To strengthen clinical capabilities and enhance competitiveness of medical products among the practitioners, Industrial Development Bureau and Taipei Medical University Biomedical Accelerator together with the Plastics Industry Development Center (PIDC) organized a Conference on Clinical Evaluation, Trials and Tracking of Medical Devices on September 22 in the GIS NTU Convention Center. This event attracted about 140 people from 99 companies.
The open speech was given by Sharon Yi, Deputy CEO of Taipei Medical University Biomedical Accelerator, and Xue Guangying, Manager of Plastics Industry Development Center. Sharon mentioned the importance of cooperating with the PIDC to assist the startup teams, and introduced accelerator service with it’s new acceleration program in 2023, and invited the startup teams (involve in medical devices, digital medical, and artificial intelligence) to join.
The conference was divided into three topics: (1) Explanation of clinical evaluation guidelines for medical devices by Zhang Rongci, the member of PIDC biomedical technology group; (2) Clinical trial planning and practice by Liu Mingzhe, deputy director of the Human Research Office of Taipei Medical University; (3) Explanation of clinical tracking regulations after the listing of clinical medical devices by Director Hu Lingyue of RusCert Technology Co., Ltd.
Miss Zhang shared that the content of clinical evaluation needs to be quantifiable in order to fulfill the criteria of clinical evaluation. She also further explained the practices and details of clinical evaluation at each stage, the calculation methods and reports of clinical trials before and after the market.
Deputy Director Liu mentioned the quality and quantity are the most important in clinical trials, but quantity precedes quality, we can only talk about quality when the quantity meets. By taking the recent examples of vaccine trials, how to make effective clinical trial planning which will affect the number of cases received. He also mentioned the planning of medical devices and clinical trials: from the regulations on clinical trials to the ARO services of Taipei Medical University, how to facilitate the arrangement of doctors and assistance in writing plans; how to do clinical trial planning CIP details, what are the precautions and planning content. In addition, he shared how Taipei Medical University assists startups to determine whether a product needs clinical trials, and the clinical trial planning initiated by IIT researchers.
Dr. Hu gave a detailed explanation on the purpose and results of clinical trial planning; the regulations of having relevant assessments before and after the clinical trials; the practice and experience on continuous tracking of clinical products after launched. She also reminded the startup teams to focus more on the planning before and after the launch of clinical products.
Group photo. From left to right: Yu Tingjun, leader of the Biomedical Technology Group of the Plastics Industry Development Center; Hu Lingyue, director of RusCert Technology Co., Ltd.; Sharon Yi, deputy CEO of Taipei Medical University Biomedical Accelerator; Liu Mingzhe, deputy director of Taipei Medical University Human Research Office; Xue Guangying, manager of the Plastics Industry Development Center; Zhang Rongci, member of the Biomedical Technology Group of the Plastics Industry Development Center.
Zhang Rongci, Member of the Biomedical Technology Group of the Plastics Industry Development Center
Open speech by Sharon Yi, Deputy CEO of Taipei Medical University Biomedical Accelerator
Liu Mingzhe, Deputy Director of Taipei Medical University Human Research Office
Xue Guangying, Manager of the Plastics Industry Development Center
Hu Lingyue, Director of RusCert Technology Co., Ltd