醫療器材產業被政府視為未來經濟發展的關鍵領域，然而其內涵與面向相當廣泛，這個產業群聚了大量類型眾多、特性各異的產品，涵蓋範疇極為廣泛，該產業受到政府法規的嚴格管控，研發週期延長，且生物技術本身具有很高的跨領域整合性與知識密集性，這形成了高度的進入門檻。因此，產業如何創造經營成功的競爭優勢，更是經營者需縝密思考努力方針。
本研究透過文獻回顧整理醫療器材展業的關鍵成功因素的理論基礎，歸納架構初步臺灣醫療器材產業關鍵成功因素。本研究採質性研究的深度訪談法，運用立意抽樣，進行專家正式問卷填寫與個別深度訪談確認架構，訪談 5 位產業內的領導廠商之高階經營主管和醫材學研機構主任所得的訪談文本，根據訪談及問卷填答內容進行資料分析，同時根據次級資料了解產業概況，以此驗證並找出各構面之關鍵因素，以期醫材產業有效管理提升與訂定策略的先導依據，並探討體制環境變遷對產業所帶來影響。
最後從分析質性訪談所獲之成果，本研究結論提出新增兩項關鍵成功因素分別為「健保制度」和「醫療需求」，針對各內在成功因素的部分應用在目前台灣的醫材產業現況去做因地制宜和深化，本研究將臺灣醫療器材產業關鍵成功因素彙整為內外部2大構面6大類共17項關鍵因素，並對於我國醫療器材產業的關鍵成功因素，擬定出產業進步的競爭策略。本研究成果期望能對於我國將來發展的政策方向，提供謹慎的指引與借鑒，作為未來相關研究範疇的參照，對於促進醫療器材產業的成長並規劃策略，保障持續的競爭力也具有助益。

The medical device industry is a key field that the government aims to elevate for future economic growth. However, due to the vast array of products under the medical device industry , along with strict government regulation and long R&D periods, the sector has high barriers to entry. Thus, the question of how to create competitive advantages for a successful operation is an issue that requires careful consideration by industry operators.
This study delineates the theoretical foundation of key success factors in the medical device industry through a literature review and establishes a preliminary framework of these factors within the Taiwan’s market. Utilizing qualitative research through in-depth interviews, this study engaged in formal questionnaire completion and individual in-depth interviews with senior executives from five leading companies in the industry, as well as heads of medical research institutions. The interview texts were analyzed based on the content of the interview and responses. Secondary data were also used to understand the overall industry situation. This approach was used to validate the key factors in each aspect, aiming to provide guidance for effective management and strategy in the medical device industry and to explore the impact of system environment changes on the industry.
The results from the qualitative interviews have led this study to consolidate the key success factors of the Taiwan’s medical device industry into two main dimensions (internal and external) with six categories, totaling 17 key factors. Based on these factors, competitive strategies for the industry's development were devised. It is hoped that the findings of this study can provide prudent advice and reference for the relevant research fields, and aid the medical device industry in development and strategy formulation, thereby maintaining its continuous competitiveness.

Barriball, K. L., & While, A. (1994). Collecting data using a semi-structured interview: a discussion paper. Journal of Advanced Nursing, 19(2), 328-335. https://doi.org/10.1111/j.1365-2648.1994.tb01088.x
Boynton, A. C., & Zmud, R. W. (1984). An Assessment of Critical Success Factors. Sloan Management Review (pre-1986), 25(4), 17.
Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101.
Brown, A., Dixon, D., Eatock, J., Meenan, B. J., & Young, T. (2008, 28-30 June 2008). A survey of success factors in New Product Development in the medical devices industry. 2008 IEEE International Engineering Management Conference,
Bryman, A., & Bell, E. (2011). Business Research Methods 3e. OUP Oxford. https://books.google.com.tw/books?id=YnCcAQAAQBAJ
Campbell, S., Greenwood, M., Prior, S., Shearer, T., Walkem, K., Young, S., Bywaters, D., & Walker, K. (2020). Purposive sampling: complex or simple? Research case examples. Journal of Nursing Research, 25(8), 652-661. https://doi.org/10.1177/1744987120927206
Cooper, R. G., & Kleinschmidt, E. J. (2007). Winning Businesses in Product Development: The Critical Success Factors. Research-Technology Management, 50(3), 52-66. https://doi.org/10.1080/08956308.2007.11657441
Giesecke, S. (2000). The contrasting roles of government in the development of biotechnology industry in the US and Germany. Research Policy, 29(2), 205-223. https://doi.org/https://doi.org/10.1016/S0048-7333(99)00061-X
Gilmartin, R. V. (1998). Winning in Pharmaceutical Research. Research Technology Management, 9-12.
Hofer, C. W., & Schendel, D. (1978). Strategy formulation : analytical concepts. West Pub. Co. St. Paul.
Leidecker, J. K., & Bruno, A. V. (1984). Identifying and using critical success factors. Long Range Planning, 17(1), 23-32.
