醫療行為追求的不僅是治癒疾病，且追求功能及美觀的最大恢復。本研究個案「創易復助癒整合系統」也有相同的訴求。醫材產業價值高是協助中小企業技術和品質升級、轉型及提升市場競爭力的最佳途徑，然發展過程中仍有不少挑戰。本研究以創新醫療器材的經營策略為研究主軸，探討我國醫療器材產業如何因應外在環境的挑戰，及找出可行之經營策略？得到以下的研究發現：
一、鞏固國內市場、籌備國際市場：醫療器材產業大部分不會因外部政治經濟環境的波動而有大幅度需求上的改變，但會隨著社會的發展、醫療器材的創新，而有新的需求。但國內因全民健保體制下，醫療院所對於醫材殺價幅度高，而行銷初期亦需仰賴區域通路商，使得產品收益更為縮減。而現今外在的國際環境混沌不明，在公司新創初期資源少，若再分散至國際市場，恐得不償失。如何強化自身產品實力，站穩國內市場，成為市場首選才是當務之急。
二、具備核心技術：中小醫療器材產業的核心技術是創造高獲利空間的基礎，也是帶動公司成長的驅動力。如何及早達到產品與市場的適合度，將是創新醫療器材開發經營的一個關鍵過程，需在研發、生產、評估、學習的過程中去調整市場與商業模式。創新醫療器材需及早從一小部分初期使用者那裡獲得回饋，並以最低成本持續改進產品，若是早期研發者即是使用者(如本個案)，更可加快達到產品與市場適合度的過程。
三、顧客關係管理：顧客關係是此個案產品是否成功銷售的關鍵，關鍵資源、關鍵活動、關鍵合作夥伴及成本結構都緊繫著提升顧客關係圍繞。且從五力分析整理，可知此產品競爭力及利潤的最大壓力源是購買者的議價能力。只有拉高產品的專屬陷入成本，才不會因客戶為爭取更好的價格而開始比價，造成價格上的競爭，影響企業利潤。

The goal of medical treatment is not only to cure diseases, but also to maximize the recovery of function and cosmesis. The case of this study, "Shoelace Wound Closure Device (EZip®)" has the same purpose to improve the quality and satisfaction of the wound treatment, with high added value. The high-valued medical device industry is one of the best ways to assist small and medium-sized enterprises to upgrade, transform, and enhance competitiveness. However, there are still many challenges in the development process. This research focuses on business strategies for innovative medical device industry, and tries to explore how the medical device industry may respond to the challenges of the environment and find feasible business strategies. The research findings are listed below:
1. Consolidate the domestic market and prepare for the international market: Majority of the medical device industry will not undergo significant changes in demand
due to fluctuations in the political and economic environment, but will have new needs with the innovation of medical devices. Due to the public health insurance system, medical institutions have a bargaining power of suppliers, and in the early stage of marketing, they also need to rely on regional distributors, which further reduces product revenue. The current international situation is chaotic, and the company only has limited resources in the initial stage of development. How to strengthen its own product strength, stand firm in the domestic market, and become the market's first choice is the first priority.
2. Possess core technology: The core technology of the small and medium-sized medical device companies is the foundation for creating added value and the driving
force for the growth of the company. How to achieve early product/market fit will be a key process in the developing a innovative medical device company. It is necessary to adjust the business model in the process of development. Innovative medical device requires early feedback from a small number of early users, and continuous product improvement at the lowest cost. If the early developers are the users (as in this case), the process to achieve product/market fit can be accelerated.
3. Customer relationship management: Customer relationship is the key to the successful marketing of the product in this case. Key resources, key activities, key partners and cost structure are planned for improving customer relationships. From Porter's five forces analysis, it reveals that the pressure of competitiveness mainly
comes from the buyer's bargaining power. Only the customers get used to the product and difficult to change their practice, then it can prevent the price competition and improve corporate profits.

目次
第一章 緒論.............................................1
第一節 研究背景與動機................................1
第二節 研究目的與問題................................3
第三節 名詞解釋......................................4
第四節 研究範圍......................................5
第五節 論文章節結構與研究流程.........................6
第二章 文獻探討..........................................9
第一節 醫療器材產業之發展現況與趨勢....................9
第二節 策略分析相關理論..............................17
第三章 研究方法.........................................32
第一節 研究架構.....................................32
第二節 研究構念.....................................33
第三節 研究方法.....................................34
第四節 研究工具.....................................38
第五節 研究對象.....................................39
第六節 資料蒐集.....................................40
第四章 研究結果.........................................41
第一節 個案說明.....................................41
第二節 研究發現與討論...............................50
第五章 結論與建議.......................................69
第一節 結論.........................................69
第二節 建議.........................................72
第三節 研究限制.....................................74
參考文獻...............................................75
附錄...................................................77
一、訪談綱要........................................77
二、訪談摘要........................................78

林怡欣(2020)。2019 年第四季及全年我國醫療器材產業回顧與展望。台灣：工研院產科國際所ITIS 研究團隊。
邱志聖(2020)。策略行銷分析架構與實務應用(五版)。台灣：元照出版有限公司。
張慈映、簡惠蓮(2020)。2020 醫療器材產業年鑑。台灣：工業技術研究院產業科技國際策略發展所。
MBA 智庫百科(2021)，摘自：https://wiki.mbalib.com/zh-tw/SWOT 分析模型
Aguilar, F. (1967). Scanning the business environment. New York: Macmillan.
Porter, M. (1979). How competitive forces shape strategy. Harvard Business Review. March/April; pp. 137-145.
Ansoff, I. (1957). Strategies for diversification. Harvard Business Review. Sep/Oct; pp.113-124.
Abell, D. (1980). Defining the business: the starting point of strategic planning. UpperSaddle River: Prentice-Hall.
Bogdan, R. C. & Biklen, S. K. (2006). Qualitative Research in Education: An Introduction to Theory and Methods: United States Edition.
Eisenhardt, K. M. (1989). Building Theories from Case Study Research. Academy of Management Review, 14(4), 532-550.
Myers, M. D. (2013). Qualitative research in business and management, Sage.
Mason, J. (2002). Qualitative researching (2nd ed.) London: Sage. Osterwalder, A. and Pigneur Y. (2010). Business model generation: a handbook for visionaries, game changers, and challengers. Hoboken: Wiley.
Smith, J. K. (1983). Quantitative versus Qualitative Research: An Attempt to Clarify the Issue. Educational Researcher, 12(3), 6-13.
Van Maanen, J. (1979). Reclaiming Qualitative Methods for Organizational Research. Administrative Science Quarterly, 24, 520-526.
Yin, R. K. (2003). Case study research: Design and methods (3rd ed.) Applied Social Research Methods Series, vol. 5: Sage Publications, Thousand Oaks.
Yin, R. K. (2009). Case Study Research: Design and Methods (4th ed.) Thousand Oaks: SAGE.
Andreessen, M. (2007). Product/Market Fit. Stanford University; Retrieved from https://web.stanford.edu/class/ee204/ProductMarketFit.html
Ries, E. (2011). The Lean Startup. New York: Crown Business.