基于标准化评价方法的医疗器械创新成果转化评估实践与策略研究——以多场景一氧化氮控制仪为例  

Practice and Strategy Research on the Transformation Evaluation of Medical Device Innovation Achievements Based on Standardized Evaluation Methods——A Case Study of Multi-Scenario Nitric Oxide Control Instruments

作　　者：胡海汐 HU Haixi(Department of Scientific Research,The First Affiliated Hospital of USTC,Division of Life Sciences and Medicine,University of Science and Technology of China,Hefei Anhui 230001,China)

机构地区：[1]中国科学技术大学附属第一医院(安徽省立医院)科研处,安徽合肥230001

出　　处：《中国医疗设备》2024年第10期139-145,158,共8页China Medical Devices

基　　金：中国科学技术大学“2022年科大新医学联合基金培育项目”(YD9110002029)。

摘　　要：目的探索将标准化评价方法应用于医疗器械成果转化评估,加强公立医院医疗器械科技成果转化评估体系建设。方法通过文献调研、案例实证研究和SWOT-PEST分析方法,系统阐释了科技成果标准化评价相关研究现状,以及标准化评价应用于医疗器械创新成果转化的指标体系和评价方法。结果共纳入28篇文献数据,提炼了3项研究特征以及5项科技成果标准化评价方法和计量模型;利用得到的模型对多场景一氧化氮控制仪进行评价,其技术创新水平为第5级,在控制精度和有效治疗剂量核心技术方面取得了突破,未来转化与产业化的主要风险是竞争风险,风险等级为Ⅳ级;结合评价结果与SWOT-PEST分析,提出“多元创新、扩展提升、测试验证、整合优化”四位一体的系统性发展战略。结论应用标准化评价,可以客观评估医疗器械创新成果所处的技术成熟度和产业化前景,为公立医院科技创新和成果转化决策提供支持。Objective To explore the application of standardized evaluation methods in the transformation evaluation of medical device achievements,and strengthen the construction of the evaluation system for the transformation of medical device technology achievements in public hospitals.Methods Through literature research,case studies,and SWOT-PEST analysis methods,the current research status of standardized evaluation of scientific and technological achievements,as well as the indicator system and evaluation methods of standardized evaluation applied to the transformation of medical device innovation achievements was systematically explained.Results A total of 28 literature data was included to extract three research features,as well as five standardized evaluation methods and econometric models for scientific and technological achievements;using these models to evaluate the multi scenario nitric oxide controller,its technological innovation level was level five,and it has made breakthroughs in core technologies such as control accuracy and effective therapeutic dose.The main risk for future transformation and industrialization was competition risk,with a risk level of levelⅣ.Based on the evaluation results and SWOT-PEST analysis,a systematic development strategy of“diversified innovation,expansion and improvement,testing and verification,integration and optimization”was proposed.Conclusions Standardized evaluation can objectively assess the technological maturity and industrialization prospects of medical device innovation achievements,providing support for public hospital scientific and technological innovation and achievement transformation decisions.

关 键 词：医疗器械 创新成果转化 标准化评价 工作分解结构 SWOT-PEST分析 技术创新就绪水平 技术突破点分析表 

分 类 号：R197.39[医药卫生—卫生事业管理]