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.

Soil mix technology for integrated remediation and ground improvement: From laboratory work to field trials

Relatively new in the UK, soil mix technology applied to the in-situ remediation of contaminated land involves the use of mixing tools and additives to construct permeable reactive in-ground barriers and low-permeability containment walls and for hot-spot soil treatment by stabilisation/ solidification. It is a cost effective and versatile approach with numerous environmental advantages. Further commercial advantages can be realised by combining this with ground improvement through the development of a single integrated soil mix technology system which is the core objective of Project SMiRT (Soil Mix Remediation Technology). This is a large UK-based R&D project involving academia-industry collaboration with a number of tasks including equipment development, laboratory treatability studies, field trials, stakeholder consultation and dissemination activities. This paper presents aspects of project SMiRT relating to the laboratory treatability study work leading to the design of the field trials. © 2012 American Society of Civil Engineers.