http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/187 2026-04-07T06:30:46Z http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/77190 標題: 鼻部生物科技醫療材料之研究; A study of nasal biotechnology medical materials 作者: 蔡瑞軒; Jui–Hsuan Tsai 摘要: 本論文分析鼻部生物科技醫療材料之運用，從巨觀的醫療器材產業市場分析，聚焦到鼻部生物醫療材料市場分析與臨床應用。 拜醫療材料的不斷發展之賜，帶動產品進步，進而改變醫療上的臨床處置，並將產品使用的臨床經驗回饋到產品研發端，進行正向的開發循環。本文討論的內容包括：鼻部解剖構造、鼻部生理、鼻部疾病、鼻部手術治療等鼻部之背景知識，也回顧止血物質的發展過程、凝血反應、止血和組織密封劑產品的市場概況、產品內容分析、產業界生態、產業鏈、臨床經驗等，進行綜合系統性的回顧。 本文研究藉由詳細的文件搜尋實際深入訪談，包括：臨床端的醫師、護理師到產業端的經銷商產品專員、業務代表、原廠產品專員等，垂直串流產業互動過程，進行綜合性的整理，讓未來研究者藉由本論文能夠更加深入探討各面向，能更全貌性地了解本產業，台灣醫療器材產業可能發展機會是配合新南向政策，開發新興市場；亦藉由臨床經驗與討論，順應全球醫材產品發展的大方向，尋求產品未來開發的可能性。; ABSTRACT This paper analyzes the application of biomedical materials for nasal biotechnology, from the market analysis of the general medical device industry, focusing on the market analy-sis and clinical application of biomedical materials for the nose. Thanks to the continuous development of medical materials, the products will be promot-ed, and the clinical protocol of medical treatment will be changed, and the clinical experi-ence of product use will be fed back to the product development side for a positive devel-opment cycle. The discussion included nasal background knowledge of nasal anatomy, nasal physiology, nasal diseases, nasal surgery, and review of the development of hemo-static substances, coagulation reactions, hemostatic and tissue sealant product market overview, product content analysis, A comprehensive systematic review of industry ecol-ogy, industrial chain, and clinical experience. This study uses a detailed document to search for actual in-depth interviews, including clinical physicians, clinical nurses, industry-side distributor product specialists, business representatives, original product specialists, etc., vertical streaming industry interaction process, comprehensive sorting, for future research through this paper, we can explore all aspects in a more in-depth manner, and we can understand the industry more fully. One of the possible development opportunities of Taiwan's medical device industry is to cooper-ate with the new southward policy and develop emerging markets. In addition, through clinical experience and discussion, in line with the general direction of the development of global medical products, the possibility of future development of products is sought. 2019-01-01T00:00:00Z http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/99186 標題: 高齡浪潮 – 臺灣長期照顧服務之制度演進與策略思維：從國際比較與管理模式觀點分析; The Silver Wave - Institutional Evolution and Strategic Approaches in Taiwan’s Long-Term Care Services: An Analysis from International Comparative and Managerial Perspectives 作者: 廖婉如; Wan-Ju Liao 摘要: 面對臺灣快速邁入超高齡社會的人口結構變化，及相應而來日益劇增的失能照護需求，現行長期照顧制度正面臨高度的政策壓力與制度挑戰。臺灣長期照顧制度自2007年之《長期照顧十年計畫》實施以來，歷經1.0至2.0階段，已逐步建立以A/B/C據點為主軸之在地化照顧網絡，擴大涵蓋多元失能群體，並在政策設計與服務供給上取得初步成效。然而，隨著2026年長照計畫2.0即將結束，加上失能人口持續增加與照顧勞動力短缺，現行制度在財政架構、給付邏輯與治理協調層面，皆面臨顯著的結構性限制。如何從現有補助型稅收體系邁向具備韌性與永續性的照顧制度，成為當前臺灣長期照顧政策亟需回應的重要課題。 本研究聚焦於臺灣長期照顧制度的制度架構與政策治理，透過歷史政策分析、國際比較與多元管理工具的應用，檢視其制度邏輯、執行困境與治理挑戰。研究運用多種策略管理分析模組，對現行制度進行多面向診斷，並輔以六個國際代表性國家之長照制度比較，深入借鑑各國在制度建構、財政規劃、服務提供模式及挑戰因應等方面的經驗，探究國際最佳實踐及其在臺灣脈絡下的在地化轉譯可能性。 研究發現，臺灣現行長照制度主要仰賴菸品健康福利捐、菸酒稅、遺產與贈與稅與特別預算等非固定性財源，缺乏穩定且具制度化的保費機制，使得制度長期營運面臨財政不確定風險；給付制度未建構功能性失能分級與彈性給付設計，導致資源分配效率與公平性不足；照顧人力體系則長期處於人力不足、待遇偏低與專業發展不明確之困境；跨部門服務資訊整合亦未健全，影響整體照顧體系的執行力與連續性。整體而言，若我國欲建構一套具備韌性、可近性與永續性的長期照顧體系，其制度核心必須從現行補助導向的稅收制，逐步轉向以社會保險制或混合制為基礎的現代照顧制度架構。 本研究據此提出三項制度演進的核心策略方向。首先，應強化財政結構的穩定性與治理協調機制，透過《長期照顧保險法》之立法與保費制度的導入，確保財政來源具可預測性，並實現跨世代風險共擔的制度邏輯。