Design and mechanical validation of commercially viable, personalized passive prosthetic feet

Current high-performance prosthetic feet work well for many users, but the low resolution of size and stiffness categories may limit walking performance for certain users. A line of prosthetic feet with a high resolution of sizes and stiffnesses, designed through amputee-specific personalization, could provide clinical and economic value. The lower leg trajectory error (LLTE) design framework facilitates the design of high-performance, amputee-specific prosthetic feet; however, previous foot prototypes were not designed to satisfy the economic, mechanical, and aesthetic requirements for commercial adoption. The aims of this work were to understand how a personalized, affordable prosthetic foot can align with the clinical-commercial ecosystem, innovate a viable future product, and inform other prosthesis designers of considerations required to connect innovation to real-world implementation. We evaluated needs by identifying how products, capital, and services flow between stakeholders, and we elucidated design requirements for a personalized prosthetic foot that can be manufactured, dis- tributed, and clinically provided. Based on material properties and manufacturing process capabilities, CNC machining of Nylon 6/6 satisfies these requirements. We present a novel parametric foot architecture that can be CNC machined, fits within a commercial foot shell, and can be designed for individual users' body characteristics and activity levels. Prototypes made using the new foot design behaved as anticipated (1-12% error in modeled displacement), satisfied industry-standard strength (ISO 10328) and mechanical performance (AOPA dynamic heel/keel) requirements, and elicited positive feedback from both amputees and prosthetists.