We are all inherently different with diverse needs for our personal health. As such, healthcare needs customized solutions to meet individuals varying needs. Today companies are offering more and more options for customization and personalization of products and services. This means additive manufacturing (AM) holds a lot of promise for the medical industry. How? An example is in the delivery of orthoses and prostheses (O&P). The current custom fabrication method used in O&P is decades old, based on plaster-molds and handcrafting, which presents an exciting opportunity for innovation. The media perception of additive manufacturing is that any design can be produced and part production is near instantaneous. This leads to the expectation of AM providing “push-button” mass-customizable products, but the reality is much more complicated.
Custom O&P are critical in assisting people with disabilities. Currently, Medicare approves more than 5 million codes for various O&P procedures and the number of O&P uses in the United States is expected to reach 7.3 million by 2020. Ankle-Foot Orthoses (AFO) are only provided by certified orthotists and contribute about 1/3 of the insurance billings from a typical O&P clinic.
The advantages of an AM solution for Ankle-Foot Orthoses are compelling:
- Reduce the long delivery time: Typical delivery time is 2-4 weeks for AFOs
- Enhance the level of accuracy: Plaster shrinks after drying and the mold does not accurately duplicate patient’s ankle and foot shape without iteration
- Eliminate multiple visits: This is taxing for users and caregivers, and drives cost
- Enhance the limited design freedom: Shapes of AFOs are limited by current manufacturing practices, which cannot fabricate orthoses that require more intricate, functional designs
The solutions to overcoming AM challenges:
- Limited AM throughput with current designs: Uneconomic throughput and limited material properties hinder the use of AM for custom AFO
- Providing a comfortable solution: Technology to deposit multiple materials is needed to provide functionality and comfort
- The end users of the design and manufacturing technology will be clinicians, not engineers: High technical barriers to entry prevent O&P providers from transforming to AM
Last month, America Makes, the National Additive Manufacturing Innovation Institute, announced the award of $8 million in funding for its most recent project call. Nine teams were awarded funding for AM related projects and one of the awardees was the University of Michigan for their proposal, Cyber-Physical Design and AM of Custom Orthoses. The University of Michigan, supported by Altair ProductDesign Inc. and Stratasys, Inc., aims to demonstrate that the design and fabrication of mass-customized AFOs is possible using fused deposition modeling technology and additive manufacturing for this application brings it closer to being a “push-button” solution. The team also includes clinical facilities (University of Michigan Orthotics and Prosthetics Center, VA Ann Arbor, and Becker Orthopedic) to ensure a technology transition and implementation path is defined.
The CYBER team will create a design workflow for AM Ankle-Foot Orthoses that balances device weight, mechanical performance, and production specifically for the fused deposition modeling process. The workflow will start from a digital scan of the patient’s foot and leg, allowing manipulation by the orthotist to create the prescription AFO geometry, develop an optimized design, and output a “printable” file. Stratasys will demonstrate the ability to deposit stiff material for structure and soft material for a comfortable interface with the human body. Finally the team will undertake automation and integration of the hardware and software capabilities to demonstrate a cloud based design service. This will minimize the computer hardware requirements for the O&P provider, while enabling software upgrades and improvements to workflows and underlying technology without any IT burden.
Our team believes that cloud-based design and additive manufacturing technologies provide the opportunity to improve healthcare professionals’ care to patients. Our ultimate goal is to achieve a “One-Day Visit” in which patients can visit a clinic and walk away in their custom orthoses on the same day. This leap in healthcare customization will display how the technology developed during the America Makes project can improve the lives of millions of people with orthoses needs.
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