SMTA International Conference Proceedings


Authors: Kevin Stokes and Paul Plante
Company: Kimball Electronics Group
Date Published: 10/11/2007   Conference: SMTA International

Abstract: Medical equipment manufacturers face unique challenges in outsourcing projects both because of the regulatory environment and also because of product life cycles which often can be up to 10 years in length. This presentation looks at some of the key challenges electronics manufacturing services (EMS) providers specializing in this area must routinely address:

-Significant variance in volumes over the life cycle of the product
-Periodic specialized engineering support needs
-Extensive test support capabilities
-Procurement strategies which support both cost competitive sourcing of “commodity” materials plus very specialized custom parts or third-party hardware
-Proactive identification of component obsolescence issues, and requirements for end-of-life buys and subsequent stocking of that material for several years
-Fast response time in product development and repair depot activities
-Extensive documentation support capabilities and required third-party quality certifications
-Ability to support fairly long end-of-life cycle requirements with limited ability to cost effectively redesign the product
-Product validation requirements which limit both the Approved Vendor List (AVL) and the ability to change processes and/or equipment on the manufacturing floor
-The ability to retain and disseminate traceability and manufacturing quality data on request as long as the product remains in use in the field.

Additionally, several project examples illustrating ways that an EMS provider and its OEM customers have teamed to address these issues will be discussed.

Key words: Medical product outsourcing, EMS, lifecycle management, contract manufacturing.

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