治理層面應建構中央統籌、地方落實與民間協作的三層次治理體系，提升制度的政策落實力與應變彈性。其次，應推動給付制度的標準化與彈性化，建立科學化的功能性失能評估架構，搭配多元給付模式與差異化自付設計，平衡資源使用效率與照顧公平性；並針對中產家庭設計適度的照顧支出上限制度，以避免資產耗盡風險，提升整體社會的支持度與制度信任。第三，應加速整合照顧人力資源與服務資訊系統，強化照顧服務員的專業認證、職涯制度與待遇改善，並建立照顧管理師制度與跨部門資料共享平台，結合「長照計畫3.0」所倡議之人工智慧輔助照顧與預測功能，以提升服務調度效率與個案照護的連續性。 然而，臺灣長期照顧制度的演進不應止於政策微調或服務擴充，更應視為一場結合系統性改革與價值導向的制度重構工程。唯有在財政穩定、治理協調與服務整合三大面向同步推進，並奠基於社會保險制度的可行演進基礎上，臺灣方能建構一個兼具公平性、制度韌性與永續發展潛能的現代長期照顧體系，進一步實現「全民共享、世代共擔、永續發展」的照顧政策願景。; Amid Taiwan’s rapid demographic shift toward a super-aged society and the accompanying surge in demand for disability care, the existing long-term care (LTC) system is under increasing policy pressure and structural strain. Since the launch of the “Ten-Year Long-Term Care Plan” in 2007, Taiwan’s LTC system has progressed through the 1.0 and 2.0 phases, gradually establishing a community-based service network centered on the A/B/C model, expanding coverage to encompass diverse groups with functional limitations, and achieving initial successes in policy design and service provision. However, with LTC Plan 2.0 nearing its conclusion in 2026, and amid a growing care-dependent population and workforce shortage, the system now faces pronounced challenges in fiscal sustainability, benefit structure, and intergovernmental coordination. Transitioning from a subsidy-driven, tax-based model to a resilient and sustainable care system has become a pressing imperative for LTC policy reform in Taiwan. This study explores the institutional design and policy governance of Taiwan’s LTC system through a multi-method approach combining historical policy review, international comparative analysis, and the application of strategic management frameworks. Multiple diagnostic models are employed to evaluate systemic strengths and limitations, supplemented by case studies from six internationally representative LTC systems from different countries. These cases provide critical insights into institutional configurations, financing strategies, service delivery models, and policy responses, offering a foundation for contextualized adaptation in Taiwan. Findings reveal that Taiwan’s LTC system remains heavily reliant on non-permanent fiscal sources - such as tobacco surcharges, alcohol and tobacco taxes, estate and gift taxes, and special budget appropriations - without a stable, institutionalized insurance premium mechanism. This exposes the system to long-term fiscal uncertainty. The benefit structure lacks a standardized functional needs assessment framework and flexible reimbursement design, resulting in inefficiencies and inequities in resource allocation. The care workforce continues to face chronic shortages, low compensation, and limited professional development, while cross-sectoral data integration remains fragmented, undermining service continuity and governance capacity. To construct a resilient, accessible, and sustainable LTC architecture, Taiwan must progressively transition from its current tax-funded subsidy model toward a social insurance-based or hybrid financing system. Accordingly, this study proposes three strategic directions for institutional evolution. First, enhancing fiscal stability and governance coordination is essential. This includes enacting a “Long-Term Care Insurance Act” and establishing a contributory premium scheme to ensure predictable revenue and institutionalize intergenerational risk-sharing. A tri-level governance framework - comprising central oversight, local execution, and civil sector collaboration - should be developed to