Regenerative medicine and its development and implementation: Fieldwork interviews

Webster, Andrew (2017). Regenerative medicine and its development and implementation: Fieldwork interviews. [Data Collection]. Colchester, Essex: UK Data Archive. 10.5255/UKDA-SN-852913

REGenableMED is an ESRC-funded project examining the dynamics of innovation within the field of regenerative medicine. Using a mixed-methods social science approach, the project undertakes a detailed analysis of the interplay between business models, measures of clinical utility, patterns of regulatory oversight and clinical workflows within healthcare settings. The results of the research will inform strategies aimed at facilitating the responsible development of effective and useful regenerative medicine products and services. The project develops the notion of institutional readiness. The progress of innovation projects is often understood in terms of technology readiness: the extent to which the innovative technology has matured and is 'ready' to be put to use. Yet successful innovation also depends upon what could be called institutional readiness, that is, whether, and if so, how far, an organisation needs to adapt to embrace a new technology given pre-existing practices and structures. Institutional readiness is particularly significant in the developing field of regenerative medicine (RM). For RM to live up to its promise of revolutionising patient care, emerging products must be accommodated within pre-existing regulatory and healthcare organisations that are accustomed to dealing with more conventional medicinal products and services or, more likely, be developed through special clinical delivery centres, such as the proposed Advanced Therapy Treatment Centres. The REGenableMED project thus examines the ways in which relevant institutions and agencies are 'readying' themselves for regenerative medicine, and the various factors that enable and hinder institutional 'readiness'. By doing this, the project has produced findings that can inform healthcare policy and commercial strategies aimed at the responsible development and adoption of novel RM therapies.

Data description (abstract)

The data set is made up of all fieldwork interviews from the 'REGenableMED' project - 72 interviews in four discrete folders. Data was generated in the UK with key research scientists, clinicians, regulators, and companies working in the cell therapy field. The main research aims that drove the project were as follows: (1) explore emerging sub-sectors of regenerative medicine in the UK, and determine how they vary according to business, clinical and regulatory models; (2) map the value creation process across the key sub-sectors and technologies identified in the Strategy for UK Regenerative Medicine; (3) derive value chain and innovation ecosystem models that will provide a better understanding of pathways to commercial development and clinical application, and the key enablers and constraints; (4) provide a forward look (via horizon scanning and diffusion studies) in respect to the social and organisational challenges that the application of regenerative medicine is likely to create, while at the same time considering how RM will need to respond to changes in the organisation and delivery of healthcare itself; (5) provide a detailed analysis across all important areas of activity, of how the field of RM is likely to evolve in the UK, what factors will constrain its future development, and how innovation can be supported to enable delivery of societal and commercial benefits; (6) to advance interdisciplinary social science methodology by furthering the integration of clinical translation and adoption/diffusion studies with value systems approaches, including qualitative and quantitative methods.

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