While we’ve already seen plenty of 3D printed prostheses and bionic limbs that replace missing arms and limbs, that is actually a relatively small portion of the collective of wearable medical devices. At some point in our lives, most of us will have worn orthotics or braces for some period of time and, as is the case for prosthetics, getting the right fit can be difficult, time-consuming and expensive. To combat those common problems, 3D printing giant Stratasys has recently founded CYBER with the University of Michigan and Altair Engineering. Their goal? To transform the orthotics industry through 3D printing.
It’s just one of those portions of the medical industry that people accept without thinking about what else is possible. If you have an injured, weakened or recovering body part, you’ll quickly be directed towards braces and orthoses (also known as orthotics). While many people wear them for just a few weeks, a significant proportion of orthotics are actually used to address long term conditions too. Muscle weaknesses, neural damage caused by a stroke, multiple sclerosis, nerve injuries, and more – orthotics are actually very frequently prescribed. A significant portion of those orthotics are going to military veterans in the US – According to the US Veterans Administration (VA), spending on those kinds of medical devices increased almost 80%, from $907M to $1.6B from 2005 to 2009, with about 1.5 million orthoses provided in 2009. And with populations aging, it is projected that up to 7.3 million US citizens could be wearing orthoses by 2020.
In short, this is thus a field that could incredibly benefit form custom-made and well-fitting wearables, and that is exactly what CYBER seeks to realize. According to Andrew Hanson and Scott Rader ofStratasys, this partnership will be working to find solutions that “leverage 3D printing and Industry 4.0 to transform the design, comfort, utility and customization of Ankle Foot Orthotics (AFO).” What’s more, they have already found funding from innovation institute America Makes.
The current mold-based production system for orthotics.
So what will this solution look like? In a nutshell, the CYBER team will seek to set up a digital workflow system that combines a cloud-based physical system with 3D printing and Altair’s OptiStruct Software. Right now, getting a custom-made orthosis takes about a month, with extensive mold making and hand-made modifications being necessary. Add that up to the insurance authorization processes and existing demand issues, and it is everything but easy or cheap for the patient. It’s also simply not very efficient. The final structures are heavy due to a constant sheet thickness, while strength and flexibility in the areas that count is non-existent.
The patient is left with a bulky limitation on his leg. Though customized, it’s is everything by optimized – and that is something 3D printing can realize. “While custom AFOs have always been created with a patient’s custom shape, additive manufacturing provides improved possibilities to truly customize the manufacturing of an AFO. The ability to adjust trim lines and alter the type or thickness of plastic has provided some basic options for tuning the flexibility of an AFO,” says Jeff Wensman from Michigan’s Orthotics and Prosthetics Center. “But, additive manufacturing, and specifically the CYBER team, is creating a process to actually ‘engineer’ and ‘design’ an AFO for a specific patient. Different amounts or types of material can be printed to provide a specified stiffness and allow areas of flexibility, based on the patient presentation. This exciting technology opens up an entirely new tool box that the clinician can use to enhance patient outcomes.”
To optimize this solution, CYBER is working on a digital platform that will allow clinicians to create Ankle-Foot Orthoses with automated tools that provides options for perfect integration of a patient’s prescription. “The engineered cyber-physical system provides the seamless integration of the cloud based algorithms with the physical component manufacture to optimize overall part geometry and its corresponding tool-paths,” they say.
Not only could this reduce waiting time to as little as a day, it also greatly reduces material waste through 3D scanning and 3D printing and reduces the need for regular doctor visits. What’s more, it will enable a very personalized form of care – enabling doctors, for instance, to provide an elderly wearer with a most light-weight option as possible. And to insure this doesn’t add additional burdens to doctors, Stratasys and Altair engineers manage the workflow and input optimization alternations.
To be fair, there are still a few obstacles that need to be overcome before this can be a realistic option. Specifically, current 3D printing solutions do not yet provide a high enough throughput to enable one-day visits. A new production system will therefore have to be adopted, one that also makes multiple material 3D printing accurate and efficient enough. On the software side, a whole clinical interface will need to be integrated into CAD design as well.
But then you’d really have a platform that could not only be efficient, but cost-effective too. The US Veteran Administration is lined up as one of the first CYBER partners, and estimates suggest that they could save as much as $1.3B per year by 2020 with a full adoption of the CYBER program. A proof of concept is scheduled for 2017. “Integrating additive manufacturing into orthotics and prosthetics patient care is an opportunity for the manufacturing community to make a positive impact in healthcare; the success of this project is expected to make the manufacturing process more efficient and reliable, so that orthotics and prosthetics service can be more accessible to people who need it,” they conclude.