Balancing the Socio-technical Preferences of Physician and Patient Stakeholders During Ankle Brace Design and Development

Extensive effort and resources has been allocated towards the production of medical devices with the aims of improving patient outcomes and expedite recovery. In the past, medical device design and development has overemphasized physician opinions on the device specifications without adequately accounting for the quality of patient interactions with the product. The resulting outcome are medical devices that fail to reach its maximum potential of clinical adoption and overall utility. The following technical and STS theses will navigate medical device design and development while properly weighing both physician and patients perspectives and preferences in aim to improve device adoption rate.
The exploration of this STS topic was motivated by the technical goal of full-length medical device design and development of a patient-personalized dynamic tensioning ankle brace. This Capstone project was inspired by the current market gap in ankle orthotics that prioritize stability at the expense of comfort. Beginning with ankle orthotic market analysis, patent research, and exploring insurance code qualifications, the goal of developing an affordable, personalized, ankle orthotic capable of rapid stability adjustments was set. Through the use of biometric scanning and 3D printing, the development team iterated through design prototypes in an effort to develop a brace that maximizes comfort without compromising stability. Future work on this project will be directed towards quantifying comfort and stability metrics and validating our device’s efficiencies over current standard of care alternatives.
With the backdrop of medical device design and development, it became evident that an important metric of design success is the device’s adoption rate within the targeted demographic. Further exploration into what impacts a device’s adoption rate led to the conclusion that both patient and physician perspectives and preferences need to be considered, or else the device will fail to be integrated into the standard practice of care. This STS thesis topic explores those physician and patient perspectives and preferences and analyzes how to properly weigh them throughout all steps of the design process. Since both hold crucial to whether the device will make a substantial contribution to the improvement of patient conditions, both physician and patient needs must be for a medical device to reach full potential.
The development of an ankle orthotic and the exploration of physician and patient perspectives and preferences have had a synergetic effect in helping the other be accomplished to a higher quality. It is clear that the expanded inquiry to achieve a greater understanding of physician and patient perspectives and preferences will yield higher levels of adoption and utilization across the entire medical device development industry.