鑑於全球人口老齡化，醫療器材產業蓬勃發展。為了在競爭激烈的市場中生存並追求永續經營，原始設備製造商(OEM)或原始設計製造商(ODM)致力於轉型自有品牌(OBM)。本文旨在從組織的角度，探討醫療器材OEM/ODM公司面臨轉型所需的資源，以找出醫療器材代工廠商轉型的時機及所需獲得的資源及能力。內容分析法用於確定五個主要構面，每個構面包括四個轉型因素。問卷發放對象為台灣的醫療器材公司中高階經理人與使用者，如醫生和護士。此外，透過決策試驗與實驗評估法(DEMATEL)分析構面和因素，以構建重要性及易取得性分析圖(IAA)和網路關聯圖(NRM)。調查結果表明，醫材相關法規是最重要的，運營管理是最容易取得的。轉型所需的資源或能力可以通過策略聯盟、併購來獲得，或是透過公司自己建立與培養，而一些因素則建議維持現狀。本研究首次定義了醫療器材產業的從代工轉型自有品牌的因素，並闡述了獲取該資源和能力的最佳策略。未來的研究可以驗證台灣以外的範圍或探索其他產業。

Given the population ageing worldwide, medical device industry is developed constantly. To survive in the competitive market and pursue sustainable operation, original equipment manufacturing (OEM) or original design manufacturing (ODM) firms and are committed to transit to original brand manufacturing (OBM). The purpose of this research is to investigate the resources and capabilities which affect medical device OEM/ODM companies’ transition to OBM from an organizational perspective. Content analysis and principal component analysis (PCA) are applied to identify five major dimensions, each of which comprises four specific factors. Questionnaires are collected from medical device companies and users, such as doctors and nurses in Taiwan. Further, the dimensions and factors are subsequently analyzed to construct the Importance-Accessibility Analysis (IAA) and Network Relationship Map (NRM) by means of decision-making trial and evaluation laboratory (DEMATEL) method. The findings indicated that Regulation System are the most important and Operating Management are the easiest to be accessed. The resources or capabilities needed for transformation can be obtained through strategic alliances, mergers and acquisitions, and self-building, while some are suggested to maintain status. The research also provides managerial suggestions of the strategies for subcontracting companies to accelerate the transition. This research is the first to define the transition factors in medical device industry and illustrate the optimal strategies to acquire the resources and capabilities through mapping the pathway. Future research can verify the scope beyond Taiwan or explore a broader range of industry.

REFERENCES
Auster, D. (1956). Content analysis in AV communication research. Audiovisual Communication Review, 4(2), 102-108.
Bai, C., & Sarkis, J. (2013). A grey-based DEMATEL model for evaluating business process management critical success factors. International Journal of Production Economics, 146(1), 281-292.
Berelson, B. (1952). Content analysis in communication research.
Bogner, A., & Menz, W. (2009). The theory-generating expert interview: epistemological interest, forms of knowledge, interaction Interviewing experts (pp. 43-80): Springer.
Central Intelligence Agency. (2018). THE WORLD FACTBOOK-TAIWAN. Retrieved from https://www.cia.gov/library/publications/the-world-factbook/geos/tw.html
Chen, D., Wei, W., Hu, D., & Muralidharan, E. (2016). Survival strategy of OEM companies: a case study of the Chinese toy industry. International Journal of Operations & Production Management, 36(9), 1065-1088.
Chen, P.-T. (2018). Medical big data applications: Intertwined effects and effective resource allocation strategies identified through IRA-NRM analysis. Technological Forecasting and Social Change, 130, 150-164.
Chu, W.-w. (2009). Can Taiwan's second movers upgrade via branding? Research Policy, 38(6), 1054-1065.
Cortina, J. M. (1993). What is coefficient alpha? An examination of theory and applications. Journal of applied psychology, 78(1), 98.
Dalalah, D., Hayajneh, M., & Batieha, F. (2011). A fuzzy multi-criteria decision making model for supplier selection. Expert Systems with Applications, 38(7), 8384-8391.
Dodgson, M., Mathews, J., Kastelle, T., & Hu, M.-C. (2008). The evolving nature of Taiwan's national innovation system: The case of biotechnology innovation networks. Research Policy, 37(3), 430-445.
