Essential requirements for resorbable bioceramic development: Research, manufacturing, and preclinical studies

Abstract

There is a large variety of commercial bioceramic bone substitutes; however, the prerequisites for bone reconstruction and tissue engineering are often absent in research and clinical applications. The main criteria for the use of bioceramics are easily handled biomaterials that are solid, injectable, and/or shapeable. Furthermore, the material must have the appropriate osteoconductive and osteoinductive properties. New bone regeneration technologies, such as “smart matrices,” must be developed and optimized to increase their suitability for bone defects and to support suitable Ortho Biology. This contribution presents the basic smart bone substitutes used for bone regeneration, which will support the twenty-first-century challenge in osteoarticular pathology to replace autografts with more efficient synthetic materials. The paper is focused on the specifications required for the smart matrix (or osteo instructive matrix), the needs of the surgeon, the clinical indications, the regulatory constraints, and product development and marketing. Finally, an example was presented of a smart matrix medical device developed and used in bone regeneration and details the cascade of steps necessary to put it on the market: research and development, meeting the regulatory criteria, preclinical and clinical data, CE mark approval, and FDA (United States Federal Drug Administration).