McCarthy, A. D., Sproson, L., Wells, O., & Tindale, W. (2015). Unmet needs: relevance to medical technology innovation? Journal of Medical Engineering & Technology, 39(7), 382-387. https://doi.org/10.3109/03091902.2015.1088093
Newmarker, C. (2022). The 2022 Medtech Big 100: The world’s largest medical device companies. Medical Design & Outsourcing. Retrieved 08/14/2023 from https://www.medicaldesignandoutsourcing.com/2022-big-100/
Rautiainen, T. (2001). Critical Success Factors in Biopharmaceutical Business: A Comparison Between Finnish and Californian Businesses. Tekes. https://books.google.com.tw/books?id=WPxxAAAACAAJ
Rockart, J. F. (1979). Chief executives define their own data needs. Harvard Business Review, 57(2), 81-93.
Scott, R. M., & Love, P. (1999). Biotechnology is booming in Washington State. Nature Biotechnology, 17(5), 449-450. https://doi.org/10.1038/8623
Showkat, N., & Parveen, H. (2017). Non-Probability and Probability Sampling. e-PG Pathshala.
Steinmetz, M. (1998). Venturing into drug discovery. Nature Biotechnology, 16(1), 17-17. https://doi.org/10.1038/5401
Suchita, M. (2021). Strategic Intellectual Property Management and spin offs during Medical Device Innovation and commercialisation. International Journal of Drug Regulatory Affairs, 9(2). https://doi.org/10.22270/ijdra.v9i2.469
Welter, C., Bosse, D. A., & Alvarez, S. A. (2013). The Interaction between Managerial and Technological Capabilities as a Determinant of Company Performance: An Empirical Study of Biotech Firms. The International Journal of Management, 30, 272.
Yin, R. K. (2003). Case Study Research: Design and Methods. SAGE Publications. https://books.google.com.tw/books?id=BWea_9ZGQMwC
Yum, S. (2021). The Cluster Characteristics of Biotechnology Industries and Their Effect on Regional Innovation Systems. Industrial Biotechnology, 17(2), 79-91. https://doi.org/10.1089/ind.2020.0026
Zenios, L. (2011). The Role of Physicians in Device Innovation: Critical Success Factor or Conflict of Interest? Stanford Graduate School of Business. Retrieved 6/28/2023 from https://www.gsb.stanford.edu/faculty-research/case-studies/role-physicians-device-innovation-critical-success-factor-or-conflict
大前研一(1985)。策略家的智慧(黃宏義譯)。長河出版社。https://books.google.com.tw/books?id=SqAVwQEACAAJ
王居卿、余強生、吳欣玫(2003)。台灣生技醫藥健康產業推動電子市集的關鍵成功因素研究。Electronic Commerce Studies，1(1)， 41-66。https://doi.org/10.29767/ECS.200306.0004
朱柔若(2000)。社會研究方法－質化與量化取向。揚智。
江家欣(2016)。台灣醫療器材廠商創新研發策略聯盟之研究例〔未出版之碩士論文〕。國立交通大學科技管理研究所。https://hdl.handle.net/11296/xq3zb9
吳忠勳等人(2022)。2022生技產業白皮書。經濟部工業局。
呂美秀(2016)。全民健康保險政策對台灣醫療器材產業經營策略的影響-以心血管產業為例〔未出版之碩士論文〕。世新大學企業管理研究所。 https://hdl.handle.net/11296/ykd2a7
李孟訓、劉冠男、丁神梅、林俞君(2007)。我國生物科技產業關鍵成功因素之研究。東吳經濟商學學報，56，27-51。
李素華(2019)。專家觀點／專利連結會壓垮台灣生醫產業與健保財務嗎？。社團法人國家生技醫療產業策進會。Retrieved 6/20/2023 from https://ibmi.taiwanhealthcare.org/zh/news_detail.php?REFDOCID=0pngijvajda4t4ub&REFDOCTYPID=0o4dd9ctwhtyumw0
李啟誠(2005)。台灣生物科技產業醫療器材類策略態勢與發展方向之分析：以五鼎、百略、及必翔公司為例。科技管理學刊，10(4)，1-41。 https://doi.org/10.6378/jtm.200512.0001
李爾芳、李旻軒、吳劭易、林怡欣、徐勤禎、張慈映、劉家豪(2022)。2022醫療器材產業年鑑。工研院產科國際所。
李顯章(1998)。台灣地區醫療儀器業發展關鍵成功因素之探討〔未出版之碩士論文〕。國立中興大學企業管理學系。https://hdl.handle.net/11296/dbx2x9
林燕(2020)。生技產業創新經銷商轉型策略之研究—以L公司為例〔未出版之碩士論文〕。國立政治大學。https://hdl.handle.net/11296/dv85be
孫中平(2007)。醫療器材外商企業在台經營發展關鍵成功因素之探討〔未出版之碩士論文〕。立德管理學院科技管理研究所。https://hdl.handle.net/11296/a84879
陳力維(2012)。醫療器材品質認證制度之研究〔未出版之碩士論文〕。逢甲大學。 https://hdl.handle.net/11296/ptc993
陳美雲(2012)。台灣醫療器材廠商風險管理關鍵成功因素之研究〔未出版之碩士論文〕。淡江大學。https://hdl.handle.net/11296/5u6369
黃珮怡(2019)。全民健保給付規定對醫療器材產業經營策略與市場形塑計畫之影響 - 以A醫療公司之A產品為例〔未出版之碩士論文〕。國立臺灣大學企業管理碩士專班。
劉家豪、徐勤禎、林怡欣、吳劭易、李旻軒、蔡彥俊(2023)。2022年第四季及全年我國醫療器材產業回顧與展望。工研院產科國際所。