2025.6.16

Expanding the Global Reach of Japan-Based Medical Device Start-Ups

On Friday, Astellas Pharma announced that they will allow biotech startups in Japan to access their open-innovation lab and office space in Tsukuba, located just northeast of Tokyo. They will also provide consultation services concerning development – including strategies to expand to markets outside Japan. We think this is a great initiative to help promote drug development in Japan and, hopefully, to help promising Japanese drug developers “Go global” with their innovative treatments. Japan’s healthcare market is one of the largest in the world, but its growth rate will decline as the population continues to decline over the next few decades. So, accessing global markets will be even more critical for Japanese drug manufacturers moving forward.

This is true for Japanese medical device manufacturers as well. While the growth rate of the medical device market in Japan is expected to be higher than that of the drug market over the next decade, Japan’s medical device market, too, is destined to decline. To maintain their current growth rates Japanese device manufactures must also consider expanding their markets outside Japan. Last month Nipro, one of Japan’s largest medical device manufacturers, announced that it aims to increase the share of its business from overseas sales from its current level of 68% (not bad!) to 77% by 2030 and to increase its share of the global dialyzer market from 22.5% to 27.9% - or about 12.6% CAGR. Sysmex is also aiming to expand the overseas sales of its "hinotori™ Surgical Robot System", Japan’s first Made-in-Japan robotic-assisted surgery system, with its first case performed in Malaysia earlier this year.

Moreover, with the COVID pandemic and the technology supply constraints stemming from the Russo-Ukrainian War, some issues with over-reliance on the importation of medical devices from outside Japan have been highlighted. In addition to promoting the development and commercialization of medical devices, the Japanese government’s recently published 2025 Basic Policy on Economic and Fiscal Management and Reform also emphasizes the importance of reinforcing the supply chain for medical devices and pharmaceuticals, and securing domestic production systems. So, maintaining a healthy environment for manufacturing medical devices in Japan is now a national priority.

Although direct assistance from large device manufacturers to medical device start-ups in Japan, like that announced by Astellas for Japan-based pharms start-ups on Friday, may be limited, we recently learned of three local initiatives that aim to support medical device developers in Japan: the Fukushima Medical Device Development Support Centre (FMDSC) started in 2016, the Osaka Chamber of Commerce and Industry Medical Device Industry Forum (MDF) started in 2003, and the Organization to Promote the Healthcare and Medical Device Industry in K(Q)yusu (HAMIQ) established in 2013. There websites are shown below:

Fukushima Medical Device Development Support Centre (FMDSC)
https://fmddsc.jp/en/

Osaka Chamber of Commerce and Industry Medical Device Industry Forum (MDF)
https://www.osaka.cci.or.jp/mdf/consultation/

Organization to Promote the Healthcare and Medical Device Industry in K(Q)yusu (HAMIQ)
https://hamiq.koic.or.jp/

These organization are staffed and supported by seasoned medical device experts in Japan and provide a range of services to Japan-based medical device developers – including testing labs, development consultation, and matching support services in Japan and outside Japan. Some are also supported by industry groups and/or larger medical device manufacturers and distributors. While they report many success cases, it is unclear how much their efforts have contributed to commercialization of novel medical devices outside Japan. However, the range of services that they provide to medical device developers in Japan that are willing to take advantage of their support is impressive.

While not exclusively for Japan, we have also noticed some industry led initiatives to help Japanese companies expand their horizons. The Asia-Pacific MedTech Acuator initiative, for example, provides a good opportunity for some companies to share their technologies regionally. The Medtech Innovator Asia Pacific initiative also recognizes and supports promising new technologies originating from Asia-Pacific countries. There also some country-specific collaborative groups like the US-Japan Healthcare Connection (formerly US-Japan MedTech Frontiers) which aims “to share best practices for medical device innovation and promote networking and collaboration between US and Japanese medical device organizations.” There are also a few other support initiatives that are less specific to the medtech sector, such as the Life Science Innovation Network Japan (LINK-J) and the Ministry of Economy, Trade and Industry’s (METI) Healthcare Innovation Hub.

GinePro primarily supports overseas medical device and regenerative medicine companies with market access and evidence generation for Japan, but we recognize that there is some great innovation taking place in Japan that may also address unmet needs in markets outside Japan [1]. So, a more fluid, two-way collaboration to bring new medical technologies to Japan and to introduce “Japan-borne” medical devices to markets outside Japan may be needed. The key is probably to find products that match the focus and core strengths of each party involved that will lead to a “win-win” for both sides. There may also be a need for more information sharing and education about innovative devices originating from Japan. As the expression goes, "If a tree falls in the woods and no one is around to hear it, does it make a sound?"

GinePro will work to support those kinds of information needs and collaborations moving forward! For example, we will be attending the Japan Health event in Osaka from June 25-27 and we are looking forward to meeting with medical device companies from around the world – as well as some of the country-specific industry groups that are supporting those companies. Drop us a line if you plan to attend!

Footnote:
[1] We were enthralled recently by a presentation by Dr. Yutaka Maruoka, Director of the Department of Oral and Maxillofacial Surgery, National Center for Global Health and Medicine, Japan Institute for Health Security, depicting his journey in developing the Vivomark tissue marker pen together with Mitsubishi Pencil Co., Ltd., and others. The Vivomark tissue marker pen, which is sold by Yasui Co. Ltd. in Japan, allows surgeons to draw precise, thin lines on bones using ink that is safe for the human body. It was born from a real medical need and overwhelming concern about the safety of its predecessor products. You can find information on the Vivomark pen and other innovative products sold by Yasui on their website below: https://yasuico.com/new-medical-devices-surgery/

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