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Yang Ming Jiaotong University is the first to obtain a medical device manufacturer and vendor license


"With the support of President Chih-Hung Lin, the Center for Innovative Medical Material Translation and Research (CIMR) has compiled and applied for two licenses for medical device vendors and manufacturers (medical software and implants) in August and September of this year respectively, which will give new impetus to the commercialization of medical devices.

According to the new system of the Medical Device Control Act, research institutions can apply for design-based medical device manufacturing and sales licenses with the consent of the competent authorities. This measure will greatly help to improve the quality, value, and technology of medical devices developed by research institutions, as well as to maximize the economic benefits of the National Science Council's grant program. Therefore, the University actively applied for the new system as soon as it was launched, and was successfully granted the two permits.

Professor Lin Junli, Director of the Center for Innovative Medical Material Translation and Research, said that the successful development of medical devices is not simply the application of engineering technology to biomedicine, but must meet the premise of "clinical needs", integration of regulatory testing / preclinical testing (or clinical testing), the establishment of industrial QMS and other stages of work, before further testing and registration for certification, and then can enter the "clinical implementation" The next step is to enter into "clinical implementation" and other applications. Therefore, the role of the Center for Innovative Medical Material Translation and Research (CIMR) in our university is to "promote the linkage of biomedical engineering," "integrate health and medical resources," "develop medical material industry clusters," and "promote innovative research and development axes" as the main axes, and to fully develop Med-Tech as the goal, injecting huge research and development translation energy for the development of medical devices in Taiwan.


The "Center for Innovative Medical Material Translation and Research" team is composed of five main research and development areas: precision medical implants, high-value biomedical materials, precision diagnostics and smart assistive devices, precision medical imaging and biomedical sensing care.
The acquisition of medical device vendor and manufacturer licenses not only helps the university's R&D team shorten the time to market for medical materials, but also strengthens the development of smart medical materials after the university's merger. Take medical software development as an example, after the pre-clinical testing and validation of the software, the QMS system can be certified; after passing the TFDA inspection by the Ministry of Health and Welfare, the manufacturing and inspection can be registered.

By obtaining the medical device manufacturer's license and sales license (certification numbers MD6101000739 and MD6201041374), the university will soon apply for medical device quality management system (QMS) certification by the Center for Innovative Medical Material Translation and Research and the university's medical software R&D team. The Center will apply for medical software registration with the TFDA of the Ministry of Health and Welfare.

In addition, the Center for Innovative Medical Material Translation and Research has obtained a medical device manufacturing and sales license, and has applied with the College of Biomedical Sciences and Engineering for the Ministry of Labor's Quality Management System Training Institute for Human Resource Development certification. In the future, our school will be able to undertake the certification course for medical material technician training of TFDA, in order to enhance the professional skills of practitioners and contribute to the development of medical material industry in Taiwan.



Medical device vendors (from left to right), manufacturer's licenses, and the Ministry of Labor's Human Resources Development and Quality Management System Training Institute Certification

(Chinese Health Network Reporter Man-Ying Huang / Taipei © Provided by Chinese Health Network)

It's amazing! The palm-sized Nephila pilipes spider is intimidating, but the spider's silk can be used to measure blood sugar and serve as a diabetes management tool. Prof. Cheng-Yang Liu and Ms. Xuan-Bei E of the Department of Biomedical Engineering, Yang Ming Jiaotong University, have successfully developed a fiber optic glucose sensor using the spider's spider silk.

Amazing! A spider with a human face spits out spider silk, but it can detect blood sugar! A new breakthrough in measuring blood glucose with fiber optics © by Chinese Health Network

With the aging population, diabetes is now a common disease. Patients who monitor their blood glucose by puncture at home are not only prone to the risk of infection, but also the puncture needle becomes medical waste after one use, so scientists are always striving to develop more convenient and real-time blood glucose detection methods.

