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.

Design and selection tools for sports equipment

This report presents work from the first nine month of a project investigating design methodologies and selection tools to promote innovations in sports equipment. Particular consideration is given to product design improvements and new market adoption of advanced materials and processes. Our aim is to couple appropriately similar technologies so as to provide a method of transfer between sports equipment designs. We would like to make barriers between isolated sports equipment markets more transparent without releasing proprietary information. A brief history of sports equipment design is included; issues particularly relevant to material and process technologies are outlined for sports equipment. A start has been made on a software program to express most of this information in a concise and accessible format. The methodology is reviewed with some industrial case studies. There is a need for further research to extend and address the design issues raised in this document; a suggested research programme is attached.