Hallstat, a nurse-founded medical-device company focused on reducing catheter-associated urinary tract infections (CAUTIs), announced plans to move manufacturing of the Hallstat Foley System to the United States or nearby countries. The decision, disclosed on October 29, 2026, is intended to lower manufacturing costs and shorten shipping times as the company prepares to introduce the device to the U.S. market. Hallstat is in active discussions with several manufacturers and is reviewing their capabilities to ensure they meet the company's quality control standards.
The move carries significant implications for the medical-device industry and hospital supply chains. By bringing production closer to U.S. customers, Hallstat aims to build a more resilient supply chain, reduce dependence on distant manufacturing hubs, and respond faster to hospital demand. The company is evaluating potential partners using a structured review that includes quality management systems, compliance with standards such as ISO 13485, experience with medical-grade silicone and urological devices, capacity to scale production, and proximity to U.S. customers. No manufacturing agreement has been finalized, and Hallstat will share updates as it selects a partner and establishes its facility.
The Hallstat Foley System was invented by Bruce Huici, a nurse with experience in cardiac catheterization and interventional radiology, after witnessing the challenges urinary catheters create for patients and care teams. The system combines several design features into one product, each targeting a known contributor to CAUTI risk: MicroTip™, a catheter tip less than one-third the size of a standard tip to reduce bladder irritation; BACTIStat™ Tubing, infused with BactiStat technology to reduce bacterial development as urine settles in the line; BermeoValve™, designed to reduce urine backflow; and CallisterCath™, 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, Founder, President and CEO. "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 emphasized that quality will not be compromised for speed. "We won't trade quality for speed," Huici said. "Any partner we choose has to meet our standards, not the other way around."
The manufacturing shift is part of Hallstat's broader strategy to combat hospital-acquired infections and improve patient outcomes. As a certified Minority Business Enterprise founded by nurses, the company designs its products with direct input from medical professionals. More information is available at www.hallstat.com.
