The global medical device market is expected to continue to expand and become a growth industry due to the aging of the population and increasing demand for medical care on a global scale. Japan's medical device market is the second largest in the world after the U.S. However, domestic medical equipment has failed to gain competitiveness, especially in the field of therapeutic use, and has been in a state of excessive imports for a long time. In 2007, the "Basic Policies for Economic and Fiscal Reform in 2007" set forth the promotion of the "Five-Year Strategy for the Creation of Innovative Medicine and Medical Devices". Since then, the environment for the development of medical devices has been rapidly improved through the strengthening of the Pharmaceuticals and Medical Devices Agency (PMDA) and the establishment of the Japan Agency for Medical Research and Development (AMED). However, the correction of excessive imports of medical devices has stalled, and further countermeasures are needed to accelerate the development of domestic medical devices.
On the other hand, there is no doubt that the creation of new medical devices is one of the major factors in meeting the health needs of the people and supporting the aging society. The development of medical devices has two missions: to meet the health needs of the people and to serve as a growth industry to drive the domestic economy. In 2016, the Cabinet approved the "Basic Plan for the Promotion of Research and Development and Dissemination of Medical Devices to Improve the Quality of Medical Care" to realize these missions. The plan includes the promotion of technological development of cutting-edge diagnostic and therapeutic devices and the fostering of human resources who can lead the creation of innovations.
With the aim of accelerating the development of innovative medical devices, Kobe University established the Biomaterials and Medical Engineering Research Project, led by the Graduate School of Engineering, and the Medical Device Implementation and Biomedical Engineering Research Project, led by the Graduate School of Medicine, in 2015 within the Kobe University Organization for Advanced and Integrated Research, the cross-departmental research organization. In 2017, the Medical Device Fabrication Engineering Center and the Center for Biomedical Engineering and Exploratory Research were established in the Graduate School of Engineering and the Graduate School of Medicine, respectively, as departmental centers. In addition, we established the "Medical Device Innovation Platform (MeDIP)" in the Kobe Biomedical Innovation Cluster with the Foundation for Kobe International Medical Alliance (Kobe IMA), and are steadily improving the environment for the development of innovative medical devices. Kobe University Hospital opened the International Clinical Cancer Research Center (ICCRC) in 2017 and established the Clinical &Translational Research Center (CTRC, branch hospital). This has enabled us to establish a place where clinical trials can be conducted in the Kobe Biomedical Innovation Cluster.
Based on the above activities both inside and outside the university, the Center for Advanced Medical Engineering Research & Development was established in April 2019 as one of the university-wide core research organizations, aiming to realize a seamless integration of medicine and engineering as a result of the past interdisciplinary research efforts led by the Graduate School of Medicine and the Graduate School of Engineering.
Furthermore, as this center is based in the Kobe Biomedical Innovation Cluster formed mainly on Port Island, it plays a role in accelerating Kobe Innovation Island concept of Kobe University by working closely with the ICCRC, companies and research facilities in the Kobe Biomedical Innovation Cluster.
By making this center a practical place for the development of medical devices, we will support the activities of students, young researchers and engineers who will be responsible for the future, and focus on the global development of medical devices originating from Japan.
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In order to promote medical-engineering collaboration and accelerate the development of medical devices, it is important to improve the environment and foster human resources. The Organization for Advanced and Integrated Research and the centers in each department of the Graduate School of Medicine and the Graduate School of Engineering have been improving the environment to a certain extent, and communication between the medical and engineering communities has been very good. However, there is a critical shortage of staff in the development environment to support the phase of medical device development that requires the most creativity, from needs assessment to concept creation. The Center for Advanced Medical Engineering Research & Development will fill this missing piece by involving industry (medical device companies) and government (PMDA, etc.) as a key research promotion organization that can make speedy decisions. It will promote the establishment of an environment in which medical engineering can be completely and seamlessly integrated and researchers from multiple fields can collaborate in an integrated manner, from the identification of medical device needs to commercialization strategies.

Currently, what is most lacking in medical device development in Japan is a medical device producer (MDP) with a medical or engineering background and knowledge of intellectual property to search for a solution to the needs and turn it into a medical device prototype. MDPs lead the medical device development teams, and we are also making efforts to train MDPs who are truly necessary for medical device development.

We will adopt an open innovation approach to accelerate development, and by establishing the center within the Kobe Biomedical Innovation Cluster, it will work closely with the International Clinical Cancer Research Center and the companies and research facilities within the Kobe Biomedical Innovation Cluster to accelerate the Kobe Innovation Island Initiative.