摘要
目的:针对国内医疗器械技术创新不足,产学研医结合不紧密的难点,研究临床工程师如何结合临床工程学的学科特色和自身职业特点在医疗器械技术创新过程发挥作用。方法:通过分析国内医疗器械现状以及医疗器械技术创新的目的、内容、特征、类型思维和方法,研究临床工程师在医疗器械技术创新过程中7个阶段的作用。结果:通过分析研究发现临床工程师在医疗器械创新过程中发挥着重要的桥梁作用,是技术创新需求的发现者、可行性的建议者,设计研发的协作组者、验证注册的讲解者、生产推广的指导者。根据临床工程师所发挥的作用,结合医院实际情况,医院计划建立一套医工结合技术创新工作机制,鼓励临床工程师参与医疗器械技术创新。结论:通过本文研究充分认识和发挥临床工程师在医疗器械技术创新过程中的桥梁作用,加强临床工程师人才队伍培养建设,提高临床工程师参与医疗器械技术创新积极性,有利于产学研医结合紧密结合,提高医疗器械技术创新水平,推动医疗器械行业持续快速发展。
Objective:To study how clinical engineers play a role in the process of medical device technology innovation in combination with the discipline characteristics and professional characteristics of clinical engineering.Methods:By analyzing the current situation of domestic medical devices and the purpose,content,characteristics,types,thinking and methods of medical device technology innovation,the role of clinical engineers in seven stages of medical device technology innovation was studied.Results:Through analysis and research,it is found that clinical engineers play an important bridge role in the process of medical device innovation.They are the discoverer of technological innovation needs,the proposers of feasibility,the coordinators of design and development,the interpreter of verification and registration,and the guide of production and promotion.According to the role played by clinical engineers and in combination with the actual situation of the hospital,the hospital plans to establish a set of working mechanism of medical engineering combined with technological innovation to encourage clinical engineers to participate in the technological innovation of medical devices.Conclusion:Through the research in this paper,we can fully understand and give full play to the role of clinical engineers as a bridge in the process of medical device technology innovation,strengthen the training and construction of clinical engineersʼtalent team,and improve the enthusiasm of clinical engineers to participate in medical device technology innovation,which is conducive to the close integration of production,study,research and medicine,and improves the efficiency of clinical engineers.The technological innovation level of medical devices promotes the sustained and rapid development of the medical device industry.
作者
杨丽晓
侯正松
朱思南
鲍奇
童佳斌
丁秀文
YANG Li-xiao;HOU Zheng-song;ZHU Si-nan;BAO Qi;TONG Jia-bin;DING Xiu-wen(Department of Medical Engineering,the First Affiliated Hospital of Naval Military Medical University,Shanghai 200433;Clinical Research Center,the First Affiliated Hospital of Naval Military Medical University,Shanghai 200433)
出处
《中国医疗器械信息》
2022年第10期1-4,167,共5页
China Medical Device Information
关键词
医疗器械技术创新
临床工程师
作用
medical device technology innovation
clinical engineer
role