The difficulties of supplying new technologies into highly regulated markets: the case of tissue engineering |
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| Authors: | Wendy Phillips Thomas Johnsen Nigel Caldwell Julian B Chaudhuri |
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| Institution: | 1. Bristol Business School , University of the West of England , Coldharbour Lane, Bristol , BS16 1QY , UK wendy.phillips@uwe.ac.uk;3. Audencia Nantes School of Management , 8 route de la Joneliere, BP 31222, 44412 , Nantes , Cedex 3 , France;4. Bristol Business School , University of the West of England , Coldharbour Lane, Bristol , BS16 1QY , UK;5. Centre for Regenerative Medicine, Department of Chemical Engineering , University of Bath , Bath , BA2 7AY , UK |
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| Abstract: | 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 customised 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 operationalising tissue engineering, based on differences in regulatory regimes between Europe and the USA. |
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| Keywords: | new technologies supply regulation |
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