FMI, a leading medical silicone molding manufacturer, announced the official opening of their ultra-clean manufacturing facility in Suzhou, China. The company has built a state-of-the-art ISO Class 7 cleanroom for medical device manufacturing as an addition to a facility owned and operated since 2004 by their parent company, Flexan Corporation. FMI specializes in manufacturing critical parts made of molded silicone rubber for implantable and disposable medical devices, surgical devices, lab equipment, and medication delivery systems.
FMI has spent three years developing and validating its ultra-clean manufacturing capabilities in the Suzhou facility and began shipping products from there to a multinational client last year. The FMI facility in Suzhou is now taking orders from new and existing clients who wish to expand manufacturing outside the U.S.
“Five years ago, our medical device OEM clients were telling us that they wanted to grow their manufacturing and marketing to emerging markets in Asia and India,” said Frank Sullivan, president of FMI. “In China, we invested in a truly state-of-the-art cleanroom that draws on everything we know from U.S. manufacturing practices and innovations. Our goal is to offer a low-cost country option with the same stringent quality systems.”