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Tools and Techniques for Evaluating the Performance of Medical Devices


April 5, 2012

Exponent is pleased to introduce our new Medical Device Bulletin, with the article," Tools and techniques for evaluating the performance of medical devices. Part 1 of 2 is a simple guide for assessing technology, understanding product failure, or examining device interactions.

“Did this medical device fail?” and “How does this medical device function and interact with its surrounding environment?” are general questions that arise during medical device product liability litigation and patent litigation, respectively. Fortunately, a wide array of tools and techniques are available to help answer these questions. These tools and techniques may assist with evaluating how the device performs under certain conditions—conditions that can be selected to represent clinically relevant or alternative use scenarios. For example, changes in the mechanical and chemical properties of a device due to different processing techniques (e.g., sterilization, aging, packaging/storage conditions) or different end-user conditions can be assessed. The effects of variations in surgical/interventional techniques, device position, or patient-specific conditions (e.g., activity, weight, tissue quality) can also be investigated. In addition, from a patent litigation standpoint, the use of appropriate tools and techniques may also help evaluate what functions a device performs, the way it functions, and any corresponding results. Ultimately, a wide armamentarium of tools and techniques, when and where applicable, is available to provide as much data as possible for understanding medical device performance.

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