Safe Medical Design

Safe Medical Design was a medical device company dedicated to improving patient safety in urology through the development of the Signal Catheter. The Signal Catheter is an FDA-cleared Foley catheter featuring a novel hub and balloon design that prevents urethral trauma by reducing excessive pressure during accidental inflation in the urethra. Founded in 2012 by a team of urologists and engineers, the company aimed to address a significant clinical need, as urethral trauma affects hundreds of thousands of patients annually. Although the product reached the commercial stage and demonstrated superior safety profiles in clinical studies, the company ceased operations in 2021. Its technology was notable for being the first to address this specific complication without requiring changes to standard clinical techniques.