The year is in Jiachen, and the spring dynasty is new! On March 6-7, 2024, the "CDIDC2024 Cardiovascular Medical Device Innovation and Development Conference" will be held in Suzhou, with the theme of "Gathering Cardiovascular Upstream and Downstream Enterprises and Promoting High-quality Development of the Industry". At the conference, Wei Xufeng, chairman and general manager of Jiangsu Meifengli Medical Technology, made a wonderful speech on the topic of "Cardiovascular Innovative Medical Devices from Animal Experiments to Clinical Research" at the main venue.
Cardiovascular innovative medical devices are currently the hottest track at home and abroad, with new ideas, new materials, new designs, and new products emerging in an endless stream. Due to the special attributes of the cardiovascular system and diseases, innovative medical devices in this field are usually high-risk Class III implantable interventional devices, with relatively complex structural composition and working principles, relatively insufficient basic research, and lack of clinical application experience and effective reference of similar products, which also brings challenges to the standardized evaluation of their feasibility, safety and effectiveness.
In vivo testing is the last link in the medical device design and development process, which is the overall verification and confirmation of product performance, including preclinical large animal research and human clinical trials. Preclinical large animal studies and human clinical trials are closely related in sequence, but there are huge differences in the specific evaluation objectives, the determination of sample size, and the selection of efficacy endpoints. How to effectively evaluate an innovative cardiovascular medical device in an efficient, standardized and economical manner in vivo testing is not only a problem that R&D enterprises, but also test institutions and regulatory review institutions need to think deeply about.