LINCOLNSHIRE, Ill.—For a company like Flexan L.L.C., receiving U.S. Food and Drug Administration registration for a facility is a milestone achievement.
The certification is as much about customer perspective in the medical market as it is about quality assurance.
The contract manufacturer of precision-molded silicone, rubber and TPE parts received the good news late last year from the FDA for its 68,000-sq.-ft. facility in Suzhou, China, which will transition from a "mold-and-ship" operation to production of primarily Class II and III finished medical components.
The Suzhou operation is the company's third FDA-registered location, as Flexan looks to expand its offerings in these high safety threshold medical device realms.
"It's no different for anyone else, if you are importing certain medical products to the U.S., the FDA has jurisdiction," said Mike Huiras, vice president of sales and marketing for Flexan. "We do have a Class 7 clean room there to manufacture silicone components for Class III medical devices. This is a big change for us as we are essentially migrating from molding operations in packaging to a pure medical finished device operation.
"From a process and medical manufacturing site, this adds a lot of perspective for OEMs since it is a high bar to cross."
In conjunction with the facility registration from the FDA, Flexan said it also has registered its first "fully finished" medical device for production, set to roll off the line at Suzhou this spring for shipment around the globe, Huiras said. Without divulging too much detail, he said the Class II component is made from silicone and TPE and used in the gastrointestinal space.
"It is an existing product on (the) market," Huiras said. "The customer came to Flexan to address a supply chain issue. Because our plan for launch met cost and quality requirements, it really turned into an example of the value we can bring to this type of situation. We are a job shop."