Biomaterials Evaluation: Conceptual Refinements and Practical Reforms

Regarding the widespread and ever-increasing applications of biomaterials in different medical fields, their accurate assessment is of great importance. Hence the safety and efficacy of biomaterials is confirmed only through the evaluation process, the way it is done has direct effects on public health. Although every biomaterial undergoes rigorous premarket evaluation, the regulatory agencies receive a considerable number of complications and adverse event reports annually. The main factors that challenge the process of biomaterials evaluation are dissimilar regulations, asynchrony of biomaterials evaluation and biomaterials development, inherent biases of postmarketing data, and cost and timing issues. Several pieces of evidence indicate that current medical device regulations need to be improved so that they can be used more effectively in the evaluation of biomaterials. This article provides suggested conceptual refinements and practical reforms to increase the efficiency and effectiveness of the existing regulations. The main focus of the article is on strategies for evaluating biomaterials in US, and then in EU

Challenges in Three-Dimensional Printing of Bone Substitutes

Hope is that tissue engineering will provide a solution to meet the growing needs for bone substitutes. Among the potential solutions, three-dimensional (3D) printing is a promising method to fabricate functional bone substitutes especially for treatment of complex and critical-sized bone defects. Despite its encouraging achievements, 3D printing of bone substitutes still faces serious challenges including mechanical strength, shape complexity, optimization of pore parameters, and vascularization. The newer approach, that is, 3D bioprinting, is also confronted with challenges, which have prevented the realization of the dream of fabricating functional patient-specific bone substitutes. This article reviews the major challenges toward 3D printing and bioprinting of bone substitutes and recent studies addressing them. Potential solutions for each challenge and future directions are also provided