology can benefit everyone, she says.

"In 3D printing, it makes no difference whether 50 identical or individual parts are made," she says. "If you use it correctly, you can produce your parts any shape anywhere and anytime. With this kind of technology, you are quite flexible."

Potential in O&P The potential of 3D printing could be enormous for O&P—which has the challenge of making devices that are standardized by design and quality while being customized for the individual patient. This kind of challenge is perfect for 3D printing, says Greg Kress, CEO of Shapeways, a 3D-printing company.

"If you don't want to be locked into a high production run or there is inherent mass customization in your design, 3D printing is by far the best solution," he says. Shapeways has been working with materials manufacturers, including EOS, to give customers quality materials to create their devices. EOS has created PA11, a biodegradable nylon material derived from castor oil that has been used in many 3D-printed products, including orthoses and prostheses.

As printers and materials improve, 3D-printed devices are also becoming more affordable, Kress says.

"Every day, 3D printing gets cheaper. Every day," he says. "The quality is better and the end product is more economical than ever before."

Not only that, but printing is also great for developing low-cost prosthetic prototypes as experts go through iterations to perfect their solution.

"If you were to make a traditional part, the mold for an injection mold would cost $500,000 to $1 million and you have to make millions of parts out of that. You have to be very committed. It doesn't allow for change."

Instead, he says, 3D-printed parts can be printed at a low cost and if they don't work out, they can be redesigned and printed again. The investment doesn't have to be big. Companies like Shapeways can print the device so the O&P practice doesn't have to bear the high cost of a 3D printer.

"There's no minimum cost to get started," Kress says. "We have proven quality because we've developed our expertise. 3D printing is hard and we have the expertise to do it."

If flexibility on a project is affordable there is more room for innovation, he says.

"It's about access," Kress says. "If you were to make a big investment on your own, you'd have to pick a technology, choose material, and it would cost a lot to change," he says. "We see our customers changing technologies and materials all the time as they try to make the best products for their customers."

The ability to make high-quality, customized products easily and on a massive scale could help fill a huge need in some parts of the world, says Fuchs.

"Globally, 80 percent of the people who need medical orthotic or prosthetic devices haven't access to any service," she says. "Only 20 percent of the real need is accessed today with existing solutions. If you can bring the high-quality custom solutions to nearly every place in the world, you can help overcome this gap."

Even with this potential, there's still a lot of room to grow, Kress says. There's also a lot more people in the O&P community who could benefit from this technology and aren't utilizing it, he says.

"A lot of O&P companies are not leaning into the technology as much as there is an opportunity to," Kress says.

Changing a Bad Reputation While 3D printing can be a manufacturing solution, it is not the full solution, the experts warn. A 3D-printed prosthesis or orthosis is only as good as its design, fit, durability, technology, and the materials it is made out of.

While there is a lot of potential for good in the world of 3D-printed O&P devices, there's also room for harm, the experts warn. Since it can be so easy to make devices with 3D printers, there have been a lot of substandard devices made by hobbyists and given to users. According to experts, some of these devices, distributed by nonprofits, came with life-changing promises but were not well tested, hadn't been vetted by medical professionals, and were made of materials that were not strong or safe enough.

"These downloadable designs make great STEM [science, technology engineering, and math] projects for schools, they start a conversation around design and disability, but they are not medical products," says Samantha Payne, COO and cofounder of Open Bionics headquartered in Bristol, United Kingdom. "They haven't been made with clinical input and they do not offer functional benefit. Parents are often left disappointed when they have been offered a ‘prosthetic solution' from the maker community but receive something ill-fitting and functionally useless. These designs have been shared with good intentions—we need to make sure that what the maker community is communicating matches what they're providing and sharing."

Growing concern within the O&P community about substandard devices prompted the American Orthotic & Prosthetic Association to release a statement in 2015 saying that the organization was intrigued by 3D-printing technology but was worried because many of the devices did not meet U.S. Food and Drug Administration requirements.

