Updated: Helix launches European operations with new site in Germany

Helix Medical LLC (Carpinteria, CA) continues the expansion of its global footprint, announcing the opening of a new 55,000-ft² facility in Kaiserslautern, Germany during MD&M West (Feb. 9-11; Anaheim, CA). Initially, the facility will provide custom silicone molding for medical device components. Within the next 12 months, it plans to add custom molding of thermoplastics, including thermoplastic elastomers (TPE) with multicomponent capabilities. Over time, it will also offer close-tolerance single- and multi-lumen extrusion of silicone and TPEs. The current staffing level of 32 is expected to double by the third quarter, as production ramps up, according to a Helix source.

The global manufacturer for the medical device, healthcare, pharmaceutical, IVD, and biotech industries will call the unit, Helix Medical Europe. Jorg Schneewind, president and CEO of Helix, says the new site fits within a strategy of local supply for the company's global customers. "Our objective is to move our operations closer to our customers so that we can serve their manufacturing and distribution needs on a global level," Schneewind said. The company opened the operation on the site of an existing facility owned by its parent company, Freudenberg. Built in the 1980s, the Freudenberg plant has strong infrastructure and staff, according to a Helix source. The spokesperson said the company has invested "millions" in the facility, including the addition of a state-of-the-art cleanroom. Schneewind and Mark Ostwald, general manager Helix Medical Europe KG, were both in attendance at the annual medical device event in Anaheim to discuss the expansion. In the past, European customers were served by the company's U.S. facilities.

Originally founded in 1984, Helix Medical is headquartered in Carpinteria, CA, where it operates an FDA-registered medical device facility, certified ISO 13485 with ISO 14644 Class 7 and 8 cleanrooms. Additional manufacturing operations are in Baldwin Park, CA; Gloucester, MA; Shenzhen, China; and now, Kaiserslautern, Germany. —[email protected]