Polymer-based materials, such as plastics and adhesives, are used in a range of medical devices from implantable devices to surgical tools to wearables. In general, polymer-based materials offer advantages such as cost and weight savings, ease of processability, resistance to corrosion, and biocompatibility in some cases. However, in the context of sophisticated device architectures and various end-use conditions, polymeric materials can display unforeseen issues. To determine what may have gone wrong, a variety of methods can be employed to perform failure analysis and understand why certain polymer materials did not perform as expected. Often times, carrying out accelerated aging tests to understand how polymer materials may change over a targeted shelf life is insightful and useful in supporting FDA submissions. In this talk, some methods utilized in carrying out failure analysis involving polymeric materials will be discussed. Microscopy, materials characterization methods, and analytical chemistry techniques can be employed and are often valuable tools to understand plastics material failures, the chemical compatibility of adhesives, and to determine whether contamination is present. Some case study examples will be discussed.

Polymer materials in medical devices: Addressing issues through material testing and failure analysis

253rd National Meeting (2017)

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