台灣地區近年來人口結構朝向高齡化發展，對於老年人口所需要之醫療手術產品需求增加，其中醫療器材產品在這類商品中占有重要之地位，在市場持續擴大之下，各醫療器材廠商也因而產生必要之因應策略。本文採用個案研究法，以台灣地區某家製造人工關節墊片的美商跨國企業為對象，描述其台灣分公司所進行之產品導入活動，並探討遇到之行銷問題以及其解決之道，協助重新檢視與擬定行銷策略，使該產品在台灣市場取得持續領先的地位、擴大競爭優勢並增加市場佔有率，同時在過程中進行策略與行銷面探索。本研究深度訪談產品經理H先生及相關人士，了解他在決策方面的考量以及執行過程，並重新檢視H經理所面臨的問題點，整理歸納後發展相關因應對策與結論，做為爾後類似活動或相關人員的參考依據。本研究中的新產品導入行銷活動項目包括：1﹒產業面的資訊掌握與分析。2﹒新舊產品及競爭產品市場概況與比較。3﹒新產品使用需求與市場評估。4﹒擬定本產品導入發展策略、全國行銷策略與執行方案。5﹒制訂全年度推廣計劃及業務量預估。6﹒導入狀況追蹤，市場反應總結與檢討。

醫療器材法律規章與監督管理制度的探討，能夠教育社會大眾遵守法律、保障醫療器材產品品質、維持市場公平競爭、保障人們使用安全和身體健康。進而對於整體醫療器材產業，可以在面對法律問題之前的法律責任、行為規則、違法情形以及類推適用作為憑據和參考。 本研究目的是(1)檢視中國大陸醫療器材法律規章之起源與形成由來。(2)瞭解中國大陸醫療器材監督管理制度的發展情況。(3)探討中國大陸醫療器材監督管理相對人違法責任與違法處罰行為。 本研究主要以「內容分析法」，從中英文參考書籍、學術論文以及相關市場報告、期刊文章等，蒐集具有醫療器材相關的法學理論、法規制度、監督管理等關聯性資料加以歸納整理並進行討論。其次，採用「比較分析法」，將歐盟、日本、中華民國以及美國之醫療器材法規和監督管理制度與中國大陸進行對比分析。本研究以中國大陸醫療器材法律體系、法規制度和監督管理三項研究構面進行觀察，期許呈現符合學術標準的信度與效度之研究結果。 研究結果發現，中國大陸《醫療器械監督管理條例》屬於「行政法規」層級。監督管理的方式主要為「產品上市前審查」與「產品上市後監督」。其中「產品上市前審查」需要遵循：(a)醫療器材檢測管理、(b)醫療器材註冊管理、(c)醫療器材生產管理、(d)醫療器材說明書、標籤和包裝管理與(e)醫療器材經營管理；「產品上市後監督」必須恪守：(f)醫療器材使用管理、(g)醫療器材廣告管理、(h)醫療器材進出口管理、(i)醫療器材不良事件監測管理、(j)醫療器材召回管理、(k)醫療器材監督檢查和(l)醫療器材行政處罰等各項法規與條例。 研究結論歸納，2014年最新修訂的中國大陸《醫療器械監督管理條例》主要是：(1)風險管理分級、(2)審查制度精簡、(3)產品流向追蹤、(4)監管功能強化以及(5)明確法律責任。 / This study aimes to determine the regulations for the supervision and administration of medical devices which is able to educate citizen to complying with the law, ensuring the quality of medical products, maintaining fair competition in the market, protecting the safety and health of people utilization. Furthermore, according to the breadth and complexity of the industry, this proposal can be directed rules as reference in case encountered juridic liability, legal issues or wrongful circumstances before acquired appreciable support from counsellor. The research topics of this article are (1) Examining the draft laws, regulations and rules and policy plots on the governance of medical devices in China. (2) Understanding the development of medical devices regulatory system in China. (3) Exploring the regulatory responsibility of medical devices and penalize illegal behavior in China. Content analysis methodology was conducted for this overview, this writings evaluated regulations of medical devices and administrative institution. Quality system regulations were also investigated by the comparative analysis along with China, European Union, Japan, Taiwan, R.O.C. and the United States. Results reveal that the regulations of medical devices are belong to administrative statute level, the supervision of meical devices is divided to pre-market review and post-market surveillance. Pre-market review contains (a) inspection management, (b) registered management, (c) production management, (d) manuals, labeling and packaging management and (e) advertisement management. Post-market surveillance embodies (f) the application of medical devices management, (g) medical devices advertising management, (h) medical devices import and export management, (i) medical devices monitoring and management of adverse events, (j) medical devices recall management, (k) supervision and inspection of medical dvices together with (l) medical devices regulations and administrative penalties, and other regulations. The findings were summarized as the following statements, the essentials on the latest revised regulations for the supervision and administration of medical devices in China in 2014 are (1) risk based classification, (2) market notification and approval, (3) products sales tracking, (4) supervisory functions strength and (5) distinct legislative liability.

