2022 Symposium on Engineering, Medicine, and Biology Applications (SEMBA 2022)

第十一屆生醫工程應用研討會

 

SEMBA 2022 will be held onsite.

 If there are any changes due to the epidemic, it will be announced immediately.

 

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Keynote Speakers

Professor J.-C. Chiao

Southern Methodist University, Dallas, TX, USA

Fellow of American Institute for Medical and Biological Engineering

jchiao@smu.edu

 

Title of Keynote Speech: Miniature Wireless Devices for Closed-loop Health Management

Abstract of Keynote Speech: Mobile technologies have changed our lifestyle significantly. Personalized tools such as wearable and implantable devices through wireless communication and power transfer have been utilized in healthcare to provide unique functions and reduce costs. Individuals can be empowered with tailored solutions without limitation in mobility or daily activities. Quantitative documentation of physiological parameters presents more accurate assessment. Direct electrical stimulation on tissues or organs can restore or improve body functions. Continuous monitoring and adaptive administration of therapy to treat symptoms via wireless body networking can adaptively optimize the closed-loop health management.

This presentation discusses the development of wireless micro devices and integrated systems for clinical applications. The systems are based on batteryless, wireless implants with enhancement in miniaturization and functionalization. Miniaturization owing to flexible substrates and the elimination of bulky batteries allows endoscopic or minimally invasive procedures to deploy the implants without painful surgeries. Several diagnosis and therapeutic treatment examples for management of gastric and neural disorders, particularly as closed-loop systems, will be introduced. These examples aim to inspire new system application ideas to address the implementation and cost challenges in healthcare and enable integration of electronics and medicines to improve human welfare and assist better living.

 

 

 

 

Professor Chii-Wann Lin

Department of Biomedical Engineering, National Taiwan University, Taiwan

cwlinx@ntu.edu.tw

 

Title of Keynote Speech: Enabling Precision Health with Biomedical Electronics

Abstract of Keynote Speech: Biomedical electronics has been the corner stone of the healthcare with numerous innovative medical devices. Advances in miniaturization, heterogeneous integration, and hard/software co-development have enabled digital transformation of modern healthcare system. Artificial intelligence, big data analytics, cloud computing, low latency communications, and immersive interactions, all these emerging technologies will help to facilitate novel service models in healthcare for better clinical outcomes and in preventive care toward precision health. I will share a few current statuses of research projects from my laboratory, e.g. complex phase space differential (CPSD) for arrythmia detection, automation of surface plasmon resonance (SPR) biosensing system, reinforcement learning (RL) algorithm for closed-loop stimulator.

 

 

 

 

Distinguished Professor Allen Ming-Lun Hsu

School of Dentistry, National Yang Ming Chiao Tung University, Taiwan

President of Association for Dental Education, Asia Pacific (ADEAP)

President of Taiwan Association of Dental Education (TADE)

mlhsu@nycu.edu.tw

 

Title of Keynote Speech: Engineering Medicine Biology – A Win-Win strategy to face the challenge of Super-Aged Society

Abstract of Keynote Speech: We are facing the challenge of super aged society in Taiwan. To live longer, our aim is to live better. Chewing is one of the basic requirements to live better and longer.

The human mandible is connected to the skull by two temporomandibular joints (TMJ). The articulating surfaces of these joints are incongruent, which provides the mandible with a wide range of movability respected to the skull. In between the articulating surfaces, a cartilaginous articular disc is situated. Generally, impaired of the TMJ function maybe due to different etiologies, such as injury to the jaw, muscle hypertonicity of the head and neck, grinding or clenching the teeth, displacement of the disc and different kind of arthritis. Some surveys have reported that 20-25% of the population exhibit one or more symptoms of temporomandibular disorders (TMD).

Our team has devoted for a long time in the etiology and management of TMD. But the success rate remains not satisfied. To be the bridge from basic research to clinical application, engineering medicine biology may be applied in clinic as dawn in the dark to face the challenge of super aged society for future demand.

