Designing with Materials: Applying Materials Data and Rational Materials Selection Methodologies in Medical Device Design

Materials have a fundamental impact on the performance and viability of medical devices. Significant advantages are gained by applying materials data effectively to make better materials decisions. Yet systematic approaches to materials data and decisions are rare in device design. This talk describes two such approaches – materials data management and rational materials selection.

Reliable materials data is vital for modeling, design, and regulatory applications. Materials data management technology, developed in the highly-regulated aerospace industry, is now being applied in medical applications. This overcomes challenges posed by the complexities of materials data (for example, storing multi-dimensional data to describe the variation of properties with parameters such as age or temperature). It captures project data and the vital relationships within this data, and enables its re-use across different projects and throughout the product lifecycle.

One use for materials data is materials selection.  Traditional selection methods included: using favorite, familiar materials, using materials that have been used before, and choosing materials based on engineering criteria once a design has been decided.  These methods are often employed late in the design process, when changes are costly and impractical.

An alternative rational selection methodology considers both engineering and biocompatibility requirements in the context of the desired performance of the device during early design stages. The goals are: an exhaustive analysis of materials options; a repeatable process that generates reliable results; and rendering materials decisions auditable. Computer software offers a practical route to achieve these goals – but there are a number of barriers to success. The talk will show how these are overcome and illustrate the methodology via case studies.