The difficulties of supplying new technologies into highly regulated markets: the case of tissue engineering

This study provides an insight into the difficulties companies encounter in transposing basic science into commercially viable healthcare technologies, focusing on the issue of establishing a dominant supply model within a highly regulated market. The core issue is how to scale-up customized scientific processes into products able to supply wider and possibly mass, markets. In tracing the development of approaches to scaling-up, the paper highlights the influence regulatory regimes have on high technology regulated products and services. The paper details the implications of two contrasting supply initiatives towards operationalizing tissue engineering, based on differences in regulatory regimes between Europe and the US.