Unlike traditional optical fibers made of glass or plastic, spider silk not only has good ductility and physical properties such as light wave transmission, but also has a high degree of biocompatibility, making it very suitable for use in the human body. After obtaining natural spider silk from a live spider, Prof. Cheng-Yang Liu's research team, in collaboration with Taipei Medical University and Taiwan Instrument Technology Research Center of National Taiwan Research Institute, first stabilized the spider silk structure with light-curing resin, and then sputtered a thin nanogold shell on the surface of the cured spider silk with an oblique thin-film sputtering technique to increase the sensitivity of the spider silk fiber to sugar concentration. The final product is a fiber optic sensor with a diameter of about a hair and visible to the naked eye.

The process of spider fiber fabrication. (Photo courtesy of Yang Ming Jiaotong University) © Courtesy of Chinese Health Network

Through the optical physics principle of surface plasmon resonance (SPR), scientists can calculate the refractive index of different sugars on metals to know their concentration changes. The optical sensor developed by Prof. Cheng-Yang Liu has been experimentally proven to maintain the same sensitivity over a year and to function normally at room temperature and human body temperature.
The research team led by Prof. Cheng-Yang Liu uses spider fiber to measure blood glucose, which can be a tool for future diabetes management. (Photo courtesy of Yang Ming Jiaotong University) © Courtesy of Chinese Health Network
In fact, in order to find suitable materials, the R&D team tried two to three different species of spiders and also caught spiders on campus for experiments, but unfortunately, the quality of spider silk was not very stable, and only after many attempts did they choose the sphinx spider as the main target. In order to get high quality spider silk, the R&D team must also learn how to keep spiders and design silk extraction methods.

The spiders were not only huge, but they were also afraid of spiders with long faces on their backs at first. In the process of making the spider silk fiber, the research team also tried a variety of resins, gold, silver, copper and other metals, so they met the bosses of reptile stores, resin manufacturers, etc., which is considered an unexpected harvest.

Prof. Cheng-Yang Liu said that diabetic patients need to monitor their blood sugar before and after meals, and a sensor that can be used in the human body for a long time and measure blood sugar accurately in real time will not only solve the patients' problems, but also achieve the goal of precision medicine and benefit more chronic disease patients.

In addition to Yang Ming Jiaotong University, the research results also include the participation of researcher Weijun Chen, researcher Zheqin Chen, and professor Jiaxiong Cheng from the Department of Medicine, National Taiwan Research Institute. The research results will be published in the September issue of Biomedical Optics Express and selected as an Editor's Choice for the publication.

Raman spectroscopy uses the scattered wavelength of light incident on an object to measure the material (the material in the picture is molybdenum disulfide)
The natural residual concentration of mercury in cosmetics in China is 1 ppm, but the Institute of Biomedical Photonics, Yang Ming Jiaotong University has successfully used magneto-plasmonic nanoparticles in combination with laser light, and surface-enhanced Raman scattering (SERS) to reach the measurement limit of 2 ppb. SERS) to reach the measurement limit of 2 parts per billion (0.2 ppb). This technique has the potential to bring a more convenient approach to heavy metal detection.

The Food and Drug Administration prohibits the addition of heavy metal mercury to cosmetic products except for natural residues, but because mercury inhibits the activity of tyrosinase in the skin and reduces melanin production, there are still unscrupulous operators who add mercury to them. Therefore, the heavy metal content of cosmetic whitening products has been the focus of inspection. However, most of these heavy metal tests can only be done in laboratories using huge instruments such as mass spectrometers.

The principle of Raman Spectroscopy, where the wavelength of light scattered into an object differs from the original wavelength, depending on the material of the object, has been considered to have potential for material analysis. However, the scattered signal is small and often disturbed by the light emitted from the object itself after illumination, making the signal difficult to resolve.



Prof. Xue Te, Institute of Biomedical Photonics, Yang Ming Jiaotong University
To overcome this problem and make the theory applicable in practice, a common method is to cover the sample with a metallic substrate, i.e., a Surface-Enhanced Raman Scattering Substrate. Prof. Surojit Chattopadhyay, M.S., M.S., and Dr. Akash Gupta of Institute of Biomedical Photonics, Yang Ming Jiaotong University (YJTU), fabricated iron oxide nanoparticles and coated them with a layer of metallic silver, and used a magnet to make the iron oxide nanoparticles aggregate.

