全球人口老化與後疫情時代的照護轉型，正驅動呼吸治療耗材市場快速擴張。然而，現有文獻多採用通用型框架探討市場進入策略，難以切中醫療耗材產業高度重視法規、臨床黏著度高的特性。有鑑於此，本研究結合 PESTEL 外部環境分析與 Porter 價值鏈內部能力檢視，建構一套專為醫療耗材產業量身打造的國際市場開發評估模型。

本研究採用多個案比較法，深入剖析 Fisher & Paykel (F&P) 與台灣某大醫療器材股份有限公司(DC Healthcare) 兩家策略路徑截然不同的企業。研究發現：F&P 採取「技術領導路徑」，透過高度垂直整合與臨床標準定義，在高端市場建立高壁壘；DC Healthcare則走「供應鏈敏捷路徑」，憑藉台灣成熟的產業聚落與全球代理商網絡，快速滲透多元市場。兩者在各自定位的市場中皆展現出獨特的競爭優勢。

最終，本研究將理論與實務深度訪談結果整合，開發出一套包含 12 項指標的雷達圖評估工具，並透過 1 至 5 分制量化各目標市場的進入可行性，期盼為醫療耗材廠商在布局國際市場時，提供具實務操作價值的決策參考。

The convergence of global population aging and post-pandemic care transformation is driving rapid expansion in the respiratory therapy consumables market. However, existing literature predominantly applies generalized frameworks to market entry strategy, failing to adequately address the medical consumables industry’s distinctive emphasis on regulatory compliance and high clinical stickiness. To bridge this gap, this study integrates PESTEL external environment analysis with Porter’s Value Chain internal capability assessment to construct an international market development evaluation model tailored specifically for the medical consumables industry.

Employing a multiple-case comparative methodology, this study conducts an in-depth analysis of Fisher & Paykel (F&P) and DC Healthcare — two firms with markedly divergent strategic trajectories. The findings reveal that F&P pursues a “Technology Leadership Path,” establishing formidable barriers in the high-end market through deep vertical integration and the definition of clinical standards, while DC Healthcare follows a “Supply Chain Agility Path,” leveraging Taiwan’s mature industrial cluster and a global distributor network to achieve rapid penetration across diverse markets. Both firms demonstrate distinct competitive advantages within their respective market positions.

Ultimately, this study synthesizes theoretical frameworks with findings from in-depth practitioner interviews to develop a radar chart evaluation tool comprising 12 indicators. Utilizing a 1-to-5 scoring scale to quantify the entry feasibility of target markets, the model is intended to serve as a practically actionable decision-making reference for medical consumables manufacturers navigating international market strategy.

一、中文文獻：
台灣醫療器材工業同業公會（TDCA）（2025）。2025 年台灣醫療器材產業年報。台北：TDCA。
台灣經濟研究院（2025）。後疫情時代台灣醫療器材出口競爭力分析。台北：台灣經濟研究院。
行政院科技部（2025）。台灣生技醫療產業白皮書 2025-2026。台北：行政院。
黃建中、李明哲（2024）。醫療耗材企業國際化策略研究——以台灣廠商為例。管理評論，43（2），45-68。
二、英文文獻：
Aguilar, F. J. (1967). Scanning the business environment. New York: Macmillan.
Anderson, E., & Gatignon, H. (1986). Modes of foreign entry: A transaction cost analysis and propositions. Journal of International Business Studies, 17(3), 1-26.
Fisher & Paykel Healthcare. (2025). Annual Report 2024-2025. Auckland: Fisher & Paykel Healthcare.
Mordor Intelligence. (2025). Global medical disposables market - growth, trends, COVID-19 impact, and forecasts (2025-2030). Hyderabad: Mordor Intelligence.
Porter, M. E. (1985). Competitive advantage: Creating and sustaining superior performance. New York: Free Press.
Root, F. R. (1994). Entry strategies for international markets. San Francisco: Jossey-Bass.
Adomako, S., Amankwah-Amoah, J., Donbesuur, F., & Ahsan, M. (2021). Strategic agility and new venture performance: Small and medium enterprises in emerging economies. International Small Business Journal, 39(5), 428–454.
Hinterhuber, A. (2022). Value-based pricing in medical devices: A systematic literature review. Journal of Business Research, 150, 636–648.
Khanna, T., Palepu, K. G., & Sinha, J. (2019). Strategies that fit emerging markets. In Harvard Business Review Classics: Emerging Markets. Boston: Harvard Business Review Press.
Svahn, S., & Westerlund, M. (2020). Relational quality determinants in medical device distribution: A study of distributor–manufacturer relationships. Industrial Marketing Management, 88, 245–256.
Simon, H. (1996). Hidden champions: Lessons from 500 of the world's best unknown companies. Boston: Harvard Business School Press.
World Health Organization. (2025). Medical devices: Managing the mismatch. Geneva: WHO.
三、法規與官方文獻：
European Commission. (2023). Regulation (EU) 2017/745 on medical devices (MDR). Brussels: European Union.
FDA. (2024). Quality Management System Regulation (QMSR): 21 CFR Part 820. Washington D.C.: U.S. Food and Drug Administration.
SFDA. (2025). Kingdom of Saudi Arabia medical devices regulation 2025 update. Riyadh: Saudi Food and Drug Authority.
ASEAN. (2025). ASEAN medical device directive (AMDD) implementation.