The increasing cost effectiveness of 3D printing sets the stage for disrupting a decades-old process for making orthotics
By Keith Loria and Janice T. Radak
No doubt: The advent of 3-dimensional (3D) printing technology has had a major impact on the field of medicine. And it’s definitely not 1-size-fits-all: Already, this groundbreaking technology has widely led to innovations in:
- replication of tissues and organs for the study of disease, drug development, and transplantation
- development of the so-called polypill for patients who require multiple medications a day
- creation of more intricate surgical tools for custom surgery
- the speed with which some surgical procedures can be performed
- development of prosthetics that improve the lives of those who depend on them.
Additive manufacturing, or 3D printing, is a disruptive manufacturing process that is allowing existing businesses to break through longstanding performance limitations while providing opportunities for new businesses to innovate new products.1 Tracing its commercial roots to the early 1980s, 3D printing technology has evolved to include 13 sub-technologies with 7 distinct process types.2
Despite their unique technological aspects, all 3D printing works in the same manner: Products are built by the addition of layers of raw materials—unlike traditional machine manufacturing, in which subtraction is used. Given that today’s preferred method of orthotics manufacturing is the 1950s-era, vacuum-forming plastic over a positive of the foot, it’s easy to see that this is a market ripe for disruption.
What’s Driving Growth in the Orthotics Market?
Overall demand for 3D-printed medical products is expected to reach $3.5 billion by 2025—up from $713.3 million in 2016.3 Foot orthotic insoles are expected to play a major role in that global growth, with projections showing an increase from $3.18 billion in 2017 to $4.58 billion by 2023. Projections for the compound annual growth rate between 2017 and 2024 vary from 6.27% to 17.7%.4
What’s driving this expansion? The raised consciousness of America’s younger generations regarding personal health and increased physical activity is a key driver; so is the increasing availability and sophistication of fitness-tracking technology. At the other end of the spectrum, other key drivers are 1) the growth of the geriatric population as Baby Boomers reach retirement and 2) the obesity epidemic, not only in adults but in children and adolescents as well.
Where Are We Now?
“We have definitely left the ‘in the future’ stage,” said Blake D. Norquist , president and chief executive officer at Norquist Medical, PLLC, which introduced 3D-printed orthotics in 2014. “It’s pretty clear we’re still in the ‘innovators’ stage, but I believe we are at the brink of the ‘early adopters’ stage and that we will see a lot of foot experts stepping into 3D-print solutions in the next 2 years.”
“While 3D-printing technology has continued to grow in its popularity and utilization, we are only scratching the surface of what is possible,” said John Stimpson, president of Cryos Technologies, Inc. Cryos expects to be fully 3D in its partner clinics and labs by the end of 2019. Stimpson notes that Cryos only produces orthotics directly from its scanning technology system.
The key to success, according to Norquist and Stimpson, is the evolution to a completely digitized workflow that captures objective patient data and seamlessly transfers it to the manufacturing process. The simplified digital process appeals to clinicians and manufacturers, whereas individualized patient data allow for truly custom fit footwear.
Both men hope the industry will avoid 2 potential pitfalls: Cutting out the experts and focusing solely on cost.
“I don’t like the idea of consumers self-diagnosing, self-prescribing, self-scanning, and self-designing their own orthotics without any expert involvement or follow-up,” said Norquist. “Yes, it can be a comfort solution that won’t harm you, but it’s nowhere near a custom orthotic assessed and designed by a professional expert.”
“Many of the technologies and materials currently being utilized for the 3D printing of footwear products are still being chosen for their low cost and not their superior performance,” Stimpson lamented. He sees the biggest advancements coming in materials science.
“In the past 10 years, we have seen an explosion of materials available for 3D printing. The result will be stronger, lighter, and more cost-effective materials that can be utilized in ways we haven’t even thought of yet. An example of these types of developments is 3D-printed back braces being custom-made for patients with scoliosis. Ultimately, these advancements will help clinicians deliver a superior product at a reduced cost to the patient at a local level.”
And those are just the types of advancement that clinicians are seeking. Steven Jasonowicz, DPM, podiatrist with the Illinois Bone & Joint Institute, said 3D footwear has the potential to create shoes and inserts that can accommodate deformity quickly and economically—something that cannot be done easily in regular shoes.
“For example, diabetics are prone to certain foot deformities which are often difficult to accommodate in regular shoes,” Jasonowicz said. “Failure to protect a diabetic foot can result in wound and infection and, ultimately, result in amputation. 3D-printed custom footwear and inserts have the potential to help prevent amputations and save a limb.”
Jasonowicz added that it’s exciting to see the potential for new materials and manufacturing methods to address some of the pathologies that the foot and ankle specialist treats daily.
“In the athlete, it allows us to create shoes and inserts to address their specific needs and foot type,” Jasonowicz said. “It’s a difference-maker across the spectrum. I think this has the potential to change the way we currently treat patients with foot deformity.”
Scott A. Spencer, DPM , associate professor in the division of surgery and biomechanics at Kent State University College of Podiatric Medicine, said 3D footwear will offer customization for a person’s foot and how it functions, and, if done properly, will have the ability to improve function.
Look at running shoes, Spencer said: “Today, each person who buys a particular model of shoe gets the exact same properties that shoe has to offer with respect to foot function. This means for some, the shoe will be ideal, but it will be less ideal for others. Now, with 3D printing, a shoe can be customized to offer differing density materials to influence foot function that can be tailored to the individual. It will also, hopefully, mean anyone acquiring a 3D-printed shoe will be guaranteed the proper size and width for their foot—something that cannot be accomplished with mass production.”
