Abstract: 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.