Reliability Requirements for Implantable Medical Devices

End-of-Project Webinar, Phase 2

  • This is for iNEMI members only
  • Presentation:  Assessment of Reliability Standards and Test Methods for Implantable Medical Devices End-of-Project Webinar (July 23, 2014)

Statement of Work and Project Statement for Phase 2

iNEMI's working group on Medical Electronics Reliability held a  project webinar on April 24 to present the results from the group's survey to assess the perceived lack of reliability, quality, and safety standards specific to implantable electronic devices. This webinar concluded Phase 1 of the project.

We would greatly appreciate your participation in Phase 2 to:

  • Ensure that the information we obtained from our industry survey is sufficiently thorough and comprehensive; and
  • Get your unique perspective on analysis of key gaps in reliability standards for implantable devices

We plan to complete recruitment of additional project members (requires iNEMI Membership) in the next few weeks, after which Phase 2 activities are expected to take 5-6 months (with weekly meetings lasting about an hour).  The anticipated outcome of Phase 2 is a white paper summarizing our findings, which we expect to publish and present at appropriate international conferences.

Presentations

Phase 1 Survey Complete

iNEMI conducted a survey to assess the perceived lack of reliability, quality, and safety standards specific to implantable electronic devices.  Survey was completed in the fall of 2012.  For more information on the survey.

Project Leaders

John McNulty, Exponent Failure Analysis Associates, Inc.
Erik Jung, Medical Microsystems

Statement of Work and Project Statement for Phase 1

Background

The proposed focus of the program is to identify the product testing that is required to ensure reliability of implantable medical electronic products (i.e., FDA Class 3).

The reliability testing standards used today for development and pre-market evaluation of implants are derived from the harsh environment operation standards applied to military, automotive or avionics products. However, these standards overstress the implants, leading to over-engineered products, and, furthermore, do not reflect the specific requirements of implantable electronic products (e.g., assuring a 20+ year lifetime in a non-benign, highly active ambient), leading to underestimation of specific failure possibilities.

The situation is becoming even more of an issue with the increased use of novel implantable electronic products that must omit fully hermetized encapsulations (e.g., Ti encasing) in order to operate properly at the desired site (e.g., implantable, subcutaneous glucose monitors, retinal implants, brain computer interfaces). Also, today’s standards for harsh environment products do not cover the specific profiles an implant may see during the long years of operation, such as X-ray screening, aggressive cell agglomeration and local chance in the ambient chemistry, which can prove a risk to the patient.

Although a manufacturer may have knowledge about a specific product for a given use case, this know-how is typically not shared among OEMs. Greater sharing of this information and agreement on industry-standard testing requirements could help mitigate several problems, such as:

  • Multiple iterations of a product design due to pre-market failures
  • Impact on overall product cost due to unnecessary iterations
  • Placing patients at risk due to non-sharing of risk factors gained by other industry participants
  • Litigation risks for failures after several years of operation

Scope of Work

Today's FDA clearance procedure calls for manufacturers to provide a full risk analysis and to trace issues related to their respective product's operations. However, the FDA evaluators rely on data derived from existing harsh environment standards and on manufacturers' own expertise, and neither of these risk management strategies foresees the issues specific to implantable electronic devices. For a number of medical devices and systems, specific standards have already been put in place to exactly counter this situation, thereby increasing both safety and market dynamics; however, for implantable electronic devices, no general set of test standards currently exists.

Standardization of recurring scenarios and their application to test routines will mitigate the risk factors and offer the industry a faster level of innovation, a higher profit and lower litigation risks, while delivering reliable products to patients.

Achieving this target is done by approaching the program in three phases:

  1. Phase 1: Review reliability standards relevant to implantable medical electronic devices
  2. Phase 2: Analyze gaps and develop protocols
  3. Phase 3: Recommend methodologies

If you are interested in participating in the development of the Phase 2 tasks, please contact Dave Godlewski (dgodlewski@inemi.org). iNEMI membership is required to join this project. Phase 2 for this project is expected to begin in June 2013.

For further information

David Godlewski
iNEMI Manager of Deployment
+1 717-651-0522
dgodlewski@inemi.org

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