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題名 醫療器材產業數位轉型機會之研究
An Examination of Digital Transformation Opportunities in the Medical Device Industry
作者 高聖凱
Kao, Simon Sheng-Kai
貢獻者 尚孝純<br>鄭至甫
Shang, Shari S. C.<br>Jeng, Don Jyh-Fu
高聖凱
Kao, Simon Sheng-Kai
關鍵詞 數位轉型
醫療器材產業
器材旅程
人工智慧
機器人技術
利害關係人理論
雙元性
創新
採用
適應
併購案例
醫療科技
監管挑戰
digital transformation
medical device industry
Device Journey
AI
robotics
stakeholder theory
ambidexterity
innovation
adoption
adaptation
M&A cases
healthcare technology
regulatory challenges
日期 2025
上傳時間 4-Aug-2025 13:32:36 (UTC+8)
摘要 本研究旨在識別醫療器材產業中的數位轉型機會。儘管新興數位科技擁有高度的轉型潛力，但受限於法規規範、利害關係人的複雜性以及臨床應用的高風險等因素，該產業在技術採用上仍面臨諸多挑戰。為此，本研究試圖彌補這些數位科技的潛在價值與其實際在醫療情境中應用之間的落差。 本研究提出「器材旅程」框架，融合利害關係人理論與雙元性概念。該框架的核心目的是識別平衡創新與營運效率的數位轉型機會，並進一步區分「採用」（即現成技術）與「適應」（針對具體情境的調整），以及「未滿足需求」（臨床驅動）與「創新需求」（市場驅動）等不同類型的需求。 在研究方法方面，本研究採用質性內容分析，並結合多個案研究設計，針對2018年至2022年間全球十大醫療器材公司所進行的22宗併購案例進行探討。研究從五個面向切入，包括：創新與轉型、器材旅程繪製、利害關係人經驗、數位技術策略，以及數位轉型機會的辨識。研究資料主要來自三角驗證後的次級資料來源，例如產業報告、白皮書與專家觀點，並經過專家諮詢以驗證其可靠性。研究設計遵循「輸入－處理－輸出」（IPO）模型，確保分析的一致性與邏輯清晰。 研究結果指出，人工智慧（AI）與機器人技術能透過改善資料存取性、系統整合性與使用效率，進而提升臨床效能與營運流程。「器材旅程」框架亦成功繪製出數位時代中器材生命週期內，利害關係人角色的動態變化。然而，法規障礙與組織對變革的抗拒仍構成重大挑戰。為因應此情境，本研究提出四項對策：智能再造、精準部署、技術重塑與客製創新。 本研究不僅深化了對利害關係人理論的應用，也提供了關於在高安全性產業環境中實踐組織雙元性的寶貴見解。「器材旅程」框架未來亦可作為多方利害關係人情境下數位轉型的參考工具，其應用潛力更可延伸至醫療以外的其他產業。
This study identifies digital transformation (DT) opportunities within the medical device industry. Despite the potential of emerging digital technologies, the sector faces challenges in adoption due to regulatory constraints, stakeholder complexities, and high-risk clinical applications. This research aims to bridge the gap between the transformative potential of these technologies and their practical implementation in healthcare settings. The study introduces the Device Journey framework, integrating stakeholder theory and the concept of ambidexterity. This framework identifies DT opportunities that balance innovation and efficiency, distinguishing between adoption (off-the-shelf) and adaptation (context-specific), as well as unmet (clinically driven) and invented (market-driven) needs. A qualitative content analysis, using a multi-case study design, examines 22 mergers and acquisitions (M&A) cases involving top global medical device firms from 2018 to 2022. Findings suggest AI and robotics improve clinical performance and workflows, while the refined Device Journey framework maps stakeholders' transformative roles across the lifecycle in digital era. However, regulatory challenges and resistance persist; four strategies—Smart Repurposing, Targeted Deployment, Tech Reengineering, and Tailored Innovation—are proposed. This research extends stakeholder theory and offers insights into organizational ambidexterity in safety-critical environments. The Device Journey framework may serve as a guide for DT in multi-stakeholder contexts, with potential relevance to industries beyond healthcare.
