Cross-border business development in medtech is rarely a straight line. Between regulatory complexity, reimbursement variability, cultural nuances, and market-specific needs, expanding into new regions requires more than a product—it demands a strategy.

At a recent LSI medtech conference in Europe, panelists Eliane Schutte (Xeltis), Jeffrey Sirek (PRIA Healthcare), Pieter Wijffels (NLC Health Ventures), and Sabine Kapasi (Enira Consulting), led by moderator Ajay Nair (The Mullings Group), tackled the topic head-on. Drawing from firsthand experience across Europe, the United States, China, India, and the Middle East, they explored what it takes to succeed in cross-border business development—from diligence and IP to commercialization, licensing, and culture.

Why “Build for Local” Beats “Build for Global”

“If you think about any new geography, the first thing is need assessment,” said Kapasi. “I don’t really believe in the term ‘build for global.’ You need to build for local—and apply it case by case.”

Kapasi’s firm, Enira Consulting, supports medtech companies entering the India-Asia corridor and the broader Global South. Her advice to companies entering new markets: start with the local context. That includes understanding disease prevalence, infrastructure gaps, and regulatory pathways. “Every large geography has its own regulatory approach,” she said. “Partnerships look very different depending on the region. You make revenues through those partnerships long before anything else.”

Sirek agreed, emphasizing timing and mutual fit. “Sometimes we try to force business development because it’s good for us. But if it’s not good for the partner, it’s not going to be a synergistic relationship.”

Timing Matters in Cross-Border Business Development

When should companies start thinking about going international?

“You don’t ever want to start a medtech company that doesn’t have legs globally,” said Wijffels. “But in the early days, it’s wise to crawl into your local shell, access government support, and stay focused.”

He pointed to a pivotal moment when strategics begin to take notice: clinical trials across multiple geographies. “When sales reps start hearing about you from physicians in their region, that’s when doors open.”

Kapasi added that the company’s goals should guide timing. “Are you looking for validation, commercialization, licensing, or partnerships? The strategy will look different depending on what you’re optimizing for.”

Licensing, IP, and Market Entry: Complex but Critical

Licensing can open doors—but only if approached strategically. Schutte shared her experience securing a licensing partner in China for Xeltis. “We started broad and narrowed, narrowed, narrowed. Eventually, we landed on three clear milestones, all in our control. That simplicity made the deal stronger.”

In markets like China, the panel agreed that the distribution channel is often the best IP defense. “Your channel is your protection,” said Schutte. Wijffels, who previously lived in China, added, “They don’t typically export IP-infringing products. If you don’t go, you don’t have any business anyway.”

Kapasi emphasized that protectability matters more than registration. “Registering IP is one thing. However, building a strong IP strategy that accounts for regional enforcement and partnership dynamics is another. In China, for example, your distribution partner is often your best protection. In regions like India, Southeast Asia, or the Middle East, companies may find more straightforward channels and better IP defensibility.”

Commercialization Is People-Driven

Cross-border success hinges on getting the right people in the right roles—early.

“You can’t do this from Zoom in the Netherlands,” said Wijffels. “If you’re entering the United States, appoint someone local and give them real freedom. That’s the only way to understand the market.”

Schutte echoed that sentiment. “You need to respect that others might know things better than you do. Hire people who’ve done it before—and trust them.”

Regarding APAC medtech, Kapasi described how companies like Roche have created multi-stakeholder partnerships to align market access with social impact. “We partnered with governments, NGOs, and pharma. That gave us scale, credibility, and long-term access to data and talent.”

Culture, Capital, and the Need for US-EU Alignment

Cultural understanding often makes or breaks a cross-border initiative.

“You could take a great person and drop them in the wrong market—and they won’t succeed,” said Sirek. “You need someone who understands that specific culture.”

Schutte offered a simple example: when hosting Chinese partners, bring real Chinese food, not the Dutch version. “Even small gestures show you’re trying to understand.”

Nair raised a critical point: 40% of the world’s healthtech IP is generated in Europe, but only 10% of capital is deployed there. That disconnect is driving a push for more U.S. investment in European medtech.

“If we bring in more U.S. capital, it will partially solve the cultural problem, too,” said Wijffels. “With money comes mentorship, support, and more fluid collaboration.”

Kapasi added that governments in the Global South are more open than ever. “Go through official government channels. They’re structured, transparent, and surprisingly welcoming. The ecosystems are maturing fast.”

Diligence, Adaptability, and the Value of Listening

For companies preparing to enter new markets, diligence is non-negotiable. Schutte recommended talking to other CEOs who’ve worked with potential partners. “What are their watchouts? What are their strengths? You need to understand how they operate before you commit.”

Kapasi urged companies not to be intimidated by the unfamiliar. “You can’t ignore the Global South. That’s where the market is. And governments are open to collaboration in ways they weren’t a decade ago.”

Sirek summed it up simply: “Start early. Understand the landscape. And find partners who can walk the journey with you—from concept to commercialization.”

Making Cross-Border Business Development an Art

Cross-border business development is as much about empathy and adaptability as it is about clinical data and IP. The best strategies are tailored, not templated. The best teams are diverse, not centralized. And the best medtech partnerships are grounded in shared needs, not just shared goals.

As Kapasi put it: “Culture and sensitivity begin with understanding the need—of the region, of your partners, of the patients you aim to serve. That’s the art.”

Want more insights from the global medtech leaders shaping the future? Join us at our next medical device conference, June 10–13, in Singapore.