基于技术就绪水平的卫生装备评价方法研究

Integrated technology assessment for medical equipment based on technology readiness levels

目的研究基于技术就绪水平的卫生装备评估方法。方法首先阐述我国卫生装备研发评价体系的现状与问题,然后分析技术就绪水平(technology readiness levels,TRL)评价的基本理论和卫生装备TRL评价的特殊需求,之后结合风险因子因素,给出了基于专家评估的卫生装备综合就绪水平评估方法。结果对手术信息管理系统进行评估,验证了该评价方法的可行性和合理性。结论本文提出的基于技术就绪水平的卫生装备评估方法,可用于综合评价卫生装备研制项目技术成熟度及质量成本及进度(quality-cost-delivery,QCD)。

Objective To study the assessment method of medical equipment research and development based on technology readiness levels （TRL）. Methods The status quo and problems of the evaluation system of Chinese medical equipment research and development were elaborated firstly, and then some useful experiences of TRL evaluation and the special demands of medical equipment TRL evaluation were analyzed. The quality risk indicator, cost risk indicator and delivery risk indicator were taken as risk factors to put forward an expert-based integrated TRL assessment method of medical equipment. Results The assessment method is proved to be feasible and realizable by assessing the operation information management system. Conclusion The TRL-based assessment method of medical equipment can be used to assess the technology maturity and quality-cost-delivery （QCD） for Chinese medical equipment research and development.