Medical Device Manufacturing Using Automation And A Digital Factory

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.
The smart machines, factory, and enterprise infrastructure are used in development, prototyping, and high-volume manufacturing, thereby allowing seamless product lifecycle transitions and ubiquitous data availability. Customizable, automated and traceable interlocks in the physical and digital factory control the quality of each unique serial number. Because there are no separate development and manufacturing systems, feedback is rapid and “know how” is transferable through multiple lifecycles.
Author(s)Source
Subrahmanyan R, Lindner J
Micro Systems Engineering, Inc. (Lake Oswego, OR)
MEDDEVICE Online, Jan 31, 2019
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