3D printing, or additive manufacturing, has been receiving significant media coverage, but the jury is still out on the effect of this technology on the O&P industry. The verdict may depend on who is on that jury, since practitioners and technicians alike have concerns about how adoption of the technology may impact their roles—and their bottom lines.
Since some O&P providers are already applying 3D printing technology to foot orthotics and prosthetic sockets, there is mounting evidence that it may change the job description for technicians, as well as the business model for central fabrication facilities. We asked industry leaders for their observations, opinions, and predictions about the potential impact of this rapidly developing production method on O&P providers and technicians and how they can prepare for a possible 3D future.
3D PRINTING ADVANTAGES
Tracy Slemker, CPO, LPO, FAAOP, president and founder of Dayton Artificial Limb, Ohio, and Prosthetic Design, Clayton, Ohio, has gained a reputation as an early innovator in the profession and was one of the first (and still only one of a few) to successfully fabricate prosthetic sockets with 3D printing. He says that there have been unexpected discoveries as his facility incorporated 3D printing and he encourages others to explore the technology. "Our O&P technicians are still doing pretty much the same thing, just using different tools; but 3D printing gives the technician a lot more possibilities and design capabilities—things they never even dreamed of."
Slemker points to socket texture as an example. "Historically the inside of the socket has always been smooth, but we're finding that by customizing the texture, making it very rough to very smooth, we can improve the fit and reduce movement that occurs between the silicone liner and/or the patient's interface and the socket wall.
"Flexibility and control in cosmetic covers, liner molds for silicone liners—we're finding out things every day that we had no idea could be done with the process. We've been working on the socket technology for about seven years, and we're also starting to work on some foot technology, as well."
Amy Braunschweiger, CO, clinical director of Infinite Technologies Orthotics and Prosthetics (ITOP), headquartered in Arlington, Virginia, has been using ITOP's 3D scanner for cranial helmets. She says she appreciates the time-saving convenience and that it takes much more accurate measurements than the plaster casting method, which translates to a better fitting helmet. She does clarify, however, that 3D scanning does not allow the practitioner to make alignment adjustments to an orthotic or prosthetic socket model, as can be done in the traditional casting process.
"Although we do have a small 3D printer on-site, we are currently only using it for smaller pediatric devices, such as prosthetic fingers, foot orthotics, and small componentry used to put together the helmet," Braunschweiger says. "We continue to use a central fab company to print the larger foam 3D models used to fabricate helmets."
IS THE TRANSITION REALLY NECESSARY?
Gary Bedard, CO, FAAOP, clinical application liaison for Becker Orthopedic, Troy, Michigan, explains the technology in barebones terms of logic and efficiency that cuts out the multiple steps of casting a negative mold to create a positive mold before creating the device. "The whole genesis of 3D printing is to make the manufacturing more simplified instead of having to go through the production of a tool, and then once you have the tool, then you produce the product on top of that tool. Now, instead of producing the tool, you'll be producing the product itself."
Some complain that the 3D print process is time-consuming. However, Bedard points out, "that time is also unattended time. You don't have to have a person monitoring the equipment in order to produce the product." Bedard first used the technology as a research and development manager for Becker in 1994. He sent the engineer's CAD design to a service bureau that fabricated a plastic prototype for evaluation, which eliminated the wait for the long turnaround of having it machined, he recalls. "Even in that era, it was faster.
"I think additive manufacturing will probably end up with a bigger footprint," he predicts, "but it will have to go through the same teething process we saw with the first generations of CAD/CAM equipment."
As predicted in 2010 ("Rapid Prototyping/Manufacturing: 'Tomorrow Is Just a Day Away,'" The O&P EDGE, September 2010), 3D printing technology is evolving rapidly. "[As] more equipment manufacturers use rapid manufacturing, the barriers to its widespread adoption are slowly coming down. Its reliability, speed, and quality are improving, costs are decreasing, and the range and durability of materials are increasing."
As a result, the impossible is becoming not only increasingly possible, but reasonable and affordable, Bedard notes, which makes it easier for technicians to become 3D literate. "We now have desktop 3D printers that you can purchase for yourself in the hundreds of dollars; they're truly approaching the price of a normal computer printer. And most technicians already have some basis in the fundamentals of computers because most people have to use word processing or e-mail or an Excel spreadsheet in order to run a lab.
"I think the bar to enter the technology is fairly low," he concludes. "As the technology progresses, then there will be companies that will be producing software not unlike what we already have in the field for CAD software."
