From concept to production: Utah company clears hurdles to bring medical device to market.

• Author: McFadden, Josh
• Position: Lessons Learned

If at first you don't succeed, try again. Utah company Catheter Connections proved this old adage to be true as it went from having an unfunded project to an innovative, one-of-kind wonder.

Perfecting the Mousetrap

Located in the University of Utah's Research Park, Catheter Connections develops vascular access products that can protect patients from life-threatening infections during infusion therapy. In fact, every year in the United States nearly 500,000 people develop catheter-related bloodstream infections. Frighteningly, up to 25 percent of these people die despite these infections being treatable. Fighting these infections can cost anywhere from $300 million to $11 billion annually.

That's where Catheter Connections has come to the rescue.

Catheter Connections' product, DualCap, is helping to decrease the harrowing statistics of infusion therapy infections. DualCap is a revolutionary infection-control technology that protects and disinfects both the needleless injection site and the end of the IV tubing. For the first time, clinicians have a fast and simple method to keep IV luers disinfected at placement and every time the line is accessed.

Designed by infusion nurses, DualCap reduces the human variability associated with IV care and provides healthcare facilities with an easy-to-use, cost-effective technology that can help in the fight against catheter-related blood stream infections. A patent is still pending for the device.

"We're the only ones in the world to figure out how to clean and disinfect tubing without getting a drop of alcohol in the tubing" says Catheter Connections CEO Vicki Farrar. "Hospitals had kept the end unprotected."

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Gaining Traction

DualCap was the winner of the 2010 Utah Innovation Awards in the Medical Devices category. But taking the concept to production and distribution wasn't easy.

"It took several years," Farrar says. "We had to convince the FDA."

The biggest hurdle Farrar and her team had to overcome was getting funding for the product. Doing this proved to be no easy task, and Catheter Connections representatives had to seek sources other than venture capitalists to raise money to develop, produce and eventually market the product.

"We were unsuccessful at first in raising money" Farrar says. "The product sells for under a dollar, and this is not the typical business model people invest in. We couldn't get big groups to invest in our model. But smaller groups understood our...