Unfortunately, Payne says, these bad products given to patients have made some in the O&P community wary of all 3D-printed devices.

"There's a lot of misinformation, and clinicians see that, and it frustrates them," she says, adding that the perception can hurt companies with well-researched, tested, legitimate medical devices. "We're entering the market with a device that is medical grade and personalized…. Others are getting it completely wrong and it's a bad reflection of what 3D printing can be and can offer, and that's not good."

One of the best ways to overcome this misperception is for manufacturers of 3D-printed devices to work with clinicians and let their expertise help in the production of the device, the experts say.

"In the end, the knowledge of the orthopedic technician needs to be realized in 3D-printed devices," Fuchs says. "Doing a scan is one thing, but bringing in the intelligence of the orthopedic technician into the design is important for the patient."

The ability to print the devices is ready, Fuchs says. What's needed now are the high-quality designs for those devices.

"On the manufacturing level, 3D printing is already there for the orthotics and prosthetics industry," she says. "But in the end, it has to go hand-in-hand with the orthopedic solution."

Working Together Partnering with O&P practitioners was an easy choice for Open Bionics, Payne says. Open Bionics built the Hero Arm, the first medically approved, 3D-printed multi-grip myoelectric arm. The company recently began distribution in the United States through an exclusive distribution agreement with Hanger Clinics, headquartered in Austin, Texas. To make the transradial prosthesis, Open Bionics went through years of testing and development. It had to pass rigorous quality standard tests in Europe and the United States to be medically approved on both continents.

"We spent a long time designing the product with amputees and what that enabled us to do was understand what problems there were in that space," Payne says. "An amputee can have an amazing bionic hand, but if it's too heavy and uncomfortable, they won't wear it."

Along with the multi-grip functionality, Open Bionics focused on the weight and temperature control to ensure that the Hero Arm was suitable for long-term use. In the end, they came up with a low-cost microprocessor hand that is able to be customized while still manufactured on a larger scale.

"The materials are exceptionally lightweight and we can create a completely custom socket and liner," she says. "We've been able to make the most affordable bionic hand, but in time it will become even cheaper."

To make sure it gets to as many people as possible, Open Bionics works with O&P practitioners to get the right specifications for the socket and liner. Practitioners can send in a scan of the limb or a plaster cast.

"Some clinicians really value the hands-on nature of plaster-crafting and value that one-on-one time with their patients," Payne says. "It's really down to the clinicians about what's best for their patients. We work with the clinicians to make sure we are giving them exactly what they think is best."

The company is also working to help dispel the stereotype of low-quality 3D-printed devices.

"I think there's a lot of fear of the unknown," she says. "What we've seen is that people are really unsure. It's the first 3D-printed multi-grip bionic hand.... We just hand them the device and they immediately get it. We have to see as many clinicians as possible because once they see it, they completely get it. We have some very cool champions now who are helping us to educate people on it."

For everything to come together, Payne says, "We trust clinicians to talk to users and provide an incredible experience. The clinicians place trust in the manufacturers and the manufacturers place trust in the clinicians."

When both groups work together to do their jobs well, the patients benefit, she says.

Mainstream 3D-printed O&P Products 3D-printed devices are no longer on the fringe of the O&P world, the experts say. Along with the Hero Arm, there are many other 3D-printed O&P devices that are being professionally fabricated on a larger scale that clinicians can consider in their own practices.

Lee Dockstader, who specializes in business development and 3D printing for HP, highlights a few companies that are already making a big impact with 3D printing, leveraging the company's Multi Jet Fusion technology to create new medical devices that take advantage of designing for 3D printing.

