本文主要思考和讨论的内容是尝试将质量源于设计（QualitybyDesign，QbD）这一理念和原则运用于一个全新的医疗器械产品研发的项目全程设计、跟踪、指导和管理，以期获得将QbD落实于医疗器械研发的一些初步方法和成功或失败两方面的一些基本经验，以及为今后进一步探索如何将QbD指导原则同医疗器械新产品研发相结合建立一个初步的研究实例和方法学案例。相较于制药企业，国内的医疗器械（包括诊断试剂）企业对GMP理念和原则的接受和推广得更晚，因而更需要有既符合科学实践原则又具有实际指导意义的新理念和新方法来指导医疗器械产品（包括诊断试剂产品）的研发、生产和市场销售的各个阶段。而POCT（PointofCareTesting），国内目前通常译作即时检验或现场检验，作为医疗器械产品中的一个特殊领域，近年来在国外，尤其是欧美市场取得了长足的发展，但国内自上世纪九十年代中期开始引进和推广血糖仪产品及妊娠和尿试纸检测等少数几个产品外，并无更多的产品推出，而临床和实际又有较广泛的应用和需要。本项目团队根据这一个情况，经过广泛的调研和认真的评估，提出了开发总胆固醇（TotalCholesterol，TC）POCT产品的计划和构想，并依据同期在北大IPEM学习所获得的QbD相关知识、方法和经验，创新地尝试在项目启动初期即将正在国内外制药领域推广应用的QbD的方法和原则运用于实际的产品研发全过程中。关键词：质量源于设计医疗器械研发即时检验总胆固醇检测仪Title：AcaseoftheapplicationofQbDrulesintheresearchanddevelopmentofmedicaldevice----theanalysisofprojectmanagementoftheinstanttotalcholesterolkitABSTRACTInthispaper，theprincipleofQbD(QualitybyDesign)conceptwasdiscussedandappliedinthewholeresearchprocessofanewmedicaldevice(MD),includingthedesignprocess,projecttracking,guidanceandmanagement.ItwasexpectedtoacquiresomefundamentalmethodandbasicexperienceofbothsuccessandfailurefromtheMDresearch,andalsotryingtoestablishaninitialresearchexampleandamethodologycasetodiscoverhowtocombinetheQbDrulewiththedevelopmentofMDproductinthefuture.Comparetothepharmaceuticalindustry,theGMPprinciplewasmuchlaterintroducedandacceptedtothemedicaldeviceindustry(includingthediagnosticreagentindustry)inChina.Soitismorenecessarytobringnewideasandnewmethodswhicharebothscientific,reasonableandpracticaltoinstructthedevelopmentofanewmedicaldeviceproductasanintegratedprocess，fromresearchtomanufacturingandtomarketingofthefinalproduct.POCTasashortformofPointofCareTestingisaspecialareaofMDproducts,whichhasmadesignificantprogressesontheU.S.andEuropeanmarketinrecentdecades.ButinChina,thepopularproductsthathasbeenintroducedasaPOCTproductincludeonlyafewsuchlikeglucometer，pregnanttestkitandurinetestkit,whilePOCTproductsareactuallymorewidelyandnecessarilydemandedandrequiredforbothhealthcareandclinicalpurposes.Accordingtosuchsituation,theteamhaslaunchedacomprehensivedevelopmentplanofTotalCholesterol（TC）productsbasedonextensivestudyandcarefulevaluation.Theknowledge,principleandexperienceofQbDlearnedinPekingUniversitywereinnovativelyintroducedintheresearchprocessattheverybeginning.Inthispaper,themethodandprincipleofQbDwasapproachedintheresearchanddevelopmentofaninstanttotalcholesteroltestkit.Themajortasksofthisprojectincludethefollowings:Keywords：QualitybyDesign,ResearchandDevelopment,MedicalDeviceandDiagnosticReagents,PointofCareTesting,TotalCholesterolTestKit目录第一章序言······························11.1研究背景·····························11.1.1QbD及其在制药行业中的应用··················11.1.2医疗器械和POCT················...
