Creating Optimal Orthotics and Prosthetics: A Case Study

The global orthotics and prosthetics (O&P) market was estimated at $8.15 billion in 2017. That number is rising worldwide every year due to an aging population, an increase in sports- and fitness-related injuries, as well as a growing volume of diabetes-related amputations and bone cancer. By the year 2050, the number of people age 60 and over is expected to double, soaring from 962 million in 2017 to 2.1 billion in 2050.
 
As demand for O&P products climbs, government medical plans and insurance companies have been scrutinizing claims more closely, not simply paying out as they once did. What this means for O&P specialists is tighter margins and a focus on delivering solutions both in great demand and not available over the counter.
 
One such O&P practice is Hagen Orthotics & Prosthetics of Willmar, Minn. The owner, Warren Hagen—a combat veteran and certified orthotist and pedorthist—has made it his focus and passion to deliver the very best O&P solutions to his patients. He believes technology plays a crucial role in this, because what has worked for many years is not always what works best. On a day-to-day basis, with his close involvement during every facet of his practice, he’s always looking for ways to make their products and service better than they were the day before.
 
Which brings us to 3D scanning. What would have only been a sci-fi fan’s dream a few years ago has today become a reality. Patients sit down, relax, and have their legs, feet, arms, or other body parts scanned with a handheld 3D scanner. This usually takes two to five minutes. The scans are then converted into 3D models destined for either a 3D printer or a specialized router that “carves” orthoses out of EVA foam and other materials—all accomplished in the office. The system offers exceptional levels of precision, cost savings, and quality of product.

“With each of the steps from scanner all the way to using the router, the time savings is at least 30 percent,” said Hagen. “In the long run, total savings in costs have been well beyond 30 percent.”

It wasn’t always this way; the office staff had used various 3D scanners over the years, yet after careful research, they finally settled on Artec Eva and Spider—two professional color 3D scanners well-known for their use in the medical and scientific fields. Both scanners use 100 percent-safe structured light, making them ideally suited for the medical field.

“Each of our Artec scanners provides us with the level of ability to produce incredible models to work with,” stated Hagen. “Eva is the best for working with larger body parts, and Space Spider is perfect for cast models and smaller, more detailed projects.”
 

When it came to designing O&P products in the past (prior to 3D scanning), the process primarily consisted of using plaster and fiberglass to make casts. While these technologies are certainly still an option if needed, they are messy and time consuming. Plaster casting takes, on average, 200 to 500 percent of the time it takes to perform a precise digital 3D scan (two to five minutes for a scan versus ~11 minutes for a cast). Cost savings are equally noteworthy, with an average cast costing more than $50 in materials, plus labor costs associated with its creation. In contrast, the cost of a 3D scan is several dollars.
 
“Many of our patients are elderly, and having to sit still for a cast is not something so comfortable for them,” explained Hagen. “That’s where Eva and Space Spider really shine…having to sit still for just a couple of minutes makes a big difference in their comfort level.”
 
In recent years, the increase in patient satisfaction has climbed from “satisfied” to “devoted.” “Our patients quickly see that this is simply not something they can buy over the counter…it’s a custom product designed exactly for them, created to perfectly match their anatomy and their lifestyle, and it’s going to last them a long time. Mobility is so important, especially when we get older. And we’re giving that back to them, with real comfort. They’re telling their friends and family about this,” said Hagen.
 
The following illustrates the process for capturing the patient’s information and the fabrication of the cast. First, the patient arrives and is evaluated, which involves a physical exam, patient history, etc. The patient’s arm, leg, or other body part is scanned with either the Eva or Space Spider; the scans are then stitched together and processed into a 3D model in Artec Studio. With a foot scan, the model is sent as an STL file to Fitfoot360 (a custom orthotics design program); for other body parts, Meshmixer is employed. Following that process, the 3D model is sent on to Aspire software to prepare the 3D model for carving, then on to the Freedom router for carving. The final 3D model can also be sent to Simplify for 3D printing.
 
 
In the case of an orthosis, after carving, the top cover is glued on and the product is taken to the patient for fitting. Using 3D printing, the practice is also designing and creating braces for legs, wrists, feet, and hands.
 
“The level of precision we’re talking about is unbeatable, and the fact that we can deliver it every time, without question, is something we just can’t ignore,” said Hagen, “And scanning with Eva and Space Spider is as easy as 1-2-3, where you see the scan right there on the screen in Artec Studio, so you know exactly that your scan is capturing all the data, because you see it happening in real time.”
 
 
They have also been using Eva and Space Spider for a process they refer to as “Shell Offset.” This entails scanning the specific body part, such as an arm or leg, and then sending the 3D model over to a program such as Meshmixer. For example, if a patient has broken her right arm, her left arm is scanned with Eva (Space Spider is used for smaller body parts) because the left arm is the straight limb. In the software, this limb is then “mirrored” to now look like the patient’s right arm. This creates the desired level of symmetry between both left and right arms.
 
From there, the 3D model of the new arm is modified to remove any defects or to add buildup in boney areas or near joints. This is to add comfort spots to the brace after it is printed. Following this, the “shell” is created by making a digital copy of the arm and increasing the offset in size to the desired thickness. The size of the 3D digital limb is enlarged in x, y, and z coordinates. Then, both the modified limb and the shell cover are selected in the software to make the hollowed shell/brace cover by using the Boolean Difference edit command in Meshmixer.
 
“This is how we create a perfect shell, cover, casing, etc.,” explained Hagen. “We also do a few things like building up key areas of the brace to reinforce against breakage, and we also use the software to cut and trim areas around the brace so that the patient can more easily remove the brace. Then we send the brace over to our 3D printer.”
 
“Our braces are designed to last many months, if not years, depending on patient use, design of the brace, and materials used,” he added. “Obviously a grandmother and a 320-pound linebacker are going to need different kinds of braces, and we’re happy to say that we can give them, or anyone, exactly what they need, each and every time.”
 

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Andrei Vakulenko is the chief business development officer at Artec 3D. Prior to this role, he was the company’s vice president of new markets. Vakulenko has over 13 years of experience as partner, CEO, and co-founder of high tech venture businesses from seed investments and incubators to venture funds management. Projects focused on IT and internet business including SaaS, mobile, e-commerce, community building, recreation and travel, biometrics and pattern recognition, e-passports and machine readable travel documents, as well as optoelectronics and gas-to-liquid technology.