Regenerative medicine and its development and implementation: an analysis of emergent value systems and health service readiness


REGenableMED examines the dynamics of innovation within the field of regenerative medicine. Using a mixed-methods social science approach, the project provides 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 have helped inform strategies aimed at facilitating the responsible development of effective and useful regenerative medicine products and services.

The project has developed the notion of institutional readiness to capture the importance of the institutional setting in which regenerative medicine is to be deployed. 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, or the capacity and willingness of key pre-existing organisations and inter-organisational structures to adopt, respond to and utilise novel technologies. 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 somehow be accommodated within pre-existing regulatory and healthcare organisations that are accustomed to dealing with more conventional medicinal products and services.

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 applicable findings that can inform healthcare policy and commercial strategies aimed at the responsible development and adoption of novel RM therapies. The results were drawn on by the 2017 House of Commons Science and technology Select Committee’s Inquiry into regenerative medicine.