在全民健保實施後，龐大的醫療器材商機，大部分由國外大廠分食，落實醫療器材產製能力本土化來爭取商機，已是刻不容緩。台灣醫療器材小廠在面對規模100倍以上之歐美大廠之強勢競爭下，適者生存之外，要如何脫穎而出。 本研究主要以台灣醫療器材小廠，聯合骨科器材公司為例，分析影響經營決策因素，進而探討聯合骨科之經營決策方向；以及分析影響融資決策因素，進而探討聯合骨科之融資規劃方向。 經本研究分析，該公司競爭策略，在產品及市場擴張策略方面，應採提高公司OEM外銷比重；在差異化及品牌策略，應採彈性配合客戶需求，提供差異化之產品服務以及採高品質中低價位策略外銷。 該公司融資規劃，在萌芽草創階段，公司仍未獲利，融資策略應以長期負債及自有權益資本為主。當公司進入成長階段時，則應發揮財務槓桿，在資產報酬率足以支付舉債的資金成本條件下，舉債程度愈高，股東權益報酬率則愈大。

關鍵字：醫療器材公司、經營策略、關鍵成功因素 論文摘要 在台灣實施全民健康保險制度以及加入WTO後，各種內外在環境的改變，促使公司的經營型態也隨之改變，在醫療器材產業競爭日趨激烈的環境下，醫療器材公司應該採取何種經營策略，才能使其在競爭激烈的環境中保有競爭優勢，是本研究主要的研究目的。 本研究的架構係採用Aaker的理論架構來進行內外在分析與策略規劃。整個研究架構分為四個階段：一、首先進行內外在分析，以界定外在環境中的機會與威脅，以及該產業的關鍵成功因素，並了解個案公司所擁有的優劣勢。二、根據以上分析，歸納出該公司所面臨的問題。三、提出可行的策略，在該策略下擬定競爭策略與營運策略。 經過本研究分析後發現國內醫療器材業的關鍵成功因素為：先進醫療器材的引入、良好的產品品質水準、行銷服務系的建立、充裕的資金、銷售人良的專業能力以及配合政府的政策。 從內外在環境分析及條件前提來看，本研究建議個案公司最適合採取成長策略，才能發揮個案公司的核心能力，尤其是應該在短期對國內市場採行產品擴張策略，在長期對國外市場採取地理擴張策略，以及適度地從事向前整合的多角化。產品擴張策略包括引進先進的醫療器材產品，以及服務的差異化；地理擴張策略主要為努力爭取國際大廠在中國大陸的產品獨家代理權；向前整合的多角化則是配合政府生物科技產業計晝，與原廠合作生產具有潛力的醫療器材產品。

中小企業轉型─以台灣醫療器材廠商為例 / The focus of this study is to discuss business transformation strategies that have been implemented by the case company, a 30-year-old small enterprise in medical market in Taiwan. The case company has been facing strong pressure from the competitive market and this study investigates the environmental causes and drivers that lead to the case company’s business transformation decisions. A case study format was used in this research and environmental factors were first introduced to readers to understand the unique background of medical market in Taiwan then what stimulated the case company’s management to make strategic decisions. In order to sustain in the market, the case company had to diversify its product lines in order to share the potential risk of distribution lost and to meet the increasing demands in the elderly related care market. SWOT analysis is used in this paper to exam the case company’s internal and external environments and help to set up strategy plans. Strategy map was used as a guideline to evaluate its transformation processes and suggestions were made for further discussion.

