基于DFSS的体外诊断试剂设计转移研究

Study on design transfer of IVD reagent product based on DFSS

我国体外诊断试剂行业进入了快速发展期,市场发展前景良好。但是由于缺乏系统的过程开发和验证方法,常常使新产品设计转移不充分,导致批量生产产品质量不稳定。文章旨在通过采用六西格玛设计(DFSS)的IDDOV流程和系统的工具、方法,来探寻体外诊断新产品设计转移的新模式,为各种来源的研发输出转移到生产线,维持批量生产的稳定质量,提供有效的设计转移流程和方法。

IVD（In Vitro Diagnostic） industry of China now enters into fast development period.But it still face the situation of unstable quality of mass production which is mainly caused by insufficiency design transfer lack of systematic process development and validation methods.The research purpose of this paper is through the use of Design for Six Sigma （DFSS） IDDOV processes and systematic tools to explore the new model of in vitro diagnostic new product design transfer, which can provide adequate and effective design transfer processes and methods for transferring a variety of sources output to the production line and maintaining the quality stability of mass production.