3D Printing Diversifies for Success

[caption id="attachment_257784" align="aligncenter" width="271"] A technician works with FDM printers. Photograph courtesy of Ascent Fabrication.[/caption] Different methods, different needs As 3D printing in O&P continues to gain traction, new and potential users bring a diverse list of needs to the table. To discover how users and providers of 3D printing are adapting, we consulted clinicians and technicians who have recently begun adopting the technology, early adopters driving the changes, and central fabrication providers who are incorporating it into their businesses. Previous doubts about the suitability of polypropylene and related materials to print a definitive weight bearing prosthetic socket are being replaced by other concerns. Chief among them is the educational challenge. That Intimidating Learning Curve Ben Jameson, CP, Jameson Prosthetics, South Carolina, recognized that 3D printing was the next big thing, but “when we don’t learn it in school, it’s hard to find resources elsewhere. I spent hours on YouTube, watching Limb & Lattice and Meshmixer instruction—I literally bought the book 3D Printing for Dummies. ” Craig Saravo, LP, ASAProsthetics, Texas, had similar technical concerns after discussing printer possibilities with vendors at an American Orthotic and Prosthetic Association conference and purchasing his printer from Filament Innovations. “I’m a smart guy, retired Navy, into technical; I can figure this out! That’s what I thought. Mike Gorski at Filament Innovations recommended someone to help set up the printer and share some ideas, and I’m grateful, because I hadn’t really thought it out. It’s not like a regular printer that you just plug in, load your doc into Microsoft Word, then hit print. There’s a lot that goes into setting that up. “Then there’s the learning curve of the printer—that’s not something that should be taken lightly. There’s also the learning curve of the software. Not everybody is CAD oriented, not a lot of people are going to be able or have the patience to do that.” Scott Allen, CP, Fitwell Prosthetics, Utah, also reports that “trying to learn it on your own is complicated. I took some courses online; I downloaded some YouTube videos. Yeah, there is a learning curve, and I’ll be honest, it takes some effort to learn how to do it. But just like anything else—once you learn it, it becomes easier and you’re able to do more things with it.” Jameson realized that he needed help and had to invest time to get it: “I’m spending all this time trying to learn—the time that I spend trying to figure it out on my own could be time well spent already knowing how to do it and implementing it at my clinic.” [caption id="attachment_257785" align="alignright" width="250"] An FDM 3D printer at work. Photograph courtesy of Ascent Fabrication.[/caption] What makes accepting and learning the new process so difficult? Joe Fairley, Ascent Fabrication, agrees that although the rate of acceptance is increasing, time is still a problem. “In most cases we can start someone off with a $250 printer and get them printing some devices in-house relatively quickly. So it’s not so much the hardware that’s the deterrent now; it’s just the amount of time dedicated to learning this.” Depending on the complexity of what users want to accomplish with their new technology, there are further challenges in working with some of the available O&P software applications that “are not quite there yet in terms of designing devices,” he says. Digital files of clinical modifications to scans that reflect a history of volumetric changes to a patient’s limb have been helpful in support of insurance claims, he explains. Replicating this within the 3D printing arena presents challenges, however. “But since 3D printing has come into play, we’re now having to design a negative shape of the socket or the orthosis instead of designing a positive shape from the limb shape in the usual manner, by just exporting that modified file from any of these softwares that would otherwise go to a carving machine during the traditional CAD/CAM process. At this new stage of CAD/CAM, where we have to create these negative shapes, there are very few softwares out there that do this very well, in a time-sensitive way. This can be intimidating to potential adopters of the additive process.” Brent Wright, CP, BOCO, cofounder and designer, Advanced 3D, offers other explanations. “In the orthotics and prosthetics industry we’ve been very good at winging it. We joke that ‘You know you’ve made it with traditional fabrication when you’ve made a mistake but you can still make it work.’ “With traditional fabrication you do have a lot of grace when you fabricate something. That grace is not extended to you when you digitally fabricate it. I believe this is why there’s a fear of moving into the digital fabrication realm. People are used to having the crutch that they can make anything work. With digital fabrication you have to be very intentional from the outset regarding what you make.” Another possible obstacle to acceptance of 3D printing is the potential inability to implement the technology on the right patient, suggests Curt Bertram, CPO, FAAOP, chief clinical officer, O&P Insight. “You have to be very specific not only regarding the patient that you’re using it on, but their level of financial coverage. Reimbursement can be a barrier to using new technology if it’s a noncovered item or not recognized by the insurance as experimental investigation. If you can’t or may not be reimbursed for providing it, you probably won’t do it.” The Mentoring Solution Fortunately, there are a number of knowledgeable sources to guide new and potential adopters around the complexities and pitfalls. In addition to offering central fabrication services of the 3D printing variety, Ascent also provides fused deposition modeling (FDM) printers and a course of study that includes ongoing future mentorship. Fairley has educated 15 new 3D printing adopters over the last two years, beginning with two days of intensive on-site instruction. “I find that learning in person is way more effective than only doing something virtually. Because it’s not just the software, it’s how the software interacts with the printer.” His students learn all the software steps, then all the hands-on 3D printing steps and postprocessing, printing the user’s choice of test sockets, flexible inner sockets, protective covers, upper- and lower-limb orthoses or TLSOs, followed up by ongoing virtual training to sharpen software skills. “Workflows are laid out step by step, so people with basic computer skills are able to follow them in Autodesk Meshmixer, and everything done on-site is recorded for their later reference.” During his initial training, Saravo focused on the software, while his technician concentrated on the hardware. They began with a very basic check socket, while Fairley introduced them to software, materials, and other designs. “It took a year and a half,” says Saravo, but since then, a lot has happened, and our business has become so much more efficient and able to provide a better product to our patients.” Jameson recalls looking for a central fab two years ago and reaching out to Fairley as he started offering this 3D printing course. “He coached me through the total basics—how to take the scan, orient the scan, and follow the process, paralleling our familiar process of prosthetics as far as casting and filling the plaster, and pulling the check socket. “Although it was daunting at first, you can equate all those traditional steps into digital steps and learn to do the workflow digitally. The best thing was we grabbed a real patient I was actively working with and took the scan from top to bottom. We just pulled it up and went through it from beginning to end.” The one-on-one of that coaching relationship continues, as Jameson acknowledges the value of having an expert problem-solver on call. “You’re going to run into hiccups,” he warns. “I was running some basic 3D printing stuff a few days ago where I couldn’t get the print to adhere to the bed. I just reached out to him with a quick little text at the last minute, and we got the job done and I was able to get it to the patient.” The Protosthetics Galileo program is a collaborative model that offers dedicated onboarding and ongoing support in a different format, stressing customization and flexibility. Protosthetics CEO Darren Jacoby explains that while their Galileo 3D printer kiosks are located within their customers’ offices, “Our Galileo program is unique in the sense that we offer all the services of a CFab, where the clinics can use their own design tools, or they can scan at any point in the process and work with their dedicated design team to get a final product that meets each clinician’s requirements. “What folks like about the Galileo program is the knowledge that they can start with the technology, and they’re going to get a working product from day one. After initial training with our customer success team, they can experiment and make adjustments to their digital flow at their own pace through our web-accessible portal and awesome customer success team. “Many people are starting to see the value in simplifying ‘going digital’ by bringing on a full-package solution that seamlessly integrates the hardware, the different materials, and the processes that have all been tried and tested.” Jacoby points out that 50 years ago, O&P practitioners were building their own products end-to-end before they began relying more on technicians. “What we’ve seen is there’s really a space for a digital technician. Not every single part of the process going through design and fabrication requires a clinician to be hands on; there are other things to do in running their clinics and businesses. So for us, the idea that [working] with a digital tech going forward is a good allocation of labor, just like they found a great spot for physical technicians in the office.” Keeping Up With Evolution [caption id="attachment_257786" align="alignleft" width="300"] Quorum Prosthetics utilizes MJF technology to produce 3D-printed Quatro sockets, developed by Johnson. Photograph courtesy of Quorum Prosthetics.