Japan Medical Device Consulting Services

In March 2024, Japan’s Ministry of Economy, Trade and Industry (METI) released a strategic plan called the “Medical Device Industry Vision 2024,” which outlines the future direction for Japan’s medical device industry. This report highlights the American market as essential for growth, presenting significant opportunities for U.S. consulting firms specializing in facilitating market entry for foreign companies into the United States—and potentially separately supporting job-creating Japanese investment in the United States. It further emphasizes the need for Japan’s medical device industry to shift focus from a reliance on the domestic market to a focus on global expansion. There are four key reasons behind this shift:

• Global Market Growth Potential: The global medical device sector is expected to grow significantly, while Japan’s domestic market is projected to grow at a lower rate.
• Population Decline: Japan’s shrinking population limits domestic market growth.
• Increasing Production Costs: Rising costs of raw materials and transportation, along with the depreciation of the yen, are driving up production costs.
• Insurance System Constraints: Prices are regulated by Japan’s national health insurance system, which frequently cuts reimbursements, leading to price reductions.

The Medical Device Industry Vision specifically identifies the U.S. market as crucial for Japanese medical device companies due to its advanced technology and status as a hub for innovative medical devices. Success and recognition in the U.S. market can facilitate global acceptance, including in other developed and developing countries. Japanese medical device manufacturers have shown strong interest in entering the U.S. market, and the release of this report by the Japanese government is expected to heighten that enthusiasm. However, entering the U.S. market involves several challenges, including market research, partnership strategies, regulatory compliance, health insurance considerations, clinical testing, funding, and marketing. Despite these challenges, an increasing number of Japanese medical device companies, including startups, are anticipated to pursue entry into the U.S. market. 

Given the information provided above, U.S. consulting firms in this sector can benefit from Japan’s new medical device industry vision by leveraging the increased demand for specialized expertise as Japanese companies seek to enter the U.S. market. Japan’s emphasis on global expansion and the American market’s critical role presents opportunities for U.S. consulting firms that offer services in market research, regulatory compliance, and strategic partnerships. As Japanese medical device manufacturers face challenges in navigating the U.S. market, consulting firms with the relevant expertise can capitalize on this demand by providing essential support, establishing themselves as key facilitators in Japanese firms’ successful market entry and expansion efforts.

The U.S. Commercial Service in Japan can help connect U.S. firms with these opportunities and, through our SelectUSA services, can help support Japanese investment decisions in the United States. If you have further questions, please contact Office.Tokyo@trade.gov.