Insoles Using 3D printing for custom insoles is already mainstream, with patients able to have their feet scanned and analyzed, and to receive custom insoles within days. For example, shoe retailer Superfeet teamed up with HP in 2017 to create a product called ME3D. Superfeet customers walk on an HP FitStation scanner to have their feet and gait analyzed. The custom scans are sent to printers where the insoles are created and shipped to the customer. The medical version of FitStation is being introduced to O&P clinics by Go4-D, which is disrupting the medical foot orthotics business model by placing the scanners and software at little to no cost and just charging for the orthotics. Other companies such as iOrthotics, headquartered in Queensland, Australia, are also utilizing scanners to make custom 3D-printed insoles.

Cranial Remolding Orthoses Treating cases of plagiocephaly has long included a custom helmet which applies gentle pressure to a baby's head, eventually reshaping the skull. Sometimes the treatment is abandoned, however, due to issues associated with the orthosis, including weight, discomfort, and repeated adjustments as the child grows and the skull changes. Invent Medical, headquartered in Ostrava, Czech Republic, uses scanning and 3D-printing technology for its Talee helmet, a custom, lightweight, adjustable alternative to traditional cranial remolding orthoses. Dockstader says one of the advantages of using 3D technology in this case is that it helps the patient receive the custom device faster—before the baby outgrows it. "A lot of the use of helmets is voluntary," he says. "This is a better treatment that is more comfortable and relatively affordable."

Sockets ProsFit, headquartered in Sofia, Bulgaria, makes custom-made sockets by using a 3D scanner, specialized cloud-based design software, and high-quality 3D printers. According to company marketing materials, using their solution, a custom socket can be finished in days rather than weeks and with as little as two appointments for the scanning and the fitting. To make the socket, practitioners can scan the patient's residual limb with a relatively low-cost scanner and then modify the design using the company's cloud-based CAD software. The socket is made with HP's Multi Jet Fusion 3D printers and shipped wherever it needs to go.

"There's no $50,000 CNC and software machine to buy," Dockstader says. "You have a $500 scanner, a laptop, an internet connection, and you are in business."

The process is so easy that he says ProsFit has been sending teams to do scans in less resourced countries where the need is the greatest for prosthetic limbs and then shipping the sockets to the end user or clinic.

The Future of 3D Printing While 3D-printed insoles and sockets are becoming mainstream and there are some advanced prostheses on the market, there still needs to be a lot more research and development before more complicated devices can be 3D printed, the experts say. Payne says it will still be a few years before a quality transhumeral device is 3D printed.

"I haven't seen any amazingly good research and development for above-elbow solutions," she says. "I think it will take a while."

Solutions for lower limbs will take even longer, she says.

"For the lower limbs, it's a whole other challenge to be load bearing," she says. "I think it will be a while before we see some really good products."

Scanner technology, which has improved, also still needs to get better, she says. The process of going from scan to device remains a challenge.

"It's not seamless yet," she says. "It can be better, and I think we will see it."

Even as the technology continues, it won't take over the role of O&P professional, says Payne.

For example, while 3D-printed insoles may be enough for moderate foot conditions, a medical professional may be necessary for more serious conditions, Dockstader says.

"The vast majority of conditions are mild to moderate. Let the scanners and software do the bulk of the work and have a medical professional review and prescribe online. For chronic conditions, the patient will be referred to an appropriate specialist," Dockstader says.

Still, Dockstader says, 3D printing has come a long way.

"It's at the bleeding edge," he says. "It's all about the infrastructure, from point of care to shipping the device. Once that's in place, I think we will see a heck of an increase. It will take an end-to-end solution to get the price and adoption to change. We are very excited to see it is already happening with FitStation, Invent Medical, Prosfit, and several others and many more coming."

The potential is there, Payne says, now it's time for the professionals to use it to the best of their abilities and continue to build quality products for their patients.

"We're right at the early stages of what 3D printing is and what it will be."

Maria St. Louis-Sanchez can be contacted at msantray@yahoo.com .

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Transtibial Amputees Adjust Strategies to Maintain Stable Gait

In Memoriam: Sepp Heim

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Pediatric Orthotic & Prosthetic Clinician Department of Orthopaedic Surgery – UCSF

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