Taking It Commercial
3D printing is already making an impact on footwear of the future. Steven K. Neufeld, MD, foot and ankle surgeon with the Orthopaedic Foot & Ankle Center, Washington, DC, points to how costly it is for manufacturers to make and store inventory for multiple lasts for shoes, along with colors and styles; 3D printing enables manufacturers to customize a shoe without the required pre-made last and colorway.
“This method allows them to manufacture shoes without the labor that was required in the past,” Neufeld said. “3D printing enables consumers to get the products that they want in a timely fashion, and it allows manufacturers to customize products without having to double their manpower and increase their labor.”
With a multi-billion-dollar orthotic industry at stake, many players are getting involved in 3D printing of orthotics and footwear, for medical and commercial reasons. Several big-name players and start-ups are already involved:
■ New Balance. At the New Balance Games in January 2013, All-American middle-distance runner Jack Bolas was the first to wear a 3D-printed insole, made using the New Balance selective laser sintering (SLS) process, which combined biomechanical data, motion capture, high-speed video, sophisticated software, and embedded sensors to identify what each runner needs to go even faster.5 (SLS has already been replaced by newer processes.*)
■ adidas introduced the Futurecraft in 2015, marketing it as the “ultimate 3D-printed personalized shoe.” On-line industry publication SneakerNews noted that “…the real draw here is where the Futurecraft gets its name from—the 3D-printed midsole and outsole unit. This opportunity offers a completely individual cushion and support system for every runner’s unique foot structure.”6 adidas’s concept was to use store-based, high-speed motion capture and force data to help runners understand how they run and how a custom insole can add stability and improve performance.
■ Nike is promoting “Nike: The Future is Faster, and It’s 3D,” the result of a partnership with HP.7 The focus is on rapid prototyping capabilities for improving the performance of individual athletes. Nike is looking not only at insoles but also using computational design to create custom 3D fabrics for uppers as well.
*See “Digital Process + Technology + Podiatric Expertise = Future of Orthotics,” page 33.
■ Feetz. And then there’s Feetz, calling itself the “Digital Cobbler”—a small, California-based business selling customizable 3D-printed shoes online using mobile technology and 3D printing.8 The company’s SizeMe technology assesses 5000 measurements of the foot using data gathered from 3 pictures taken with the customer’s cellphone camera. The company claims that its shoes are good for the industry standard 500 walkable miles, and that customers can simply return them and Feetz will take care of recycling—a service that appeals to younger consumers.
“Eventually, it is expected that 3D printing will be available for people to have in their homes and it will become much like Amazon,” surgeon Neufeld said. “Once materials improve for orthotics, we will be able to print out orthotics for patients while they wait, and this will decrease wait times for products and enable us to help more people. There are already manufacturers out there that 3D print orthotics, but the materials are still very stiff. It takes time to receive the products and adjusting the products is still more difficult.”
Podiatrist Spencer noted there are already several companies that will custom 3D-print shoes for a person, or will fabricate custom insoles for people utilizing 3D printing; however, cost is still holding the practice from becoming widespread.
“It is still not cost effective to 3D print shoes or insoles,” he said. Another sticking point, he noted, is the time it takes to 3D print; people not familiar with 3D print manufacturing confuse it with printing a document at home and are surprised—negatively—by the amount of time it actually takes.
Custom Fit for Pedal Pathology
Still, Spencer said, 3D printing has the potential to revolutionize the way doctors manage pedal pathology—not only from a standpoint of customization, but from a cost-effective standpoint.
“In the next 10 years, the day will come that a patient will come into a podiatrist’s office, be evaluated, and a scan of the patient’s foot will be sent directly to a 3D printer and, based on the exam, a truly custom foot orthotic will be printed to impact the patient’s foot in a way that we may not be currently doing,” Spencer said. “Or a diabetic patient will be evaluated and, ultimately, a scan of this patient’s foot will be sent to a 3D printer to fabricate custom shoes and custom insoles to protect and improve foot function.”
Marcia Graddon, ATC, BOCPD, certified athletic trainer and pedorthist at The Orthopaedic Foot & Ankle Center, noted that 3D printing for footwear is important because it is going to give consumers better-fitting products, faster, as they will be custom-made for the wearer.
“Until now, people had to fit within a standard to buy footwear, or they had to spend a fortune to have their shoes custom made. Many of those shoes are not attractive and this discourages people from buying what is needed for their problems,” she said. “This is going to help our industry, because people will start wearing shoes that have a better fit, ultimately decreasing foot problems due to ill-fitting footwear.”
Price Is a Barrier (But Not for Long)
Because of cost, only a select few are able to afford 3D-printed shoes at the moment. As the industry grows and technology improves, however, these products will become readily available.
“3D printing is the future—not just in shoes but in the medical world in general,” Graddon concluded. “It is a growing industry where the possibilities will be endless. While currently the costs of the equipment are well beyond the range that most people would be able to obtain, a good printer eventually will become a household tool.”
Keith Loria is a Washington, DC-based freelance writer. Janice T. Radak is Editor of LER: Lower Extremity Review. Manufacturers cited here did not create or approve this copy.
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- Nike. At Nike, the future is faster, and it’s 3D. Press release. May 17, 2016. https://news.nike.com/news/nike-hp-3d-printing. Accessed December 31, 2018.
- Feetz. Our story. https://www.feetz.com/Custom-Fit-Shoes-Our-Story. Accessed December 31, 2018.