Our trial on biomedical engineering research and education system related to medical regulatory science

I would like to introduce our new biomedical engineering research and education system related to medical regulatory science. This system has been operated in TWIns, which is an abbreviation for Tokyo Women’s Medical University and Waseda University Joint Institution for Advanced Biomedical Sciences. TWIns opened in 2008 as the first collaborative research institute between a school of medicine and a school of science and engineering in Japan. The present number of residents at TWIns is 600, including 300 graduate students. I personally had a critical experience on “First in Human (FIH)” twice throughout my 40-year developmental life on ventricular assist devices. Therefore, I strongly believed an importance to establish a practical environment to cultivate human resources on medical regulatory science. As for a biomechanical engineering research, we have established dry- laboratories to provide practical tools to assess safety and effectiveness of medical treatments and to set up reliable test platforms for assessing the performances of keep-coming new medical devices. In addition, in 2010 we opened a joint graduate school that offers the first government-approved PhD degree program in Medical Regulatory Science. We hope this unique environment will contribute to the future success of those who experience our new concept, called another EBM: Engineering-Based Medicine.