This technique of using laser light to combine nanoparticles to enhance Raman spectroscopy through surface enhancement has been used to measure the natural residue of mercury in commercially available whitening cosmetics, and it can detect the limit of mercury ion concentration up to 2 ppb (0.2 ppb), which is much lower than the current requirement of 1 ppm in Taiwan. This shows that this technology is not only more sensitive in detection but also has the potential to be applied to detection.



500 nanometers of magnetic plasma nanoparticles
Professor Sitt said that if cosmetics contain heavy metals, they may be poisoned by long-term trace absorption through the skin. Although today's heavy metal detection methods are accurate, they require a large number of samples and professional technicians to operate in the laboratory. The process of using Raman spectroscopy to detect substances is simple and fast, as long as the light can be irradiated substances can be detected, including solids, liquids, gases, etc..

Many scientists have invested in the development of nanosubstrates for surface-enhanced Raman scattering in the hope that this theory can be put into industrial applications. This time, Yang Ming Jiaotong University has successfully found a nanoparticle that can amplify Raman signals and be used for detecting cosmetics by wrapping iron oxide with a silver coating; how to steadily regulate the structure of metal nanoparticles and create a reusable substrate is a challenge for future commercialization. This study was published in 2021 in Sensors and Actuators B: Chemical, No. 337, an important journal for photoelectric sensing technology.


Source: Laser light + metal nanoparticles push the limit of mercury detection to 0.2 ppb at Yang Ming Jiaotong University - NYCU National Yang Ming Jiaotong University

The Department of Biomedical Engineering at Yang Ming Jiaotong University, Professor Zhong Jiwen said that silk protein has a proven track record as a biomaterial because of its high biocompatibility, and he has also used the same material to make heart muscle patches that repair heart muscle cells.
In Taiwan, more than 40,000 people are equipped with pacemakers, and now scientists have discovered a biomaterial made from silk that can convert heart muscle cells that would otherwise not discharge electricity into heart rhythm cells that can beat themselves, allowing the heart to resume beating. This major discovery has changed the way people think about the treatment of arrhythmias and has led to a study from Taiwan that was featured in the top international journal Nature Biomedical Engineering.

The heartbeat of about 60-100 beats per minute comes from the discharge of the sinoatrial node of the pacemaker, a spontaneous electric current that allows the heart's muscles to contract and pump blood throughout the body. However, as we age, the organ always wears out over time. Because of the aging failure of the pacemaker rhythm cells, a slow heartbeat may occur, such as sinus syndrome and atrioventricular conduction block, resulting in weakness, difficulty breathing, fainting, and even sudden death, with a prevalence of about 1% to 2%. The prevalence rate is about 1% to 2%. This figure may be higher in elderly people over 65 years old.

The current treatment for this heart-borne disease is a two-hour surgery to install a pacemaker in the body. However, the pacemaker requires battery replacement in about 6 to 8 years, invasive surgery also has the risk of surgical infection, and even in the era of the prevalence of cell phones, such installation of electronic pacemaker patients must also be as far away from the heart as possible, so scientists invariably hope to find alternative methods.

The research team, led by Professor Zhong Jiwen of the Department of Biomedical Engineering at Yang Ming Jiaotong University and Dr. Yu-Feng Hu of the Department of Cardiology at the Taipei General Hospital, successfully used silk from a modified farm in Miaoli, Taiwan, to purify silk protein gel, which was injected into the hearts of mice to convert heart muscle cells that would otherwise not beat into pacemaker rhythm cells that could discharge electricity. This is the first time that silk proteins have been used as surgical sutures and artificial dressings, but this is the first time that silk proteins have been found to have mechanical and biochemical properties, as well as cellular transformation and bioelectricity production.

In animal studies, the research team found that silk proteins can be used as biomaterials to initiate the ectopic expression of calcium mucin in cardiac muscle cells, initiating a series of downstream mechanisms that allow the heart to be recharged and restored. In other words, the research team has re-generated the cells that discharge electricity from the heart. In this way, once the sinus node ages or becomes diseased, the newly generated cells can take over the important role of discharging electricity to keep the heart beating.



