Developing innovation governance readiness in regenerative medicine: lessons learned from the Macchiarini crisis

The generation and clinical adoption of workable therapies in regenerative medicine has been slow, despite its alleged potential to relieve suffering and improve health outcomes. This has been explained by a fundamental difference between advanced cell and gene therapies and conventional drug- and device-based therapies, raising questions about how the readiness of existing healthcare systems to adopt such therapies can be evaluated and improved. In this paper, we use the lessons learned from the Macchiarini crisis at the Karolinska Institute in Sweden to take the first step in formulating the concept of innovation governance readiness. We propose it as a tool to help evaluate and improve the ability of private, public and civil society actors to work together to build and put into practice therapies based on emerging medical technologies such as regenerative medicine.