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.

Market-pull and technology-push in manufacturing start-ups in emerging industries

Purpose - As traditional manufacturing, previously vital to the UK economy, is increasingly outsourced to lower-cost locations, policy makers seek leadership in emerging industries by encouraging innovative start-up firms to pursue competitive opportunities. Emerging industries can either be those where a technology exists but the corresponding downstream value chain is unclear, or a new technology may subvert the existing value chain to satisfy existing customer needs. Hence, this area shows evidence of both technology-push and market-pull forces. The purpose of this paper is to focus on market-pull and technology-push orientations in manufacturing ventures, specifically examining how and why this orientation shifts during the firm's formative years. Design/methodology/approach - A multiple case study approach of 25 UK start-ups in emerging industries is used to examine this seldom explored area. The authors offer two models of dynamic business-orientation in start-ups and explain the common reasons for shifts in orientation and why these two orientations do not generally co-exist during early firm development. Findings - Separate evolution paths were found for strategic orientation in manufacturing start-ups and separate reasons for them to shift in their early development. Technology-push start-ups often changed to a market-pull orientation because of new partners, new market information or shift in management priorities. In contrast, many of the start-ups beginning with a market-pull orientation shifted to a technology-push orientation because early market experiences necessitated a focus on improving processes in order to increase productivity or meet partner specifications, or meet a demand for complementary products. Originality/value - While a significant body of work exists regarding manufacturing strategy in established firms, little work has been found that investigates how manufacturing strategy emerges in start-up companies, particularly those in emerging industries. © Emerald Group Publishing Limited.