Dr. Yu-Feng Hu and Prof. Ji-Wen Chung of the Department of Cardiology at Northwestern University have discovered that biomaterials made from silk proteins can convert cardiac muscle cells that would otherwise not discharge electricity into self-beating heart rhythm cells, allowing the heart to resume beating.
The company's main goal is to provide the best possible service to its customers.

The research team tried dozens of biomaterials and finally found a way to use silk protein, said Professor Zhong Jiwen of the Department of Biomedical Engineering at Yang Ming Jiaotong University. He said that silk protein is highly biocompatible as a biomaterial, in fact, there are signs, including artificial skin, surgical sutures, wound dressings can be found in its trace. He has also used the same material to make myocardial patches to repair heart muscle cells, showing that domestic silk has the potential for advanced medical applications.

Dr. Yu-Feng Hu and Professor Chung met at a conference four years ago, sparking this collaboration. Dr. Yu-Feng Hu describes how he found that the heart muscle cells "came to life" and kept beating when he incubated them on Chung's silk proteins, and began the research to find out why.

The study was published in Nature Biomedical Engineering, a division of Nature, and proved that in addition to stem cell culture and gene therapy, biomaterials also have the potential to treat heart-borne diseases.

Source: Silkworm protein restores a heart that has stopped beating, and a team at NYCU successfully uses biomaterials to convert heart muscle cells into rhythm cells - NYCU

Deputy Director of Social and Family Affairs Department, Ministry of Health and Welfare, Mei-Mei Chang (left) presents a certificate of appreciation to Director Li Shu-Ching
This year also marks the 20th anniversary of the ICF and Assistive Technology Research Center, a university-level research center of National Yang Ming University of Transportation, helping to promote assistive device services for people with physical and mental disabilities, and the establishment of the Multifunctional Assistive Device Resource Integration and Promotion Center commissioned by the central government. At the National Liaison Meeting on Nov. 26, the Deputy Director of the Social and Family Affairs Department of the Ministry of Health and Welfare, Mei-Mei Chang, presented a certificate of appreciation to the team led by the Director of ICF, Shu-Ching Li, for their contribution to the development of assistive technology services in China over the past 20 years.

In her acceptance speech, Ms. Lee talked about the 20 years of her life spent in running the Center and building the national assistive device service system, and cited the following five major achievements of the Center in the past 20 years.

First of all, the center introduced the core concept of the international assistive devices classification standard - ISO 9999 at the early stage of the development of the assistive devices service system in China. It is the first achievement of the Center to shape the development of assistive services in China from a broad perspective.

Furthermore, since 2005, the team of the Center has been commissioned to build the "Aids Resource Portal" in Taiwan, which integrates all the information on aids in the fields of industry, government, academia, research, and medicine, and is a valuable and leading platform of aids information in the world. This is the second major achievement of the Center.



The Social Welfare Administration of the Ministry of Health and Welfare thanks the ICF and Assistive Technology Research Center of Yang Ming Jiaotong University for its 20 years of assistance in promoting the development of assistive technology services.
In addition, with the joint efforts of all of us, the new system of ICF for the protection of the rights of the physically and mentally disabled was launched in 2012, making "assistive devices services" a statutory service for the physically and mentally disabled in China. As a WHO observer in 2019, Director Li was pleased that our country has a state-of-the-art system of assistive devices that is proud of the world. Helping to plan and promote a new system of assistive services based on professional understanding and meeting needs is the third major achievement of the Center.

The key to the success of the auxiliary service is not only the training of human resources and the professional quality management of the auxiliary service centers, but also the experience of our country over the years shows that strengthening the support function of county and municipal governments through evaluation indicators and guiding the integration of services between county and municipal governments and auxiliary service centers, instead of focusing only on the auxiliary service centers, is a pragmatic and highly effective approach, which is also a model worthy of international promotion. The fourth major achievement of the Center is to establish evaluation indicators that effectively promote the success of the auxiliary aid services in Taiwan.

