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.

Innovation processes within the healthcare industry: Determining critical success factors aligned to product strategies

The impact of differing product strategies on product innovation processes pursued by healthcare firms is discussed. The critical success factors aligned to product strategies are presented. A definite split between pioneering product strategies and late entrant product strategies is also recognised.

The impact of architectural uncertainty on product introduction in dispersed environments

This research addresses product introduction dispersed across locations and companies. Mechanisms appropriate to integrate activities in collocated teams may not serve dispersed teams well. A semiconductor design licensor was studied in depth to explore how dispersed product introduction varies with uncertainty. We found that autonomous teams focused on sub-products (micro-products) were used rather than cross-functional teams in departments with high architectural uncertainty. Both types of teams were effectively dispersed across locations and companies. This suggests that small high-technology companies may find it easier to expand into new geographies and product lines than was previously believed.