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. The move matters because it signals a commitment to supply-chain resilience and cost efficiency for a device designed to address a persistent and costly hospital-acquired infection.
The company is in active discussions with several manufacturers and is reviewing their capabilities to confirm they meet Hallstat's quality control standards. Once a new manufacturing facility and partnership are established, Hallstat plans to launch the Hallstat Foley System in the U.S. The timing and location of the manufacturing shift are not yet finalized, but the strategic intent is clear: bring production closer to the hospitals that will use the device.
"Our priority has always been patients and the nurses who care for them," said Bruce Huici, Founder, President and CEO of Hallstat, and inventor of the Hallstat Foley System. "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."
The Hallstat Foley System combines several design features aimed at reducing CAUTI risk. These include MicroTip™, a catheter tip less than one-third the size of a standard tip; BACTIStat™ Tubing, infused with BactiStat technology to reduce bacterial development; BermeoValve™, designed to reduce urine backflow; and CallisterCath™, a catheter made of 100% medical-grade silicone as an alternative to latex. Huici, a nurse with experience in cardiac catheterization and interventional radiology, invented the system after witnessing the challenges urinary catheters create for patients and care teams.
Hallstat is evaluating potential manufacturing partners through a structured review that includes quality management systems and compliance with standards such as ISO 13485, experience producing medical-grade silicone and urological devices, capacity to scale production, and proximity to U.S. customers. "We won't trade quality for speed," Huici said. "Any partner we choose has to meet our standards, not the other way around." No manufacturing agreement has been finalized, and the company will share updates as it selects a partner and prepares for U.S. market introduction.
The implications of this announcement extend beyond Hallstat's own operations. By prioritizing domestic or near-shore manufacturing, the company aims to strengthen supply-chain oversight and transparency—factors that became critical during recent global disruptions. For hospitals, faster delivery and consistent quality could translate into more reliable access to an infection-prevention device. For the market, Hallstat's entry adds a nurse-designed option to the Foley catheter segment, potentially pressuring competitors to innovate on CAUTI reduction. Hallstat is a certified Minority Business Enterprise, and more information is available at www.hallstat.com.
