Product development in tissue engineering.

Tissue engineering may be defined as the application of the principles and techniques of biomedical engineering to products and processes involving living cells. As such it is located at the confluence of traditional medical device technology, molecular pharmacology, and cell biology. Effective function at this interface has proven both elusive and critical in tissue engineering research and is likely to remain a determinant of success or failure as products move from research through development and into clinical practice. As a further challenge, regulatory processes, traditions, and approval pathways are rather different for medical devices than for Pharmaceuticals and biologies, and commercialization of hybrid products will require knowledge and expertise in both areas. This review compares and contrasts the development cycle for medical devices and pharmaceutical products and highlights the major development issues facing emerging tissue engineering products.