A new project is being launched by the International Electronics Manufacturing Initiative (iNEMI; Herndon, VA; www.inemi.org) to develop testing and use condition guidelines to help ensure reliability of electronic components used in medical applications. The Medical Components Reliability Specifications Project is the first organized under the consortium’s new Medical Technology Integration Group (TIG).
“As is happening in so many industries, medical products are increasingly relying on electronics for their functionality,” says Jim McElroy, CEO of iNEMI. “As would be expected, there are unique requirements relating to reliability and operating conditions for components used in these applications.”
“Several of our members told us they would like for iNEMI to address some of the issues related to medical electronic components for implantable applications. In response, we organized the Medical TIG and are developing new collaborative efforts in this area,” he continues.
The Medical Components Reliability Specifications Project will develop test and extrapolation methodologies that can be used to predict reliability of components in actual use conditions. Leveraging industry knowledge and existing standards, the project team plans to create a minimum set of requirements for electronic components used in implanted or life-critical devices. The project will also develop guidelines that provide information about when testing should be done, what kind of testing is required, and how to apply test results such that they are relevant to the use conditions developed.
Adopting commonly accepted testing, extrapolation analysis, materials, and processes will help manufacturers achieve proven quality, reliability, and consistency while also helping suppliers focus on a single set of criteria, instead of having to meet different requirements for each customer.
The team has defined four areas of concentration: discretes (e.g., surface-mount multilayer chip capacitors, surface-mount tantalum capacitors, surface-mount resistors and surface-mount inductors); array packages (e.g., CSP, BGA); substrates and interconnects; and hybrids.
“There are very high expectations for reliability in medical devices, especially implantable devices, and a product’s reliability is significantly affected by the components used in that product,” comments Anthony Primavera, Boston Scientific CRM and chair of the iNEMI Medical TIG and the Medical Components Reliability Specifications Project. “Drivers such as high quality and reliability, shorter development cycles, a simplified supply chain, extended product life cycles, and increased complexity of medical electronics have resulted in a need for guidelines and specifications for assessing the reliability of electronic components used in medical devices. This project will develop specifications for testing medical electronics and will work with the appropriate standards-making body or bodies to implement those specifications.”
The industry-led consortium is made up of approximately 70 manufacturers, suppliers, industry associations and consortia, government agencies, and universities. The consortium also works with government, universities, and other funding agencies to set priorities for future industry needs and R&D initiatives. For more information about the project, contact David Godlewski, iNEMI, at [email protected] or go to www.inemi.org/cms/projects/medical/Medical_Components_Reliability_Specifications.html.