REGenableMED Project Synopsis
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.