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 for all: designing for the motion-impaired user

Designing for all requires the adaptation and modification of current design best practices to encompass a broader range of user capabilities. This is particularly the case in the design of the human-product interface. Product interfaces exist everywhere and when designing them, there is a very strong temptation to jump to prescribing a solution with only a cursory attempt to understand the nature of the problem. This is particularly the case when attempting to adapt existing designs, optimised for able-bodied users, for use by disabled users. However, such approaches have led to numerous products that are neither usable nor commercially successful. In order to develop a successful design approach it is necessary consider the fundamental structure of the design process being applied. A three stage design process development strategy which includes problem definition, solution development and solution evaluation, should be adopted. This paper describes the development of a new design approach based on the application of usability heuristics to the design of interfaces. This is illustrated by reference to a particular case study of the re-design of a computer interface for controlling an assistive device.