The pre-market approval and clinical application of innovative medical devices should be based on high-quality evidence, proving their reliability, safety and effectiveness. In 2016, the IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up) collaboration modified the original IDEAL framework and recommendation to the IDEAL-D methodological framework for the entire life cycle evaluation of innovative medical devices. The framework included five stages, namely the preclinical development stage, idea stage, exploration stage, assessment stage and long-term follow-up stage. This paper aims to interpret the study purpose, content and design at each step of the IDEAL-D framework based on IDEAL framework and recommendation (2019) to provide practical methodological guidance for the design and conduct of clinical research on innovative medical devices.
Citation: GUO Qiong, FENG Kun, LONG Youlin, LIN Yifei, XIANG Jin, HUANG Jin, DU Liang. Interpretation of the methodological framework of clinical research on innovative medical devices. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2022, 29(7): 828-833. doi: 10.7507/1007-4848.202205018 Copy
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