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.

A policy dimension required for technology roadmapping: Learning from the development of emerging wind energy industry in China

Innovation policies play an important role throughout the development process of emerging industries. However, existing policy studies view the process as a black-box, and fail to understand the policy-industry interactions through the process. This paper aims to develop an integrated technology roadmapping tool, in order to facilitate the better understanding of policy heterogeneity at the different stages of new energy industries in China. Through the case study of Chinese wind energy equipment manufacturing industry, this paper elaborates the dynamics between policy and the growth process of the industry. Further, this paper generalizes some Chinese specifics for the policy-industry interactions. As a practical output, this study proposes a policy-technology roadmapping framework that maps policy-market-product- technology interactions in response to the requirement for analyzing and planning the development of new industries in emerging economies (e.g. China). This paper will be of interest to policy makers, strategists, investors, and industrial experts. © 2011 IEEE.