A panel at LSI USA ‘24 brought together industry leaders to explore strategies for expanding internationally, addressing regulatory challenges, forming partnerships, and securing reimbursement. Here are six key points from the discussions to help navigate the global medtech market.

Market Preparation and Prioritization

Emerging medtech companies must carefully select international markets by considering regulatory environments and local market dynamics. David Webster of Body Vision Medical stated, "You often come across dealers who feel they can cover all of Europe, but Europe differs from state to state. Despite us wanting to look at Europe like the United States, you need to find country distributors." This insight underscores the necessity of a tailored approach for each region, ensuring that companies are well-prepared for the unique challenges and opportunities each market presents.

Navigating Regulatory Complexities in the Global Medtech Market

The introduction of the EU MDR has presented significant challenges for the life sciences industry, but early planning and dialogue can help navigate these complexities. Matthias Bellmann of TUV SUD emphasized, "Come talk to us, come talk to us early. The MDR now gives us the opportunity also to talk to you. Even if you're talking about submission in 2026, now would be a good time to reach out." This proactive approach can help medtech companies mitigate risks and streamline the regulatory approval process, ensuring smoother market entry.

Importance of Strong Local Partnerships

Building strong, mutually beneficial relationships with local partners is vital for successful market entry. Kevin Chu pointed out, "You have to find people you trust—and there’s no shortcut for doing that except to spend the time, go to the local market, and talk to people in those spaces." Trustworthy local partners can provide invaluable insights into regulatory requirements, market dynamics, and business practices, facilitating smoother and more efficient market penetration.

Reimbursement as a Commercial Risk

Reimbursement has become a more significant commercial risk than regulatory approval for early-stage innovators. Ryan McGuinness noted, "Reimbursement has leapfrogged the regulatory risk—especially in the United States. It's become a very important part of a company's existence." Companies must now prioritize understanding and securing reimbursement to ensure commercial success. This shift in focus highlights the critical role of financial planning and strategy in the global medtech market.

Challenges and Opportunities in Asian Markets

Entering Asian markets, particularly China, Japan, and Korea, presents unique hurdles and opportunities. Kevin Chu emphasized the importance of local insight, stating, "No Western company should ever try to do it alone. The best source of information is the distributors on the ground—talk to the people who are actually working in those local markets." This local knowledge is invaluable for navigating regulatory and market entry challenges, ensuring that companies can effectively tap into the vast potential of the Asian medtech market.

Balancing Costs and Market Needs

Balancing the costs of entry and operation with market needs is critical for global expansion. David Webster highlighted the stark differences between markets, stating, "In the United States, it’s about how much revenue can be driven out of it. When you leave the US and go elsewhere, it’s about how to lower the costs." Understanding these dynamics helps tailor strategies to different markets, ensuring that products are economically viable and aligned with local needs.

Conclusion

The full recording of the panel can be found in LSI’s resource hub at the link below:

• International Expansion, Market Development, and Cross-Border Partnerships in the US, EU, and APAC 

These discussions demonstrate the importance of strategic planning, local partnerships, and understanding regulatory and reimbursement landscapes for successful expansion into the global medtech market. By focusing on these areas, medtech companies can navigate the complexities of international markets and achieve sustainable growth.