Spotlight on Helix Medical

A contract manufacturer serving the medical market, Helix Medical also produces a proprietary line of finished medical devices, giving the company a unique perspective on the no-compromise demands of the healthcare industry.

California’s Silicon Valley is famous, but lesser known is the state’s Silicone Beach, located in and around Santa Barbara, where high technology is applied to a different sector—medical devices. Starting life in Santa Barbara but since moving 13 miles to Carpinteria, contract manufacturer Helix Medical is an important part of the region’s burgeoning healthcare sector and can be considered a charter member of its Silicone Beach.

Rob Wilkinson, director of quality, has been with Helix for 15 years, seeing its start in Santa Barbara, as well as its move to Carpinteria at the end of 1993. Today the company has expanded to three contiguous buildings with 65,000 ft² of manufacturing space, including LIM, compression/transfer, insert, micro, and two-shot molding, plus extrusion, assembly, packaging, and sterilization. In April, it converted a warehouse distribution center into a Class 8 cleanroom, adding eight injection molding machines sized from 40-60 tons, and an overhead crane.

In addition to supplying molded and extruded components and assemblies to the medical market, Helix is ISO certified 13485:2003 as a finished medical device manufacturer thanks to its InHealth line of Blom-Singer Voice Prostheses and Tracheoesophageal Puncture (TEP) products for laryngectomy patients, and a proprietary brand of platinum-cured silicone tubing and fluid-handling components. With that certification comes a requirement to track everything that enters and leaves the building, from raw materials to packaged devices.

Nowhere is that more evident than in the company’s document room, where Helix maintains a history for everything it ships, from seven years to the life of the product. Give the company a lot number, and it can give you a product’s complete history from cradle to grave.

The fact that it must meet such rigorous record-keeping and manufacturing requirements lends the company credibility when it seeks business with medical device OEMs, according to Chris Woodruff, director of marketing at Helix. “[The device certification] is a very nice asset or confidence point for customers considering contract manufacturing services with us,” he explains, “because they know all the products coming out of Helix Medical, whether proprietary tubing or products made to their drawings, are going to be manufactured under an ISO medical device quality system—it’s a nice differentiator.”

Building No. 1 on Helix’s campus houses extrusion of single and multilumen tubing, as well as profiles. At the heart of the Class 7 cleanroom are seven custom-configured extruders, which run high-consistency silicone rubber. Material is brought through a positive-pressure room, and for some products, barium sulphate is compounded in to impart radio opaqueness. The tubing, which must be crosslinked, is sent through an infrared light, with surface temperatures measured to assess curing. A tensioning wheel draws tubing in, measures a length, and then cuts, with a twin-access laser micrometer determining the outer diameter. Wilkinson says tubing is extruded as small as 0.06 inch with up to nine lumens. In addition to a Class 8 assembly area with sterile packaging, the extrusion building has a quality control room with a full range of ASTM testing.
 
Building No. 2 houses injection molding, with LSR and thermoplastics running on horizontal, vertical, and even a micromolding unit. In addition to compression transfer molding machines, the company runs vertical and horizontal machines, with three more verticals recently added.
 
Helix, which is owned by elastomeric seal joint venture Freudenberg-NOK, has seen the ranks of medical suppliers swell as manufacturing firms flee struggling markets like automotive, but it still feels the sector is expanding enough to support itself and many additional players. “I think there’s enough general market growth that everyone can pursue his own specialty, or a certain area of medicine,” Woodruff says, adding that Helix alone touches 12 segments within the broader medical sector. —Tony Deligio