The Medical Device Strategy Institute (MDSI), Japan’s premier think tank focused on the medical device industry, held its first forum on 7 October. Experts from industry, government and academia gathered to discuss the past quarter century of Japan’s medtech industry and sketched their visions of its future. “Our aim is to hold a forum every time we issue a research paper, and make policy proposals through discussion,” said Satoshi Watanabe, president of the Japan Association for the Advancement of Medical Equipment, MDSI’s main body. “Now is the time for us to learn from the past, draw the ideal picture of the future, and map out action plans.”
During the past 25 years through 2008, the size of Japan’s medtech industry more than doubled in value to 2.22 trillion yen (€19 billion). Yet, local companies lost international competitiveness, as the number of imports quintupled during that same period. Shohei Nakano, MDSI’s senior researcher who published a paper on industry trends since 1984, said at the forum that the causes of Japan’s deteriorating competitiveness were the strengthening yen, the government’s move in the mid-1990s to encourage national hospitals to buy foreign medical devices, and the failure by Japanese companies to correctly forecast long-term medical needs. “Two of the three reasons are external factors, so self-help efforts alone cannot help revive the industry,” said Nakano. ”I expect the government to support the medtech industry as Japan’s key industry.”
Representing the government, Niko Kato, an officer at the Ministry of Economy, Trade and Industry (METI), raised issues such as the lack of cooperation between medical science and engineering, insufficient funding by the government for R&D, reluctance by medtech companies to adopt new technologies and a shakeout of companies in the international arena. Nevertheless, Kato sees a rosy future: Japanese medical devices could still excel, she said, if the government and industry pool their wisdom and power.
“Technologies to prevent disease, to make noninvasive and unrestrained diagnosis possible, and to store and analyse medical data will be widely available in our daily lives by 2030,” said Kato. With the help of nearly 900 experts, she mapped out technological targets that should be achieved to develop the medtech industry in the next 20 years. In this “Strategic Technology Roadmap” of METI, she forecasts a surge in exports and greater self-sufficiency for the Japanese medtech industry.
Representing academia, Professor Hiroshi Kasanuki of the Joint Graduate School of Tokyo Women’s Medical University and Waseda University stressed the importance of advancing regulatory science and creating new systems where all parties can work more collaboratively to create medical devices that respond to patient needs. A cardiovascular specialist with more than 40 years of experience, Kasanuki worked hard to get cardiac resynchronisation therapy rapidly approved by Japan’s regulatory body. It was made available in the market in 2004, only four years after US FDA approval. (By contrast, implantable cardiac defibrillators came on the market in Japan 11 years after US FDA approved them.) “If doctors heed patient needs and push hard for early introduction, devices can be approved much sooner,” he said.
At the end of the forum, the three speakers were joined in an hourlong debate by two members of industry: Hiroshi Misawa of Terumo Corp. and Eishi Harasawa of Nihon Koden Corp. All of the panelists agreed on the need for cooperation among industry, government and academia. “In the end, medical devices are for patients. Regulatory offices, manufacturers and medical organisations should share a common understanding and use a common language with patients,” Kasanuki said.
About 400 people attended the forum in Tokyo on 7 October. The MDSI think tank plans to hold its second forum in December to discuss the amount of time it takes to get medical devices approved for reimbursement.Miki Anzai