Japanese Medtech Association Launches Think Tank, Cautions Against Burdensome Regulations

May 25, 2010 – 10:39 pm

Japan’s first think tank focused on the medical device industry has been established. The Medical Device Strategy Institute (MDSI) will initiate research and generate dialogue on policy issues of interest. Among its projects is a paper on market trends spanning a quarter century. It is a noteworthy development because Japan’s medtech market, which is the second largest in the world, has been the subject of relatively few quantitative studies, writes Miki Anzai, associate editor of Japan Medical Design & Manufacturing Technology (JMDMT) magazine. JMDMT is published by Canon Communications LLC, which also maintains this blog.

Japan’s $24 billion medical device industry has doubled in value over the past 15 years, but continued growth is in jeopardy as tough regulatory requirements create new obstacles for manufacturers and distributors of medical devices.

In response, the Japan Association for the Advancement of Medical Equipment, which was founded in 1971, established the MDSI think tank in April to raise awareness of the medical device industry’s societal and economic importance. The institute says it will identify outstanding issues such as regulations and approval processes based on its own surveys as well as provide analysis of the global industry. It seeks to promote a better understanding of the Japanese medical device industry’s role in society by making proposals to the government and emphasising the importance of a government-led strategic approach.

The institute published its first paper in April on the amount of time it takes to get devices approved for reimbursement. According to the report, manufacturers must wait an average of 13 months from the time a request is submitted to the regulatory body until the device is declared eligible for reimbursement by the government. In August, a second paper focusing on market trends will be published, says MDSI Chief Researcher Sohei Nakano. “It’s going to be a thorough study of the market, as we will look into data over the course of 25 years,” says Nakano. “A survey of just 10 years is not enough to grasp the real trend, so we will go for 25 years.”

As each paper is made public, MDSI will hold study meetings and collect and consolidate opinions from members of government, industry and academe. The MDSI intends to publish three research papers annually, and publish a set of official proposals every three years.

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