PURSUING 3D EDUCATION
"With the O&P schools all at an MSPO [master of science in prosthetics and orthotics] level," says Bedard, "probably 30 percent of students are coming into the MSPO programs with an undergraduate degree in engineering, and those students are very comfortable with engineering software." He points out that entrepreneurial students can buy—or develop and sell—ready-made designs on websites like Shapeways, and practices can use the designs to make a molding dummy, put it on their model, and enhance their own product. This replaces a process that used to be expensive, complex, and slow.
Tom Most, CP, BFA, CAD operator and digital sculptor and designer, expressed frustration with the typically slow rate of acceptance and adaptation to change within O&P. He jokes that "one of the last technical innovations that the industry adopted was using laminated resins in the 40s. That's about where they stopped." He points out that the first commercially available 3D print technology was developed at the Massachusetts Institute of Technology (MIT), Cambridge, in the 1980s and was commercially viable in 1982. He has been active in the rapid prototyping field since the late 1980s, and is enthusiastic about legitimate recent advances in the area.
Most describes a breakthrough introduced in November 2013 when Fripp Design, Sheffield, England, demonstrated the first successful 3D print using silicone—done on a small desktop printer. The process eliminates the need to mold and cast each piece. "Do a digital sculpt of the missing anatomy, and send it to a digital printer, and have it printed in silicone—in the color to match the patient's skin."
Examples of 3D prints created for an anaplastologist. Photograghs courtesy of Tom Most.
Most, who uses the 3D process in art as well as in prosthetics, has also applied digital principles to help an anaplastologist create facial prosthetics that are more exact than the traditional hand-sculpted, hand-cast pieces. "Initial tests showed that it would probably save her about 60 percent of her time and give a much more accurate fit, because the prosthesis is based on a scan of the patient, not a cast. Whether you're an anaplastologist or a prosthetist, no matter how good you are, if you put silicone on soft tissue, you're already deforming it. And you're getting an impression of the silicone deforming the soft tissue; with a digital scan you're getting exactly what's there.
"I came into the O&P field from 30 years in rapid prototyping and wondered why they weren't using this technology," Most adds. The interest is certainly there, he says, pointing to the packed houses and standing-room only crowds at his presentations at O&P industry shows and meetings. "People want to know about it—especially the new residents and younger people getting into the field. They're all over this, but nobody's teaching it to them."
In response, Most sees the need to develop an educational module that can be dropped into any school's MSPO or technician program. "I often hear complaints that there's nothing in the budget for CAD software—so a couple of slides in my PowerPoint [presentation] are digital sculpts that I've done with absolutely free software. There's a ton of open-source code programs on the net that you can use to modify your file and get it print ready."
Bedard observes that graduates from the tech schools have some computer expertise. "Once somebody does identify a software package that's specific to O&P for using additive manufacturing, then you'll have the training programs in place to educate these technicians."
Jared Howell, CPO, director of the Master of Science in Orthotics and Prosthetics Program, and assistant professor in the School of Allied Health Sciences at Baylor College of Medicine, Houston, Texas, admits that while class time spent on this technology is limited, it is definitely being taught, and a 3D printer is available for student use on projects. "Thus far, the 3D printing of prosthetic components and parts has been presented in our program—the concept of 3D printing, the impact additive manufacturing might have on the future of O&P, and opportunities to practice and use it—to play with it, essentially."
Howell's own background in product design and development, prior to accepting the directorship of the Baylor program, helped him become "very familiar with additive manufacturing." Beyond a doubt, he says, students recognize 3D printing as the wave of the future. In fact, he says Baylor has a student who is designing a new prosthetic hand to be printed as a single piece using additive manufacturing. Refinements are needed, and students are actively working on understanding the problems and how to address them with additive manufacturing.
"There will come a day," he predicts, "where we custom design a socket, interface, and foot, literally printing it all at once. That technology may be a decade away, but [O&P technicians] need to prepare for it now by understanding mechanical design and knowing the possibilities that exist for the future. This will enable them to be early adopters and know what they need to be successful, if and when this technology becomes more readily available in our profession."
Howell advises technicians to continue to track the rapid evolution of additive manufacturing and to continue to educate themselves, utilizing the web and talking to experts in O&P and in other fields. The material is out there. "Sometimes technicians are the ones that identify the latest and greatest and may be the ones who are able to implement this technology first. Often practitioners are hesitant to try new things or put in the time to master the new manufacturing options. Well-educated technicians may be the ones to make these new technologies viable." He says he believes that "additive manufacturing is coming to the profession; technicians and practitioners alike should understand it."
"Technicians have always added creativity to projects," Slemker adds, "and I don't think that's going to change. Printing is just a tool to expand on their creativity—if they embrace it."