Eisenhardt, K. M. (1989). Building theories from case study research. Academy of Management Review, 14(4), 532-550.
Ekaterina, T. Y. (2018). The Main Policy Directions in the Sphere of Small and Medium-Sized Enterprises' Development in Taiwan in 2010-2016. VESTNIK TOMSKOGO GOSUDARSTVENNOGO UNIVERSITETA ISTORIYA-TOMSK STATE UNIVERSITY JOURNAL OF HISTORY, 53, 127-137.
export.gov. (2018). Healthcare Resource Guide: Taiwan. Retrieved from https://build.export.gov/main/industry/health/healthcareresourceguide/eg_main_108622
FDA. (2018). Classify Your Medical Device. Retrieved from https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm
Fontela, E., & Gabus, A. (1976). The DEMATEL observer, Battelle Geneva Research Center, Geneva, Switzerland. DOI, 10, 0016-3287.
Food and Drug Administration, MOHW. (2015). Taiwan medical device industry import and export review. . Retrieved from https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f636699719181064464
George, D., & Mallery, P. (1999). SPSS® for Windows® step by step: A simple guide and reference: Allyn & Bacon.
Graneheim, U. H., & Lundman, B. (2004). Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse education today, 24(2), 105-112.
Hitzler, R. (1994). Wissen und Wesen des Experten Expertenwissen (pp. 13-30): Springer.
Hobday, M. (1995). East Asian latecomer firms: learning the technology of electronics. World Development, 23(7), 1171-1193.
Hobday, M. (2000). East versus Southeast Asian innovation systems: comparing OEM-and TNC-led growth in electronics. Technology, Learning, and Innovation: Experiences of Newly Industrializing Economies, 129-169.
Holsti, O. R. (1969). Content analysis for the social sciences and humanities. Reading. MA: Addison-Wesley (content analysis).
Hu, C.-L. (2017). Overview of biotechnology industry in Taiwan. Retrieved from http://www.cieca.org.tw/v_comm/inc/download_file.asp?re_id=2998&fid=35219
Industrial Development Bureau, MOEA. (2018a). 2019 Introduction to Biotechnology and Pharmaceutical Industries in Taiwan.
Industrial Development Bureau, MOEA. (2018b). Biotechnology Industry in Taiwan. Retrieved from https://old.www.biopharm.org.tw/download/Biotechnology_Industry_in_Taiwan_2018.pdf
Jolicoeur, P., & Mosimann, J. E. (1960). Size and shape variation in the painted turtle. A principal component analysis. Growth, 24(4), 339-354.
Kassarjian, H. H., & Kassarjian, W. M. (1988). The impact of regulation on advertising: A content analysis. Journal of Consumer Policy, 11(3), 269-285.
Landis, J. R., & Koch, G. G. (1977). The measurement of observer agreement for categorical data. Biometrics, 159-174.
Lee, K., Song, J., & Kwak, J. (2015). An exploratory study on the transition from OEM to OBM: Case studies of SMEs in Korea. Industry and Innovation, 22(5), 423-442.
Lee, M., Yoon, K., & Lee, K.-S. (2018). Social network analysis in the legislative process in the Korean medical device industry. INQUIRY: the journal of health care organization, Provision, and Financing, 55, 0046958018791858.
Lee, W.-S., Huang, A. Y., Chang, Y.-Y., & Cheng, C.-M. (2011). Analysis of decision making factors for equity investment by DEMATEL and Analytic Network Process. Expert systems with Applications, 38(7), 8375-8383.
Lee, Y.-C., Chung, P.-H., & Shyu, J. Z. (2017). Performance Evaluation of Medical Device Manufacturers Using a Hybrid Fuzzy MCDM.
Lien, Y.-P. (2009). An empirical study of OEM in Taiwan's apparel industry. Global Economic Review, 38(3), 297-319.
Lin, C.-J., & Wu, W.-W. (2008). A causal analytical method for group decision-making under fuzzy environment. Expert Systems with Applications, 34(1), 205-213.
