Flexan reaches medical 'milestone' with Suzhou plant

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."

Registration of the component was made more remarkable by the virtual reality under which it was developed, Huiras said.

With no travel between Flexan engineers and the customer due to the pandemic, development and testing was done through Zoom meetings, phone calls and shared data.

"It really was a pretty big accomplishment," Huiras said. "Hats off to our teams."

And Flexan, which serves a range of markets with elastomer goods, said it has seen demand ebb and flow in numerous areas during the pandemic, requiring the company to prioritize its portfolio offerings, which comprise about 60-percent non-elective surgery products and about 40-percent elective surgery products on the medical side.

"From the very beginning we reacted quickly in establishing a chain of communication to understand customers' supply needs," Huiras said. "We saw a downturn in elective (surgeries), and even if it was a non-elective procedure and it could be delayed, we saw a downturn there."

Flexan saw "a huge uptick" in the respiratory space with ventilators, and Huiras said the company has garnered new business because of the ventilator projects.

Huiras added that Flexan formed its employee safety pandemic policies from its experiences at the Suzhou plant, implementing best practices before CDC guidelines were available stateside.

Class I, II and III medical products

As a custom contract manufacturer—or "job shop," as Huiras said, traditionally making high-mix, low-volume components—the onus is on Flexan to manufacture its parts to required levels of scrutiny.

It sometimes can be a challenge, however, to know whether Flexan or an OEM is the sanctioning entity for a "finished device"—one of the thresholds for FDA registration.

"When it leaves the manufacturing site, the intended use of the product needs to be achieved in its native form," Huiras said.

According to the FDA, risk determines the class number in medical components—the higher the class, the greater the risk and need for safety parameters.

About 95 percent of Class I items, including elastic bandages, manual stethoscopes and bedpans, do not require FDA clearance to market in the U.S. Class II devices include powered wheelchairs and pregnancy test kits, while Class III devices include pacemakers and breast implants.

"As a silicone molder, about 60 percent of the components we manufacture are used in a whole range of implantable devices—from incontinence devices to cardiac rhythm management to hydrocephalus shunts," Huiras said. "Sterility is very high with these and they require a higher level of silicone purity."

All three of Flexan's FDA-registered facilities—Suzhou, Salt Lake City and Lincolnshire—produce niche, contracted medical components, though Chicago remains the spot for rubber molding and overmolding to different metal components. For instance, Flexan produces valve controls and pumps in Chicago for Caterpillar-brand U.S. Army vehicles, and aerospace and agriculture remain important markets for Flexan as well.

"Our end markets are expansive," Huiras said. "If you look at Salt Lake, it is a little more upstream in the medical vascular access space, producing catheters, split catheters, tunnelers and a whole range of dilators. Even in Chicago we have a number of medical components. Chicago assisted with the ventilator projects that saw a massive increase due to COVID."

A history of flexibility

When Sears Roebuck & Co. was looking to improve its circular sanding tool in 1946, they selected the rubber molding capabilities of the Lilleberg brothers, who molded a flexible rubber piece onto a metal circular sander for the retail giant—creating the Sears flexible sander.

The brothers' flexibility served them well then, as they went on to establish Flexan L.L.C. in 1946. The ability to improvise and overcome, whether in product development or market orientation, has remained a company virtue ever since, as Flexan changes once again to meet customer demand.

"Everything is getting smaller," Huiras said. "Looking to the future, we want to provide repair and aid in diagnostic, therapeutics and pain management. But how do we go about finding customers? It's about providing our services. We do not control growth—our customers do."

After years of experience in the rubber molding sector, Flexan established FMI (Flexan Medical Division) in 1989. This quickly proved to be a boon for Flexan, leading to global expansion with the establishment of the Suzhou facility in 2004.

Flexan also incorporated a facility in Salt Lake City (mainly TPEs, with molding, extruding packaging and assembly) and moved its global headquarters to Lincolnshire, Ill., in 2017, where a Silicone Center of Excellence was established.

Flexan now has more than 800 employees across its four locations.

"New technology is where you want to hitch your wagon, because it will pull you along," Huiras said. "That is how we look at our markets. Our strategy is to work with OEMs, but also startups. We will make the part and see where they go.

"We are confident that our dedicated team in Suzhou is prepared to support our first full device production program, along with additional new business we expect to support in Suzhou in the future. Our experience operating in China for nearly two decades has prepared us for this next stage in our growth as a global services provider."