Phiex advisor Dr. Rick Kuntz was formerly Medtronic’s chief medical and scientific officer. [Photo courtesy of Kuntz]
Phiex is developing a new method for medical device sterilization using a dry powder that generates chlorine dioxide gas inside product packaging.
The company sees a big opportunity to offer an alternative to ethylene oxide (EtO) sterilization, which is the most commonly used method in medtech but faces new safety regulations over health risk concerns.
“It’s clear that EtO’s going to have to go away. It’s just not going to be tolerated … and I just think this is the best alternative,” Kuntz said today in an interview with Medical Design & Outsourcing.
Kuntz joined Medtronic in 2005 as SVP and president of neuromodulation and was promoted to chief scientific, clinical and regulatory officer in 2009. At the end of his Medtronic career as chief medical and scientific officer, he oversaw medical affairs, health policy and reimbursement, clinical research activities, and corporate technology for the world’s largest medical device manufacturer.
Kuntz retired from Medtronic in April 2022 under the company’s mandatory retirement policy for executive officers when they hit age 65. He’s currently a board director for Rockley Photonics and DiaMedica Therapeutics.
Before joining Medtronic, Kuntz practiced medicine as an interventional cardiologist at Brigham and Women’s Hospital in Boston. He also founded the Harvard Clinical Research Institute (HCRI) and was its chief scientific officer. HCRI (now known as the Baim Institute for Clinical Research) is a university-based contract research organization that coordinates National Institutes of Health and industry clinical trials with the FDA.
After Kuntz retired from Medtronic, Phiex Chief Technology Officer Sumner Barenberg — who invented the startup’s technology — introduced him to Phiex CEO and co-founder CL Tian.
CL Tian is co-founder and CEO of Phiex. [Photo courtesy of Phiex]
Kuntz will familiarize Phiex with Medtronic’s product lines and leverage his network to help the startup build relationships within the medtech industry.
“When I met CL, they had already been connecting with material scientists at Medtronic that actually worked in my group,” Kuntz said.
Kuntz says EtO’s days are numbered as city, state and federal regulators take aim at commercial sterilization plants.
“When I was at Medtronic, we talked about EtO a lot because of the Steris and Sterigenics problems,” he said. “Being on the executive committee of the company, we would talk about what we were going to do about sterilization. … It’s a burning platform. We’ve got to be able to figure out how to move away from that, and I know [Medtronic’s} operations group has been looking for alternatives.”
Regulators and the industry say safety is paramount in the debate over EtO, not just for sterilization plant workers and neighbors, but for patients who need devices free of infection-causing microbes. Even if EtO’s use isn’t limited by regulators, EtO sterilization is already at or near capacity and alternatives would increase the volume of medical devices that can be sterilized.
Kuntz said he wants to help advance what he sees as the best alternative and a new option to increase sterilization capacity.
“Getting safe devices into patients is my biggest concern,” Kuntz said, later continuing, “I want to make sure that we have continuous ability to implant and use medical devices.”
