HERNDON, VA – iNEMI’s Component Specifications for Medical Products Project has published a report on its work to identify and define a set of component-level reliability qualification methods for critical electronic components used in implantable and wearable medical devices.

"The need for component-level specifications for medical applications has been long identified; however, there are currently no medical industry specifications to qualify components or their suppliers," said Bill Bader, CEO of iNEMI. "As a result, every component that is purchased for high-reliability medical products must be individually qualified. In order to develop an industry standard, a clear understanding of the failure mechanisms of critical components is required, as well as the reliability and performance requirements of the critical components in medical devices. This project has helped the industry take the first steps toward that understanding."

The iNEMI report summarizes the work conducted by the project team to identify relevant critical components. Using a case study of tantalum capacitors, they assessed the level of understanding and technical knowledge needed to develop a relevant specification for that component that would be appropriate for medical devices. The project focused on tests and screens from relevant existing test methodologies and standards available in the electronics industry.

The report notes that a number of relevant screens and test methods are typically used, but they do not all consider the unique requirements of medical device applications. It recommends a methodical approach and commitment of resources are required, particularly on the part of the end equipment or medical device manufacturer, to communicate with the component suppliers and consult experts in other high-reliability fields to relate the testing required to the application of the component.

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