SBIR Phase II:Development and Design Verification of a Reusable, No-Touch Catheter System

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be to advance a novel, reusable, intermittent, urinary catheterization system from a functional prototype to the final production-equivalent device. By progressing the system through additional design improvements and FDA submission, the goal of this project is to enable the product to reach the hands of individuals who require intermittent catheters to urinate. Current intermittent urinary catheter use is fraught with complications including frequent urinary tract infections, expensive supplies, and large material footprints, as well as the generation of a significant amount of plastic waste. This project seeks to improve the current catheter landscape by allowing for commercialization of a reusable catheter system that will reduce contact contamination during insertion, reduce plastic waste, and enable widespread use of high-quality urinary catheters by decreasing the per-use cost. Through these improvements, healthcare costs associated with intermittent catheterization can be dramatically decreased. Additionally, based on frequent interactions with individuals who catheterize and suffer from impaired dexterity, the design of the system will incorporate the needs and ideas of people who are often ignored during innovation within the current catheterization space.This Small Business Innovation Research (SBIR) Phase II project will finalize the design of a novel, reusable, intermittent urinary catheterization system and portable reprocessing device as well as advance the system towards commercialization. Intermittent urinary catheterization is a technologically static field that has not changed significantly since the 1970s, with minimal improvements in urinary tract infection risk, supply cost, and environmental waste reduction. While the associated SBIR Phase I project established proof-of-concept catheter reprocessing, the Phase II project will include optimization and more advanced microbiologic efficacy testing. This assessment will focus on specifically addressing concerns regarding lubrication and compactness brought up during SBIR Phase I customer discovery activities, as well as multiple reuse reprocessing.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.