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When Failure Is Not An Option: Improving Medical Device Reliability

Strategies and protocols to improve medical electronic device reliability and how these strategies will benefit both the patient and the manufacturer.

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Medical electronics are expected to operate safely over extended periods of time to provide monitoring, therapeutic or life-sustaining functions for patients. Without built-in reliability, these devices could experience failures or malfunctions that greatly increase the possibility of infection or death. In the movie Apollo 13, NASA’s Gene Kranz (played by actor Ed Harris) made the phrase “Failure is not an option” famous when discussing the Apollo 13 Moon landing mission. Similarly, failure is not an option when it comes to medical electronics devices.

Numerous reliability approaches exist in the medical electronics industry to prevent failures. Component and module reliability is typically determined by the parametric performance following a suite of stress tests. Stress tests are often derived from an industry standard and usually do not consider the capability of the device under specific use-conditions, such as implantables, defibrillators or other medical applications requiring safety measures. Extrapolation of these test results to failure rates is therefore not feasible or useful. Improving the effectiveness and efficiency of reliability assessment throughout the life cycle of implantable devices is essential, but it can also be a significant challenge.

With the continued consolidation of major electronics industries and the proliferation of materials and component changes, including smaller parts, reduced gate geometries, advanced packaging technologies and new materials, it is increasingly necessary to establish baselines and methodologies for reliability assessment. In this white paper, we will discuss the strategies and protocols to improve medical electronic device reliability and how these strategies will benefit both the patient and the manufacturer.

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