Component Specifications for Medical Products

Project Leaders

Co-leader: Diganta Das (CALCE-UMD)
Co-leader: Peter Lampacher (Vibrant MED-EL)

End-of-Project Webinar

Component Specifications for Medical Products End-of-Project Webinar (March 25, 2014) (iNEMI members only)

Presentation of Survey Results

Component Specifications for Medical Products:  Webinar on Task 1 - Outcome: Industry Survey (January 29, 2013)

Statement of Work and Project Statement

Background

There are no medical industry specifications for the qualification of components or their suppliers. Thus every component that is purchased for high-reliability medical products today must be individually qualified.

This situation increases costs for component manufacturers since every medical device OEM can have different requirements. This high cost of business can make the component manufacturers unresponsive to the medical device market. The lack of standard specifications thus adds time and cost to the introduction of new components, new technologies and, ultimately, new products.

This project will define a set of component-level reliability qualification methods (screens and tests) for electronic components used in implantable and wearable medical devices. The goal is to develop specifications that can be accepted by device OEMs as well as supported by component suppliers. These tests and screens will be identified from relevant existing test methodologies and standards available in the electronics industry at large.

Scope of Work

The primary purpose of the project will be to develop a method for developing a test and screen matrix for electronic components that can be used to qualify the reliability performance of components for implantable and wearable electronic medical devices. These tests and screens will be identified from relevant existing tests methodologies and standards available in the electronics industry at large. The goal is to develop specifications that can be accepted by device OEMs as well as supported by component suppliers.

This project will result in an industry-standard reliability method that can be implemented by medical device manufacturers within their component management processes. In those cases when critical defects and failure mechanisms or test methodologies are already known, the implementation process will be easier. For those situations in which the failure mechanisms or test methodologies are not known, this project will be part of a more complex solution.

Meeting Schedule

Presentation: organizational webinar will be held on February 9, 2012

Steps for Joining the Project

Please note: iNEMI membership is required to participate in the Component Specifications for Medical Products Project.  The period for becoming a founding member of this project closed on February 17, 2012; however, new members can be added to the project if approved by majority of the team.  Steps for joining the project are outlined below.

For iNEMI members:

  • Complete and sign the project statement
  • Fax the completed statement(s) to +1 (703) 834-2735 or scan and email to infohelp@inemi.org

For non-members:

Further Information

Grace O'Malley
+353 87 9040 363
gomalley@inemi.org

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