A SYSTEMS PERSPECTIVE ON PROSTHETIC DEVICE DESIGN, USE, AND OVERSIGHT

Upper-limb prosthetic technologies (ULPTs) aim to help people who have suffered limb-loss due to amputation or congenital condition. Despite advances in ULPT design over the past 25 years, users show a consistently high rate of discontinuing use of their prosthetic devices. At present, efforts to understand this lack of continuity have focused primarily on improving technical aspects of prosthetics (e.g. devices that better mimic human biology). In practice, however, ULPT design involves a suite of design processes. This point is well supported by a recent U.S. Food and Drug Administration white paper outlining stages for medical device production. These include stages of idea conception, design, pre-clinical and clinical testing, and regulatory steps for product distribution to the user. Despite this generalized design framework, little research has been done to explore how different ways of implementing this process may influence the rate of user adoption and long-term satisfaction with ULPTs. To address this gap, we have conducted a preliminary exploration of interactions between key stakeholders involved in ULPT device design, development, and deployment. Through a critical review of the literature, we identify three key features of current design processes for ULPTs that may increase the likelihood of abandonment. First, greater attention to the design and creation stages may impair adaptability to individual user needs. Second, the earlier stages of device design seldom incorporate input from potential users. This lack of feedback from users means that key functional and usability features may be absent from the final product. Last, the current structuring of intellectual property and patent protection in the ULPT field may limit sharing of device hardware and software specifications. This may prevent sharing of ideas between industry and academic research laboratories when it comes to clinical testing, as well as prevent clinicians and prosthetists from making device adjustments to suit individual user needs in real-life settings. Together, these points illustrate the importance of non-technical aspects of ULPT design in shaping user uptake. We propose that increasing communication and information sharing between different parties in the ULPT design process, as well as introducing user feedback earlier in the design process, may help increase device success from a user perspective. We believe this will improve functional outcomes for ULPT users and may serve to improve the design process more broadly with regard to other assistive technologies.