Sunday, May 11, 2025
5/11/2025
Development of an Automated, Reusable No-Touch Catheter System - CathBuddy, Inc. will, in the course of this two-year project, perform human factors studies with intervening design activities; this will inform and shape the development of the Aurie reusable intermittent urinary catheter system to maximally improve the lives of individuals utilizing intermittent catheters to manage neurogenic bladder by increasing community engagement by improving independence and spontaneity and decreasing urinary tract infections as a result of catheter use. The system will be submitted for FDA approval following completion of FDA-required testing in the 1st year of the grant; the second year will be utilized to make user-requested improvements to the system to broaden its commercial appeal and impact. 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. The objectives are: 1) to 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 a V2 System with the input of Lived Experience advisors, and 4) validate the V2 system improvements with a new group of catheter users. Anticipated 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. We also anticipate positive qualitative feedback surrounding use of the system. Expected products of this project include 1) key data regarding the safety and usability of the V1 Aurie System, which will are required for FDA approval of the system, 2) a finalized and validated V2 system design.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).