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描述 博士
國立政治大學
科技管理與智慧財產研究所
111364502
資料來源 http://thesis.lib.nccu.edu.tw/record/#G0111364502
資料類型 thesis
dc.contributor.advisor 尚孝純<br>鄭至甫zh_TW
dc.contributor.advisor Shang, Shari S. C.<br>Jeng, Don Jyh-Fuen_US
dc.contributor.author (Authors) 高聖凱zh_TW
dc.contributor.author (Authors) Kao, Simon Sheng-Kaien_US
dc.creator (作者) 高聖凱zh_TW
dc.creator (作者) Kao, Simon Sheng-Kaien_US
dc.date (日期) 2025en_US
dc.date.accessioned 4-Aug-2025 13:32:36 (UTC+8)-
dc.date.available 4-Aug-2025 13:32:36 (UTC+8)-
dc.date.issued (上傳時間) 4-Aug-2025 13:32:36 (UTC+8)-
dc.identifier (Other Identifiers) G0111364502en_US
dc.identifier.uri (URI) https://nccur.lib.nccu.edu.tw/handle/140.119/158396-
dc.description (描述) 博士zh_TW
dc.description (描述) 國立政治大學zh_TW
dc.description (描述) 科技管理與智慧財產研究所zh_TW
dc.description (描述) 111364502zh_TW
dc.description.abstract (摘要) 本研究旨在識別醫療器材產業中的數位轉型機會。儘管新興數位科技擁有高度的轉型潛力，但受限於法規規範、利害關係人的複雜性以及臨床應用的高風險等因素，該產業在技術採用上仍面臨諸多挑戰。為此，本研究試圖彌補這些數位科技的潛在價值與其實際在醫療情境中應用之間的落差。 本研究提出「器材旅程」框架，融合利害關係人理論與雙元性概念。該框架的核心目的是識別平衡創新與營運效率的數位轉型機會，並進一步區分「採用」（即現成技術）與「適應」（針對具體情境的調整），以及「未滿足需求」（臨床驅動）與「創新需求」（市場驅動）等不同類型的需求。 在研究方法方面，本研究採用質性內容分析，並結合多個案研究設計，針對2018年至2022年間全球十大醫療器材公司所進行的22宗併購案例進行探討。研究從五個面向切入，包括：創新與轉型、器材旅程繪製、利害關係人經驗、數位技術策略，以及數位轉型機會的辨識。研究資料主要來自三角驗證後的次級資料來源，例如產業報告、白皮書與專家觀點，並經過專家諮詢以驗證其可靠性。研究設計遵循「輸入－處理－輸出」（IPO）模型，確保分析的一致性與邏輯清晰。 研究結果指出，人工智慧（AI）與機器人技術能透過改善資料存取性、系統整合性與使用效率，進而提升臨床效能與營運流程。「器材旅程」框架亦成功繪製出數位時代中器材生命週期內，利害關係人角色的動態變化。然而，法規障礙與組織對變革的抗拒仍構成重大挑戰。為因應此情境，本研究提出四項對策：智能再造、精準部署、技術重塑與客製創新。 本研究不僅深化了對利害關係人理論的應用，也提供了關於在高安全性產業環境中實踐組織雙元性的寶貴見解。「器材旅程」框架未來亦可作為多方利害關係人情境下數位轉型的參考工具，其應用潛力更可延伸至醫療以外的其他產業。zh_TW
dc.description.abstract (摘要) This study identifies digital transformation (DT) opportunities within the medical device industry. Despite the potential of emerging digital technologies, the sector faces challenges in adoption due to regulatory constraints, stakeholder complexities, and high-risk clinical applications. This research aims to bridge the gap between the transformative potential of these technologies and their practical implementation in healthcare settings. The study introduces the Device Journey framework, integrating stakeholder theory and the concept of ambidexterity. This framework identifies DT opportunities that balance innovation and efficiency, distinguishing between adoption (off-the-shelf) and adaptation (context-specific), as well as unmet (clinically driven) and invented (market-driven) needs. A qualitative content analysis, using a multi-case study design, examines 22 mergers and acquisitions (M&A) cases involving top global medical device firms from 2018 to 2022. Findings suggest AI and robotics improve clinical performance and workflows, while the refined Device Journey framework maps stakeholders' transformative roles across the lifecycle in digital era. However, regulatory challenges and resistance persist; four strategies—Smart Repurposing, Targeted Deployment, Tech Reengineering, and Tailored Innovation—are proposed. This research extends stakeholder theory and offers insights into organizational ambidexterity in safety-critical environments. The Device Journey framework may serve as a guide for DT in multi-stakeholder contexts, with potential relevance to industries beyond healthcare.en_US
