Assuring Reliability In Medical Device Manufacturing Using Automation And A Digital Factory

By Ravi Subrahmanyan and Juergen Lindner

When medical electronics fail, patient outcomes may be significantly impacted. To avoid this dilemma, medical electronics are specifically designed to be highly reliable. Unfortunately, that approach alone is no longer sufficient given the increasing miniaturization and functional integration of medical electronic assemblies, lack of redundancy, faster product lifecycles, and use of new combinational technologies. This article details how a controlled, data-rich, and cost-efficient environment is being used by Micro Systems Engineering, Inc. (MSEI) to deploy a fail-safe, fast response strategy for manufacturing highly reliable medical electronics. This innovative data-rich approach allows companies to be assured that their products are manufactured consistently, and that any anomalies in performance are rapidly detected and responded to accordingly.