Flexan subsidiary expands into bigger Chicago-area building

Lincolnshire, Ill. — FMI LLC continues to expand in response to growth in the silicone contract manufacturing medical market.

The firm has relocated into a new 70,000-square-foot building in Lincolnshire, about 25 minutes away from its previous facility and still in the Chicago area. The old site spanned three buildings and 22,000 square feet. The new site, which will be formally opened with a ribbon cutting on May 19, will consist of a 20,000-square-foot Class 7 clean room, nearly quadrupling in size.

Financial details were not disclosed. The facility's clean room was certified at the end of March and ISO registration complete in April.

FMI is a subsidiary of Chicago-based Flexan LLC, which operates its own 65,000-square-foot facility in Chicago focused on rubber molding for industrial applications.

In addition to consolidating its operations from three buildings under one roof, Mike Huiras, director of sales and marketing, said the firm simply needed more space. The new building will be able to house all of FMI's existing equipment, nearly 100 employees and still have room left to add more capacity.

"As we were looking to add capabilities, we've been successful with a number of projects that are upcoming, we realized we've outgrown our space," he said. "To facilitate and enhance our ability to continue to grow and serve customers, we knew we had to move to a new space."

FMI already plans to break into the silicone extrusion space with the addition of three new lines centered around silicone tubing. Flexan CEO Jim Fitzgerald said the lines will focus on a combination of catheter products that need a tube and other silicone tubing applications for medical devices.

The firm currently operates about 40 silicone molding lines that primarily focus on precision molded silicone components for tight tolerance applications — like components for pacemakers, defibrillators and long-term implantables.

The new site primarily will focus on the FMI business, but Fitzgerald said the firm might add a white room to house some of Flexan's industrial business that requires a higher containment area.

"Regardless of the growth, we saw an opportunity to become a more efficient organization," Fitzgerald said. "We were also adding some new manufacturing capabilities, both silicone extrusion and medical device assembly. We didn't have the space to offer either of those services in the structure that we had."

FMI had a few key objectives when identifying a site: It needed a building that could handle its capacity plus give it some breathing room to add more business; it wanted to make minimal disruptions to its current work force's commute; and the firm sought to position itself in a favorable location to attract new talent.

There was also one other challenge.

"There's a lot of large warehouse facilities that would have accommodated what we needed," Huiras said, "but the other challenge was parking. We had to balance the size of the facility with the amount of parking for the personnel."

Lincolnshire is located in Lake County, keeping FMI close to Chicago's O'Hare Airport and along a major rail line. The proximity to the old facility means some of the firm's work force will have less of a commute as they were already coming from the area.

But Fitzgerald said the Lake County/northern Chicago area has a wealth of medical original equipment manufacturers. The firm said the area is home to about 700 medical device and tooling companies with some 50 medical-related corporate headquarters and an estimated 20,000 employees.

Huiras said FMI intends to add more engineers and quality manufacturing personnel in the coming year. Fitzgerald estimated that the work force will increase by about 20 percent.

The new building gives FMI the chance to streamline operations. Instead of having three functions spread out across three buildings—one for administration, one for manufacturing and the other for inspection—all those processes can come together more efficiently.

"We took a lot of time with the staff to not only ensure a state-of-the-art facility, but it's also a state-of-the-art facility that is attractive to new employees," Huiras said.

Flexan and FMI are both continuing to chase new opportunities for their respective businesses. The current trend of medical device original equipment manufacturers looking to shrink their list of preferred suppliers plays into the company's hands because FMI has established strong quality controls and has shown a willingness to invest in its manufacturing processes, Huiras said.

He added that FMI has had many customers asking for expanded capabilities, which was the driving force behind its acquisition of Medron LLC earlier this year. Based in Salt Lake City, Medron offers a range of outsourcing services, including high-volume manufacturing, customer private label capability, design engineering, product development and prototyping. It works with a variety of materials, primarily thermoplastics, urethanes and silicone.

With more medical customers asking for two-shot and overmolded components, the thermoplastics business will help complement FMI's deep-rooted silicone presence, Huiras said.

"The key driver for the OEMs is to have a partner that has expanded capabilities and a very solid quality system to support that," Huiras said. "As you become a key sourcing supplier, the logical next question is 'What else can you provide to us?' The key for us is to expand our capabilities while maintaining our solid quality system and ensure that everything from design control to tracking shipments to tracking the quality of the parts is maintained."

The acquisition came on the heels of an expanded presence in Europe. Flexan recently hired Werner Karau to serve as the firm's direct contact for commercial, technical and project-related inquiries. Currently in Europe, the company focuses on high-precision custom molding for hearing aids and its FMI division produces Class II disposable and Class III implantable medical devices.

The firm does not currently have a manufacturing presence in Europe, but it does have a base in Asia-Pacific for both industrial and medical capabilities in China through its 35,000-sq.-ft. facility, complete with a clean room.

Even though Flexan and FMI have their sights set on growing abroad, Fitzgerald stressed that there's also plenty of growth opportunities here in the U.S.

"Part of our growth is going to be capturing more share with our existing client base," he said. "A large number of our med device clients are U.S. multinationals that have a presence in Europe and Asia. We want to align with them to support their initiatives to consolidate suppliers. We're seeing the benefits alone driving a lot of our value. We're in good standing with those companies as they're looking to reduce the number of preferred suppliers they're working with."