骨组织病损植入器械定制设计的审评关注点

摘要

骨组织病损植入器械定制设计的技术审评关注点,集中于临床需求的工程转化、术前性能验证和临床确认三方面,涉及到影像学信息处理、组织附着与固定、手术规划和工具、设计规范和说明、有限元分析、台架试验、上市前后临床研究等,综合运用生物力学、力学生物学、盲态交叉复验、临床试验动态设计等适应性的风险评价方法.%The evaluation concerns on custom design of implant for bony defect focus on engineered transformation of clinical needs, pre-operation performance verification and clinical validation. These concerns refer to manipulation on imageology information, tissue adhesion and fixation, surgery planning and instruments, design specification and instruction, finite element analysis, bench testing, around market clinical research et al. The evaluation integrates adaptive risk evaluation methods such as biomechanics, mechanobiology, blind crossover reproducility and dynamic design of clinical study et al.