Tissue-engineering promises an era of regenerative medicine using products combining manufactured materials with animal or human tissues or cells. Bio-engineered skin systems are in the marketplace and other products such as cartilage and blood vessel prostheses are under development. These products currently face regulatory uncertainty, falling between national and European regulations for medical devices, pharmaceuticals, tissues, and consumer products.
In these circumstances, international manufacturers address a complex set of alternative national regulatory routes and informal local strategies for technology assessment and obtaining marketing approval. Thus various proto-regulatory activity is taking place, primarily between regulators, manufacturers, standard-setting bodies, scientists and clinicians. This highlights the social and interorganisational relations of trust and expertise underlying formal regulation in conditions of scientific uncertainty.
Research in this area will use comparative case study methods: (a) to evaluate the mutual implications of trends in TE and in governance, regulation and evidential processes; (b) to extend conventional health technology assessment by analysing the sociology and political economy of regulatory activity; (c) to analyse the implications of stakeholders' risk/benefit discourses for public health, healthcare policy and innovation/competitiveness; (d) to evaluate governance frameworks for the assessment and introduction of tissue-engineered medical products in the UK and Europe.