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 company said the move is intended to lower manufacturing costs and shorten shipping times as it prepares to introduce the product to the U.S. market.
The decision matters for hospitals and clinicians because CAUTIs are among the most common hospital-acquired infections, and the supply chain for urological devices has faced pressure in recent years. By bringing production closer to customers, Hallstat aims to strengthen supply-chain resilience and increase oversight of quality control, according to the company.
Hallstat is in active discussions with several manufacturers and is reviewing their capabilities to confirm they meet the company’s quality control standards. Once a new manufacturing facility and partnership are established, the company plans to introduce the Hallstat Foley System to the U.S. market. No manufacturing agreement has been finalized.
“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.”
Huici, a nurse with experience in cardiac catheterization and interventional radiology, invented the system after seeing firsthand the challenges that urinary catheters can create for patients and care teams. The system combines several design features into one product, each designed to address 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, a material chosen as an alternative to latex.
“As a nurse, I saw how often catheter-related infections complicated a patient’s recovery,” said Huici. “I designed this system to tackle the problem at its source. Every feature exists because someone at the bedside needed it.”
Hallstat said it 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.
“We won’t trade quality for speed,” said Huici. “Any partner we choose has to meet our standards, not the other way around. We’re taking the time to get this right, because hospitals and patients deserve a product they can trust every time.”
The manufacturing shift is a strategic step for a small, minority-owned business preparing to compete in the U.S. catheter market. Hallstat is a certified Minority Business Enterprise founded by nurses and dedicated to fighting hospital-acquired infections and improving patients’ quality of life. More information is available at www.hallstat.com.
“This is a decision about accountability,” said Huici. “Moving manufacturing closer to our customers gives us more oversight, more transparency, and a stronger foundation for the next chapter of Hallstat.”
