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題名 臺灣醫療器材業者國際化策略之研究
Internationalization strategies of Taiwanese medical devices firms
作者 謝秀欣
Hsieh, Hsiu-Hsin
貢獻者 于卓民
謝秀欣
Hsieh, Hsiu-Hsin
關鍵詞 醫療器材
國際化策略
OEM
ODM
OBM
Medical devices
International strategy
OEM
ODM
OBM
日期 2019
上傳時間 7-八月-2019 17:14:06 (UTC+8)
摘要 臺灣生技產業包括製藥產業、應用生技產業與醫療器材產業。生技產業素來為臺灣科技重點發展項目，隨著國外生技產業開始商業化發展，臺灣也陸續透過人才培育及研發計畫等生技政策的推動，以期能完善我國生技研發能量，而後能立足臺灣、放眼全球。雖然臺灣生技產業陸續茁壯，但是臺灣市場規模有限，臺灣廠商也開始邁入國際化經營；其中生技製藥產業在新藥開發有亮眼成績，但是在國際化經營部分確尚處於起步萌芽階段；相對於臺灣醫療器材產業，過去臺灣憑藉優異的工業製造能力，以及電子業代工所建立的能量，因此成為國際醫療器材大廠產品供應鏈的一環，也因此逐漸精進與建立醫療器材研發能量，開始自有品牌產品的開發。
本研究透過個案研究的方式，以國際前三大醫療器材廠商，和臺灣六家已國際化經營，且產品屬於醫療器材生命週期中的萌芽期之廠商，為研究對象；探討醫療器材廠商在國際化經營時，所需要具備的企業基礎資源，以及行銷資源，以及產業環境對國際化經營的影響；另外，醫療器材屬於生命週期長、是與生命相關而法規規範嚴謹的產品，各國在醫療器材產品的規範限制也都不盡相同，因此醫療器材在國際化經營的時候，勢必得在產品進入當地市場時，就要了解當地市場的規定，而個案廠商是如何突破和解決這些產業環境的限制，了解其國際化經營模式與策略。
研究結果發現臺灣醫材廠商國際化經營時必須具備七項重要的國際化經營策略與做法，更解析出其中自主研發、生產製造、專利、臨床效果、臨床學術、全產品線等為企業在國際化時需要建置的公司基礎資源；以及國際行銷(自主銷售)、國際行銷(代理商)、品牌等三大項公司行銷資源。行銷資源建置時，必須要仰賴基礎資源的支援，且著重在組織架構、流程知識、智慧財產等高階生產要素的架構。同時廠商在資源建置時，還需要隨時觀察產業環境變化，並能提出因應策略。產業環境變化包括區域市場的關稅障礙和非關稅障礙(法規、查驗登記、監管制度、通路變化等)，以及全球環境大趨勢變化。另外，個案廠商除了組織研發團隊，建置公司內部研發能量外，也從為國際大廠OEM/ODM的過程中，深化產品開發和製作的技術，讓自身具備有設計研發、生產製造的核心能量；即使在開發自有品牌產品，欲拓展產品線時，也是根據公司自身的核心技術來進行延伸，達到跨事業的能力移轉(transferring competencies)的多角化策略，透過新品開發、收購與既有事業活動相關連的新事業等，藉由一個或多個價值創造功能的共通性(commonality)，來進行能力移轉。
The biotechnology industry in Taiwan includes the pharmaceutical industry, the application of biotechnology industry and the medical devices industry. The biotechnology industry has always been a key developing area in Taiwan`s technology field. With the commercialization of international biotechnology industry, Taiwan has also promoted biotechnology policies such as talent cultivation and R&D plans hoping to improve the R&D energy of Taiwan’s biotechnology and then the firms from Taiwan can expand internayinally. Although Taiwan’s biotechnology industry has grown stronger, Taiwan’s market is still limited. Taiwan’s manufacturers are also beginning to operate internationally. Among them, the biotechnology pharmaceutical industry has outstanding achievements in the development of new drugs. However, the international operation is still in its infancy. Comparing with the Taiwan medical devices industry, relying on Taiwan’s excellent industrial manufacturing capabilities and the energy built by the electronics CEMs, the medical devices firms have been part of the supply chain of international firms, gradually improving their R&D capabilities, and starting to development their own brands for their own medical devices.
This study is based on case studues. Taking the top three medical devices firms in the world and six Taiwanese companies that have been operated internationally as research objects. This study will explore the essential internal resources and external resources when the medical devices firms operate internationally, as well as the impact of the industrial environment on international operations. In addition, medical devices are related to human life and have strict regulations, which vary from country to country. Therefore, medical devices firms are necessary to understand the regulations of the local market when importing their products. In the case studies, we can learn how firms breakthrough and resolve the limitations of these industrial environments and understand their international business models and strategies.