[/caption] Since the technology is changing almost daily, investing in a state-of-the-art 3D printer that might be obsolete within a year is a realistic concern, some say. Some manufacturers of the printers, like Jacoby, however, stress that updates to their printers are provided at no cost. According to Joe Johnson, CP, owner, Quorum Prosthetics, Colorado, “3D printing is the future of O&P.” A champion of the latest in prosthetic technology—some of which he developed himself (the Quatro socket design)—Johnson continues to work in collaboration with HP, utilizing their Multi Jet Fusion (MJF) printer as they pursue evidence to support the weight bearing capability of their 3D-printed prosthetic sockets and strive to develop a socket standard. Their recently released partnership study, “Carbon fiber vs. printed with HP Multi Jet Fusion (MJF) technology and HP 3D High Reusability (HR) PA12 material,” confirmed that 3D-printed definitive sockets are safe for patient wear. 1 Since testing protocols for sockets had not previously existed, the design of the testing methodology posed a challenge. Sean McClure, R&D engineer and director, Quorum, warns in the white paper, “[Custom total sockets] are custom to the individual and not an ‘off-the-shelf’ product that is mass-produced in the same way or with the same level of control as the other components. This nature makes it impossible to standardize and regulate the design and fabrication of such products.” This challenge and related exploration of the thoughts behind the study, reaction to its results, and future research implications are addressed in the HP Webinar “Socket Showdown: 3D Printing vs. Traditional Socket Fabrication Methods.” (To view the webinar, visit reinvent.hp.com/us-en-3dprint-socket-showdown-opwebinar.) Interestingly, Dustin Kloempken, 3D MJF printing application engineer, HP, notes that Invent Medical also participated in the webinar. “They used the same patient data (i.e., the same limb shape) to create their own socket, known as the AUGO socket, and conducted tests similar to HP’s. 2 The lifelike limb Invent Medical used in their testing mechanism better simulates real-world conditions, since bodies are ‘squishy.’ The dental cement limb used in our HP study exerts more force on the socket, causing it to fail sooner than it would in practice. Their results are arguably more realistic and reflective of a patient’s experience. “From this, one can see how a carbon fiber layup design compares to a digitally equivalent MJF-printed socket, as well as how two MJF sockets with the same patient data but different designs compare. “Overall, the results are promising and somewhat surprising,” Kloempken says. “From an industry perspective, we still don’t fully understand what defines a ‘quality’ socket; thus, this information can be interpreted in various ways depending on one’s perspective.” Focusing on the logistical advantages of serving patients with MJF technology, Johnson says, “My tech takes 16 hours to produce a carbon Quatro socket. The MJF printer can print it in two and a half hours. In the future—even within the next year—automation will be able to produce the same socket in just a few minutes. It’s not the printing—but the engineering—that’s making the difference.” Quorum is also printing flexible inner liners for hybrid sockets. “These liners are made using TPA or TPU,” he explains. “But for those who have previously relied on the strength of carbon, and are uncomfortable without the confidence, we can also print a carbon fiber insert for that sense of security that carbon gives them.” Also new in the printer materials arena is a copoly polypropylene called CPX. CEO Mike Gorski, PhD, MBA, founded Filament Innovations in 2015 as a manufacturer of 3D printers, and recently also added materials manufacturing. “We got pulled into the prosthetic industry by Brent Wright, one of our first customers. He asked if I’d ever tried printing a prosthetic. Never thought about it; didn’t know what to do.” In 2017-18, however, he partnered with Mitsubishi Chemical Group in developing a material for prosthetic sockets. “At the time check sockets were being used a lot with PetG for 3D printers. But we wanted to go beyond that with Mitsubishi Chemical Group, to a preparatory socket that’s copoly polypropylene, which we developed using a proprietary material called CPX. We are preparing the commercialization of a new material, called CPX-KyronMAX, which is designed to be a long-term use socket material.” He expects two new CPX formulations for definitive socket applications to be available soon. [caption id="attachment_257787" align="alignright" width="300"] Rustin Hughes, an active adaptive athlete, dons his 3D-printed definitive socket. Photograph courtesy of Quorum Prosthetics.[/caption] “We are hoping that Filament Innovations has the first FDM printer hardware and the filament to be able to create a definitive prosthetic socket. Our Icarus 3D printer is designed specifically for the prosthetic market. Most of our customers use it to print their sockets, either check or preparatory, and the ultimate goal is to be able to move into definitive. If we can accomplish our goal, then printing a definitive socket will only take one to two hours, and cost around $50 in materials. The hardware is designed for high-flow 3D printing, with larger nozzles that can deposit more plastic faster. Typically sockets in our machine take one to two hours to print, and most of our customers manually postprocess the socket in about 15 minutes. So it’s probably two and a half to three hours from the time they click print to the time it’s ready to fit onto