http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/187 2026-10-05T19:23:58Z 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/123456789/104814 標題: 高濃度血小板血漿製備標準化與市場價值研究： 法規與臨床應用可行性分析; Standardized Preparation and Market Value Study of PRP: Feasibility Analysis of Regulations and Clinical Applications 作者: 魏希如; Hsi-Ju Wei 摘要: 高濃度血小板血漿（Platelet-Rich Plasma, PRP）富含血小板衍生生長因子（PDGF）、轉化生長因子（TGF-β）與血管內皮生長因子（VEGF）等多種生物活性分子，能促進組織血管新生、抗發炎與細胞增殖，廣泛應用於骨科、復健科、皮膚醫美及創傷修復等再生醫學領域。然而，傳統自體液態 PRP 之床邊即時採集與離心製備方式存在高度異質性，不同設備與操作參數導致血小板濃縮倍數、白血球含量及生長因子釋放曲線差異巨大，進而影響臨床療效的一致性與可重複性。此外，液態PRP採血後須即時使用，無法確認製品之品質，為弭平臨床異質性，冷凍乾燥技術被引進於PRP製備，能有效保留生長因子活性並實現定量、常溫長期保存與單次採血多次使用之優勢，推動PRP從傳統床邊即時製作轉型為標準化生物製品。 在管理法規層面，台灣現行對自體PRP治療主要聚焦於離心套組等「醫療器材」之第二等級管理與醫療廣告限制，但在醫療機構之臨床操作規範、場地設施與品質監管上缺乏明確法律層級標準。隨著台灣於2026年1月1日正式施行「再生醫療雙法」，凍乾技術製作之自體PRP之法規定位面臨空窗與適法性挑戰。按「再生醫療法」第3條第3款規定，再生技術已將「使用血液製劑」排除在外；若將PRP定性為「細胞衍生物」納入「再生醫療製劑條例」，則因自體PRP具備「自體、床邊即時、單一病人使用」之特性，欠缺商品化、規格化與批量生產等藥品許可證要件，強制要求其辦理查驗登記顯與立法初衷相悖。同時，於無菌實驗室製備PRP之離心濃縮過程並不涉及細胞培養或改變細胞特性的「細胞操作」，亦不符合申請細胞操作許可（GTP查核）之條件，致使新穎PRP製備技術發展陷入既非製劑亦非指定技術之規範困境。 為破解此法規困境，本研究深入探討借鏡日本再生醫療「雙軌」管制架構之可行性。日本於2014年建構「醫療技術走安確法（再生醫療等安全性確保法）、上市產品走藥機法（醫藥品醫療器材等法）」之分流管理制度，日本醫療機構提供自體PRP治療被明確歸類為安確法下之「再生醫療技術」，並依注射部位實施風險分級管理：將血液加工物用於關節腔內注射（如退化性膝關節炎）歸為第二種再生醫療（中風險）；用於關節外注射（如牙科或皮膚科）則歸為第三種再生醫療（低風險）。醫療機構須提交提供計畫並經認定委員會審查，製備器材則回歸藥機法之醫療器材規範；若涉及自體凍乾PRP之集中加工，則須於取得許可之細胞培養加工設施內進行。 本研究綜合整理台日法規比較後指出，台灣再生醫療雙法之立法精髓與日本雙軌體系高度相似，自體凍乾PRP應參考日本「安確法」之低度管理精神，明確定位為「醫療行為/技術軌」而非「藥品/製劑軌」。政策上應落實主管機關自2017年確立之三大核心原則：以治療為目的且具科學實證、施行前充分告知並取得病人同意、使用TFDA核准之合法設備並符合感染控制。同時，倡議產業建立標準化製備程序與參數報告，將PRP製程透明化與規格化。本研究建議政府應明確自體凍乾生物材料之技術軌申報途徑，以落實病人近用醫療權益、提升醫療品質並促進再生生醫產業之永續發展。; Platelet-Rich Plasma (PRP) is rich in a variety of bioactive molecules, including platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), and vascular endothelial growth factor (VEGF). It promotes tissue angiogenesis, exerts anti-inflammatory effects, and stimulates cell proliferation, and is widely applied in regenerative medicine fields such as orthopedics, rehabilitation medicine, dermatology and aesthetic medicine, and wound repair. However, the conventional bedside point-of-care collection and centrifugal preparation of autologous liquid PRP is highly heterogeneous; differences in equipment and operating parameters lead to substantial variation in platelet concentration factors, leukocyte content, and growth factor release profiles, thereby affecting the consistency and reproducibility of clinical outcomes. Moreover, liquid PRP must be used immediately after blood collection, making it impossible to verify product quality. To eliminate such clinical heterogeneity, freeze-drying (lyophilization) technology has been introduced into PRP preparation. This technique effectively preserves growth factor activity and enables quantification, long-term storage at room temperature, and the advantage of multiple uses from a single blood draw, driving the transformation of PRP from traditional bedside point-of-care production into a standardized biological product. At the regulatory level, Taiwan's current regime for autologous PRP therapy focuses primarily on Class II regulation of "medical devices" such as centrifugation kits, and on restrictions on medical advertising, but it lacks clear statutory-level standards for clinical operating protocols, facilities and premises, and quality oversight within medical institutions. With the formal implementation of Taiwan's "dual acts on regenerative medicine" on January 1, 2026, the regulatory positioning of freeze-dried autologous PRP faces both a regulatory vacuum and challenges to its legal applicability. Under Article 3, Subparagraph 3 of the "regenerative