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姓名 阮俊仁(Chun-jen Juan)  查詢紙本館藏   畢業系所 工業管理研究所在職專班
論文名稱 以屬性導向新產品開發之流程塑模與分析– 以醫療器材產業為案例
(Process Modeling and the Analysis of Attribute-driven New Product Development–The Medical Device Industry as a Case)
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摘要(中) 在現今高度競爭激烈及全球化的趨勢下,新產品開發(New Product Development, NPD)儼然成為企業突破傳統窼臼、創造新利基的一種方式;以醫療器材製造業而言,由於醫學的日新月異、社會老年化的來臨及健康管理的日漸普及促使醫療器材業者紛紛投入新產品開發。然而醫療器材新產品開發的高研發門檻、廣泛的技術應用及醫療法令等種種限制,導致醫療器材之新產品開發常常功敗垂成。以台灣地區而言,醫療器材新產品開發正如雨後春筍般的蓬勃發展,故本研究提出一個可行的方案來解決醫療器製造商在新產品開發階段中所遭遇的問題如(1)顧客的需求的失焦 (2)產品規格定義的不穩定性 (3)新產品開發任務的執行不力 (4) 新產品開發專案團隊的效率不彰及(5)不完善的新產品上市.
本研究利用同步工程方法論(Concurrent Engineering, CE)建構在屬性導向模式(Attribute-driven design, ADS)並結合新產品開發流程及IDEF3方法來研究ODM或OEM醫療器材製造商在新產品開發時,訂定新產品之各項屬性,以期引導新產品開發團隊解決在新產品開發流程所面臨的困境; 如資源管理上的困難、團隊的目標分岐及開發時程的不確定性.來整合並管控新產品開發團隊,使新產品達到顧客需求、縮短開發時程之目標,最後以目前某醫療器材製造商之新產品開發為例來驗証其方法及流程之可行性。
摘要(英) Nowadays, companies must confront high levels of competition and extensive globalization. New product development (NPD) is a way to boost up enterprises and achieve optimum benefits. In the medical device industry, there have been rapid advancements in technology and medical practices, as well as ageing of the population, increases in the number of diseased individuals, and increasing respect for health-care management. The medical device industry is now faced with stiff competition in the development of novel medical devices. In Taiwan, the design of new medical devices is just starting to be competitive. However, designing new medical devices requires diversification, complexity and consistency. The basic theories and technical applications of medical devices span the fields of medical science, biotechnology, physiology, material science, mechanical engineering, electronics engineering and electrical engineering. Also, medical devices help in the diagnosis, treatment and prevention of human disease, and/or affect the structure and function of the human body. As a result, this dissertation attempts to provide a method by which one can figure out the problem as such as (1) failure to address customer wants and needs; (2) Unstable product definition; (3) Poor quality execution of key NPD tasks; (4) A poorly-structured, ineffectual project team and (5) Premature product launches.
This dissertation applies concurrent engineering (CE) methodology by attribute-driven design (ADS). Then, the method combines new product development (NPD) and integrated computer-aided manufacturing (ICAM) DEFinition (IDEF3). The proposed method first defines product attributes in an NPD project for ODM or OEM medical device manufacturers. The study addresses the difficult scenario that occurs when the NPD team faces problems during the NPD process, like problems with resource management, target inconsistencies, and uncertainties in the development schedule. The dissertation also utilizes the proposed method to integrate and monitor the NPD team, as it strives to fulfill goals, like meeting customer requirements and reducing the time to market. Finally, this dissertation applies the model to a specific new device case, so as to verify that the method is both effective and efficient.