reinforce responsiveness and implementation resilience. Second, standardizing and refining the benefit structure is critical. A scientifically grounded functional assessment system, diversified benefit packages, and tiered co-payment mechanisms can improve efficiency and equity. Designing a care expenditure cap for middle-income households can further mitigate asset depletion and strengthen public confidence. Third, integrating care workforce development and information systems is vital. This entails improving professional certification, career pathways, and compensation for care workers, establishing a case management system, and building a cross-sectoral data-sharing platform. These should be aligned with AI-powered care system and predictive models, as proposed in the LTC Plan 3.0, to optimize resource deployment and ensure care continuity. Ultimately, Taiwan’s LTC reform must move beyond incremental policy adjustments or service expansion and instead embrace a comprehensive institutional transformation grounded in long-term vision and social values. Only through the concurrent advancement of fiscal sustainability, coordinated governance, and integrated service infrastructure, anchored in a viable social insurance framework, can Taiwan build a modern LTC system that embodies fairness, institutional resilience, and sustainable capacity, fulfilling the policy vision of “universal coverage, intergenerational solidarity, and long-term sustainability.” 2025-01-01T00:00:00Z http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/97891 標題: 高價基因治療藥物的健保定價挑戰與策略：Zolgensma案例分析; Challenges and Strategies in Pricing High-Cost Gene Therapy Drugs under Health Insurance: A Case Study of Zolgensma 作者: 彭元建; Yuan-Jian Peng 摘要: 本研究探討了高價基因治療藥物Zolgensma在台灣健保定價挑戰與策略，以對脊髓性肌肉萎縮症（Spinal Muscular Atrophy, SMA）的案例進行分析，並參考韓國經驗做比較。 隨著人口老齡化和醫療技術的進步，台灣的全民健康保險面臨巨大財務壓力，高價新藥的引進尤為突出。本研究旨在分析兩國在Zolgensma健保核價過程中的共通點與差異，並探討相關利益者（政府、藥廠、病友）在核價過程中的角色與影響。 研究方法包括文獻分析法及個案研究法，透過系統性地分析台灣與韓國的醫療保健統計資料、學術文獻和政策法規文件，來比較兩國在Zolgensma核價過程中的政策框架和法規要求。 研究發現，台灣和韓國均面臨高價基因治療藥物對健保基金的重大財務衝擊，兩國在核價過程中均採用醫療科技評估（HTA）及風險分擔協議（RSA）來降低財務風險。然而，台灣的審核時程較長，影響了新藥核准的速度，韓國則透過更快速的核價程序及付款方式以減少財務衝擊。此外，相關利益者在核價過程中的角色和影響存在差異，政府政策、藥廠的市場策略以及病友的權益訴求均對核價結果產生重要影響。 本研究提出了政策建議，包括提升基因治療的認識和支持、加強國際合作及多方利益相關者參與，以促進基因治療技術的應用和發展，確保患者能及時獲得所需的治療。預期研究結果將為政府决策者、醫療機構及藥廠在制定和執行核價策略時提供實證依據，進一步完善高價藥物的支付和核價政策。; This study explores the pricing challenges and strategies for the high-cost gene therapy drug Zolgensma in Taiwan's National Health Insurance (NHI) system, focusing on the case of Spinal Muscular Atrophy (SMA) and drawing comparisons with South Korea's experience. With the aging population and advancements in medical technology, Taiwan’s NHI faces immense financial pressure, particularly regarding the introduction of high-cost innovative drugs. This research aims to analyze the similarities and differences in Zolgensma pricing processes between Taiwan and South Korea and to examine the roles and impacts of key stakeholders (government, pharmaceutical companies, and patient groups) in these processes. The research methodology includes literature analysis and case study methods, systematically analyzing healthcare statistics, academic literature, and policy documents from Taiwan and South Korea. These data were used to compare the regulatory frameworks and policy requirements for Zolgensma pricing in the two countries. The findings reveal that both Taiwan and South Korea face significant financial challenges from high-cost gene therapies in their healthcare