Zhang Jiazhen, Zhai Bao, Gao Jintao, Li Zheng, Zheng Yufeng, Ma Minglong, Li Yongjun, Zhang Kui, Guo Yajuan, Shi Xinli, Liu Bin, Gao Guobiao, Sun Lei
Center for Medical Device Evaluation, National Medical Product Administration, Beijing 100081, China.
Guangdong-Hong Kong-Macao Greater Bay Area, Center for Medical Device Evaluation and Inspection of NMPA, Shenzhen 518045, China.
Regen Biomater. 2022 Nov 15;10:rbac093. doi: 10.1093/rb/rbac093. eCollection 2023.
The 'plainification of materials' has been conceptualized to promote the sustainable development of materials. This perspective, for the first time in the field of biomaterials, proposes and defines 'plain metallic biomaterials (PMBs)' with demonstrated research and application case studies of pure titanium with high strength and toughness, and biodegradable, fine-grained and high-purity magnesium. Then, after discussing the features, benefits and opportunities of PMBs, the challenges are analyzed from both technical and regulatory aspects. Regulatory perspectives on PMB-based medical devices are also provided for the benefit of future research, development and commercialization.
“材料的简化”已被概念化,以促进材料的可持续发展。这一观点在生物材料领域首次提出并定义了“纯金属生物材料(PMB)”,并给出了高强度、高韧性纯钛以及可生物降解、细晶和高纯度镁的研究与应用案例。然后,在讨论了PMB的特点、优势和机遇之后,从技术和监管两个方面分析了挑战。还提供了基于PMB的医疗器械的监管观点,以利于未来的研究、开发和商业化。