Procedures for the evaluation of tissue-engineering processes, including those used for the testing of the relevant biomaterials, have not been developed in a logical manner. This perspectives paper discusses the limitations of testing regimes and recommends a very different approach. The main emphasis is on the existing methods for assessing the biological safety of these biomaterials, which, it is suggested, are irrelevant for evaluating materials that are intended to facilitate the generation of new tissue. An algorithm is proposed that sets out the pathway from materials design and characterization through to the production of a file that sets out full biocompatibility, functionality, and tissue incorporation data that are suitable for regulatory consideration for first-in-man experiences. Central to this algorithm is the choice of animal models and the real-time monitoring of the implanted construct performance.
Keywords: biocompatibility; biomaterials; chemical characterization; functionality testing; mechanotransduction; preclinical testing.