medicine act," regenerative techniques already exclude "the use of blood preparations." If PRP were characterized as a "cell derivative" and included under the "Regenerative Medicine Products Act," then because autologous PRP has the characteristics of being "autologous, bedside point-of-care, and for single-patient use," it would lack the drug-license requirements of commercialization, standardization, and batch production. Mandating its inspection and registration would clearly contradict the original legislative intent. Furthermore, the centrifugal concentration process for preparing PRP in a sterile laboratory does not involve cell culture or any "cell manipulation" that alters cellular characteristics, and therefore does not meet the conditions for applying for a cell manipulation license (GTP inspection). This results in the development of novel PRP preparation technologies being caught in a regulatory dilemma where it is neither a formulation nor a designated technology. To resolve this regulatory dilemma, this study examines in depth the feasibility of drawing on Japan's "dual-track" regulatory framework for regenerative medicine. In 2014, Japan established a bifurcated management system in which "medical techniques are governed by the “Act on the Safety of Regenerative Medicine” (ASRM), while marketed products are governed by the “Pharmaceuticals and Medical Devices Act” (PMD Act)." In Japan, the provision of autologous PRP therapy by medical institutions is clearly classified as a "regenerative medicine technique" under the ASRM, and is subject to risk-tiered management based on the injection site: the use of processed blood products for intra-articular injection (e.g., for knee osteoarthritis) is classified as Class Ⅱ regenerative medicine (moderate risk), whereas use for extra-articular injection (e.g., in dentistry or dermatology) is classified as ClassⅢregenerative medicine (low risk). Medical institutions must submit a provision plan for review by a certified committee, while the preparation equipment reverts to the medical device regulations of the PMD Act; where the centralized processing of autologous freeze-dried PRP is involved, it must be carried out within a licensed cell processing facility. After synthesizing a comparison of the Taiwanese and Japanese regulations, this study points out that the legislative essence of Taiwan's dual acts on regenerative medicine is highly similar to Japan's dual-track system. Autologous freeze-dried PRP should follow the low-intensity regulatory spirit of Japan's "ASRM" and be clearly positioned within the "medical practice/technique track" rather than the "drug/preparation track." At the policy level, the three core principles established by the competent authority since 2017 should be implemented: therapy must be conducted for therapeutic purposes and supported by scientific evidence; patients must be fully informed and their consent obtained prior to treatment; and only legal equipment approved by the TFDA may be used, in compliance with infection control. At the same time, the study advocates that industry establish standardized preparation procedures and parameter reporting, so as to render the PRP manufacturing process transparent and standardized. This study recommends that the government clarify a technique-track reporting pathway for autologous freeze-dried biological materials, in order to safeguard patients' right of access to medical care, enhance the quality of care, and promote the sustainable development of the regenerative biomedical industry. 2026-01-01T00:00:00Z 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