北京生物醫(yī)學(xué)工程

基于技術(shù)創(chuàng)新協(xié)同機(jī)制的中國醫(yī)療器械標(biāo)準(zhǔn)化建設(shè)

Medical device standardization in China based on synergetic mechanism for technical innovation

作者：杜然然歐陽昭連陳薇周平池慧

單位：           中國醫(yī)學(xué)科學(xué)院醫(yī)學(xué)信息研究所北京協(xié)和醫(yī)學(xué)院（北京 100020）        

關(guān)鍵詞：醫(yī)療器械；標(biāo)準(zhǔn)化；技術(shù)創(chuàng)新；S曲線；協(xié)同機(jī)制

分類號(hào)：

出版年·卷·期（頁碼）：2014·33·6（641-645）

摘要：

目的根據(jù)中國醫(yī)療器械產(chǎn)業(yè)技術(shù)發(fā)展規(guī)律，探討中國醫(yī)療器械標(biāo)準(zhǔn)化建設(shè)在技術(shù)創(chuàng)新方面應(yīng)注意的問題，為醫(yī)療器械產(chǎn)業(yè)發(fā)展提供參考。方法針對(duì)中國醫(yī)療器械標(biāo)準(zhǔn)化建設(shè)現(xiàn)狀，運(yùn)用協(xié)同學(xué)理論構(gòu)建中國醫(yī)療器械標(biāo)準(zhǔn)化建設(shè)的協(xié)同架構(gòu)及分析維度框架，以技術(shù)創(chuàng)新協(xié)同機(jī)制為視角，基于S曲線理論構(gòu)建了醫(yī)療器械標(biāo)準(zhǔn)化建設(shè)的S曲線分析模型。結(jié)果構(gòu)建了包含技術(shù)、知識(shí)、關(guān)系及利益協(xié)同機(jī)制的分析維度框架，突出了以創(chuàng)新體系、市場需求及監(jiān)管機(jī)制為導(dǎo)向的中國醫(yī)療器械標(biāo)準(zhǔn)化體系。結(jié)論提出了醫(yī)療器械標(biāo)準(zhǔn)在早期階段、起草與協(xié)同階段、實(shí)施與商用階段的相關(guān)發(fā)展思路和建議，具有一定的科學(xué)性及參考價(jià)值。不僅為增強(qiáng)中國醫(yī)療器械產(chǎn)業(yè)市場競爭力創(chuàng)造了良好條件，同時(shí)也為搶占國際標(biāo)準(zhǔn)戰(zhàn)略制高點(diǎn)提供了參考。

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.

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