隨著世界經濟的發展與人民所得的提升，人們越來越關注於自己的健康，對於個人健康資訊的掌握，也漸趨積極主動。既然民眾開始將健康相關知識需求擴大至非醫療專業領域的健康資訊與服務上，這樣的轉變儼然將帶來一些嶄新的機會和挑戰。 任何網路系統的重心都是建立在人與人之間的通訊之上，而虛擬社群就在這樣的基礎之下因應而生。「虛擬社群是一個運用網際網路全球性、時間縮減等特性，讓具有相同特性卻由於時空的區隔無法聚集在一起的一群人可以聚集在一起。這群人聚集在一起的時候，對彼此共同特性所衍伸出來的需求、資源、出版內容產生了影響力，進而帶來豐厚的利益。」 經濟的提升與人口老化帶來醫療器材產業與健康照護服務日益龐大的市場，其中個人醫療器材產業是本研究所探討的重點，這個產業具有「法規管理嚴格」、「產品整合各產業技術」、「研發能力為競爭核心」、「產品具高利潤高附加價值」、「公司品牌信譽相對重要」等特性。 社群網路的發展越來越蓬勃，人們對醫療保健的需求也越來越龐大。健康社群是一個商機無限的市場，也帶來許多的改變和問題。本研究針對線上社群、線上健康社群進行深入探討，歸納出三種健康社群的營運方式和四種獲利模式。最後以「資訊不對稱的消失」、「資訊透明化與數位名聲」、「回歸消費者導向」、「統計資訊的運用」四個面向來探討線上健康社群所帶來的影響、機會、因應方式。並對優盛公司四大產品面做出發展建議。

產業聚落為國際科技發展潮流，在高科技產業發展中，產業聚落的發展將會對國家競爭力產生影響，因此產業園區的發展不僅要充分規劃建設良好的硬體基礎建設與軟體的協調使用，更重要是要對本身的發展目標有明確的意識與定位。 近年來由於人類生活素質逐漸提升，及球人口結構逐漸偏向老年化，健康管理與照護的需求與日俱增，再加上高齡化與健康照護相關議題的發燒，使得全球生技醫療器材產業成為炙手可熱的明星產業，也被視為我國政府積極推動的產業之一。而醫療器材產業為我國生技產業總營業額中所占比例最高者，本研究透過南部生技醫療器材產業聚落發展計畫為例，探討政府推動產業聚落發展之成效評估，及發展此計畫之延續型計畫之必要性。 本研究透過文獻探討及深度訪談方式，研究參與南部生技醫療器材產業聚落發展計畫中不同利害關係人觀點對於此計畫之成效評估。本研究以五項評估標準發展出十三項評估項目，透過訪談計畫制定者、計畫執行者及計畫參與者方式，探討以其觀點對於參與此計畫之想法及建議。研究發現本計畫執行至今，在基礎建設完整性、產學研合作方式及程度、技術轉移及產品上市過程順暢度、資訊交流滿意度、服務品質及效率、參與計畫滿意度、建立地區形象、創造國內外投資及創造競合的環境等項目，在各利害關係人間中取得正面共識，且認同彼此的目標及作法，成功達到本計畫執行之目的。但仍有人才培育計畫、下游產業鏈完整性、經費補助合宜性及提供有彈性的勞動力市場項目，尚未於本研究之利害關係人間取得正面共識，但此些項目本非一蹴可幾，需靠經驗累積及長期經營。另外，主要績效指標中有二項為計畫完成後三年之目標，包含創造就業人數及創造年產值項目，目前執行狀況與目標相差較大，但因目前投入廠商多處於草創階段，無論是用人或投資皆未達高峰，以致年產值相對未達高峰，後續將會陸續增加。 因此本研究評估，本計畫執行至今成效良好，若計畫可延續，未來再於產業聚落內做必要的投資，將可延伸本計畫所建立之基礎，使產業聚落更趨完善，精益求精。

繼石化紡織之後，電子資訊產業成為台灣經濟發展上再度提供了二十多年的高度成長時期，也替台灣傳統產業提供結合了更多科技技術於傳統產業，為產業加以升級，替傳統產業提升企業競爭力。如今電子資訊產業已進入成熟期，台灣經濟若要再有持續的成長動力，必須再尋求其他合適台灣發展的產業。 全球醫療器材市場規模在2005年達新台幣52,800億元。若以6% 年成長率估計，2008年市場規模將會成長至新台幣62,080億元，相當吸引台灣企業投資發展。台灣企業自1990年開始發展紅外線體溫計、血壓檢測器等醫療器材產品。1998年台灣企業再度大膽投入研發血糖檢測器、隱形眼鏡、及醫療用導管，目前均有相當的表現成果。 注射器市場規模約新台幣1,800億元，其產業單純的特性相當吸引台灣企業考慮投資發展。約於2000年陳文龍先生獲得第一代自毀式安全注射器的產品專利，於2000年初期正當台灣資本市場有充沛資金，藉助於陳文龍先生的專利成立了數家安全注射針筒的新公司，各家各自投入大部分的資金於購買專利，以及投入專利改良、主要國家專利申請、量產能力的建立、通路開發上。緊接著資金吃緊使得募資更加困難，正考驗經理人的智慧如何去突破此一困境。 重複使用與針刺傳染的醫療器具，造成更大的社會成本，美國政府為了解決每年高額的社會成本，於2000年11月06日由柯林頓總統簽署『安全注射針筒』法案，並訂定2004年後開始全面強制實施，規定全部醫療院所必須提供『安全注射針筒』來保護醫療相關從業人員。法令的強制要求將有希望加速安全注射針筒的發展。 本研究主要採用文獻探討以及個案訪談作為主要的研究方法，先藉由產業與產品的市場分析建立初步的認識，再藉由文獻探討建立起論文整體之架構以及相關理論之說明定義所需探討之研究變項，之後再以注射器的公司現況比較，產銷供應鏈建立發展機會來加以說明。說明所觀察現象的具體意義，以及背後的思考邏輯。而可得到以下初步之研究結論： 量產產品在世代交替過程中之產業特性、醫療器材之進入障礙高、新舊產品世代交替過程中的新產品與新興公司的機會、台灣企業發展空間與價值主張等四部份。根據以上特性獲得研究結論: 『安全注射針筒』非常適合台灣公司發展。 / Following the petrochemical industry and the textile industry, the electronics and information industry has become the major economic development in Taiwan for more than 20 years of high growth period and has advanced competitiveness of the Taiwan traditional industry by applying technologies to the industry. However, the electronics and information industry has entered a period of maturity. It is necessary to seek other potential industries in order to continue Taiwan's economic growth