CUED Publications database

Technology confidence in early stage development of medical devices

Johnson, J and Moultrie, J (2012) Technology confidence in early stage development of medical devices. International Journal of Innovation Science, 4. pp. 57-70. ISSN 1757-2223

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Abstract

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.

Item Type: Article
Uncontrolled Keywords: Early phase technology development Healthcare pipeline Medical device development Medical device innovation Proof of concept
Subjects: UNSPECIFIED
Divisions: Div E > Manufacturing Systems
Depositing User: Cron Job
Date Deposited: 07 Mar 2014 11:29
Last Modified: 08 Dec 2014 02:39
DOI: 10.1260/1757-2223.4.2.57