Lastly, the ICF and Assistive Technology Research Center of National Yang Ming University of Transportation has been hosting the Assistive Devices and Long-term Care Exhibition since 2016, which is an international professional exhibition with more than 100,000 visitors for three consecutive years. Among the many functions of this exhibition, it provides a positive learning platform for assistive technology professionals to learn about the latest international assistive technology development, and through a more comprehensive understanding of the products and manufacturers, it will be conducive to the improvement of professional services. The fifth major achievement of the center is to successfully link the three elements of assistive technology development: professionals, industry and products.



2021 Aids and Long-term Care Exhibition
Director Lee said that there are still many goals to be developed in the future, which need to be improved step by step in a competitive manner.

First of all, 2022 will be a new era for our country's auxiliary aids services, including the draft amendment of the benchmark table of auxiliary aids for the physically and mentally disabled, which has been notified through the efforts of the Social Welfare Department and is scheduled to be officially implemented on September 1 next year. It is expected that the new system of auxiliary aids will be implemented smoothly next year, including the continued support of county and municipal governments and the smooth transformation of auxiliary aids centers, so as to successfully move to the next stage.

In addition, for the successful implementation of the new system of aids for the mentally and physically disabled and Long Term Care 2.0, the participation of inter-ministerial units is very important, including the effective performance of the functional roles of each ministry and the positive interaction and cooperation between ministries.

Finally, the current situation shows that the volume of long-term care assessment services in most county and city auxiliary care centers has increased significantly, which indicates the inevitable trend of further integration of mental and physical disabilities and long-term care services in the social welfare system, including the integration of auxiliary care center audits by the central authorities.

Under the leadership of Director Li, the Multifunctional Assistive Devices Resource Integration and Promotion Center has assisted the Ministry of Health and Welfare in the vertical and parallel coordination of various units for 20 years, and has worked hard to promote the policy of assistive device services, the training of assistive device professionals, and the development of the industrial market. We look forward to your continued support and to working together for a better and more prosperous future!



Source: 20 Years of Glory! "ICF and Assistive Technology Center of Yang Ming Jiaotong University Receives Certificate of Appreciation for 20 Years of Contribution - NYCU National Yang Ming Transportation University

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The Department of Biomedical Imaging and Radiology of National Yang Ming Jiaotong University (hereinafter referred to as Yang Ming Jiaotong University Department of Medical Radiology), one of the leading departments in Taiwan to train medical radiologists and medical physicists, signed a multi-million scholarship and multi-year cooperation agreement with Platinum Technology Co. In addition to clinical services and further studies, students will have the option to engage in industrial services and R&D.
Dean Lin Junli of the School of Biomedical Sciences and Engineering, Yang Ming Jiaotong University, said in his speech that the cooperation between the enterprise and the Department of Medical Radiology has become a model of medical talent cultivation, which will attract more outstanding students to the development of medical technology. Yang Feng Yi, Director of the Department of Medical Radiology, Yang Ming Jiaotong University, also expressed that the signing of this multi-year contract expresses the determination of the academia and the enterprise to jointly promote the cultivation of talents in the long term, and hopes that the medical professionals will be involved in the research and development of industrial applications in the coming years to consolidate the sustainable development of the relationship between the two parties.

President Chih-Hung Lin of Yang Ming Jiaotong University expressed his enthusiasm for the bilateral cooperation between the university and the industry, which coincides with the university's recent promotion of the Ten-Year Vision Plan of One Tree, One Hundred Harvest.
Platinum Technology Co., Ltd. is a technology company whose core business is material development and manufacturing, optical thin film design and manufacturing, and has been actively involved in the development of nuclear medicine in recent years, with complete material development and process technology. In the past, Platinum Technology has been cooperating with the nuclear medicine team of Yang Ming Jiao Tong University for many years. Now, Platinum Technology attaches more importance to the cultivation of nuclear medicine talents and professional research and development in the Department of Medical and Radiological Sciences of Yang Ming Jiao Tong University, and has provided a 10-year scholarship of $1.2 million to encourage the cultivation of nuclear medicine and molecular imaging bachelor and master talents.

