Kensuke is a regulatory affairs expert in Japan who has spent nearly 30 years at the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA), working at the core of regulatory science, including medical device review. 

At PMDA, Kensuke served as Executive Director overseeing the medical device review division, leading the review of innovative medical devices. He contributed to accelerating medical device development through industry-academia-government collaboration, resolving the device lag, and advancing international harmonization, and drove the domestic adoption of numerous medical devices. 

He now applies his extensive regulatory experience to academia, serving as Specially Appointed Professor at the Center for Next-Generation Medical Innovation, Kochi University Hospital Faculty of Medicine, as well as Visiting Professor at Tohoku University, Part-Time Lecturer at Waseda University’s Faculty of Science and Engineering, and Evaluation Committee Member for the Japan Agency for Medical Research and Development (AMED), where he focuses on medical device development, clinical research, and regulatory strategy.