More than 7 million people in United States will use orthotic devices by 2020

The University of Michigan has partnered with Altair Engineering (Troy, MI) and Stratasys (Eden Prairie, MN) to form the Cyber team, which aims to improve the design and manufacture of orthotic products. It was recently selected and funded by America Makes, the National Additive Manufacturing Innovation Institute (Youngstown, OH), to collaborate on a solution that will leverage 3D printing and Industry 4.0 to transform the design, comfort, utility and customization of ankle foot orthotics (AFO). This solution will incorporate digital design, additive manufacturing through 3D printing and leverage industry leaders at the University of Michigan Orthotics and Prosthetics Center to deliver on emerging Industry 4.0 trends.

Stress loading and concentration analysis will allow for AFO part optimization.

Orthotic products are defined as passive devices worn by people to support an injured or weakened body part. Braces are a common example, but orthotics also encompasses devices used for long-term care to address multiple impairments that may result from stroke and other conditions. As the population ages, demand for orthotic devices will grow significantly. It is estimated that more than 7 million people in the United States will use orthoses by 2020. And yet, the techniques used to manufacture these products are decades old; 3D printing and its mass customization capabilities is a perfect fit to bring this sector into the 21st century.

A blog on the Stratasys website describes the traditional process for producing AFOs. Skilled orthotists and technicians take an  impression of an individual’s lower leg with fiberglass cast tape; pour liquid plaster into this impression to create a positive model; modify the plaster model by hand to account for bony prominences as well as pressure tolerant areas; vacuum form a thermoplastic sheet around the model; and hand-trim the plastic orthosis to its final shape.

“The pain points of this process start with a typical delivery time of two to four weeks due to the skilled labor required, insurance authorization processes and the demand on this resource from the numerous patients requiring this care in orthotic centers,” write Stratasys’ Andrew Hanson, Applications Engineer, and Scott Rader, General Manager, Medical Solutions, on the blog. “The process uses a significant amount of disposable plaster materials, has limited capability to optimize the structure or the weight due to a constant sheet thickness across the orthosis and does not incorporate modern analytical techniques that ensure optimization of the strength and flex of the AFO to maximize a patient’s mobility.”

The Cyber team is improving on this process by applying additive manufacturing and creating a process to engineer and design AFOs for a specific patients. “Different amounts or types of material can be printed to provide a specified stiffness and allow areas of flexibility, based on the patient presentation,” says Jeff Wensman, Clinical/Technical Director, University of Michigan, Orthotics and Prosthetics Center. “This exciting technology opens up an entirely new tool box that the clinician can use to enhance patient outcomes.”

The project, as described in the blog post on the Stratasys website, involves automated tools that clinicians would use to create the patient’s prescription. Cloud-based algorithms are seamlessly integrated with the physical component manufacture to optimize overall part geometry and its corresponding tool-paths.

The advantages of an additive manufacturing solution include a dramatic reduction in delivery time from as much as four weeks to one day; enhanced accuracy through the use of 3D scanning; and greater design freedom, as conventional technologies have limitations when it comes to more intricate, functional designs.

Hanson and Rader write that military veterans and their families, through the U.S. Veterans Administration (VA) in Ann Arbor, MI, will be among the first recipients of this new breed of orthotics. The plan is to deploy the program nationwide to VA Orthotics & Prosthetics locations once testing is complete. According to the American Orthotic Prosthetic Association (AOPA), the use of this technology could save Medicare as much as $1.3 billion annually by 2020 after full deployment of this solution to the VA network.

This project is scheduled to complete its proof of concept in 2017.