which is the sustained impetus to the Taiwan industrial development. The global market size of the medical equipments industry amounted to 52,800 hundred million New Taiwan dollars (NTD) in 2005, and if estimated by the 6% annual growth rate, the market size in 2008 will grow to 62,080 hundred million NTD, thus this industry certainly attracts Taiwan enterprises. In truth, since 1990, Taiwan enterprises have began to develop high-tech medical equipment products such as infrared thermometers and blood pressure detectors. As 1998 Taiwan enterprises started to invest research and development (R&D) in blood sugar detectors, contact lens, and catheters, currently such R&D have showed significant achievements. Among medical equipments, the market size of syringes is approximately 1,800 hundred million NTD, and the nature of its industrial characteristic really attracts Taiwan enterprises. About year 2000, Chen, Wen-Long obtained the first generation of self-destructed safety syringes patents. In the meantime, Taiwan capital market had abundant funds to establish several new ventures with the aid of Chen’s patents. Also, each company invested the majority of funds to purchase patents, proceed patents improvements, apply patents in major countries, establish mass production capacity, and develop channels. Shortly afterward, the difficult situation of financial problems and raising funds arose, and it has tested manager's wisdom to break through this difficult situation since then. The repetitive use and the acupuncture infection of medical equipments result in the greater social cost. In order to solve such high annual social cost, President Clinton signed “Needlestick Safety and Prevent Act” in November 6, 2000, began in 2004 to start comprehensive enforcement, and stipulated all medical institutes to provide safety syringes to protect medical practitioners. This Act has accelerated the development of safety syringes. This study takes literature review and case interviews as the major research methods. First, the market analysis of this industry and products provides preliminary understanding. Second, literature review establishes the overall framework of this study and relevant definitions of theories and research variables. Then, this study compares the present situation of syringes companies and explains opportunities of establishing production supply chain. After demonstrating the above, this study illustrates meanings and logic behind them. Finally, the preliminary conclusions of this study include four parts: The replacing industrial characteristic in mass production of industrial products, high barriers to entry the medical equipments industry, the opportunities of new products and new ventures in this generation of replacing old products with new products, and the development opportunity and value of Taiwan enterprises. After all, the major conclusion of this study is that “safety syringes” is a great business opportunity for Taiwan enterprises.