This study found seven important international business strategies and practices when operating internationally. It concluded that the internal resources are independent R&D, manufacturing, patents, clinical effects, clinical academics, and full product lines and the external resources are international marketing (independent-sales), international marketing (agents) and brands. During building of external resources, it’s necessary to rely on the support of internal resources and focuses on the structure of high-level production factors such as organization, process knowledge, and intellectual property, etc. At the same time, the firms also need to observe the changes in the industrial environment at any time and should be able to propose reponses. Changes in the industrial environment include tariff barriers and non-tariff barriers in the regional market (e.g., regulations, inspection registration, insurance authority, changes in the marketing channel, etc.) as well as the changes in global environmental trends. Furthermore, the case companies also establish their capabilities in designing, developing, and manufacturing during the process of engaging in OEM/ODM businesses. Even when developing its own branded products and expanding its product lines, it is based on the cross-transfer of its own technology to new businesses and integrating its own technology with the new technologies along with acquisitions.
參考文獻 中文文獻
1. 于卓民、巫立宇、蕭富峰(2009)。國際行銷學，3版。台北：智勝文化事業有限公司。
2. 中華民國海關資料庫 https://cus93.trade.gov.tw/
3. 公開資訊觀測站 http://mops.twse.com.tw/mops/web/index
4. 方至民(2006)。國際企業管理：建構全球營運優勢，一版。台北：前程文化出版
5. 卓永進(2006)。「OEM/ODM/OBM模式在臺灣工業電腦的適用性」。國立政治大學企業管理學系碩士論文。
6. 陳弘信(2007)。國際企業管理，一版。台北：三民書局股份有限公司出版
7. 陳振祥(1997)。「ODM策略之理論架構與實證」。國立臺灣大學國際企業研究所博士論文。
8. 張慈映、郭大維、游佩芬、蕭伯彥(2018)。2018醫療器材產業年鑑，台北：工業技術研究院產業經濟與趨勢研究中心。
9. 經濟部工業局(2018)。2018生技產業白皮書，台北：經濟部工業局。
10. 趙郁文(1998)。跨國委託製造對臺灣資訊電子廠商營運能力之提升效果。中山管理評論，第六卷第四期，1113-1116。
11. 榮泰生(2014)。圖解研究方法，台北: 五南出版。

英文文獻
1. Barney, Jay & William S. Hesterl(2008). Strategic Management and Competitive Advantage: Concepts and Cases, 2nd ed, NY:Pearson College Div
2. BMI Research https://bmo.bmiresearch.com/
3. Hill, Charles W.L., Schilling, Melissa A.& Gareth R. Jone(2017). Strategic Management Theory, 12th ed., KY: Cengage Learning.
4. Hill, Charles W.L. (2016). International Business: Competing in the Global Marketplace, 12th ed., NY: McGraw-Hill College.
5. Kumar, V. & Velavan Subramaniam (1997). A Contingency Framework for the Mode of Entry Decision. Journal of International Business Studies, 32(1), 53-72.
6. Nature Reviews Drug Discovery https://www.nature.com/nrd/
7. Orthoworld (2017). The Orthopaedic Industry Annual Report., OH: ORTHOWORLD INC.
8. Pan, Yigang., David K. Tse (2000). The Hierarchical Model of Market Entry Modes. Journal of International Business Studies, 31(4), 535-555
9. Vernon, Raymond(1966). International Investment and International Trade in the Product Cycle. The Quarterly Journal of Economics, 80(2), 190-207
10. Welch, Awrence S. and Reijo Luostarinen (1988). Internationalization: Evolution of a Concept. Journal of General Management,14(2), 34-55.
