【作者】 余辉；

【导师】 陶俐言； 田海峰；

【作者基本信息】 浙江大学 ， 工程管理（专业学位）， 2022， 硕士

【摘要】 S公司是一家专注于腹腔镜外科手术机器人研发与生产的初创式医疗设备企业,公司发展具有非常好的市场机遇,但同时也面对着惨烈的市场竞争环境,如何更快更好的完成对腹腔镜外科手术机器人的研发并顺利推向市场,已经成为S公司面临的重大课题。决定企业核心竞争力最重要的一个因素就是新产品研发能力,而产品研发流程则是一个公司运营的核心流程,只有合理的产品开发流程设计才能保证公司产品研发得以高效完成,不断提高市场竞争力。论文以S公司腹腔镜外科手术机器人研发流程作为研究对象,通过访谈和问卷调查的方式对腹腔镜外科手术机器人研发流程的现状进行研究和分析,总结归纳了研发流程管理中产品研发成本过高,研发周期太长,研发效率不高等三大主要问题,并进一步的分析了现有问题产生的原因。基于问题的总结和原因的分析,论文提出了新研发流程设计的目标和原则,并运用IPD集成开发管理理论确定新研发流程设计方案的总体框架。紧接着运用基线管理理论对整个腹腔镜外科手术机器人项目的研发阶段进行重点里程碑的设定。结合项目实际,运用进度管理的相关知识确定开发过程的关键路径,考虑到医疗器械的特殊性,论文还将风险管控的思路融入新研发流程的设计中,确保将研发风险损失降到最低。在完成对新研发流程的设计后,为了有效落实新研发流程方案的实施,论文不仅提出了包括引入医工结合平台,建立跨功能项目组,成立研发品质管理部门和技术开发部,DFMA开发模式等具体的实施方案,而且建立了一套统一的管理方式和制度来保障整个新研发流程真正落地实施。最后,论文通过流程程序分析法从几个不同维度对新旧流程下的实施效果进行对比评价。评价结果表明,通过新流程的实施,研发流程较改善前工序减少了7项,研发周期缩短了32天,所需研发人员数量减少了15人,单次的研发成本较改善前降低约人民币96万元,充分验证了新研发流程方案实施的有效性。论文通过对腹腔镜外科手术机器人项目研发流程的设计改进和研究,不仅为S公司整个研发管理体系的建设奠定了一定的理论和实践基础,同时也对其它类似的高端医疗器械公司的流程管理具有一定的参考和借鉴意义。更多还原

【Abstract】 S company focus on R&D and manufacturing of laparoscopic surgery robot,the company has good market development opportunities,but also faced with the fierce market competition,how to better and faster complete the laparoscopic surgery robot R&D and launch the market successfully has become a major topic for S company.New product R&D ability is an embodiment of the core competitiveness of an enterprise,and the product R&D process is the core process for company management,only a appropriate R&D process can ensure that the company’s new products development can be completed efficiently and constantly improve the market competitiveness.The Paper research the R&D process of S company’s laparoscopic surgery robot,sums up three main problems through interviews and questionnaire for laparoscopic surgery robot R&D process,they are the high cost of R&D process management,long R&D cycle time and low R&D efficiency,the paper also analyse the root cause for them.the paper raise the objectives and principles of the new R&D process design based on the summary of the problems and the cause analysis,,and determines the overall framework of the new R&D process design using the IPD theory.Then the baseline management theory is applied to set key milestones for the whole development phase of laparoscopic surgical robot project.Considering the particularity of medical devices,the paper also integrates the idea of risk control into the design of the new R&D process to ensure that the R&D risk loss is minimized.After completing the design of the new R&D process,in order to effectively implement the new R&D process,the paper not only raise the specific implementation plans including the introduction of medical and industrial integration platform,the establishment of cross-functional project team,the establishment of R&D QA department and technical development department,DFMA development mode,etc.But also a set of unified management methods and systems have been established to ensure the implementation of the whole new R&D process.Finally,the paper compares and evaluates the implementation effects of the new and old processes from several different dimensions through process program analysis method.The evaluation results show that the R&D procedure is reduced by 7 items,the R&D cycle time is shortened by 32 days,the number of engineer is reduced by 15 people,and the single R&D cost is reduced by about 960,000 yuan compared with the previous process after the new process implementation,which fully verifies the the new process effectiveness.Through the design improvement and research on the R&D process of laparoscopic surgical robot project,this paper not only lays a certain theoretical and practical foundation for the construction of the entire R&D management system of S Company,but also can give a certain reference for other similar high-end medical device companies on the R&D process management.更多还原