 

 

 

 

https://ihumen.utm.my/wp-content/uploads/2021/04/Hau-Photo2-Jasmine-Hau-206x300.png

Dr. Hau Yuan Wen

School of Biomedical Engineering and Health Sciences, Universiti Teknologi Malaysia, Malaysia

hauyuanwen@biomedical.utm.my

 

Title of Keynote Speech: An intelligent heart rhythm monitoring device for early heart disease detection and prevention: From Algorithm towards Commercialization

Abstract of Keynote Speech: Cardiovascular diseases (CVDs) are the top silent killer in the world which cause 17.9 million people die every year and contribute to 31% of all global deaths. One approach to improve the heart care quality is by deploying "homecare monitoring" to reduce the risk of fatality, so that the public could acquire electrocardiogram (ECG) signal at anywhere and anytime for frequent monitoring of cardiac conditions. Arrhythmia is one of the important precursors for cardiovascular disease that can be diagnosed via ECG. This presentation discusses a design of an intelligent heart rhythm monitoring device which able to detect and self-classify multiple life-threatening arrhythmias as a strong indicator of various CVDs based on single-lead ECG. The invention is designed based on integration of multi-stage artificial intelligent (AI) machine learning algorithms, Multi-Processor System-on-Chip (MPSoC) architecture, field-programmable-gate-array (FPGA), and Internet-of-Things (IoT) technology. The sharing includes the algorithm exploration based on the consideration of targeted accuracy and computation performance, the design of the intelligent heart monitor using hardware/software co-design technique, as well as the functionalities supported by mobile app for the purpose of real-time heart rhythm monitoring and arrhythmia detection. In addition to that, the challenge and R&D experience of the invention along the journey from algorithm modelling towards commercialization throughout different stages of Technology Readiness Level (TRL) will also be discussed.

 

 

 

 

Invited Speakers

Dr. Ding-Han Wang

College of Dentistry, National Yang Ming Chiao Tung University, Taiwan

dhwang@nycu.edu.tw

 

Title of Invited Talk: Application of patient-specific mobile extended reality (MXR) system

Abstract of Invited Talk: In recent years, the remarkable development of digital dentistry has created a requirement for the clinician to process three-dimensional (3D) images of each patient specifically. These popular 3D images can be teeth models – acquired from intra-oral scanner (IOS), bone models – acquire from CT or MRI scanning, and designed objects such as surgical guides, teeth- or implant-supported prosthesis. After plenty of image processing steps supported by computer-aided design software (CAD), those models can be physically presented following the computer-aided manufacturing (CAM) process such as milling or printing. This manufacturing process is compulsory in many medical and dental applications such as surgical plans, surgical simulations, surgical guides, or final prosthesis. On the other hand, virtual 3D model is an alternative format that can be applied in a variety of applications in dentistry such as dental education, communication between dentists - dental technicians, patient education and consultation, telemedicine, etc. Mobile extended reality (MXR) are burgeoning technology that has the potential to greatly enhance patient care. Visualizing patient-specific 3D imaging data in these enhanced virtual environments may improve surgeons’ understanding of anatomy and surgical pathology, thereby allowing for improved surgical planning, superior intra-operative guidance, and ultimately improved patient care. It is important that radiologists are familiar with these technologies, especially since the number of institutions utilizing extended reality is increasing. This topic gives an overview of MXR and describes the workflow required to create anatomical 3D models for use in MXR using smartphone devices.

 

 

 

 

Prof. Nguyen Van Hieu

Department of Physics and Electronic Engineering, University of Science (Vietnam National University- Ho Chi Minh city), Vietnam

nvhieu@hcmus.edu.vn

 

Title of Invited Talk: A smart farming approaches for Cucumis Melo L. leaf diseases detection

Abstract of Invited Talk: Agriculture industry is moving toward autonomy due to shortage of manpower in recent years and it will soon become much worse as time passes. Advanced technologies such as artificial intelligence (AI), the Internet of Things (IoT) can provide realistic solutions to the challenges are facing. Therefore, this research focuses on applying an AI&oT approach regarding smart farming for the detection of Muskmelon (Cucumis melo L.) leaf diseases. Powdery mildew, has been a long concern to farmers and has always been among the first studied plant pathogen, along with anthracnose and verticillium wilt diseases were included in the scope of this study.

