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.

Stakeholder engagement in early stage product-service system development for healthcare informatics

This paper presents the findings from four case studies on stakeholder engagement in new health information and communication technology (ICT) product-service system (PSS) development. The degree of connectivity between the new health ICT PSS and its intended operating environment has emerged to be an important contextual factor that may impact the decision of stakeholder engagement in the early stage development process. Along with the proposition of a four-level framework to guide stakeholder identification for new PSS development, three stakeholder engagement propositions that are based on the degree of connectivity are developed. Analysis has shown that there can be two types of connectivity: data and process. Moreover, each connectivity type can be characterized by how much the new PSS is connected with its environment: independent if there is no linkage, linked if it interfaces with, or incorporated if it is embedded into. Furthermore, depending upon whether and to what extent the PSS has data and process connectivity with its intended operating environment, the stakeholder engagement needs in early stage development vary. The propositions presented in this paper provide important directions for future work exploring PSS characterization and stakeholder engagement decision in early stage new PSS development in the healthcare industry. © 2013 PICMET.