Disruptive and Constructive: 3-D Printed O&P Devices Gain Momentum

The potential to take design to a new level is within reach thanks to 3-D printing. Once seen as an innovative way to create prototypes, the technology is now finding its place across several fields within the health care industry, with physicians, clinicians, researchers and hobbyists finding ways to turn designs into objects that make patients’ lives easier.

This is largely in part to the increasing affordability of 3-D printers, according to Mark H. Michalski, MD, from the Investigative Medicine Program in the Department of Diagnostic Radiology for Yale University School of Medicine in New Haven, Conn.

Models, organs, cells and devices

“Just about every field of medicine is exploring 3-D printing,” Michalski told O&P Business News. “Right now the most active areas of clinical medicine that are utilizing 3-D printing are usually procedural or surgical fields … Basically any time you need a better representation of a particular patient’s anatomy, that is a place in medicine [in which] you could use 3-D printing.”

Physicians and practitioners can create 3-D anatomical models that allow them to better plan for surgery and treatment. Michalski and co-author Joseph S. Ross, MD, in a study published in the Journal of the American Medical Association posit that the use of 3-D models could reduce operating room time and improve surgical results because the models – created from preoperative imaging data – can be used along with computer programming to generate surgical plans. These models can help students to better visualize normal anatomy versus pathology. Michalski said 3-D models also can help bridge the communication barrier with patients facing complex medical issues.

Cover_image_LIM Innovations

Source: LIM Innovations

“One very exciting thing to me is that [physicians and practitioners] can potentially use these models to demonstrate what is going on to the patients,” he said.

Of course, 3-D models are just the beginning. Recent innovations have led to 3-D printed devices, cells and even organs. Organs created through 3-D printing can be used to test potential drugs or to test organ regeneration ideas, while devices such as prostheses and orthoses can easily and inexpensively be adjusted for size and fit. These new options allow objects to be tailored to a patient’s anatomy.

Mark H. Michalski, MD

Mark H. Michalski

“It is certainly helpful that clinicians can start working with these devices and exploring their utility. 3-D printing is a wide open field and there is a lot that we can do with it,” Michalski said. “But I think the nice thing about decreasing costs of 3-D printing is that [3-D printers] become commodity instruments. They are in the hands of the patients.”

He added, “Increasingly patients are owning their own health care and are responsible for their own health. I think that is a great thing, that the doctor is becoming a partner in it and that innovators are finding ways to solve the problems of their own health and the health of those around them. I think 3-D printing is a way of empowering those types of people.”

Increasing accessibility

Nowhere is this new accessibility more evident than in the field of O&P, and the most well-known organization putting 3-D printed O&P devices into the hands of patients and their families is e-NABLE, the online network that connects volunteers with (mostly young) transradial amputees to create customized 3-D printed prosthetic hands for children who need them.

The e-NABLE community has grown exponentially since the creation of that first prototype, and held its first conference on 3-D printed prostheses in November 2014, which was attended by more than 400 people, according to Jen Owen, a founding member who voluntarily maintains e-NABLE’s website and blog.

“We sent about 20 to 25 families home [from the conference] with hands that they assembled themselves and we had at least 125 medical professionals who assembled hands that day as well,” she said.


Creating lasting partnerships

Forging relationships with prosthetists was one of the goals of the conference, and Owen said e-NABLE will continue to work toward this.

“We hope that in the coming months we can start to get more prosthetists involved in figuring out how they can create these [devices] for patients,” she said. Additionally the e-NABLE community continues to expand outside the world of O&P.

Jon Schull, PhD

Jon Schull

Jon Schull, PhD, founder of e-NABLE and Research Scientist in MAGIC (Center for Media, Arts, Games, Interaction and Creativity) at RIT, said that while the future of 3-D printed prostheses has yet to be determined, one thing is certain: “We absolutely are willing to work with medical professionals,” he said.

Schull noted that what he calls an “inaccurate cliché” has come to prominence, namely the idea that 3-D printed hands are replacing $40,000 devices.

“It is not really true, and we do not mean to be saying that,” he said, adding that one of his colleagues, a prosthetist, creates a “Cadillac of body powered hands” that retails for several thousand dollars and is attached to insurance, a warranty and prosthetic care. “They are not really comparable.”

Owen added that e-NABLE’s primary purpose is to aid children and their families who are part of an uninsured and underserved population.

“Children are growing so fast. Being able to print them a new device every 6 months for less than what it costs to take a family of five out for burgers and milkshakes is a blessing for many,” she said.

Using technology for good

Working with or just learning about e-NABLE has inspired people in different ways based on their interests and capabilities.

