90BISB0029

This two-year project performs human factors studies with intervening design activities to inform and shape the development of the V1 Aurie reusable intermittent urinary catheter system. This project aims to improve the lives of individuals who utilize intermittent catheters to manage neurogenic bladder by decreasing urinary tract infections as a result of catheter use, thereby increasing community engagement and improving independence and spontaneity. The goal of this project is to employ frequent user collaboration to validate the finalized design of the V1 Aurie system leading to FDA submission and develop a V2 system design. Project objectives are to: (1) complete a chemical characterization study and a toxicological risk assessment, (2) complete a summative human factors study to show that lay person users can use the device without physician supervision, (3) develop and implement design strategies for development of a V2 System with the input of lived experience advisors, and (4) validate the V2 system improvements with a new group of catheter users. Outcomes include the integration of feedback from a diverse group of intended users throughout the design and development process as well as the mitigation of potential risks associated with the use of the Aurie system. Products include: (1) key data regarding the safety and usability of the V1 Aurie System, which is required for FDA approval of the system, and (2) a finalized and validated V2 system design.