本研究旨在探討創新醫療器材於上市前驗證及市場導入過程中所面臨的法規與市場挑戰，並以能資國際股份有限公司開發之可攜式 X 光機為個案，分析其在「法規策略」與「市場策略」雙軌整合下的成功經驗。研究主要運用文獻分析與深度訪談法，建構出以「策略性驗證設計」與「創新擴散導向行銷」為核心的分析架構。
研究結果顯示，創新醫療器材的成功導入取決於法規合規與市場採用之同步推進。於上市前階段，企業若能以策略性驗證設計整合 FDA、TFDA 及 MDR 三大體系要求，並提早規劃臨床資料與品質管理，可有效降低法規不確定性與跨國申請成本。在市場導入階段，企業透過 4P 行銷策略（產品、價格、通路、推廣）結合創新擴散五要素（相對優勢、相容性、可試用性、可觀察性、說服與確認），成功促進醫療機構採用與偏鄉場域擴散。
綜合分析，本研究提出「法規—市場雙軌整合模型（Dual-Track Integration Model）」，指出法規策略提供制度性信任，市場策略建立社會性信任，兩者交互作用形成創新醫材擴散的正向循環。理論上，本研究補足醫材創新研究對法規面探討之不足；實務上，則可為醫療新創企業於法規規劃、產品定位與市場導入上提供具體參考。未來研究可進一步透過跨國比較與量化實證，以驗證本模型於不同法規體系下之適用性。

This study investigates the dual challenges of regulatory compliance and market adoption in the pre-market validation and commercialization of innovative medical devices. Using the case of Energy Resources International Co., Ltd. and its portable X-ray machine, this research analyzes how the company integrated regulatory strategies and market diffusion strategies to achieve successful product introduction. Through literature review and in-depth interviews, a conceptual framework combining strategic validation design and innovation-diffusion-oriented marketing was established.
The findings indicate that the successful implementation of innovative medical devices depends on the synchronized advancement of regulatory and market strategies. In the pre-market stage, firms that adopt a strategic validation approach—integrating the requirements of FDA, TFDA, and MDR regulations and planning clinical validation and quality management early—can reduce regulatory uncertainty and international submission costs. During market diffusion, applying the 4P marketing strategy aligned with the five attributes of the Diffusion of Innovation Theory effectively accelerates user adoption in clinical and remote-care settings.
Overall, this study proposes a Dual-Track Integration Model, wherein regulatory strategies establish institutional trust and market strategies build social trust, jointly forming a positive feedback loop for innovation diffusion. Theoretically, the study extends the application of diffusion theory into the regulatory domain; practically, it provides actionable guidance for med-tech startups in regulatory planning, product positioning, and market entry. Future research may further validate this model through cross-national comparison and quantitative analysis.

中文文獻
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衛生福利部食品藥物管理署（TFDA）, （2023）. 醫療器材分級（第一級、第二級、第三級）相關說明. TFDA 官方網站.
衛生福利部食品藥物管理署（TFDA）, （2017）. 醫療器材查驗登記作業準則. TFDA 官方資訊.
核能安全委員會（Nuclear Safety Commission, Taiwan）,（2025）. 放射線作業／醫療用游離輻射設備安全與防護相關規範（含操作距離、遮蔽等要求之依據）. NUSC 官方資訊
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