“We have a bunch of humanitarian offshoots happening – teams heading to Kenya and Haiti and some Boy Scout troops in Baltimore are now making hands and arms to send to various clinics and hospitals in underserved areas of the world for children who have lost limbs due to war, disease or natural disasters,” Owen said. “We have gotten more interest from high schools and universities who are putting e-NABLE hands into their classrooms as part of their curriculum in STEM classes.”

Claire Gutermuth

Claire Gutermuth

Claire Gutermuth, a student majoring in psychology at Davidson College in Davidson, N.C., found a new career path after discovering e-NABLE during an internship at The Tech Museum of Innovation in Silicon Valley, Calif.

“They taught me how to 3-D print on my first day there,” Gutermuth said of the museum. “I thought the technology of 3-D printing was cool, but I wanted to see it do something useful. I had been kind of searching the Internet looking for things that would really be impactful that could be 3-D printed, and that is how I found [e-NABLE].”

After creating a prosthetic hand from an e-NABLE model she found online, Gutermuth displayed the model in the museum and was soon recruited to create a hand for a 9-year-old girl. She continued to work with e-NABLE and has since created another 3-D printed prosthesis.

Gutermuth is envisions the future of 3-D printed devices as a form of humanitarian aid.

“One thing that I am excited for that I have also been doing a fair amount of research on is the implications of the developing world, because there are so many problems [from] lack of materials to lack of trained personnel that can fit these properly. I think if you can just have a [3-D] printer on site it can solve so many of those problems. [In] some places their wait list just to see a doctor – not even a trained prosthetist – is over a year. If you can just get somebody in to do a 3-D scan of their limb and have it printed out on site for a very low cost, you can solve a lot of the issues in getting people in developing countries these devices,” she said.


Creating a new industry

But 3-D printing is not stopping with humanitarian aid. A number of technology based companies are pointing to 3-D printed devices as the up-and-coming market in O&P.

Keith Weber

Keith Weber

At VixMed-3D, Keith Weber, innovation and 3-D engineer and Tom Most, lead CP, are working on arm prostheses as well as custom fitted limb covers to allow better integration with generalized prosthetic limbs.

“Companies still seem to be hesitant to convert to 3-D or additive manufacturing, likely because of the lack of training and education, but other individuals are … incorporating it into their practices. We are getting a lot of requests to make parts and devices for practitioners, so it is slowly filtering into day-to-day practice,” Most said.

According to Dima Elissa, ProofX, LLC CEO, the company has branched off to form a second company, VisMed3D, with the slogan “printing for the future of 3-D health,” to meet the need of this new field.

“Surgeons and health care providers are now seeing measurable benefits and value in patient outcomes as a significant variable to reduce health care costs,” Elissa said, adding that she sees the spread of 3-D printing through O&P as another way for practitioners to customize care to patients’ needs.

“Technology is rapidly changing,” Weber said. “This miniaturized CNC (computer numerical control) technology is localizing production. I see the tools as being an upgrade that replaces existing mass manufactured parts, giving the client a better experience. The closest analogy I can think of is a shoe cobbler that built shoes with only hand tools vs. a modern day shoe shop that has a band-saw, drill, sander, vacuum molder and electric sewing machine. Between the two shops, the process overview is the same, the skill sets differ a bit and the end product differs a lot in the speed and quality.”

Next steps for O&P

Prosthetic hands are becoming more popular and well-known, but continued innovation is leading to more and more O&P devices that can be created through a 3-D printer. Practitioners and in some cases patients can now purchase or create their own 3-D printed orthoses including insoles and back braces, and recently Pratt Institute student and budding designer William Root announced the creation of the “Exo-Prosthetic” artificial leg, which he can print in exoskeleton form using laser-sintered titanium. Many companies also are beginning to explore 3-D printed prosthetic components.

Mark S. Hopkins, PT, CPO, MBA

Mark S. Hopkins

“I think there is great potential,” Mark S. Hopkins, PT, CPO, MBA, CEO and president of Dankmeyer Inc. Prosthetics & Orthotics, told O&P Business News. “Probably two things will happen [in the future]. One, local providers will probably have a small [3-D] printer as part of their set of tools … We will use that for small jobs because small printers are cheap. We will use that for rapid prototyping, for small parts or to prototype ideas for the prosthesis or orthosis or for our own tools. That would be one model – people will have their own printers in their own offices and will use them as best they can for whatever they can get out of them.

“But then I think central fabricators are going to offer 3-D printing as an alternative manufacturing option to traditional vacuum-forming or laminating sockets or interfaces over plaster positive models of several varieties,” he added. “So the central fabricators who have large volume will come to us and [offer to manufacture the piece the way they always have, or via 3-D printing]. They will tell us [what] the benefits [are] of doing that. Some of the machines that produce high-end, accurate and durable 3-D-printed pieces are very expensive. I just do not think people who are on the front lines seeing patients every day are going to be able to afford that – they just will not have the volume to sustain it. So they will subcontract it.”


