Medical Device Development
13:30-15:10
Join us for a captivating session on "Medical Device Development" featuring two distinguished speakers. Dr. Aichi Chien, a renowned expert in cerebral vascular disease and medical device innovation, brings awards and groundbreaking patents to the table. Dr. Yin-Pen Chang, Founder and CEO of Qualtech Consulting Corporation, is a global leader in regulatory consulting with a mission spanning three decades to advance MedTech in Asia. Together, they offer unique insights into regulatory challenges, innovation, and the future of medical devices. Don't miss this dynamic discussion! |
Yin-Pen Chang
CEO @ Qualtech |
Dr. Chang is the Founder and Chief Executive Officer of Qualtech Consulting Corporation, a regulatory consulting and CRO company with more than 100 employee located in 13 countries providing the professional support to medical device stakeholders in the world.
Yin-Pen Chang received his Ph.D. in Mechanical Engineering (specialized in Material Science), Tatung University, Taiwan, and is an Adjunct Associate Professor at the Institute of Mechatronic Technology, National Taipei University of Technology |
Ai-Chi Chien
Professor @ UCLA |
Aichi Chien, Ph.D. is a Professor in the Department of Radiological Sciences and the Biomedical Physics IDP Graduate Program in the David Geffen School of Medicine at UCLA and Ronald Reagan UCLA Medical Center.
Dr. Chien's research interests have been centered on cerebral vascular disease and treatment effectiveness analysis, and encompass the integration of science and engineering for clinical decision-making and individualized medicine. Dr. Chien’s work has been recognized with more than 20 awards from the medical community, including the American Heart Association, Brain Aneurysm Foundation, and international organizations, such as the Society of Interventional Radiology. Dr. Chien is the principal investigator of an American Heart Association Innovative Project Award to develop novel software for clinical stroke treatment. Currently, Dr. Chien is the sole principal investigator of a five-year NIH R01 award to study human brain vascular structure and aneurysms. She is also responsible in five NIH R01 projects as a co-investigator. Dr. Chien’s research also broadly impacts the medical device industry. She is the lead inventor of eight US patents on medical inventions. Her research has been featured in various news outlets, including Fierce Medical Devices, Interventional News, Endovascular Today, and Neuro News. Because of her expertise in clinical vascular disease treatment, Dr. Chien frequently serves on Center for Scientific Review grant review panels in the US National Institute of Health. Dr. Chien has also been recognized as a Fellow of the American Heart/Stroke Association (AHA), elected as a member of AHA Research Leadership Academy, and elected as the AHA Oversight Advisory Committee to oversee the AHA National Effort of Strategically Focused Research Networks. As results of her scientific contribution and profound influence in stroke research, in 2023, Dr. Chien is nominated by NIH and elected as a standing member for the NIH Center of Scientific Review. |
Moderator
Chi-Feng Mario Chang
PhD Student, USC Experienced Biomedical Engineer in the medical device industry. Currently, assist market access for medical devices to the Asian market. Familiar with medical device regulatory policy and market information in different Asian countries. Assist in expanding business in Asia. |