dc.description.tableofcontents Acknowledgements ii Abstract iv Content vii List of Tables x List of Figures xi Chapter 1. Introduction 1 1.1 Research Background 1 1.2 Research Motivation 3 1.3 Research Questions & Objectives 5 Chapter 2. Literature Review 7 2.1 Digital Transformation and Medical Device 7 2.1.1 Digital Transformation 8 2.1.2 Medical Device - Uniqueness of Medical Device 9 2.1.3 DT in the Medical Device Industry 17 2.2 Stakeholders in Device Journey 20 2.2.1 Stakeholder Theory - Device Journey Perspective 20 2.2.2 Device Journey Analysis 23 2.3 Leveraging Digital Technologies to Enrich Stakeholder Experience 39 2.3.1 Ambidextrous Organizations 39 2.3.2 Enriching Stakeholder Experience in Device Journey 41 2.3.3 Leveraging Digital Technologies in Device Journey 45 Chapter 3. Research Methodology 50 3.1 Conceptual Framework 51 3.2 Research Design 53 3.3 Data Collection 59 3.4 Data Analysis 60 Chapter 4. Research Results 63 4.1 Analysis of Selected Cases 63 4.2 Cross-Case Analysis 161 Chapter 5. Findings and Discussion 164 5.1 Refined Device Journey Methodology 164 5.2 Transforming Stakeholder Roles in the Digital Era 170 5.3 Distinctive Effects of DT on the Medical Device Industry 182 5.4 Strategies for Identifying and Implementing DT Opportunities in the Medical Device Industry 187 Chapter 6. Conclusions 200 6.1 Research Summary 200 6.2 Theoretical Implications 204 6.3 Managerial Implications 205 6.4 Implications for Stakeholder Roles 208 6.5 Limitations and Future Research 209 References 212 Appendix 1 230 Appendix 2 233 Appendix 3 237zh_TW
dc.format.extent 5879726 bytes-
dc.format.mimetype application/pdf-
dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0111364502en_US
dc.subject (關鍵詞) 數位轉型zh_TW
dc.subject (關鍵詞) 醫療器材產業zh_TW
dc.subject (關鍵詞) 器材旅程zh_TW
dc.subject (關鍵詞) 人工智慧zh_TW
dc.subject (關鍵詞) 機器人技術zh_TW
dc.subject (關鍵詞) 利害關係人理論zh_TW
dc.subject (關鍵詞) 雙元性zh_TW
dc.subject (關鍵詞) 創新zh_TW
dc.subject (關鍵詞) 採用zh_TW
dc.subject (關鍵詞) 適應zh_TW
dc.subject (關鍵詞) 併購案例zh_TW
dc.subject (關鍵詞) 醫療科技zh_TW
dc.subject (關鍵詞) 監管挑戰zh_TW
dc.subject (關鍵詞) digital transformationen_US
dc.subject (關鍵詞) medical device industryen_US
dc.subject (關鍵詞) Device Journeyen_US
dc.subject (關鍵詞) AIen_US
dc.subject (關鍵詞) roboticsen_US
dc.subject (關鍵詞) stakeholder theoryen_US
dc.subject (關鍵詞) ambidexterityen_US
dc.subject (關鍵詞) innovationen_US
dc.subject (關鍵詞) adoptionen_US
dc.subject (關鍵詞) adaptationen_US
dc.subject (關鍵詞) M&A casesen_US
dc.subject (關鍵詞) healthcare technologyen_US
dc.subject (關鍵詞) regulatory challengesen_US
dc.title (題名) 醫療器材產業數位轉型機會之研究zh_TW
dc.title (題名) An Examination of Digital Transformation Opportunities in the Medical Device Industryen_US
dc.type (資料類型) thesisen_US
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