因為人口老化，生醫材料的快速發展，使得低侵入性醫療器材產業成長快速，而個案公司因為擁有突破性的產品，因此在這幾年業務成長的速度相當快，組織也在這幾年快速的擴充。在組織擴充的同時，個案公司發現人力資源的制度及人才的缺乏，因此引入職能發展及招募的概念，並同時招募人力資源的人才，而在推行職能工具的同時，因為業務主管多年來都以非結構性的面談及應徵者的基本資料，進行甄選，也招募到某些傑出的業務人員，使得整體的銷售達成率，都一直是兩位數的成長，因此當人力資源主管以人力資源的理論，提供業務主管一套更好的甄選方式時，卻發現人力資源主管與業務主管，對於甄選條件有完全不同的看法。 本研究從文獻資料中，瞭解職能的意義，並且透過不同產業間，職能的比較，及個案公司業務的流程，以理論的方式輔以實際業務主管對於優秀業務人員職能的觀察，分析個案公司職能模型的適用性。另外，本研究也利用個案公司常用的甄選條件，包含業務人員的基本資料，及2005年的績效評分，領導職能及銷售能力職能的評分結果，與表示績效的三個效標進行統計分析，以瞭解個案公司職能模型的效標效度。最後與所有的業務主管訪談，瞭解業務主管對於職能的認知，及列出具有鑑別力的職能項目，以整體分析個案公司職能模型的方式，舉出科學性的證據，支持人力資源主管推行職能工具，並替個案公司找到更好的甄選條件。 本研究的科學分析結果，並無法解決人力資源主管的問題，因此本研究利用推論的方式，對於實務上的困境提出解決的方式，建議人力資源主管應該先與業務主管進行溝通，建立在業務主管前的信賴度，並且暸解業務主管所採用的甄選條件，並以這些甄選條件及職能的內容與業務主管進行討論，找到適合個案公司的甄選條件及職能面試方式。 / Recent years have witnessed significant growth in the market for less-invasive medical products due to increases in the average age of the population and the rapid development of the biomaterials industry. The company that served as the research-site for the present study also enjoyed a high growth rate and organizational expansion thanks to its ability to produce cutting-edge products that were well-aligned to these market trends. Recognizing the need to improve its existing human resource pool and hire new talent during this period of rapid organizational expansion, the company introduced new forms of competency-based internal development and recruitment. However, since the company’s sales managers had relied upon non-structured interviews and reviews of applicants' basic information as recruitment criteria in the past, they felt that the previously-used methods of recruitment had proven effective by their prior outstanding sales performance levels. Accordingly, the HR manager’s attempts to promulgate competency-based recruitment techniques were met with resistance by the company’s existing sales managers. The present study reviews the literature on the competency model by defining it, discussing its overall validity, and comparing competency models that have emerged in various industries. Moreover, it sketches the case company’s business model and offers observations of its outstanding salespersons. Next, the case company’s recruitment criteria, sales-staff information and performance records, leadership competency, and function competency data for the year of 2005 are analyzed according to three sales performance indicators to confirm the criteria validity of its competency model. All of the firm’s sales managers took part in our interviews to test their levels of understanding of competency, as well as to identify distinguished competency items. In short, the purpose of the