Hallstat, a nurse-founded medical-device company focused on reducing catheter-associated urinary tract infections (CAUTIs), announced plans to move manufacturing of its Hallstat Foley System to the United States or nearby countries. The move 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 confirm they meet the company's quality control standards.
The decision carries significant implications for infection prevention and supply-chain resilience in U.S. hospitals. By bringing production closer to home, Hallstat aims to build a supply chain it can stand behind—one that delivers consistent quality, lower costs, and faster delivery to the hospitals that need it. Founder, President and CEO Bruce Huici, a nurse who invented the system, said the priority has always been patients and the nurses who care for them.
The Hallstat Foley System combines several design features into one product, each designed to address a known contributor to CAUTI risk. These include 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™, a catheter made of 100% medical-grade silicone as an alternative to latex. Huici said he designed the system to tackle the problem at its source, with every feature existing because someone at the bedside needed it.
Hallstat is evaluating potential manufacturing partners using a structured review of their capabilities, including 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 as demand grows, and proximity to U.S. customers to shorten shipping times and strengthen supply-chain resilience. Huici emphasized that the company won't trade quality for speed and that any partner must meet its standards.
No manufacturing agreement has been finalized. Hallstat will share updates as it selects a partner, establishes its facility, and prepares for U.S. market introduction. Huici described the decision as one about accountability, giving the company more oversight, more transparency, and a stronger foundation for its next chapter. For more information, visit www.hallstat.com.