關鍵字(中) ★ IDEF3
★ 醫療器材(Medical Device)
★ 同步工程(CE)
★ 屬性導向同步工程 (Attribute-driven Concurrent Engineering)
★ 新產品開發(NPD)
★ OEM
★ ODM
關鍵字(英) ★ New Product Development (NPD)
★ Medical Device
★ Concurrent Engineering (CE)
★ Attribute-driven Concurrent Engineering (ADCE)
★ IDEF3
★ OEM
★ ODM
論文目次 中文摘要 i
Abstract ii
致 謝 iv
List of Tables ix
Chapter I Introduction 1
1.1 Background……………………………………………………………………..1
1.2 Motivation………………………………………………………………………1
1.3 Research Objectives……………………………………………………………2
1.4 Thesis Organization…………………………………………………………….3
Chapter II Literature Review 5
2.1 Overview of the Medical Device Industry…………………………………….5
2.1.1 Definition of Medical Device 5
2.1.2 Classification of Medical Devices 6
2.1.3 Marketplace Review for Medical Devices 7
2.2 Introduction to Concurrent Engineering…………………………………...…8
2.2.1 Definitions of Concurrent Engineering 8
Source: Ke (2001) 9
2.2.2 Introduction to Integrating Product and Process Design 10
2.2.3 Issues of Concurrent Engineering 12
2.2.4 Benefits of Concurrent Engineering 13
2.3 New Product Development……………………………………………………15
2.3.1 Introduction to New Product Development 15
2.3.2 The Process of New Product Development 15
2.4 IDEF (Integrated Computer-Aided Manufacturing (ICAM) DEFinition) Methodology…………………………………………………………………16
2.4.1 Construction of IDEF Methodology 16
2.4.2 Introduction to the IDEF Family 17
Chapter III Overview of New Product Development and Proposed Methodology 19
3.1 Proposed Methodological framework………………………………………..19
3.2 Attribute-driven Concurrent Engineering Methodology…………………...19
3.2.1 Introduction of Attribute-Driven Concurrent Engineering (ADCE) 19
3.2.2 Definition of Attribute-driven Specification (ADS) 20
3.2.3 Application of ADS to design control 22
3.2.4 Application of ADCE 23
3.3 Integration Definition Method for Process Description Capture (IDEF3)...28
3.3.1 Introduction to IDEF3 28
3.3.2 Basic Element of IDEF3 Process Description 30
3.3.3 Symbols for IDEF3 Objects 32
3.3.4 IDEF3 Relationships 33
3.3.5 Advantages of IDEF3 37
3.3.6 A Process Example of IDEF3 Process-centered Schematic 37
Chapter IV Application of the Proposed Methodology 41
4.1 Description of the NPD process for Medical Devices……………………….41
4.1.1 Introduction to the Customer-Related Process 45
4.1.2 Introduction to the Product Development Process 47
4.2 Combining ADCE Methodology with NPD………………………………………54
4.3 Infrastructure of ADCE- NPD process by IDEF3………………………………..61
4.3.1 Description of ADS Driven Control in the Design Phase 61
4.3.2 Description of ADS Driven Control in the Engineering Phase 64
Chapter V Case Study: Auto-injector Medical Device 67
5.1 Background Overview……………………………………………………………..67
5.1.1 The Auto-injector Market 68
5.2 Scenario Description: Implementation of Auto-injectors by ADCE-NPD……...69
5.2.1 Architecture of the Proposed Auto-injector 70
5.2.2 Definitions for the ADS table in the Design Phase 71
5.2.3 Definitions for the ADS table in the Engineering Phase 72
5.2.4 Implementation of Auto-injector’s NPD Architecture 74
Chapter VI Conclusions and Recommendations 84
6.1 Conclusions...............................................................................................................84
6.2 Recommendations for Further Study……………………………………………..85
Reference 86
參考文獻 Reference
中文部分:
1. 王嘉玲:CALS 之模型方法分析---IDEF,ARIS 與OOA/OOD,2006年11月03日,取自http://www.axon.com.tw/。
2. 中綱科技:IDEF 0,3 Concept And BPwin Operation,2006年11月03日,取自http://www.axon.com.tw/。
3. 中華民國藥事法,行政院衛生署,2005。
4. 醫療器材優良製造規範,行政院衛生署,1999。
5. 柯博棋,「發展一物件導向機能展開系統-以建構元件式ERP系統」,國立中央大學,碩士論文,2001年。
6. 王柏元,「以IDEF模型化製造現場監控系統之研究-以微機電生產管制系統為例」,國立中央大學,碩士論文,2007年。
英文部分:
1. Boehm, Barry, “A Spiral Model of Software Development and Enhancement,” IEEE Computer, 1988, pp. 61-72.
2. Business Week, 8 May Issue, 1989
3. Brissaud, D., Tichkiewitch, S., “Innovation and manufacturability analysis in an integrated design context,” Computers in Industry, Volume: 43, Issue: 2, October, 2000, pp. 111-121.
4. Cleetus, Joe, Concurrent Engineering and Software Development, Concurrent Engineering Research Center, Feb 2001.
5. Cooper, R.G. and Edgett S.J.. “Overcoming the Current Crunch in NPD Resource, Stage-Gate Inc. and Product Development Institute Inc., 2007.
6. Cooper R.G., Klienschmidt E.J., “Uncovering the Keys to New Product Schusses,” Engineering Management Review, pp.5-18, winter 1993.
7. Cooper R.G., “Stage-Gate Systems: A New Tool for Managing New Products,” Engineering Management Review, pp. 5-12, fall 1991.
