Research & Presentations
Considerations for the Development of 3-D-Printed Upper-Limb Prostheses By Jorge M. Zuniga, PhD; Matthew J. Major, PhD; Jean L. Peck, OTR/L; Rakesh Srivastava, MS, CPO; James Pierce; and Nicholas Stergiou, PhD
Introduction The development of 3-D printing for the manufacturing of prostheses and orthoses has resulted in cost-reduction strategies, better accessibility, and customization of prosthetic designs. The widespread use of 3-D printing and the existence of myriad prosthetic designs available on the Internet allow clinicians and researchers from different disciplines to manufacture their own devices. Given the dearth of studies discussing the practical application of 3-D-printed upper-limb prostheses, the current paper describes the technical considerations for the implementation of these devices in rehabilitation and research settings. Specifically, considerations on remote fitting procedures, durability, regulatory implications, and bench testing results are discussed. Background Advancements in computer-aided design software and additive manufacturing techniques (i.e., three-dimensional or 3-D printing) offer the possibility of designing, printing, and fitting prosthetic hands and other assistive devices at a very low cost. Previous studies 1-5 have described low-cost prosthetic hands, arms, and shoulders
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with practical and easy fitting procedures that can be performed remotely. Importantly, in children the durability of the 3-D-printed prostheses is challenged continuously due to their activity levels and outgrowth of the prostheses.6 Therefore, the cost effectiveness of 3-D printing makes repairs and upgrades of prostheses substantially more affordable.6 In general, previous publications1-4,6-8 have presented different aspects of the development of 3-D-printed prostheses for children, and the consensus is that 3-D printing is a promising manufacturing method for the development of these devices. There is a lack of information, however, with respect to the fitting procedures, assembly, durability, and regulatory implications. The U.S. Food and Drug Administration (FDA) recently published guidelines for the industry outlining technical considerations associated with the 3-D-printing processes and recommendations for testing and mechanical characterizing 3-D-printed devices.9 However, the literature still lacks a comprehensive review that can provide practical technical considerations for the implementation of 3-D-printed upper-limb prostheses in a clinical or research setting.