Lin, C.-L. (2015). A novel hybrid decision-making model for determining product position under consideration of dependence and feedback. Applied Mathematical Modelling, 39(8), 2194-2216.
Lin, C.-L., & Kuo, C.-L. (2018). A service position model of package tour services based on the hybrid MCDM approach. Current Issues in Tourism, 1-33.
Lin, C.-L., Shih, Y.-H., Tzeng, G.-H., & Yu, H.-C. (2016). A service selection model for digital music service platforms using a hybrid MCDM approach. Applied Soft Computing, 48, 385-403.
Martilla, J. A., & James, J. C. (1977). Importance-performance analysis. The Journal of Marketing, 77-79.
McMillan, J. H. (1996). Educational research: Fundamentals for the consumer: ERIC.
Meda, S. A., Stevens, M. C., Potenza, M. N., Pittman, B., Gueorguieva, R., Andrews, M. M., . . . Pearlson, G. D. (2009). Investigating the behavioral and self-report constructs of impulsivity domains using principal component analysis. Behavioural Pharmacology, 20(5-6), 390.
Meredith, J. (1998). Building operations management theory through case and field research. Journal of Operations Management, 16(4), 441-454.
Neuendorf, K. A. (2016). The content analysis guidebook: Sage.
Niu, B., Wang, Y., & Guo, P. (2015). Equilibrium pricing sequence in a co-opetitive supply chain with the ODM as a downstream rival of its OEM. Omega, 57, 249-270.
O'Rourke, N., & Hatcher, L. (2013). A step-by-step approach to using SAS for factor analysis and structural equation modeling: Sas Institute.
Phadermrod, B., Crowder, R. M., & Wills, G. B. (2019). Importance-performance analysis based SWOT analysis. International Journal of Information Management, 44, 194-203.
ResearchAndMarkets.com. (2018). Global Medical Device Market Report 2018-2023: Trends, Forecast and Competitive Analysis. Retrieved from https://www.researchandmarkets.com/research/7ptv6z/global_medical?w=4
Shen, K.-Y., Hu, S.-K., & Tzeng, G.-H. (2017). Financial modeling and improvement planning for the life insurance industry by using a rough knowledge based hybrid MCDM model. Information Sciences, 375, 296-313.
Tzeng, G.-H., Chiang, C.-H., & Li, C.-W. (2007). Evaluating intertwined effects in e-learning programs: A novel hybrid MCDM model based on factor analysis and DEMATEL. Expert systems with Applications, 32(4), 1028-1044.
Wang, Y.-S. (2018). Buyer–seller relationships of the dental devices industry in Taiwan: perspective of relationship. Journal of Business-to-Business Marketing, 1-18.
Weber, R. P. (1990). Basic content analysis (Vol. 49): Sage.
Wikipedia. (2019, May 02). Content analysis. Retrieved from https://en.wikipedia.org/wiki/Content_analysis
Wilson, I. (2013). The OEM-OBM debate: Factors influencing Chinese firms' branding decisions in their internationalisation process.
Wongpreedee, K., Kiratisin, A., & Virutamasen, P. (2015). Entrepreneurial mindsets for innovative brand development: Case studies in jewellery education. Procedia-Social and Behavioral Sciences, 195, 2236-2241.
World Health Organization. (2018). Ageing and health. Retrieved from https://www.who.int/news-room/fact-sheets/detail/ageing-and-health
Xiao, R., & Chi, T. (2015). An exploratory study of branding strategies in the Chinese casual wear market. American Journal of Business, 3(1), 1-8.
Yan, H.-D. (2012). Entrepreneurship, competitive strategies, and transforming firms from OEM to OBM in Taiwan. Journal of Asia-Pacific Business, 13(1), 16-36.
Yan, H.-d., Chiang, C., & Chien, C. S. (2014). From original equipment manufacturing to branding: entrepreneurship, strategic leadership, and Taiwan’s firm transformation. International Entrepreneurship and Management Journal, 10(1), 81-102.
Yang, L. W., Ping, L. Y., & Nan, Q. C. (2010). Research on self-directed innovation path from OEM to ODM, OBM in enterprise. Paper presented at the 2010 International Conference on Logistics Systems and Intelligent Management (ICLSIM).