Bill Layman, CPO, BOCPO, and his son, Brian Layman, CP, BOCPO, of IDM of LA (Innovative Digital Manufacturing), Kenner, Louisiana, are living proof of the value of educating yourself in new technology. Their use of CAD and scanners over a ten- to 12-year period was a natural stepping stone into 3D printing five years ago—an involvement that has led to the development of new patent-pending techniques on printed sockets, and potentially performing some central fabrication work for others. Bill Layman, himself an amputee, serves as a test subject and is wearing sockets that the Laymans made using the 3D printing process, which they are continually improving. "We're still in the baby stages," he says, "but I've been wearing [a 3D printed socket] for a while, and I've had good success with it."
"We initially came across mention of 3D printing on the Internet; we already had scanners and software," explains Brian. Their experimentation led to significantly greater efficiency in other areas as well: The test sockets that used to take a week or two to create can now be done in an hour for a transtibial socket and an hour and a half for a transfemoral socket. Their carver carves out the model, they vacuum form the plastic, "and we're looking to speed up the finishing process, too—and still deliver a good product relative to alignment and shape."
A year ago they began working with Stratasys, Eden Prairie, Minnesota, to print the first few sockets with a large industrial-size printer, the FORTUS 400mc. Since then they have purchased their own FORTUS 400mc, and worked with materials such as ULTEM and FDM® Nylon 12. "What's nice about the 400 is that it is capable of printing different materials as the materials get better," says Bill. "We'd like to really perfect the in-house process before going onto the next stage [of accepting central fabrication business]," he adds.
In exploring the possibilities, they work outside prosthetics with artists and others in the community who are aware of the applications and discoveries that can be shared between the medical, engineering, food, and fashion industries. "Look up 3D printing on the Internet and you'll come across everything under the sun. [We] just want to push the envelope with prosthetics and really try to put out a good product for the patient," Brian says.
Like Most, the Laymans have accumulated a body of knowledge and unique experience and insights working with 3D printing that they're willing to share. Bill says he looks forward to making their IDM teachable system available to O&P schools.
"I think all the bigger companies are going to jump on board with this sooner or later," Bill says. "Eventually they're going to have to start teaching some more specialized 3D printing material down the road. It's coming. Once everyone sees that it can be used and it's not going to break—that it's a better way—more people are going to want to do it." Brian agrees. "It's another tool in the shed for technicians—and it's one they'll need and use."
TAKING THE INITIATIVE
Because of the affordability of entry-level 3D printers, Slemker says, "I know if I were a technician, I would have one just for personal use—[even] if I had to buy it myself. You're educating yourself. There are a tremendous amount of forums online and also on YouTube for different 3D printing techniques and applications. Get help from somebody that has a little bit of background, but if you can't, you can do it yourself. That's how we did it. Within the last few years we bought a small MakerBot® 3D printer as a training tool. It changed the culture within the organization—and made people realize that this technology is not coming, it's here."
Slemker emphasizes that embracing the technology is the most important thing. "You don't have to be the guy who knows everything there is to know about it as it relates to your field. There's going to be a lot of self-training since you're breaking new ground with implementing it in your field."
PROGRESS OR CONSEQUENCES
Most of the experts we talked with shared the opinion that 3D printing is going to be a case of "either get on the train or get run over by it." "This isn't going to go away," Slemker cautions. "It's like the cell phone—if anything, it's going to get bigger and bigger, and it's going to change the way we do business. But it's also going to open up even further our ability to customize and to design componentry. " He also sees potential for change in O&P roles. "I think the relationship between the technician and practitioner is going to change. It's somewhat like starting over again. [As a practitioner] you're going to become much closer with your technician on solving problems and issues. There's still a very significant place for technicians with skill and will."
Most cautions that "what's really going to make schools and O&P businesses sit up and take notice is when they start noticing that they're losing business to a separate franchise. I can envision a little franchise or satellite office opening up in a therapist's office, and O&P providers being reduced to just pattern-finishing the items, if not losing the work completely. When it hits us in the pocketbook, providers will take notice, but by then it may be too late."
Bill Layman worries about the consequences of inaction within the O&P profession, while less-qualified entrepreneurs seize the opportunity for profit. "There are a lot of people out there wanting to get into prosthetics because they can get a 3D printer. That's going to create a lot of issues down the road. I'd recommend that anyone with this idea should go to an O&P school…and get some engineering background while you're there.
"The things we hear out there are unreal: People with the ambition to create their own orthotics and their own prostheses is a great thing, but they need to know a little bit about orthotics and prosthetics before they hang out their shingle."
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.