Development and Evaluation of a Process to Advance Orphan Assistive Technology Prototypes for Small Batch Production

Abstract Assistive technology (AT) is defined as any item or product system that is used to increase, maintain, or improve functional capabilities of persons with disabilities. Orphan AT has the defining characteristic of a potential user group that is too small to support adequate research and development. As a result, many Orphan AT devices might not be commercialized because development costs outweigh the expected sales volume. The objective of this project was to develop and evaluate a process to advance Orphan AT functional prototypes for small batch production. The process consists of four activities separated by a decision point. It begins by identifying an unique AT prototype that was designed for a person with a disability. It then clearly defines the target user group and identifies predicate technology and alternative strategies used to meet the functional goal. The outcome of these activities is used to decide whether to proceed. Further development proceeds by performing a functional assessment that includes both human factors and device functionality and a manufacturing assessment that optimizes production and manufacturing options for small batch production. The process was deployed in the design of four Orphan AT devices. After completion, the process was evaluated by three long-standing AT professionals. The process to advance Orphan AT functional prototypes for small batch production appears to be a pragmatic and cost-effective approach to reduce barriers associated with Orphan AT commercialization.