In this work, a system for autonomous collection of leaf photos and environmental parameters was built. The microcontroller reads values from sensors (temperature, air humidity, soil moisture and lux) from the environment of the cantaloupe orchard. NodeMCU ESP8266 receives and transmits data to Output devices and displays it via Blynk App of smart phone. The camera captures images of Cucumis Melo L leaves and stems that will be displayed on a smartphone and automatically saved in Google Drive. The photos will then be uploaded to a cloud storage embedded with an AI model to determine whether the pictured leaf contains any of the included diseases. The result will then be sent to the farm manager/workers and suggest management solutions. The deep learning model has been trained to achieve up to 90% of accuracy while detecting healthy and unhealthy leaves with the included pathogens. The developed system is among the first steps of smart farming in developing countries with many challenges.

 

 

 

 

Prof. Shuenn-Yuh Lee

Department of Electrical Engineering, National Cheng Kung University, Taiwan

ieesyl@mail.ncku.edu.tw

 

Title of Invited Talk: Cardiovascular Disease Detection, Analysis and Evaluation System-On-Chip and Platform

Abstract of Invited Talk: There are several medical devices are made to monitor their heart to avert the heart diseases. Moreover, body sensor networks (BSNs) based applications or wearable devices have become more acceptable to the people for monitoring the real-time health information, such as the electrocardiogram (ECG) and phonocardiogram (PCG). In order to early detect and diagnose, a low-power wireless system on a chip (SOC) stuck on the body or as a wearable/portable device for heart disease diagnosis is required. In this forum, the bio-signal acquisition SOC and platform with the features of low power consumption, wireless transmission, on-time monitoring and diagnosis with artificial intelligence (AI) will be presented. Moreover, it is efficient to electrically generate neural action potential to control dysfunctional organs. Therefore, the telemetry integrated circuits will be required because they can transmit or receive data to or from according to implantable body sensor network. In this forum, a closed-loop implantable micro-stimulator system on chip (IMSoC), which possesses the sensing of a physiological signal, disease identification, micro-stimulation, and wireless data/command transmission, will be also presented.

 

 

 

 

Special Talks

尤景良

高昌生醫股份有限公司, 臺灣

yujohn.growtrend@gmail.com

 

Title of Special Talk: 呼吸照護創新產品CDMO

Abstract of Special Talk: 以正壓呼吸器核心技術,衍生睡眠呼吸器(MiniCPAP)/主動式面罩(LungProT)等系列產品,提供呼吸照護三段五級市場的CDMO方案。

 

 

 

 

一張含有 牆, 服飾, 個人, 穿著 的圖片

自動產生的描述

Hsu Fu-Shun M.D.

CEO of Heroic Faith Medical Science Co., Taiwan

fshsu@heroic-faith.com

 

Title of Special Talk: 醫療獨角獸國際市場與取證查驗登記臨床試驗之路

Abstract of Special Talk: 聿信醫療是全球領先的醫療級呼吸音辨識技術公司,擁有抗噪科技、連續呼吸音海量資料庫及終端裝置深度學習高速推論的技術,這三項成果已轉化成專門為麻醉鎮靜病患安全而設計的呼吸監測產品。

而產品逐漸走向國際,一個新的醫療科技面對保守的產業,從法規申請、臨床試驗規範、各國審計單位等挑戰之時,仍須兼顧使用者需求與期待,如何積極快速地邁入國際市場的取證之路。

 

 

 

 

Y

Y.S. Kuo, Ph.D.

CEO & Founder of Comdek Industrial Corp., Taiwan

yskuo@comdek.com

 

Title of Special Talk: Value Creation in New Product Development

Abstract of Special Talk: In order to have a successful project of New Product Development, there are several important elements that must be considered during the research and development process. It includes technical innovation, product positioning, and market planning. In this session, I will emphasize project management and market studies are the key components of value creation. I will use an existing case to echo my perspective even under limited resources.

 

 

 

 

Workshop Speakers

Acacia Yu 俞亭君

Asia Pacific Biomedical Device Association, Taiwan

Acacia7@pidc.org.tw

 

Workshop Topic: Eco-system to Accelerate Medical Devices Innovation

Abstract of Workshop: In recent years, the healthcare industry has experienced tumultuous change. As healthcare costs escalate on an unsustainable trajectory, a high priority is being placed on medical technologies that deliver good outcomes at an affordable cost. The global medical technology landscape is evolving rapidly, with large-scale demand for improved healthcare and a new focus on frugal innovation for developing economies. In this changing environment, we need a reliable innovation process and eco-system to overcome the complex and challenging landscape.

