SBIR-STTR Award

Orthotics and Prosthetic (O&P) clinics serve as the primary facilities at which 1.9 million U.S. amputees receive care. The design and fabrication of custom prosthetic devices is an integral part of how these O&P facilities provide patient care. Current prosthetic fabrication methods are costly and labor intensive, relying heavily on traditional manual manufacturing techniques. 3D-scanning and printing of prosthetic devices is seen as a viable solution to solving O&P clinic inefficiencies. However, no viable additive manufacturing system exists to assist prosthetists in the fabrication of their prosthetic devices. This project focuses on investigating current scanning, software, and printing technologies to determine what existing components could be used in an effective prosthetic manufacturing system. Additionally, this project will focus on determining key requirements for the development of a software package specifically for the digital fabrication of prosthetics. To commercialize this system nationally, a central fabrication (C-Fab) facility will first be established for the purpose of modifying body scans and printing usable lower limb prosthetic check sockets. This technology system will not be limited to the fabrication of limb sockets solely; the proposed innovation is poised to scale and streamline the workflow for the fabrication of all types of prostheses.

This project aims to create a commercially viable 3D printed prosthetic product line which is superior, cost effective and more efficiently utilizes clinician time. Phase 1 demonstrated the feasibility of a process that uses a low-cost 3D scanner to capture limb shapes, converts the scan data into a computer model file of the 3D printable socket, and prints a strong, durable socket that can be mounted to a prosthesis system. The Phase II project builds on the results of Phase I in collaboration with the Veterans Administration, a state sponsored university and commercial small businesses. It focuses on creating a scanning system and developing an expanded array of prosthetic and orthotic solutions. These designs will be tested to the full extent of the ISO standard, comprehensive human studies for safety and efficacy will be performed, and the developed process will be integrated into an effective prosthetic manufacturing system. An innovative, multi-axis carbon fiber 3D-printer will be developed to allow utilization of optimized materials for fabricating the commercially desired products. Reifys design concepts will take advantage of additive manufacturing (AM) capabilities to improve the standard of care for amputees, increase clinician efficiency, and create products that have never before been available.