EPA shutdowns and a mammoth plaintiff settlement against Ethylene Oxide (EtO) created a logistical nightmare for the medical device industry. Phiex Technologies co-founder & CEO CL Tian and her team are on a mission to change all that.
Most medical devices and supplies are sterilized before they get to the hospital, during or after manufacturing, and for half of the market (20 billion devices in the U.S. annually, according to the FDA), sterilization is performed using Ethylene Oxide (EtO). The U.S. Environmental Protection Agency (EPA) designated EtO as a human carcinogen in 2016, and began flagging sterilization facilities across the country for higher-than-acceptable EtO emissions, leading to several shutdowns since 2019 – and numerous lawsuits. That created a logistical logjam of huge proportions. In September, the first lawsuit to see trial ended with a guilty verdict against one of the largest EtO providers, resulting in a $363 million settlement for the plaintiff.
Phiex Technologies, which recently won MedTech Innovator’s top award at AdvaMed’s MedTech Conference, from a field of more than 1,000 of the world’s best emerging companies, was founded in 2020 to address this huge problem. John Compton spoke with Phiex co-founder & CEO CL Tian about the scope of the challenge, how Phiex addresses the problem, and her advice for up-and-coming entrepreneurs.