11. Yin, R. K. (2009). Case Study Research: Design and Methods, 4th ed. Thousand Oaks, CA: Sage. [中譯本：個案研究法]
描述 碩士
國立政治大學
企業管理研究所(MBA學位學程)
107363048
資料來源 http://thesis.lib.nccu.edu.tw/record/#G0107363048
資料類型 thesis
dc.contributor.advisor 于卓民zh_TW
dc.contributor.author (作者) 謝秀欣zh_TW
dc.contributor.author (作者) Hsieh, Hsiu-Hsinen_US
dc.creator (作者) 謝秀欣zh_TW
dc.creator (作者) Hsieh, Hsiu-Hsinen_US
dc.date (日期) 2019en_US
dc.date.accessioned 7-八月-2019 17:14:06 (UTC+8)-
dc.date.available 7-八月-2019 17:14:06 (UTC+8)-
dc.date.issued (上傳時間) 7-八月-2019 17:14:06 (UTC+8)-
dc.identifier (其他 識別碼) G0107363048en_US
dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/125072-
dc.description (描述) 碩士zh_TW
dc.description (描述) 國立政治大學zh_TW
dc.description (描述) 企業管理研究所(MBA學位學程)zh_TW
dc.description (描述) 107363048zh_TW
dc.description.abstract (摘要) 臺灣生技產業包括製藥產業、應用生技產業與醫療器材產業。生技產業素來為臺灣科技重點發展項目，隨著國外生技產業開始商業化發展，臺灣也陸續透過人才培育及研發計畫等生技政策的推動，以期能完善我國生技研發能量，而後能立足臺灣、放眼全球。雖然臺灣生技產業陸續茁壯，但是臺灣市場規模有限，臺灣廠商也開始邁入國際化經營；其中生技製藥產業在新藥開發有亮眼成績，但是在國際化經營部分確尚處於起步萌芽階段；相對於臺灣醫療器材產業，過去臺灣憑藉優異的工業製造能力，以及電子業代工所建立的能量，因此成為國際醫療器材大廠產品供應鏈的一環，也因此逐漸精進與建立醫療器材研發能量，開始自有品牌產品的開發。
本研究透過個案研究的方式，以國際前三大醫療器材廠商，和臺灣六家已國際化經營，且產品屬於醫療器材生命週期中的萌芽期之廠商，為研究對象；探討醫療器材廠商在國際化經營時，所需要具備的企業基礎資源，以及行銷資源，以及產業環境對國際化經營的影響；另外，醫療器材屬於生命週期長、是與生命相關而法規規範嚴謹的產品，各國在醫療器材產品的規範限制也都不盡相同，因此醫療器材在國際化經營的時候，勢必得在產品進入當地市場時，就要了解當地市場的規定，而個案廠商是如何突破和解決這些產業環境的限制，了解其國際化經營模式與策略。
研究結果發現臺灣醫材廠商國際化經營時必須具備七項重要的國際化經營策略與做法，更解析出其中自主研發、生產製造、專利、臨床效果、臨床學術、全產品線等為企業在國際化時需要建置的公司基礎資源；以及國際行銷(自主銷售)、國際行銷(代理商)、品牌等三大項公司行銷資源。行銷資源建置時，必須要仰賴基礎資源的支援，且著重在組織架構、流程知識、智慧財產等高階生產要素的架構。同時廠商在資源建置時，還需要隨時觀察產業環境變化，並能提出因應策略。產業環境變化包括區域市場的關稅障礙和非關稅障礙(法規、查驗登記、監管制度、通路變化等)，以及全球環境大趨勢變化。另外，個案廠商除了組織研發團隊，建置公司內部研發能量外，也從為國際大廠OEM/ODM的過程中，深化產品開發和製作的技術，讓自身具備有設計研發、生產製造的核心能量；即使在開發自有品牌產品，欲拓展產品線時，也是根據公司自身的核心技術來進行延伸，達到跨事業的能力移轉(transferring competencies)的多角化策略，透過新品開發、收購與既有事業活動相關連的新事業等，藉由一個或多個價值創造功能的共通性(commonality)，來進行能力移轉。		zh_TW
dc.description.abstract (摘要) The biotechnology industry in Taiwan includes the pharmaceutical industry, the application of biotechnology industry and the medical devices industry. The biotechnology industry has always been a key developing area in Taiwan`s technology field. With the commercialization of international biotechnology industry, Taiwan has also promoted biotechnology policies such as talent cultivation and R&D plans hoping to improve the R&D energy of Taiwan’s biotechnology and then the firms from Taiwan can expand internayinally. Although Taiwan’s biotechnology industry has grown stronger, Taiwan’s market is still limited. Taiwan’s manufacturers are also beginning to operate internationally. Among them, the biotechnology pharmaceutical industry has outstanding achievements in the development of new drugs. However, the international operation is still in its infancy. Comparing with the Taiwan medical devices industry, relying on Taiwan’s excellent industrial manufacturing capabilities and the energy built by the electronics CEMs, the medical devices firms have been part of the supply chain of international firms, gradually improving their R&D capabilities, and starting to development their own brands for their own medical devices.
This study is based on case studues. Taking the top three medical devices firms in the world and six Taiwanese companies that have been operated internationally as research objects. This study will explore the essential internal resources and external resources when the medical devices firms operate internationally, as well as the impact of the industrial environment on international operations. In addition, medical devices are related to human life and have strict regulations, which vary from country to country. Therefore, medical devices firms are necessary to understand the regulations of the local market when importing their products. In the case studies, we can learn how firms breakthrough and resolve the limitations of these industrial environments and understand their international business models and strategies.
