Finding Balance in Innovation
Status of development promotion policy for medical devices in Japan
By Shohei Nakano, PhD
In my opinion, Japan’s medical device industry, which was shining in the 1980s, began to stagnate in the mid-1990s after the collapse of the bubble economy. Initially, the cause was thought to be Japan’s regulatory system, and discussions to revise the system were given priority.
In the mid-2000s, the social issue of the “device gap” emerged, and the regulatory system was reformed with the aim of creating a global standard while listening to the opinions of the US industry. Thanks to these efforts, the regulatory system has reached the point where it is said to be at the same level as that of the United States— and even ahead of the US in some of its initiatives.
Policy Matters
However, reform of the regulatory system alone will not revive the Japanese medical device industry. Even if the system is up to international standards, promising medical technologies need to be developed before they can be approved. In other words, innovation policies that encourage this development are also extremely important.
AMED’s Medical Device and Healthcare Project will conduct R&D on medical devices and healthcare that contribute to the advancement of diagnosis and treatment, prevention, and improvement of quality of life by integrating AI and the Internet of Things.
In March 2001, the Medical Engineering Technology Industrial Strategy Consortium was established through the joint efforts of industry, academia, and government. Various discussions were held until March 2013 with the aim of improving industrial technology and strengthening the international competitiveness of medical devices, since they contribute to the advancement of medicine and people’s health.
In March 2003, the Ministry of Health, Labour and Welfare (MHLW) announced the Medical Device Industry Vision, with the aim of providing superior and safer innovative medical devices. The vision set the next five years as a period of focus to promote innovation and formulated an action plan to strengthen the international competitiveness of the industry by supporting specific fields. It was revised as the New Medical Device and Medical Technology Industry Vision in September 2008 and the Medical Device Industry Vision 2013, in June of that year.
The Basic Plan
Replacing the MHLW’s industrial vision is the Basic Plan for the Promotion of Research, Development, and Dissemination of Medical Devices to Improve the Quality of Medical Care Received by the Public, also known as the Medical Device Basic Plan. This was approved by the Cabinet in May 2016 and is the Japanese government’s first basic plan dedicated to medical device policy based on the Medical Device Promotion Act.
This basic plan outlines the core policies and measures to be comprehensively and systematically implemented for the research, development, and dissemination of medical devices to ensure that Japan will continue to have access to the most advanced medical care. At the same time, it aims to make the medical device industry a driving force of the domestic economy and an industrial field that is expected to grow and develop further.
The various measures based on this basic plan are implemented not only by the MHLW, but also by the Cabinet Secretariat; the Ministry of Education, Culture, Sports, Science and Technology; the Ministry of Economy, Trade and Industry; the Japan Agency for Medical Research and Development (AMED), and other related ministries and agencies.
Growing Ecosystem
Thanks in part to the support of these innovation policies, Japan’s medical device development trends are gradually showing signs of improvement.
The number of Japanese physicians launching their own startups has been increasing since around 2012, and there have been successful cases of these startups obtaining approval and insurance reimbursement.
Progress in the field of digital health are particularly noteworthy, and the development of medical devices and software using artificial intelligence (AI) is becoming increasingly popular. The 2015 introduction in Japan of Stanford University’s Biodesign, a project-based course for graduate and post-doctoral students keen to become entrepreneurs, has also been a driving force and this trend is likely to continue.
The number of companies providing commercialization support is also growing. In the past, only pharmaceutical affairs consulting was available, but now there is an increasing number of companies that offer a wide range of commercialization assistance, including research support, design, manufacturing, regulatory affairs, sales channel development, and incubation, as well as venture capital companies specializing in medical devices and healthcare. An ecosystem is being established in Japan.
In the past, the development of therapeutic devices was not a strong point, but over the past few years there have been some success stories creating such devices as well as treatments. These include:
Drug-eluting stents
Stent grafts
Catheters to remove emboli from central circulation
Non-absorbable local hemostatic agents for the central circulation
Photodynamic therapy
Thermoregulatory systems for cooling the brain
Boron neutron capture therapy
Nicotine addiction treatment applications
Ventilators
Phase 2
As further enhancement of innovation policy is expected, the second phase of the Health and Medical Care Strategy, which defines a higher-level research and development (R&D) strategy for the medical field, began in FY2020. What was previously referred to as the Medical Device Project has been modified into a broader initiative called the Medical Device and Healthcare Project.
AMED’s Medical Device and Healthcare Project will conduct R&D on medical devices and healthcare that contribute to the advancement of diagnosis and treatment, prevention, and improvement of quality of life by integrating AI and the Internet of Things, measurement technology, robotics technology, and more. The budget for FY2021 is ¥10.9 billion.
At the same time, the government will provide the necessary support to enable researchers and companies outside the medical field to conduct R&D in an appropriate manner, and plans to build an infrastructure for data utilization with an awareness of the global trend of digital transformation.
In recent years, Japan’s medical device industry, which had been stagnant since the mid-1990s, has finally begun to show signs of recovery.
In the medical field, the balance between innovation policy and regulation policy is extremely important, and it seems that equilibrium has finally been achieved. I hope that Japan’s medical device industry will regain its brilliance, and I look forward to investment from the United States.
Shohei Nakano, PhD
Executive director Japan Association for the Advancement of Medical Equipment (JAAME)
THE JOURNAL
Vol. 58 Issue 5
A flagship publication of The American Chamber of Commerce in Japan (ACCJ), The ACCJ Journal is a business magazine with a 58-year history.
Christopher Bryan Jones, Publisher & Editor
