在当今的商业环境中有一种越来越明显的趋势，即企业成功的能力取决于其新产 品研发的能力。因此，企业进行新产品研发的过程、将创意商业化的过程以及他们使 用的策略定位和建立主导竞争地位都是企业面临的重要问题。产品研发流程是 S 公司 的核心流程,随着市场竞争日益激烈,S 公司注意到此前的研发流程存在产品不满足客 户需求、研发周期过长、部门沟通不畅、流程繁琐复杂等问题,对产品研发流程进行 优化就非常必要。戴明 W. Edwards Deming 认为，在企业所面临的所有问题以及关 于优化的研究中，有 94%是由流程的问题引起的，仅有 6%是由于其他原因所导致的。 本论文以 S 医疗器具公司为例，针对 S 公司医疗新产品研发流程为研究对象,通 过并行工程理论和流程优化论系统性地分析了 S 医疗器具公司的研发流程。首先对 S 公司整体概况及其研发流程现状进行了介绍,分析了产品研发流程中各阶段存在的问 题。其次，结合并行工程理论、流程优化理论，提出对 S 公司医疗新产品研发流程的 优化方案，主要包括四个方面：（1）拓宽需求来源，医工结合（2）引入并行工程， 缩短研发周期；（3）打破部门沟通壁垒，建立跨职能的项目团队。（4）运用 ESIA 方法优化流程，压缩非增值项。最后，为了确保新产品研发流程有效执行,提出了包 括领导层的支持,建立奖惩机制等流程实施必不可少的保障措施。本文对 S 公司医疗 新产品研发流程的研究和优化,不仅对于 S 公司的研发流程改进具有指导意义，而且 对于跟 S 公司具有同样问题的企业也有一定的参考价值。 关键词：医疗器具；研发管理；流程优化III Abstract Product research and development process is the core process of S Medical device company. As we know, the market competition is becoming more and serious, S company has noticed that the previous development process has problems such as lack of market investigation and long development cycle, so it is necessary to optimize the product development process. In 1986, W. Edwards Deming put forward: "based on my own experience, I estimate that of all the problems faced by enterprises and all the opportunities for optimization and improvement, 94% are partly caused by the system (process), and only 6% are caused by some other special reason. This paper takes S medical device company as an example and systematically analyzes the R&D process of S medical device company according to the concurrent engineering theory and process optimization theory. Taking S company's medical product research and development process as an sample, firstly, this paper introduces the overall status of S company, and analyzes the problems existing in each stage of product development process. At the same time, combining the theory of concurrent engineering and the theory of process optimization theory, solutions were proposed, and the R&D process of S company's medical products was optimized and reformed.(1) increase source of needs, combine engineering with medicine; (2)enhance efficiency by introducing concurrent engineering theory; (3)introduce cross function R&D team to facilitate communication . (4)compress non-value-added items to simplify the process. So as to make sure the effective implementation of the optimized process, this paper puts forward three safeguard measures which are necessary for the implementation of the optimized process, including support from top leaders and the establishment of reward and punishment mechanism etc. The research and optimization of S company's research and development process mentioned in this paper not only help S company’s process optimization, but also has certain enlightenment and reference function for similar enterprises' product development process optimization. Keywords：Medical Device ; R&D Management ; Process Optimization目录 致谢.........................................................................................................................................I 摘要.......................................................................................................................................II Abstract................................................................................................................................ III 第 1 章 绪论..........................................................................................................................1 1.1 选题的背景及意义......................................................................................................1 1.1.1 选题背景................................................................................................................1 1.1.2 研究目的................................................................................................................3 1.1.3 研究意义................................................................................................................4 1.2 国内外研究现状..........................................................................................................5 1.2.1 国外研究现状........................................................................................................5 1.2.2 国内研究现状........................................................................................................6 1.2.3 文献评述................................................................................................................8 1.3 研究内容与基本框架..................................................................................................9 1.3.1 研究内容................................................................................................................9 1.3.2 基本框架................................................................................................................9 1.4 研究方法....................................................................................................................10 1.5 创新点........................................................................................................................11 第 2 章 理论基础................................................................................................................12 2.1 新产品研发知识........................................................................................................12 2.1.1 新产品研发的概念及过程..................................................................................12 2.1.2 新产品研发过程存在的问题及原因..................................................................13 2.2 研究的理论基础........................................................................................................15 2.2.1 并行工程理论......................................................................................................15 2.2.2 流程优化理论......................................................................................................16 第 3 章 S 公司医疗器具新产品研发流程现状及问题分析.............................................18 3.1 S 公司简介及组织框架.............................................................................................18 3.2 S 公司医疗器具新产品研发流程现状.....................................................................193.2.1 研发组织架构分析..............................................................................................19 3.2.2 产品研发流程解析..............................................................................................21 3.3 S 公司医疗器具新产品研发流程问题解析.............................................................23 3.3.1 基于访谈法对 S 医疗器具公司的现有研发流程问题进行解析..................... 23 3.3.2 基于问卷调查法对 S 医疗器具公司的现有研发流程问题进行解析............. 26 3.3.3 基于研发数据对 S 医疗器具公司的现有研发流程问题进行解析................. 33 3.4 现有研发流程中的主要问题及原因分析................................................................34 3.4.1 产品不满足客户需求.........................................................................................34 3.4.2 研发周期过长，研发效率低下.........................................................................36 3.4.3 部门沟通不畅.....................................................................................................38 3.4.4 流程繁琐复杂，非增值项过多........................................