Grouping materials and processes for the designer: an application for cluster analysis.

In this paper, an analytical tool - cluster analysis - that is commonly used in biology, archaeology, linguistics and psychology is applied to materials and design. Here we use it to cluster materials and the processes that shape them, using their attributes as indicators of relationship. The attributes that are chosen are important to design and designers. The resulting clusters, and the classifications that can be developed from them, depend on the selected attributes and - to some extent - on the method of clustering. Alternative classifications for design that is focused on the technical or aesthetic attributes of materials and the materials and shapes allowed by processes are explored.

Designing for validation of medical devices and equipment

Validation is important in the design, development and production of medical devices since effective and appropriate validation plays a vital role in defining the success of a product in both technical and economic terms. Regulations and quality standards lay out the requirements for product validation, but it is left to each individual manufacturer to establish and maintain their own validation procedures. More recently, there has also been a change of emphasis in the regulations and standards that encourage the integration of validation into the development process. However, this poses particular challenges to the manufacturer since there is a distinct lack of guidance to assist this integration. This workbook provides the first real guidance on good design practices for medical device development. It has been developed through extensive consultation with device manufacturers and analysis of regulatory requirements. The approach is intended to assist manufacturers in meeting the new regulations.