Integrative Celerity Research (ICR) for Medical Devices/CRDS-FY2007-SP-14
Executive Summary

Medical devices surrounding us serve in many ways for diagnosis of diseases, treatment, health and improvement of QOL. For example, the introduction of a gastroscope realized early diagnosis of gastric cancer and nearly halved the mortality from gastric cancer compared with that in the 1970s. With recent introduction of positron emission tomography (PET), there are great expectations for early diagnosis of intractable diseases such as Alzheimer’s disease and cancer.

Despite of high technical capabilities in such areas as electronics, semiconductors and materials and many potential technologies that could become a core in new medical devices, the reality is that the development of medical devices is lagging behind in Japan. In the export and import of medical devices, there is an import excess of over 500 billion yen. There has bee almost no ongoing development of therapeutic devices that may be at high risk for human bodies. The attitude towards the development fearing of an accident in the worst case is a problem by itself, but the biggest cause is attributed to the fact that a system to promptly advance clinical research for the development of a medical device, to which improvements are often made while actually using it, has not been improved.

In order to break down such situation, we need measures to promptly advance the development of innovative medical devices, while solving various problems in terms of research and development, industry and regulations. For this purpose, we have applied the concept of “Integrative Celerity Research (ICR)” that forecasts goals of clinical studies and advance each research and development phase in an integrative and prompt manner to the development of medical devices and surveyed the current situation and problems in the development of medical devices. As a result, we make the following two proposals as effective measures to solve the problems arising in the development of medical devices.

1. Introduction of new application system for medical devices (Japanese-version IDE): To consolidate a consultation service for the development of medical devices and introduce a system that enables the review side to give advice and support to the development side from the initial stage of research and development. At the same time, to relax the regulations according to development phases and consider a mechanism that reduces the research and development costs.

2. Establishment of a research and development platform that has a commanding role: To establish a system that allows consistent support from a seed stage to practical use to achieve the development of innovative medical devices. For this purpose, to build an organization with a commanding role and introduce a system that allows related government offices, the Ministry of Education, Culture, Sports, Science and Technology, Ministry of Economy, Trade and Industry and Ministry of Health, Labour and Welfare, to provide continuous support from each position. In the development of high-risk devices in particular, to clarify the roles of universities, ventures and leading companies and make sure efficient development of medical devices.

By realizing the above proposals, we can expect to clarify review standards which were unclear, make the development process of medical devices by the concerted efforts of the public and private sectors smooth and dramatically promote clinical applications of advanced manufacturing technologies and life science of the Japanese origin. On the other hand, technologies and companies in different fields can also join the development of medical devices, revitalizing the medical device industry itself and enhancing the attractiveness of the industry. As a result, it will be possible to use domestic pace makers and cardiac/coronary artery catheters that now depend on imports. It is also expected that guarantee of health and medical care of the Japanese people by domestic products, which has not been currently realized, may become possible.