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Archimedes Leadership Summit

The Archimedes Center for Health Care and Medical Device Cybersecurity, is hosting an educational leadership summit on November 23 for healthcare and medical device executives and researchers to learn about new cybersecurity regulatory requirements to manufacturer medial devices for use in the United States, China, and the globally regulated medical device market.

第一届国际医疗设备安全论坛将于11月23日在浙江杭州召开，嘉宾包括美国东北大学Kevin Fu教授、浙江大学徐文渊教授、美国得克萨斯大学圣安东尼奥分校Qian Chen教授、MedCrypt战略科学家等，欢迎注册参会。更多信息和参会注册请访问：https://www.secure-medicine.org/events/2023-archimedes101about-0

Location

The workshop takes place on the campus of Zhejiang University in Hangzhou, China. Registrants will receive the logistics information by email.

Abstract

We will explain new technical requirements for pre-market cybersecurity review and how companies can better prepare for successful pre-market clearance applications of medical devices. The discussion will be valuable for medical device business lines subject to new medical device cybersecurity regulations in many countries including the United States and China

The Leadership Summit includes breakfast and lunch with our distinguished guests. This workshop is for in-person attendance only. Virtual/hybrid attendance is not provided.

 

 
Our Archimedes events attract the top medical device and pharmaceutical manufacturers in the world. Past participants at Archimedes events include Chief Information Security Officers, Product Security Managers, and Product Engineering Directors from companies including Medtronic, Abbott, Phillips, and more.
 

If you have additional questions, please contact us at archimedes@northeastern.edu

 

Guest Speakers

 

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"How to Succeed at Regulatory Clearance for Medical Device Security Engineering"

Professor Kevin Fu

Director, Archimedes Center for Health Care and Medical Device Cybersecurity
Former Acting Director, US FDA CDRH Medical Device Security
IEEE Fellow, ACM Fellow, AAAS Fellow
 
Kevin Fu is Professor of Electrical and Computer Engineering and the Khoury College of Computer Sciences and Bioengineering at Northeastern University in Boston, USA, where he directs the Archimedes Center for Health Care and Medical Device Cybersecurity. Fu previously served as the nation's inaugural Acting Director of Medical Device Cybersecurity at the United States Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) and Program Director for Cybersecurity at the Digital Health Center of Excellence (DHCoE). His research vision is a world where science-based security is built-in by design to all embedded systems: medical devices, healthcare delivery, autonomous transportation, manufacturing, and the Internet of Things. His research lab focuses on analog cybersecurity—how to model and defend against threats to the physics of computation and sensing. Fu is most known for his security research on cryptographic and low-power inventions to defend against vulnerabilities in an implantable cardiac defibrillator. His research led to a decade of revolutionary improvements at medical device manufacturers, global regulators, and international healthcare safety standards bodies. Security solutions resulting from this research foresaw the risks of malicious software affecting hospitals a decade before ransomware began to disrupt clinical workflow worldwide.

Fu has been recognized as an IEEE Fellow, ACM Fellow, AAAS Fellow, Sloan Research Fellow, and MIT Technology Review TR35 Innovator of the Year. He received best paper awards from USENIX Security, IEEE Security & Privacy, and ACM SIGCOMM. His research on pacemaker security received an IEEE Security & Privacy Test of Time Award. He chairs the USENIX Security Test of Time Awards Selection Committee. He chaired the USENIX Security PC and served as the inaugural co-chair of the AAMI cybersecurity working group to create the first FDA-recognized consensus standards to improve the security of medical device manufacturing. He founded the Archimedes Center for Health Care and Medical Device Cybersecurity, and co-founded the N95decon.org team for emergency reuse decontamination of N95 masks during pandemic shortages. Fu received his BS, MEng, and PhD from MIT. He earned a certificate of artisanal bread making from the French Culinary Institute, builds wood-fired brick ovens, and enjoys woodworking.
 
 
 
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"Security for Health Care and Clinical Engineering"

Professor Guenevere Qian Chen

Associate Professor, Electrical and Computer Engineering, The University of Texas at San Antonio

Guenevere Chen joined UTSA faculty in 2017 and has since focused her research efforts primarily on the field of cybersecurity. Her current cybersecurity research encompasses a wide range of areas, including SCADA systems, Internet of Things (IoT) and IoT-enabled systems, digital health and medical devices, AI-driven intrusion detection systems, software vulnerability detection, and the creation of secure federated-learning AI models. Additionally, she is strongly committed to advancing cybersecurity education and workforce development, with a special focus on empowering underrepresented minorities. 

Chen has contributed to her field by publishing research in top-tier peer-reviewed conferences
and journals including USENIX Security, ACM Computing Surveys, the Journal of Parallel and
Distributed Computing, and the IEEE Internet of Things Journal. Her SALSI-funded research
paper, “State of Science in Alarm System Safety: Implications for Researchers, Vendors, and
Clinical Leaders,” won The Association for the Advancement of Medical Instrumentation
(AAMI) 2023 Publication Award. Her research paper, “Near-Ultrasound Inaudible Trojan (Nuit):
Exploiting Your Speaker to Attack Your Microphone,” was published by USENIX in 2023 and received global coverage in nine different languages, including English, Chinese, Japanese,
Russian, German, and others. 
Chen earned her Ph.D. in Electrical and Computer Engineering from Mississippi State
University. Before joining UTSA, Chen was an assistant professor and coordinator of the
computer science technology program at Savannah State University.

 
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"Security for the Medical Internet of Things"

Professor Wenyuan Xu

Professor, Electrical Engineering, Zhejiang University and USSLAB.

Wenyuan Xu is a professor in the college of Electrical Engineering, Zhejiang University. She received her B.S. degree in electrical engineering with the highest honor from Zhejiang University in 1998, an M.S. degree in computer science and engineering from Zhejiang University in 2001, and the Ph.D. degree in electrical and computer engineering from Rutgers University in 2007. She was an associate professor in the Department of Computer Science and Engineering, University of South Carolina. Her research interests include embedded system security, smart grid security, and smart systems security. Dr. Xu is a co-author of the book Securing Emerging Wireless Systems: Lower-layer Approaches, Springer, 2009. She received the United State NSF Career Award in 2009 and was selected as the 1000 Young talents of China in 2012. She obtained an ACM CCS best paper award in 2017 and listed on the security researcher hall of fame in 2014 and 2016. She has served on the technical program committees for several IEEE/ACM conferences on wireless networking and security, and she currently serves as the associate editor of TOSN.

 
 

 

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"Telehealth Cybersecurity: Securing the Remote Patient Monitoring Ecosystem"


Axel Wirth

Chief Security Strategist, MedCrypt

As Chief Security Strategist, Axel Wirth provides strategic vision and industry leadership to MedCrypt and its customers. In this role he helps guide the company in critical security strategy decisions. As an advocate for compliance, privacy, and security—and ultimately patient safety—in healthcare, Wirth draws from over 30 years of international experience in the industry. His extensive background includes engineering leadership as well as business development roles with Siemens, Analogic, Mitra, Agfa, and Symantec. His education includes a BS in electrical engineering (BSEE) from the University of Applied Sciences, Düsseldorf (Germany) and an MS in engineering management (MSEM) from The Gordon Institute of Tufts University.