Examining patient benefit

A few forward-thinking companies already are beginning to use 3-D printing for O&P device components and challenging its utility at the same time.

Andrew Pedtke, MD

Andrew Pedtke

The team at LIM Innovations, led by Andrew Pedtke, MD, a San Francisco Bay area orthopedic surgeon, has created an adjustable prosthetic socket utilizing 3-D printed components. The socket is now commercially available.

“The ingenuity is not in the use of 3-D components but in the design that facilitates rapid and scalable fabrication with improved function and performance,” Pedtke said. The socket’s modularity combined with 3-D printing technology offers significant time advantages over those created through traditional fabrication. In contrast with the typical labor-intensive craft fabrication process, 3-D methods such as scanning and printing can facilitate socket production quickly minimizing casting and other time-consuming methods. While a typical socket takes 30 days to create, the goal at LIM is to reduce that to 3 days.

Pedtke believes that is just the beginning. “Orthopedic surgeons use more devices than most health care professionals and work closely with prosthetists, who are some of the very few [providers] who fabricate actual medical technology they deliver,” he said, “and as I see it, the challenge for our health care system is not simply making more medical devices faster and cheaper but more technology, faster and cheaper that most importantly improves function and performance.”

Both 3-D printing and traditional socket fabrication still result in a “snapshot in time” and as dynamic beings, amputees need technology that is not only rapidly fabricated but rapidly changing in form and function, he said. Thus, for Pedtke and his team, “the goal at LIM is centered around the adjustable and dynamic nature of our socket,” not just the way it is made.

However, adjustability is just one avenue of direction for socket functionality. Pedtke and colleagues at LIM focus on identifying amputee needs and incorporating them into their socket technology through a process he calls “User Generated Innovation,” which focuses industrial design and engineering efforts on purposeful solutions for amputees.

“The answers lay in the questions we ask patients, not just in the tools to make them,” Pedtke said.

One obstacle to the use of 3-D printers at O&P clinics is lack of knowledge about the devices. As 3-D printing becomes more ubiquitous and affordable, Most said O&P practitioners will need to educate themselves about the technology to reap the benefits.

“There is still a need for more training and education,” he said. “The great news is that O&P schools now offer master’s [degree] programs, but most are not yet including CAD [computer-aided design] – at least not in terms of 3-D printing – and how to use the necessary software.”

He added, “The O&P industry is still using older file formats (such as .aop) which can isolate them from newer global technologies. 3-D [printing] can help reduce costs but it will take time to help providers or organizers understand the cost benefits of adopting or switching to the newer technologies.”

Weber said practitioners should learn as much as they can about 3-D printers before purchasing one, so they can make sure the one they buy will fit their needs.

“There is a machine that is right for the challenge and there are machines that are overkill and machines that do not work in certain environments,” he cautioned. “So make educated decisions when purchasing new equipment.”

Hopkins said the O&P community’s next step is to tackle the challenge of implementation by addressing practical business concerns associated with a new technology.

“I think someone needs to demonstrate to [O&P practitioners] exactly how to use a 3-D printer in clinical practice – basic, everyday practice,” he said. “What is the bread and butter of using it? Do you purchase the printer yourself and run it yourself, or do you subcontract it to somebody else who owns a 3-D printer and they do [the printing] for you? And why? What would be the real benefit – are you going to save money, are you going to improve care, are you going to do both? I think there are a lot of potentials out there but I do not think anybody has demonstrated exactly how to integrate 3-D printing into everyday practice.”


Pedtke echoed this idea, stating, “For now, 3-D printing is still a tool in a field of many unanswered questions.”

Hopkins said Dankmeyer Inc. is collaborating with a research group to explore the options for 3-D printed devices. He also is investigating 3-D printers to potentially purchase for the office. But the most important consideration for this new technology, Hopkins said, is making sure it helps O&P practitioners better serve their patients.

“I think there has been way too much focus on 3-D printing. The printer is not the most important thing … [Practitioners may be] trying to put them into practice without even acknowledging why they want to do it,” he said. “I think the service part of it [should be] at the forefront. How are we going to provide service to patients that is better? And if 3-D printers make that happen, that is fantastic.”

Hopkins added, “It is a great tool, and I am looking forward to using one.” – by Amanda Alexander

For more information:

Michalski M. J Am Med Assoc. 2014;doi:10.1001/jama.2014.9542.

Disclosure: Elissa, Gutermuth, Hopkins. Michalski, Most, Owen, Pedtke, Schull and Weber have no relevant financial disclosures.

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