This study found seven important international business strategies and practices when operating internationally. It concluded that the internal resources are independent R&D, manufacturing, patents, clinical effects, clinical academics, and full product lines and the external resources are international marketing (independent-sales), international marketing (agents) and brands. During building of external resources, it’s necessary to rely on the support of internal resources and focuses on the structure of high-level production factors such as organization, process knowledge, and intellectual property, etc. At the same time, the firms also need to observe the changes in the industrial environment at any time and should be able to propose reponses. Changes in the industrial environment include tariff barriers and non-tariff barriers in the regional market (e.g., regulations, inspection registration, insurance authority, changes in the marketing channel, etc.) as well as the changes in global environmental trends. Furthermore, the case companies also establish their capabilities in designing, developing, and manufacturing during the process of engaging in OEM/ODM businesses. Even when developing its own branded products and expanding its product lines, it is based on the cross-transfer of its own technology to new businesses and integrating its own technology with the new technologies along with acquisitions.		en_US
dc.description.tableofcontents 目錄
第一章、 緒論 1
第一節 研究背景與動機 1
第二節 研究問題與目的 2
第三節 研究流程與章節介紹 3
第二章、文獻探討 4
第一節 國際化國際化動機 4
第二節 國際市場之進入模式 5
壹、進入之時間點(When)因素探討 5
貳、如何(How)進入海外市場 6
第三節 資源基礎論(Resource-based Theory) 8
第四節 經營模式的轉換 9
第三章、研究方法 11
第一節 研究架構 11
第二節 個案研究法 11
第四章、醫療器材產業概述 14
第一節 全球醫療器材產業概述 14
壹、全球醫療市場現況 14
貳、主要區域國家醫療器材市場現況 17
參、主要國家醫療器材法規制度 18
貳、臺灣醫療器材市場現況 20
第二節 國際醫療器材廠商國際化經營 24
壹、全球第一大醫療器材廠：美敦力Medtronic 24
貳、全球第二大醫療器材廠：嬌生集團Johnson & Johnson 25
參、全球第三大醫療器材廠：費森尤斯集團Fresenius Medical Care (FMC) 26
第五章、個案介紹 29
第一節 聯合骨科器材股份有限公司 29
壹、公司基本介紹 29
貳、公司經營現況 32
參、國際化經營 35
第二節 大瓏企業股份有限公司 42
壹、公司基本介紹 42
貳、公司經營現況 44
參、國際化經營 46
第三節 鐿鈦科技股份有限公司 51
壹、公司基本介紹 51
貳、公司經營現況 52
參、國際化經營 56
第四節 雃博股份有限公司 61
壹、公司基本介紹 61
貳、公司經營現況 65
參、國際化經營 68
第五節 環瑞醫投資控股股份有限公司 72
壹、公司基本介紹 72
貳、公司經營現況 76
參、國際化經營 77
第六節 明達醫學科技股份有限公司 83
壹、公司基本介紹 83
貳、公司經營現況 85
參、國際化經營 87
第六章、個案分析 90
第一節 競爭優勢與進入策略 90
壹、個案廠商國際化策略作法與比較 90
貳、個案廠商國際化經營之順序 94
第二節 績效評估 101
壹、個案廠商國際化經營績效現況 101
貳、個案廠商國際化經營績效評估 102
第七章、結論與建議 106
第一節 研究結論 106
壹、產業環境對醫療器材廠商的國際化經營的影響為何？ 106
貳、臺灣醫療器材廠商的國際化經營模式與策略為何？ 107
第二節 研究建議 108
壹、對臺灣醫材產業國際化的建議 108
貳、後續研究建議 108
參考文獻 110
中文文獻 110
英文文獻 110		zh_TW
dc.format.extent 33766968 bytes-
dc.format.mimetype application/pdf-
dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0107363048en_US
dc.subject (關鍵詞) 醫療器材zh_TW
dc.subject (關鍵詞) 國際化策略zh_TW
dc.subject (關鍵詞) OEMzh_TW
dc.subject (關鍵詞) ODMzh_TW
dc.subject (關鍵詞) OBMzh_TW
dc.subject (關鍵詞) Medical devicesen_US
dc.subject (關鍵詞) International strategyen_US
dc.subject (關鍵詞) OEMen_US
dc.subject (關鍵詞) ODMen_US
dc.subject (關鍵詞) OBMen_US
dc.title (題名) 臺灣醫療器材業者國際化策略之研究zh_TW
dc.title (題名) Internationalization strategies of Taiwanese medical devices firmsen_US
dc.type (資料類型) thesisen_US
dc.relation.reference (參考文獻) 中文文獻
1. 于卓民、巫立宇、蕭富峰(2009)。國際行銷學，3版。台北：智勝文化事業有限公司。
2. 中華民國海關資料庫 https://cus93.trade.gov.tw/
3. 公開資訊觀測站 http://mops.twse.com.tw/mops/web/index
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dc.identifier.doi (DOI) 10.6814/NCCU201900433en_US