2020-07-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/661175摘要：本案以成為世界級之醫材公司為目標。本實驗室研究倍頻顯微術長達二十餘年，獲得國際萊卡獎肯定。本產品致力於解決病理切片市場耗時耗力之檢驗過程，可望將現今為期一週之病理切片流程，縮減至數小時之內即可完成。大幅減少檢驗人員人力需求及病患等待的困擾。此外傳統病理切片在特定條件中(例：病灶在臉部、同時有多處病灶、糖尿病患者、非癌症病灶)不適合進行切片，而倍頻顯微術之非侵入式特性，並根據單一病灶提供”病灶化”的醫療資訊，更加實現精準醫療。 以美國為例，目前全美僅有約4萬人受過訓練之病理科醫師及檢驗人員，但每年有超過1,800萬件取樣報告需完成，導致等候時間拉長。而美國健康保險於病理切片之花費2019年已超過12億美元，每年仍以3~5%持續成長。 將光學應用於病理切片(以下稱作虛擬切片)為近五年出現之新興市場，市場上無單一龍頭廠商壟斷市場，主要競爭技術OCT及RCM技術皆無法提供病理等級之關鍵資訊。本案之倍頻顯微術經台大醫院臨床實驗證實，能夠提供與病理切片同等級之影像資訊，讓醫生更快速、精準進行判讀。 本計畫籌組團隊，結合產學界之精英，透過跨領域專業知識及人脈資源，結合價創計畫之協助，預計於此前期案中完成醫研用原型機，並結合未來正式案完成之臨床用原型機，讓產品更輕易進入市場。 <br> Abstract: In this proposal, we aim to create a world-class medical device company. Prof. Sun’s research group has been developing harmonic generation microscopy (HGM) for more than 20 years and won tremendous amount of international recognition including the Leica Innovation Award. HGM, the product, is dedicated to solve the time consuming and labor-intensive inspection process issue of the pathological biopsy market. It has been clinically proved that the current one-week pathological biopsy process will be reduced to within half an hour, thus significantly reducing the labor requirements of inspectors and the waiting time of patient. In addition, traditional pathological biopsy is less desirable for skin lesions under certain conditions, for example, non-cancer lesions, the lesions on the face, multiple lesions at the same time, and diabetic patients. In contrast, the non-invasive HGM provides "lesionized" medical information according to the histopathological information of each single lesion, thus achieving unprecedented precision medical decisions. Taking the United States as an example, there are currently around 40,000 trained pathologists and technicians in the United States, only capable of completing 18 million histopathology reports each year. A more effective technology will assist the dermatologists and pathologists for the current limiting situation. The cost of U.S. health insurance for pathological biopsy had exceeded US $ 1.2 billion in 2019, and it continues to grow by 3 to 5% every year. The application of optics to pathological biopsy (referred to as virtual biopsy in the following) is an emerging market that has appeared in the past five years. There is no single leading company monopolizing the market, and the main competing technologies, OCT and RCM, cannot provide critical information for dermatologists’ decision, for example, the pathological grades. The harmonic generation microscopy in this case has been confirmed by clinical trials at National Taiwan University Hospital as the only noninvasive solution to provide the same level of histopathological information as physical biopsy, allowing doctors to diagnose on site noninvasively and accurately. In this short 6-month proposal, our team combines the elites of in the fields of Industry-University, and we aim to finish our design and construction of a medical research prototype, as the first step toward a spin-off company out of National Taiwan University.醫材公司虛擬病理切片倍頻顯微數商化原型機Medical devicevirtual biopsyharmonic generation microscopycommercializationprototype