In recent years, we have further developed a cloud-based medical information platform and integrated the booming AI services and telemedicine in Taiwan and abroad to gradually create a new medical service and user environment. In the medical imaging and AI services, we need talents who are familiar with medical imaging, AI features and foreign language skills from the Department of Medical and Radiology of Yang Ming Jiaotong University. In addition to the $300,000 scholarship for three years, the program also provides paid internship opportunities for bachelor's and master's degree students to enhance their career development and field experience.

While most of the medical personnel training in China is aimed at clinical professional services and obtaining national licenses, the Department of Medical Technology of Yang Ming Jiaotong University has not only been deeply engaged in training top medical technology personnel for a long time, but also continues to innovate and make breakthroughs as a benchmark for research and development in related fields both domestically and internationally. Now, the Department of Medical Technology of Yang Ming Jiaotong University has joined hands with platinum technology and business tool technology, which are the benchmark companies in China, to jointly create a job market for the industrial development of medical talents.
The CEO of Platinum Technology, Mr. Xinmiao Peng, and the General Manager of Business Tools Technology, Mr. Wei-Neng Ding, are both alumni of Jiaotong University. Both of them laughed at the opportunity to give back to their alma mater after this year's merger, and will continue to participate in the cultivation and development of cross-disciplinary talents in the fields of information and medicine, and materials and medicine to create more valuable sparks.

      

　　第六任生物醫學暨工程學院於8月5日上午吉時舉行交接典禮儀式，本校多位長官撥冗蒞院觀禮，場面熱鬧不已，交接典禮上林奇宏校長親自監交學院印信，六年前之今日亦是梁賡義前校長親自監交，象徵著對學院承先啟後、繼往開來的祝福。
　　林校長感謝吳俊忠院長過去六年來對生醫工程學院的辛勞與貢獻，特別製作感謝紀念獎牌贈予吳院長，同時感謝吳院長願意暫代醫技系主任乙職，並期許在林峻立院長及各系所主管的通力合作帶領之下，未來院務必能蒸蒸日上。
  

　　林峻立院長對醫工學院有極高期許，於典禮上提出幾項未來學院規劃重點，包括持續培育醫學與工程跨域人才並發展Med-Tech，教學提升並與交大校區密切合作，成立大型研究團隊爭取計劃，結合本床教學醫院資源及拓展產學合作，使本院研研發成果在產醫學密切合作下能有效落地，同時配合國際化趨勢，推動教學及行政國際化等，相信在林峻立院長帶領之下，未來生物醫學暨工程學院必能開拓新局，展現新的風貌。
　　活動尾聲，本次參與典禮之嘉賓長官於生醫工程館大廳合影留念，在眾多祝福聲下，活動劃下完美的句點，並也開啟嶄新的領航。
 

白金科技股份有限公司與生物醫學影像暨放射科學系企業贊助簽約儀式

　　吳俊忠院長擔任生物醫學暨工程學院六年職務，任期自2015.08至2021.07，卸任之際，於疫情之下，於七月三十日舉辦卸任感恩茶會，當天學院參與教職員約四十名，依據防疫要點採梅花座入座，場面溫馨感人。

　　吳院長先回顧過去六年的工作內容，從內部員額、外部檢討、教學規劃、研究團隊、空間優化、經費爭取等，在吳院長任內下逐一落實，他更說明當初應聘時給自我期許的4E(EFFORT、EFFICIENCY、EFFECTIVENESS、EXCELLENCE)，同樣將此工作信念傳遞給在座的每位嘉賓，演講最後，吳院長感性地說：「感謝當初遴選委員的厚愛、梁賡義校長的聘任，以及全院師生行政人員的幫忙，才能順利完成六年的任期」。

　　最後，為表達吳俊忠院長對學院的辛勞與付出，由新任林峻立院長準備唐三彩駿馬代表學院全體教職同仁作為謝禮，並由楊雅如副院長及吳育德副院長代為致贈，於活動結束後與在座所有嘉賓一同於生醫工程館大廳合影留念。

   

 

吳俊忠院長卸任感謝茶會資訊，歡迎蒞臨參與!