Technology confidence in early stage development of medical devices

Innovation is a critical factor in ensuring commercial success within the area of medical technology. Biotechnology and Healthcare developments require huge financial and resource investment, in-depth research and clinical trials. Consequently, these developments involve a complex multidisciplinary structure, which is inherently full of risks and uncertainty. In this context, early technology assessment and 'proof of concept' is often sporadic and unstructured. Existing methodologies for managing the feasibility stage of medical device development are predominantly suited to the later phases of development and favour detail in optimisation, validation and regulatory approval. During these early phases, feasibility studies are normally conducted to establish whether technology is potentially viable. However, it is not clear how this technology viability is currently measured. This paper aims to redress this gap through the development of a technology confidence scale, as appropriate explicitly to the feasibility phase of medical device design. These guidelines were developed from analysis of three recent innovation studies within the medical device industry.

Classification and choice in product design

Life is full of difficult choices. Everyone has their own way of dealing with these, some effective, some not. The problem is particularly acute in engineering design because of the vast amount of information designers have to process. This paper deals with a subset of this set of problems: the subset of selecting materials and processes, and their links to the design of products. Even these, though, present many of the generic problems of choice, and the challenges in creating tools to assist the designer in making them. The key elements are those of classification, of indexing, of reaching decisions using incomplete data in many different formats, and of devising effective strategies for selection. This final element - that of selection strategies - poses particular challenges. Product design, as an example, is an intricate blend of the technical and (for want of a better word) the aesthetic. To meet these needs, a tool that allows selection by analysis, by analogy, by association and simply by 'browsing' is necessary. An example of such a tool, its successes and remaining challenges, will be described.