 

 

 

 

一張含有 個人, 小男孩, 年輕, 擺姿勢 的圖片

自動產生的描述

吳秉泫

財團法人塑膠工業技術發展中心,台灣

bingshiuan21@pidc.org.tw

 

Workshop Topic: 醫療器材安全性驗證規劃

Abstract of Workshop: 目前醫療器材在上市申請之前要進行哪些的風險分析,除了收尋相關參考指引或透過已上市產品的資訊收集,如何從分析當中規劃醫療器材相對應的驗證走向,如何選擇適合的執行方法以及參數條件,驗證結束後的結果確認以及問題分析要怎麼知道是否正確,讓醫療器材的安全性的評估是完整的且符合相關法規要求。

 

 

 

 

溫瑾婷

財團法人金屬工業研究發展中心, 臺灣

pc007480@mail.mirdc.org.tw

 

Workshop Topic: 醫療器材品質管理系統(ISO 13485QMS)及委託製造要求介紹

Abstract of Workshop: 針對甫進入醫療器材領域的設計及製造業者,說明該如何從醫療器材生命週期的角度,去安排及建置公司內部品質管理系統。另說明當產品部份製程涉及委託製造時,應如何符合臺灣法規相關要求。

 

 

 

 

鍾宜榛 Yvonne

財團法人金屬工業研究發展中心, 臺灣

yizhen@mail.mirdc.org.tw

 

Workshop Topic: 醫療器材查驗登記與廣告法規要求介紹

Abstract of Workshop: 你我從出生到死亡都會接觸並使用的醫療器材,主管機關是如何把關?完成查驗登記才可販售,但可以隨意宣傳廣告嗎?產品暢銷的背後,如果未注意相關法規要求,可能在產品上市銷售時誤觸法網。以一貫之,醫療器材的安全性及有效性為主軸,讓我們一起揭開這層神秘的面紗。

 

 

 

 

SZU-YU LEE

Taiwan Food and Drug Administration

lsy1014@fda.gov.tw

 

Workshop Topic: The Regulations of Quality Management Systems for Medical Devices in Taiwan

Abstract of Workshop: In order to improve the management system of medical devices, the Ministry of Health and Welfare of Taiwan promulgated a new Medical Devices Act in 2021, and further revised the quality management system regulations for domestic and foreign medical devices manufacturers. Before providing medical devices to the market, it is necessary for manufacturers to establish the quality management system in the factory according to the regulations of the quality management system. All activities of the medical device life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities, are controlled by the quality management system to ensure the safety, quality and effectiveness of medical devices for the public.

 

 

 

 

陳維聆WEI-LING CHEN

衛生福利部食品藥物管理署醫療器材及化菻~組, 台灣

lynnchen.k@gmail.com

 

Workshop Topic: 醫療器材管理架構及法規

Abstract of Workshop: 隨著科技日新月異及全球高齡化世代的來臨,對於醫療器材的需求大增,致使醫療器材產業蓬勃發展,為順應國際潮流,配合我國新政策方案,11051日開始實施醫療器材管理法,將原本醫療器材管理由過去「藥事法」中抽離,建立醫療器材追溯性,對醫療器材製造與販賣業者規範管理。專法建構更完整之醫療器材全生命週期管理制度,並針對醫療器材之產品特性,規劃相關管理制度,包含醫療器材之維修管理、販賣及供應型態之限制、強化醫療器材品質系統及運銷管理、部分低風險產品之電子化登錄制度、許可證彈性效期之核給、醫療器材臨床試驗制度及醫療器材安全監控、主動通報等,保障消費者安全,精進醫療器材之管理機制。未來我國醫療器材管理制度將持續與國際接軌,透過法規協和降低我國產業面對國際市場之法規障礙,強化保護消費者使用醫療器材之安全並兼顧產業發展,以提升我國醫療器材產業之國際競爭力。