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What makes for a successful contract electronics manufacturing relationship and what does a medical device company need to keep in mind and consider during the selection process?
Once the decision has been made to use an electronics manufacturing services (EMS) company, selecting the right one involves several steps. Although most EMS companies perform the same basic services, every EMS company is different. You can tell when you walk into a place, examine the equipment and processes, and speak to the people.
Number 1: Prepare a List of Requirements
The initial basis for narrowing down your selection is to prepare a list of the basic requirements you expect an EMS provider to meet and detail specifically what you want the EMS to do—design, prototyping, material selection and purchasing, manufacturing, test, process validation, shipping and logistics, etc. Do you need manual or automated processes, small quantities or volume manufacturing? Is the EMS able to offer the range of services that meet your needs?
Number 2: Certifications
Does the EMS provider have the appropriate quality certifications to manufacture the product? There is no room for error with medical devices. A basic requirement for the medical market is ISO 13485:2003, the medical device manufacturing certification. This certification states the requirements for a comprehensive management system for the design and manufacture of medical devices, ensures that medical devices meet customer and regulatory requirements, and establishes a commitment to quality. The FDA’s Quality System Regulation 21 CFR (Code of Federal Regulations) 820 requires medical device manufacturers to perform a process validation when the process is not fully verified by a subsequent inspection or test. Process validation ensures that a process consistently produces a product that meets its specifications. It is an important component in the design, prototyping, and manufacturing process and one that, if done correctly, can save a considerable amount of time, money, and resources. By using an EMS provider that already has ISO 13485:2003 certification, regulatory bodies know that certain procedures and requirements will be met, so certification is less labor-intensive and approvals proceed more easily.
Number 3: Location
Check out where the EMS is located, where design and manufacturing are done, and make sure the size of the company is a good fit for your needs and products. Do you want the product manufactured close to where your company is located, close to where the product will need to be distributed, or are you manufacturing large volumes where cost is a major factor so a low-cost geography might be more beneficial? Considerations in choosing a location are the complexity of the device, process transfer, IP protection, shipping costs and time, and the degree of involvement you will need throughout the process.
Editor's Note: This article originally appeared in the January 2016 issue of SMT Magazine.