systems. Both countries utilize Health Technology Assessment (HTA) and Risk-Sharing Agreements (RSA) to mitigate financial risks. However, Taiwan’s longer review timelines delay new drug approvals, whereas South Korea adopts faster pricing procedures and payment methods to alleviate financial pressure. Additionally, the roles and impacts of stakeholders in the pricing process differ: government policies, pharmaceutical market strategies, and patient advocacy significantly influence the pricing outcomes. This study provides policy recommendations, including increasing awareness and support for gene therapies, strengthening international collaboration, and enhancing multi-stakeholder engagement to promote the application and development of gene therapy technologies. These measures aim to ensure timely access to treatment for patients. The findings are expected to offer empirical evidence for policymakers, healthcare institutions, and pharmaceutical companies in formulating and implementing pricing strategies, thereby improving policies related to the reimbursement and pricing of high-cost drugs. 2025-01-01T00:00:00Z http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/7320 標題: 食品生技業擴張型原廠設計代工製造模式A-ODM之探討-以B公司為例; A Study on the Augmented Original Design Manufacturing (A-ODM) Model for Food Biotechnology Industry--The Case of B Company 作者: Lan-Mei Weng; 翁藍美 摘要: 全球人口結構的老化伴隨著相關慢性疾病患者的增加，在科技進步以及預防醫學及養生概念的興起，造就營養保健食品產業的蓬勃發展。 本研究目的在探討食品生技業B公司的A-ODM的經營模式(A即Augmented;擴張的原廠設計代工製造)，本模式除涵括ODM原有的代工製造及開發設計業務外，更垂直整合至上游的原料開發、下游的行銷及售後支援服務。B公司專注於A-ODM的經營模式，未成立自有品牌(OBM)，也不從事代工製造(OEM)業務，這有別於其他主要生技同業橫跨三者的經營模式，在過去5年創造營收複合年成長率(CAGR)高達53%，居同業之冠。 B公司定位為原料或產品供應者的角色明確，其與顧客之間只有合作沒有競爭，可建立互利長久的夥伴關係，且提供顧客的全方位A-ODM服務模式，從探索消費者需求並掌握時下流行趨勢、功能性原料開發、設計製造產品、售後如智慧財產權的專利申請、產品進出口諮詢等支援服務，以此差異化服務的競爭優勢，創造高達95%的顧客回購比率，也締造近5年稅後淨利CAGR高達84%，居同業之冠。; The graying society accompanied with increasing chronic disease patients combined with the advancement of science and technology as well as the booming of preventive medicine and health-preserving concept have facilitated the flourish development of the nutrition health food and dietary supplements industry. The purpose of this study is to analyze a food biotechnology company, B Company’s A-ODM (Augmented- Original Design Manufacturing) business model which includes product design, development and manufacturing plus vertical integration to upstream material development and downstream marketing and customer service. B Company’s devotion to the A-ODM business model, without involvement in OBM and OEM business has distinguished itself from other biotechnology industry players and has created a 53% CAGR on its revenue over the past 5 years, highest among Taiwan food biotechnology industry. B Company played as a material and product supplier role with cooperation only, no competition to its customers. This clear position enabled the establishment of a long term mutual beneficial partnership relation with a comprehensive A-ODM service to its customers. The A-ODM service includes exploring customers’ need, envisioning future trend, developing functional raw materials, designing and manufacturing products, after sale service such as intellectual property rights related patent application, and products export/import consultation and support. This distinguished turnkey service advantage brought a high 95% customer return rate and created a record high 84% CAGR on its net profit after tax over the past 5 years, also highest among Taiwan food biotechnology industry. 2019-01-01T00:00:00Z