a patient.” Design is critical, he warns. “You could have a half-million-dollar machine, but if you don’t have a design for it, it’s not going to work out too well. We have some customers to whom we recommend designers for the sockets—some want to bring it in-house and do it themselves, and for them we suggest the Orten software from Proteor, a design program that’s really popular with our customers. Their software for prosthetic sockets makes it really easy to scan and modify. And Rapid Plaster design software from PVA Med can now be used for any printer.” Design—Key to Success Whether you choose MJF or FDM/FFM, “It really comes down to the design of the prostheses themselves,” Wright advises. “I get to see very good and very poor designs. You could take a very poor design and print it with very good material or process, and it would still fail. So you really have to have a solid understanding of design and then use the appropriate tool to 3D print.” When Kat Yee, CPO/L, clinic manager, ProCare Ottobock.care, Georgia, envisioned a possible 3D-printed solution to a unique patient referral, she needed a designer’s help and called on Wright to achieve it. The patient had experienced her very short transfemoral amputation years earlier and presented with a significant hip flexion contracture that severely limited her leg or hip extension. “I realized that her definitive socket would have to be fabricated the traditional way—by layering carbon and bonding a plate in the right position. It was going to be really heavy and was also going to require a number of offset plates to get her weight line where it needed to be in order to accommodate that flexion contracture. It was going to be impossible to position the bonding plate optimally to completely accommodate her hip flexion contracture.” During lamination, accumulated resins can add unwanted weight, so a potential 3D-printed alternative seemed attractive—if doable. Her consult and guidance from Wright helped create a lightweight one-piece socket that effectively resolved the problem by using a simplified fabrication process that minimized the number of components needed to achieve the desired alignment. “I think that our industry is discovering that we can print things out of much sturdier materials than we thought,” Yee says. “And softwares are becoming better adapted to create exactly what we need to use them for. So 3D is becoming a lot more attractive. I think clinicians faced with a unique case would be surprised by the options and versatility it offers. More than likely, there’s a way to get from point A to point B even without much technology in your office.” As O&P clinicians begin serving an increasing number of osseointegration (OI) patients, there’s room for creative problem-solving/troubleshooting here with 3D printing, as well. Scott Annis, MSPO, CPO/L, clinical manager, ProCare Ottobock.care, posed a question to Procare’s Shane Grubbs, CPO/L, FAAOP: His OI patients require a custom platform for weight bearing as they go through the rehabilitation protocol. Not intended for walking, the stationary platform is placed on the ground or a scale to allow the patient to get used to weight bearing and allows integration to progress. “Some companies use a traditional stubby or side-kick foot, but those jointed feet are designed for ambulating, and are a bit more robust than we needed,” Annis says. “We had been making them out of on-hand materials—foam, soling, crepe, old pieces of Vivak plastic, but the growing number of OI patients merited an intentionally designed solution, and I asked Shane if a 3D-printed option might be possible.” [caption id="attachment_257788" align="alignright" width="300"] Prototype of a 3D-printed OI stubby foot. Photograph courtesy of Shane Grubbs.[/caption] After experimenting with different printing techniques and materials, Grubbs designed a better, lightweight, and more functional and economical solution that could be printed after hours. His stubby foot was easy to design, he says. “It looks almost like the end of a plunger; it press-fits into the pylon, and it’s soft so they can comfortably push down on it. It works so well that we may start printing those type of feet for patients when they first start walking, too.” There are an increasing number of O&P practitioners, Annis notes, that are focused on understanding the design and the material side of 3D printing; then there are others asking questions and asking what’s possible to create to fill a need. “The collaboration between those two worlds is where we end up with the things that work—or things that don’t work that are sometimes just as educational—learning steps as we make progress. “I’m by no means a 3D printing expert—but I do know how to ask questions about better ways than our time-honored traditional methods. You don’t have to be an expert to talk to the right people that can maybe make it happen.” Design using 3D printing isn’t always about making a device for a patient, Wright points out. “Sometimes it’s about making your job easier by creating a fixture to hold your tools so that everything’s a bit more organized—something that helps you save time in your laminations. It’s very low-risk, high-reward to have a 3D printer in your office to create, on the fly, these devices that help