Regenerative medicine as a disruptive technology: Implications for manufacturing and clinical adoption

Although regenerative medicine has been described as a disruptive innovation, there has been little critical enquiry into the nature and location of the disruption. This paper, based on ten cases in the UK, analyses the nature of disruption for allogeneic and autologous therapies in terms of manufacturing, distribution and adoption in clinical settings. We discuss the challenges of dealing with inherent variability in living systems and how this necessitates co-evolution of technologies and innovations. We propose that understanding of the distinction between disruptive and incremental innovation, and of the nature, extent and location of the disruption across sectoral value chains, can help to guide company innovation strategies and government innovation support policies for regenerative medicine, as already proposed for industrial biotechnology.