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Exponent Newsletter: Tools and Techniques for Evaluating the Performance of Medical Devices

News

December 13, 2012




“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 may assist with evaluating how the device performs under certain conditions—conditions that can be selected to represent clinically relevant or alternative use scenarios.

This two-part guide is intended to provide a basic understanding of what tools and techniques are available and their potential uses. The first part, published earlier this year, discussed evaluation of mechanical properties and the chemical and physical characteristics of biomaterials and medical devices.

In this second part of the newsletter, electrochemical characterization and medical imaging are described. Depending on the application and purpose of the investigation, not all tools and techniques may be relevant. In addition, it is important to consider the environment and parameters under which the device is being evaluated, and whether those factors may influence device performance.