you support your fabrication and workflow—it doesn’t have to go on the patient. That’s the beauty of 3D printing. Creating an easy-to-print lab tool could be your ground floor entry; then you start moving up to do something like a finger—or a partial hand for diagnostic purposes—or something for pediatrics; building blocks that build your confidence and your skills.” Wright also recommends taking advantage of the digital record-keeping capability built into the process of 3D printing. “It remembers and creates precisely the same thing you did last time. Use the digital record to rectify mistakes as well as to make modifications to suit anatomical changes without recasting, while maintaining a helpful patient history of your work for the patient. The digital record also allows you to anticipate and plan for typical patient issues—padding or lattice structures in an area where transtibial patients can experience fibular head pressure or distal tibia pressure. The worst thing that could happen is that the patient is more comfortable. The best thing is that you give them an extended period of time before they experience pressure in those areas.” 3D Printing’s Promise: Miles to Go? As 3D printing evolves sporadically and in sometimes unexpected directions, Bertram advises caution. “You can separate yourself from your competition by being an early adopter and innovator with any new technology, like 3D printing. But as a clinician, 3D printing is less about you fabricating and more about you seeing and serving more patients, while your high-quality innovative fabrication comes to you in a box from a central fabrication facility. [caption id="attachment_257789" align="alignright" width="344"] Fairley, center, educates personnel at a client facility about 3D printing workflows. Photograph courtesy of Ascent Fabrication.[/caption] “At the rapid pace of change of the software, machines, and materials used in 3D printing, in my opinion you’re better off outsourcing rather than investing in that technology—especially if you’re small. CFab facilities or print services invest in the technology and software for you, keeping up with updates and expertise, and working with designers to achieve your objective. You can consume the latest 3D technology as you need it. And when you’re not using it, it doesn’t cost you. “Look for niche central fab facilities who specialize, so you can shop for the expertise you need,” Bertram says. “Maybe your 3D printing solution is the out-of-the box experience you are looking for. You spend more time seeing patients; that’s the central fab model.” Saravo points out a disconnect between the printer companies and the software, much of which is not designed for prosthetic applications. “The tools need to be designed for the end user—the prosthetist, with the simplicity to deliver the product. They’re trying to get it together, but the software is still lacking. Joe Fairley is on the right track, working to incorporate all the complexities into one software suite that you load up, do your modifications, then you hit print. Once that happens, I think it will be available for the masses—and I think we’re getting there.” Frank Snell, CPO, FAAOP, president and CEO, Snell Prosthetics & Orthotics, Arkansas, heads a century-old family-owned business built on a philosophy of “the latest in technology, the best in care.” “But in the world of 3D printing, we have been cautious,” he says. He’s explored 3D printing connections, but found them lacking: A diagnostic socket, printed to his specifications, took four to six hours to make out of filament, while “my technician can turn out a test socket in less than 45 minutes out of a totally clear material, where this filament material is translucent—you can’t see through it. So it’s not really as good as what we make in less time. And there’s no cost saving with that at all.” He shares the opinion of some in O&P that “3D printing is just not ready for prime time.” But since an opportunity has recently arisen for Snell P&O to create cranial remolding helmets for a children’s hospital, and he is aware that the latest in helmet technology is 3D printing, Snell is launching into an additive opportunity teamed with Invent Medical, experienced fabricators in this area. “There are some items that central fabrication laboratories can 3D print, and because I’m purchasing through a laboratory, I don’t care how they make it—as long as I can get a quality product in the end,” he says. Judith Philipps Otto is a freelance writer who has assisted with marketing and public relations for various clients in the O&P profession. She has been a newspaper writer and editor and has won national and international awards as a broadcast writer-producer. REFERENCES Carbon fiber vs. printed with HP Multi Jet Fusion (MJF) technology and HP 3D High Reusability (HR) PA12 material. https://static1.squarespace.com/static/620bd59129cd766e1c41d5f5/t/65cf9f052561680ccd85ffaf/1708105480822/HP_Socket_Testing_PA12_Material_White_Paper.pdf Mechanical testing summary 3D printed transtibial socket Invent Medical. https://augosocket.com/study/mechanical-testing-summary-augo.pdf .

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Tectonic Changes in Ukraine’s O&P Industry

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