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2/25/2015 | 2 MINUTE READ

Injection Molder or Medical Device Supplier?

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The line between molders and medical device suppliers is increasingly being blurred as formerly custom shops take on finished device production.

Close inspection of booths at the recent MD&M West trade show at the Anaheim Convention Center revealed an interesting phenomena. Whereas in the past, molders exhibiting at the show might fill their display cases with individual components they’ve made to showcase their capabilities in the medical market, many can now show finished devices they’ve taken on, up to and including, packaging.

At the 2014 edition of MD&M, Nypro Healthcare told me the company was “not just about injection molding anymore” and a year later they backed that up with news that they’ve ramped up cleanroom injection molding in support of a finished medical device.

Custom molder and contract manufacturer, Mack Molding, which traded the computer/business equipment sector for medical back in 2000, announced the addition of another cleanroom of its own to support a move into medical disposables at MD&M.

EJ Bio Med, a division of Eldon James, highlighted its new Denver, Colo. facility, finished in 2013, at MD&M. According to EJ Bio Med, the facility, which offers injection molding, extrusion and assembly, is one of the only U.S. companies that can “manufacture, assemble and package PVC-free tubing and connectors in a single Class 7 cleanroom.”

GW Plastics, Bethel, Vt., used the show to announce the addition of two 240-ton high-speed Netstal injection molding machines and automation to expand its capability in the high-volume disposable medical device market, part of its bid to support the company’s “growing medical device molding and contract assembly business.”

Diversified Plastics, Minneapolis, Minn., announced the installation of a 1,300-sq-ft controlled environment production room at the show, saying the space is available for use in “product assembly and packaging operations with increased cleanliness requirements.”

S.E. Ward Sokoloski, VP and general manager of medical molder Helix Medical, explained to me how his company’s Baldwin Park, Calif. operation achieved FDA registration in support of it manufacturing devices, telling me the company is moving past “just contract molding.” In 2014, the company began fabricating a new medical device used in IVs in six different sizes.

“The response has been overwhelming,” Sokoloski said. “When we got FDA registered in 2014, we opened our doors for customers and told them we only deal with medical. Customers like that. The analogy I use is, ‘Would you rather eat a buffet or a have a specialized dinner?’”

Sounds like more and more processors in the medical space will be cutting other end markets from their molding menus in the near future. (Pictured below, Diversified Plastics new controlled environment manufacturing space.)