study was to support the establishment and promotion of more effective HR manager promoting competency concepts and recruitment criteria. The scientific results of the study were unable to solve directly the problems encountered by the HR manager in his attempts to employ competency-based hiring procedures. The study attempted to solve the ensuing differences between the sales managers and the HR manager via theoretical implications and suggestions that the HR manager communicate with the sales managers to augment their mutual trust and understand fully the recruitment criteria employed by the sales managers. In this way, it was shown that increased communication and understanding between the HR manager and the sales managers would lead to better overall recruitment criteria for the case company.

隨著全球醫療器材產業以及藥物傳輸系統技術的蓬勃發展，產品需求預測提升。為了滿足客戶訂單與配合客戶設計製造之需求，企業規模不斷地成長，卻也帶來一連串的挑戰，客戶的要求越來越嚴苛，產品趨向少量多樣，產品上市時程縮短，時間與效率逐漸成為企業保持競爭力的關鍵。 精實六標準差結合精實生產與六標準差的優點，具有減少浪費、加速流程、降低流程變異的功能，廣泛應用於製造業，是一套熱門的管理方法。本研究便以導入精實六標準差於個案S公司，運用DMAIC的手法配合精實生產的精神，探討現有流程可能存在的缺失。改善的焦點在首件前置作業流程，目的是要提升首件成功率進而改善生產績效。研究中發現工程師為首件前置作業的關鍵影響因素，是改善的主要標的；經過改善團隊重新規劃流程，利用標準化的作業程序，並提出一套在職訓練與資格認證的方案執行之後，一次首件成功率從75.10%提昇至86.15%，改善11.5%，平均首件花費時間減少2.32小時，改善率59.79%，結果顯示運用精實六標準差提升生產績效具有顯著之成效。 / The rapid growth of global medical device industry and technology of drug delivery system accompany with the increment of demand forecast. In order to fulfill the customer orders and requirements, the scale of the enterprise keeps growing and brings a serious of challenges: the higher level of customer requirements, the growing trend of small- volume- large- variety production, shortened time-to–market schedule. Time and efficiency have gradually become essential for the enterprise to retain competitive. Lean Six Sigma combines the advantages of lean production and six sigma, it can reduce the waste and speed up the process as well as decrease the process variation through statistical approach, which is a popular management methodology and widely applied in manufacturing industry. The purpose of this study is to introduce Lean Six Sigma (LSS) to S company, trying to find the potential failure in current process via DMAIC steps and lean thinking. The improvement is focus on operation before first article pass, project goal is to increase first article pass rate. We find the engineer is key input variable during the process. After reorganized the process flow and implemented new On-Job Training (OJT) and qualification programs, the study result shown that first article pass rate has increased from 75.10% to 86.15%, the improve rate is 11.5%; the average waste time of first article has reduced 2.32 hours, the improvement rate is 59.79%. We can conclude that there is a significant improvement on production performance by applying Lean Six Sigma