8. Cusumano, M., Japan’s Software Factories, A Challenge to U.S. Management. Oxford, U.K.: Oxford Univ. Press, 1991.
9. DAS, S.K. and ALMONOR, J.B, “A Concurrent Engineering Approach for the Development of Medical Devices”, INT. J. Computer Integrated Manufacturing Vol.13, No. 2, 139-147, March 2000.
10. European Commission:”Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices”, 1990.
11. European Commission:”Council Directive 93/42/ EEC concerning medical devices”, 1993.
12. European Commission:”Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices”, 1998.
13. Global Harmonization Task Force, Study Group 1: ”Essential Principles of Safety & Performance of Medical Devices”,GHTF.SG1.N020R5, 1999.
14. Grzinich, J. C., Thompson, J. H., Sentovich, M. F., “Implementation of an integrated product development process for systems,” Innovation in Technology Management - The Key to Global Leadership. PICMET '97: Portland International Conference on Management and Technology, pp. 427–430, 1997.
15. Handfield, B. R. et al., “Involving suppliers in new product development.” California Management Review, Vol.42, No. 4, pp.59-82, 1999.
16. Humphrey, W. S. et al., “A method for assessing the software engineering capacity of contractors,” Software Engineering Institute, Pittsburgh, PA, Feb, 1989.
17. Mayer, R. J., Painter, M.K., and DeWitte, P.S., IDEF Family of Methods for Concurrent Engineering and Business Re-engineering Application, Knowledge Based System Inc.,1994.
18. Industry Technology Intelligence Service(ITIS), “2006 Taiwan Industrial Outlook--- Medical Device Industry”, http://www.itis.org.tw/web/Reports.jsp, 2006
19. Krause F. L., Kimura F., Kellberg T., Lu S.C-Y, “Product modeling: a keynote paper,” Ann. CIRP 42 (2), pp. 696-706, 1993.
20. Nagalingam S., and Harris H.R., “A Guide to Introducing Concurrent Engineering in Your Organisation.”, Center for Advanced Manufacturing Research (CAMR), Dec, 2001
21. Pillai, A.S., Joshi, A. and Rao K.S. (2002). “Performance measurement of R&D Projects in a Multi-Project, Concurrent Engineering Environment”, International Journal of Project Management Vol. 20, Issue 2, Pages 165-177, February 2002.
22. Paulk, M. C., Curtis, B., Chrissis, M. B., and Weber, C. V., Capability Maturity Model for Software, version 1.1, Software Engineering Institute Pittsburgh, PA, 1993.
23. Prasad, B., “Concurrent Engineering Fundamentals: Integrated Product and Process Organization,” Vol. I, II, Prentice Hall PTR, ISBN 0-13-14763-4, 1997.
24. Royce W. W., “Managing the development of the large software systems: Concepts and techniques,” in PROC, WESCO, 1970.
25. Solhenius G., “Concurrent Engineering,” Ann. CIRP 41, 1992.
26. Tichkiewitch, S., “CAD/CAM to integrated design,” Int. J. CAD/CAM Computer Graphics 9 (5), pp. 609-621,1994.
27. Tichkiewitch, S., “Specications on integrated design methodology using a multi-view product model,” Proceedings of Third Biennial Joint Conference on Engineering Systems Design & Analysis, Montpellier, 1-4 July, ASME, 1996, pp. 101-108.
28. Tichkiewitch, S., Kasusky, E. Chapa, “Methods and tools for integration and holonic design,” Inc. J. CAD/CAM Computer Graphics 12 (6), pp. 647-667, 1997.
29. US. Congress, “FEDERAL FOOD, DRUG, AND COSMETIC ACT”, Portions Revised or new 1997.
30. Swanson K., McComb D., Smith J., and McCubbrey D., “The application software factory: Applying total quality techniques to systems development,” MIS Quart., Dec. 1991.
31. Turino, J., “Managing Concurrent Engineering---Buying Time to Market, Van Nostrand Reinhold, New York 1992
32. Takeishi, A., “Bridging inter- and intra- firm boundaries: Management of supplier involvement in automobile product development.” Strategic Management Journal, 22, 403-433, 2001.
33. XM Song, MM Montoya-Weiss, “Critical Development Activities for Really New versus Incremental Products”, Journal of Product Innovation Management, 1998.
34. Mayer et. al., “Information Integration For Concurrent Engineering (IICE) IDEF3 Process Description Capture Method Report”, Knowledge Based System Inc., September 1994.
指導教授 高信培(Hsing-pei Kao) 審核日期 2008-5-28
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