Clinical translation of biomedical materials and the key factors towards product registration

SummaryBiomedical materials have been developed for facilitating tissue regeneration and healing enhancement. Although research on biomedical materials has made great progress in material innovation and preclinical testing, the bottleneck is their translation from research and development to clinical applications; that is, the current rate of product registration and industrialization is low, which directly affects their clinical applications. In this paper, we introduce the basic features of biomedical materials towards the making of medical products and the experiences of our group in research and clinical translation of biomaterials for bone-tissue regeneration in the last few years. Based on our experience, we propose that the translational medicine platform (TMP) is an effective route to facilitate the progress of biomedical materials from bench to bedside. Moreover, from the viewpoints of scientific technology and management, the functions of TMP were also addressed. Relationships among TMP, research institution, enterprise, and government were also explored from the viewpoints of technological innovation, chemical engineering integration, fund raising, and management. This paper provides a theoretical and practical reference for clinical translation of biomedical materials.