OUTSOURCING NEWS

David Hale of Smart Sourcing Inc. (SSI; Farmingdale, NY) says that although manufacturers in China have made significant strides in improving medical device technology and product quality, the real challenge is to identify the correct factory and manage the product at every stage.

To that end, SSI has added a new division that enables U.S. companies to outsource medical device component manufacturing and assembly to Asia. The division from SSI employs a proprietary network that aims to reduce product manufacturing costs. It has more than 80 prequalified vendors throughout China and two regional offices in Shanghai and Ningbo.

According to SSI, companies can see 30–80% cost reduction, depending on the labor. “SSI had been embedded in China for nearly a decade,” explains Hale, president of the firm. “We knew that the only way to succeed was to scrutinize and qualify the plants and personnel and have on-site presence.”

Hale says that the firm has instituted a test program of producing OEM medical components, such as injection-molded parts, printed circuit board assemblies, and subassemblies for box building. “This enabled us to confirm the manufacturing capabilities [of the China-based facilities] and, most importantly for this market, confirm the quality system that is ISO 9001 and ISO 13485 certified,” he says.

The company can accommodate Class I, II, and III cleanroom environment needs and can work with an OEM at any point from manufacturing, packaging, or assembly.

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