Medtech World News: Pedantic Regulations Hinder Japanese Medtech Industry’s Ability to Compete

January 3, 2011 – 12:06 pm

Miki Anzai, Associate Editor of Japan Medical Design & Manufacturing Technology, recently interviewed Terumo Corp. General Manager Kunimasa Katayama. She filed this report about their conversation.

Over the past 25 years, Japan’s medtech industry has more than doubled in size, to US$23.9 billion, but its imports have quintupled during the same period, heightening concerns that local companies are losing their international competitiveness.

To gain insights into the dynamics of Japan’s medtech industry and its singular challenges, I spoke with Kunimasa Katayama, general manager of Terumo Corp.’s R&D Center. Katayama will chair the international conference at MEDTEC Japan 2011 on 20 and 21 April in Yokohama, Japan. The event is organized by UBM Canon, which also publishes this blog.

During the course of our conversation, Katayama drew attention to some of the systemic roadblocks that are hampering industry’s progress in the global marketplace. He attributes some of Japan’s waning competitiveness to the government’s pedantic regulations, calling for the need to implement an investigational device exemption similar to one that is in effect in the United States.

“Unlike medicine, medical devices need lots of revisions during development. In Japan, you have to re-apply for approval each time you make a partial revision to the device,” says Katayama. “That’s an enormous burden to manufacturers.”

He also notes that Japan lacks a venture capital mindset. Few people are willing to make risky investments, and that affects the medical device industry. Japanese society doesn’t reward innovation. For example, a huge obstacle exists for manufacturers sourcing materials and parts. Suppliers to the medical device industry deal in small quantities but take on high risk. If there is a problem with a product and it gets the media’s attention, that company’s bottom line can be severely hit. “That’s why many component suppliers simply refuse to provide their products for medical applications,” says Katayama.

Katayama has asked Tokyo University Specially Appointed Professor Chiaki Sato to make a presentation at the MEDTEC Japan 2011 conference explaining that there is no example of a parts supplier having lost a lawsuit in the United States for providing products that were used in a device that malfunctioned.

Katayama expects MEDTEC Japan 2011 to serve as a meeting point for suppliers and device makers as well as a springboard for applied innovation. “There are many innovative technologies out there, which we don’t know about yet. It’s almost impossible to develop a brand new technology only for medical devices, because the volumes are too small compared with the automotive and home appliance sectors. It will be a great opportunity for both parties to find ways to cooperate in the medtech field,” he says. For example, MEDTEC exhibitor Asahi Intec, which used to be an automobile parts maker, is now making guidewires for catheters and propeller maker Nakashima Propeller is now manufacturing artificial joints. “We are welcoming newcomers to the medtech industry,” says Katayama.

The full interview will be published soon in Japanese on

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  1. 2 Responses to “Medtech World News: Pedantic Regulations Hinder Japanese Medtech Industry’s Ability to Compete”

  2. To call a spade a spade, it’s the PMDA (legal authority approving medical products) that is hindering progress in the Japanese market. Everybody in the industry knows that, but there is no way around the PMDA. They are in charge and set the rules. Devices which are used for many years in USA or Europe sometimes require a clinical trial in Japan. Moreover, some products will be be never be seen in Japan as companies are not ready to spend the time and money to products registered.

    By Jay on Jan 10, 2011

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