Initially, Bi-Link supplied primarily electrical components and metal stampings to customers in the medtech space, which did not require ISO 13485 certification. But about four years ago, it achieved ISO 13485 certification for its Shanghai plant, says Terri Marion, Medical Segment Marketing Manager. That became a necessity as the company began supplying Tier 1 medical device OEMs. "As our relationships with global medical device OEMs expanded and deepened, it became increasingly important to have standardized practices and capabilities at all of our manufacturing plants," Marion told PlasticsToday. Bi-Link is generally demand-driven with regards to certifications, she added, and as a longtime supplier to the auto industry, the company has ISO 9001 and ISO TS 16949 certification at all of its facilities, she added.

The company currently leverages its metal stamping, injection molding, insert molding and automated and manual assembly expertise to provide medical device companies with a range of components and assemblies. These parts are typically found in surgical devices, drug-delivery systems, in vitro diagnostic devices and diabetes care products, said Marion.

Bi-Link is committed to helping all of its customers improve time to market, reduce manufacturing costs and streamline supply chain management, and to further these goals, it has transitioned from managing projects to a program management role. "We are uniquely positioned to assist customer engineering teams in the earliest phases of product development," explained Marion. "We've invested heavily in open innovation during the pre-prototyping phase, providing in-house samples from 3D-printed molds to enable concept validation and rapid design iterations," she added. This has slashed development cycles to hours and days rather than weeks and months. "By providing insights based on solid design for manufacturing principles, Bi-Link helps customers make better up-front decisions and move quickly and efficiently from the initial idea to the next level of development," said Marion.

Building on that idea, the company has launched what it calls The Hardware Store, an open environment designed by engineers for engineers where they will find all the resources they need to move forward on product development projects. The first Hardware Store opened in North Carolina's Research Triangle Park in November 2014 and a second one was launched in San Diego last month. Response has been extremely positive, added Marion.

The announcement of ISO 13485 certification coincides with the completion of a cleanroom at the Juarez facility, which is scheduled to officially open in early September, with production starting in October. It is equipped with two electric 40- and 150-ton injection molding machines.

With its global footprint, emphasis on innovation and ability to develop and manufacture plastic and metal assemblies under one global roof, Bi-Link can supply medtech customers with the right parts really fast, stressed Marion. And they can rest easy, knowing that its all being done under ISO 13485 guidelines.