【摘要】 目的根据中国医疗器械产业技术发展规律,探讨中国医疗器械标准化建设在技术创新方面应注意的问题,为医疗器械产业发展提供参考。方法针对中国医疗器械标准化建设现状,运用协同学理论构建中国医疗器械标准化建设的协同架构及分析维度框架,以技术创新协同机制为视角,基于S曲线理论构建了医疗器械标准化建设的S曲线分析模型。结果构建了包含技术、知识、关系及利益协同机制的分析维度框架,突出了以创新体系、市场需求及监管机制为导向的中国医疗器械标准化体系。结论提出了医疗器械标准在早期阶段、起草与协同阶段、实施与商用阶段的相关发展思路和建议,具有一定的科学性及参考价值。不仅为增强中国医疗器械产业市场竞争力创造了良好条件,同时也为抢占国际标准战略制高点提供了参考。更多还原

【Abstract】 Objective To analyze the pattern of technical development in the medical device industry and discuss technical innovation challenges faced by medical device standardization so as to provide reference for further development of medical device industry in China.Methods The study applied synergetic theory to establish the synergetic framework and analytical scheme for medical device standardization with consideration of its current status.The study also built S-curve analytical model for medical device standardization based on Synergetics of technical innovation.Results The study set up an analytical framework with Synergetics of technology,knowledge,relationship and benefit for medical device standardization with focus on innovative scheme,market demand and regulatory mechanism.Conclusions The study proposed recommendations for medical device standardization in the stages of its early preparation,coordination,implementation and commercialization,with certain reference and scientific value.The study not only improved the competitive power of Chinese medical device products,but also provided strategies for Chinese industry to serve as a leading role in establishing international medical device standards.更多还原