If you think selecting an electronics manufacturing services partner is challenging, consider the ramifications of outsourcing medical device components and systems. Medical device OEMs must balance the need for consistent quality and conformance to product and regulatory requirements with the equally essential need to get new products to market quickly and efficiently.

      Given the level of investment needed to develop new products and shepherd them through the regulatory process, medical device manufacturers typically focus on product design, technological innovation, and market access to maximize their opportunity for success. Expending resources (both human and financial) on infrastructure to support an adequate manufacturing operation can dilute focus from their core competencies.

      Just as design partners can serve as a source for technological innovation, a competent EMS provider will serve as a source for business, manufacturing and operational innovation and efficiency that can be leveraged for competitive advantage. The key in the selection process is determining who can provide a seamless and efficient extension of your operation while conforming to the critical requirements imposed by the FDA and other regulatory bodies.

      Each year, OEMs spend billions outsourcing electronics production, and much of this expenditure is wasted. Why? Because choosing the wrong supplier can result in significant cost, product quality, and customer retention issues. Consider the risks of a wrong choice:

      Cost overruns. Quotation accuracy from both the OEM and the EMS provider is essential if cost overruns and price creep are to be avoided. It begins with the quality and thoroughness of the quotation package, which must adequately identify your expectations and requirements. A robust evaluation process ensures proper alignment with a qualified contract manufacturer.

      Downstream quality problems. The only thing worse than poor quality at your CM is the latent quality problems that won’t appear until days after your product ships and is in use. While inspection can improve quality yields, robust process controls will build reliability into your product. And that only comes with experience building products similar to your own. Whether you choose to make product in house or outsource, it is important to recognize that you are responsible for the quality of the product delivered to your customer. FDA 21 CFR Part 820 was established to regulate the quality systems used in the manufacture of medical devices. It can serve as the foundation for assessing a prospective CM’s ability to consistently provide product that conforms to your requirements. Once the selection process is complete, frequent process audits and business review sessions will maintain the focus on operational excellence.

      Jeopardizing your production pipeline. Ineffective material management and capacity planning, poor quality yields, insufficient administrative or engineering bandwidth, or simply a misalignment between...  

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