Hallstat, a nurse-founded medical-device company focused on reducing catheter-associated urinary tract infections (CAUTIs), has announced plans to move manufacturing of its Hallstat Foley System to the United States or nearby countries. The decision is intended to lower manufacturing costs and shorten shipping times as the company prepares to introduce the product to the U.S. market. Hallstat is currently in active discussions with several manufacturers and is reviewing their capabilities to ensure they meet the company's quality control standards.
The move matters because it signals a strategic shift toward a more resilient and accountable supply chain for a device designed to address a persistent hospital-acquired infection risk. By bringing production closer to U.S. customers, Hallstat aims to gain greater oversight and transparency over manufacturing, which could help ensure consistent quality and faster delivery to hospitals. The company has not yet finalized a manufacturing agreement, but it is evaluating partners using a structured review that includes quality management systems and compliance with recognized medical-device standards such as ISO 13485, experience producing medical-grade silicone and urological devices, capacity to scale production reliably, and proximity to U.S. customers.
The Hallstat Foley System was invented by Bruce Huici, a nurse with experience in cardiac catheterization and interventional radiology, who serves as Founder, President and CEO. The system combines several design features into one product, each aimed at a known contributor to CAUTI risk: MicroTip™, a catheter tip less than one-third the size of a standard tip designed to reduce bladder irritation during drainage; BACTIStat™ Tubing, drainage tubing infused with BactiStat technology designed to reduce bacterial development as urine settles in the line; BermeoValve™, a valve designed to reduce urine backflow in the drainage tubing; and CallisterCath™, a catheter made of 100% medical-grade silicone as an alternative to latex.
“Our priority has always been patients and the nurses who care for them,” said Huici. “Bringing production closer to home is about building a supply chain we can stand behind—one that delivers consistent quality, lower costs, and faster delivery to the hospitals that need it.” He added that the company “won't trade quality for speed” and that any partner must meet Hallstat's standards. The manufacturing strategy also carries implications for supply-chain resilience, as shorter shipping times and domestic or near-shore production could reduce exposure to disruptions. For hospitals evaluating CAUTI-prevention tools, the planned U.S. market introduction could eventually offer a new option that integrates multiple risk-reduction features into a single system.
Hallstat is a certified Minority Business Enterprise founded by nurses and dedicated to fighting hospital-acquired infections and improving patients' quality of life. The company plans to share updates as it selects a manufacturing partner, establishes its facility, and prepares for U.S. market introduction. More information is available at www.hallstat.com.
