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研究生: 黃薾生
ER-SHENG HUANG
論文名稱: 跨國企業績效管理個案研究-以醫療器材製造為例
KPI Management in the Medical Device Industry: A Multinational Company Case Study
指導教授: 林希偉
Shi-Woei Lin
口試委員: 謝志宏
CHIH-HUNG HSIEH
紀佳芬
Chia-Fen Chi
學位類別: 碩士
Master
系所名稱: 管理學院 - 工業管理系
Department of Industrial Management
論文出版年: 2017
畢業學年度: 105
語文別: 中文
論文頁數: 39
中文關鍵詞: 代理人理論資訊不對稱國際多角化醫療器材
外文關鍵詞: Agency Theory, Information Asymmetry, International Diversification, Medical Device
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  • 多角化經營之跨國公司,因囿於地理與資料傳遞的限制,其管理往往透過制定關鍵績效指標(key performance index, KPI)來評鑑地區分公司的管理績效,然而這些關鍵績效指標多未考量不同產業之特性與需求,因而造成管理上的困境。
    本論文以代理人理論為架構,分析隸屬一家跨國控股公司旗下醫療事業體的個案公司—荷蘭醫材企業有限公司,並探討當母公司新任CEO本著經濟成長的追求,宣告其管理計畫與收益規劃後產生的衝突與管理議題。本研究尤其專注於探討個案公司在醫療器材部分的管理,因為醫療器材特殊的產業屬性,其設計、製造、銷售等皆受到各國衛生主管機關的高度關注,因此強調更嚴謹的風險與品質管理。然因著委託人與代理人(子公司經理人)之間目標衝突,代理人可能出現刻意隱藏資訊或者降低品質管制水準的動機。除探討醫療器材產業的特殊屬性,個案分析中亦深入探討醫療器材產業的管理重點,以及企業在運營的過程中需要注意的管制。
    本論文包含個案本文和教師手冊兩部分,希望能藉此培養專業經理人之決策思維能力,期望日後遇到相似業種與管理議題時,能從個案中獲得不同角度的啟發,調整思考層面,確保產品安全與性能,而非僅著重於以利益主之管理績效。


    This study investigates the management problem related to one branch company of a multinational enterprise that owns four business units including oil, military, aero-space and medical device. For chasing the goal of maximizing profits, the new CEO of this multinational enterprise set ambitious target revenues of the group and all it branches, without considering the special characteristics or requirements of medical device industry. The agency theory is thus used as an analytical framework to investigate how the case company, a Taiwan branch company which belongs to the unit of medical device and is responsible for producing transmission cable of physical signal, react to the decision of the CEO.
    In particular, the discussion in this case study focused mainly on the management issues related to medical device manufacturing. Because the manufacturing of medical devices is strictly regulated and controlled by local authorities, different requirements are applied to different classifications of medical devices, and national regulations related to design, material, manufacturing processes, packaging and labeling all need to be strictly followed. However, the information asymmetry and the misalignment of goals between the branch and the parent company might provide incentives for the managers of the branch company to conceal key information or to reduce the level of quality inspection.
    This case study not only helps managers to understand the fundamental differences between the requirements of local authorities for medical devices and those for the regular products, but also encourage them to think beyond financial KPIs when designing a good management system.

    摘要 I ABSTRACT II 致 謝 III 目 錄 IV 圖目錄 VI 表目錄 VII 第一章、個案本文 1 1.1 開場白 1 1.2 設立台灣分公司 1 1.3 魔鬼就在日常作業中 4 1.4 魔鬼長存 9 1.5 個案公司發展沿革歷史 10 1.6 討論問題 10 第二章、教師教學指導手冊 12 2.1 教學目標 12 2.2 課前準備 13 2.3 學員課前討論 15 2.4 適用理論 15 2.5 問題與參考答案 17 2.6 教學建議與時間分配 25 參考文獻 26 附錄一:醫療器材分類分級與GMP需求 28 附錄二:製造業藥商及販賣業藥商取得醫療器材上市許可流程 29 附錄三:行政院衛生署食品藥物管理局書函 30 附錄四:人物與時間表 31

    參考文獻
    中文文獻
    徐世輝,民88,全面品質管理著,華泰文化事業。
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    英文文獻
    Cartwright, D. (1949). Some principles of mass persuasion: Selected findings of research on the sale of United States war bonds. Human Relations, 2(3), 253-267.
    Deming E. W. (1986). Out of Crisis, MIT Press, Cambridge, Massachusetts.
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    ISO/TC 176/SC 2. (2015). ISO 9001 Quality Management Systems — Requirements, ISO Copyright Office, Geneva, Switzerland.
    ISO/TC 210, (2016). ISO 13485 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes, ISO Copyright Office, Geneva, Switzerland.
    Jensen M. C. and Meckling W. H. (1976). Theory of The Firm: Managerial Behavior, Agency Costs And Ownership Structure ,Journal of Financial Economics, 3(4), 305-360.
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    網頁文獻
    MDDI Staff ,2014,Top 40 Medical Device Companies。取自http://mddionline.com/article/top-40-medical-device-companies
    行政院,2016,台灣生物經濟產業發展方案,中華民國 台灣。取自http://www.ey.gov.tw/Upload/RelFile/26/734174/e370e2cd-3468-4491-a5b8-fa5aa4e290e7.pdf
    衛服部,2017,醫療器材分類分級與GMP需求,中華民國 台灣。取自http://www.hbmsp.sipa.gov.tw/itri/tw/images/Legal2_1.htm

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