Navigating Regulatory and Commercial Hurdles Across Borders: Insights from the MedTech Malta Luncheon

Today, at the Mediterranean Conference Centre in Valletta, Malta, a select group of industry leaders and decision-makers gathered for an exclusive luncheon on the critical topic of cross-border regulatory and commercial hurdles. Held as part of the MedTech Malta 2024 conference, this invite-only event, was hosted by Goodwin, a global law firm renowned for its expertise in the life sciences and healthcare sectors, and MedTech Impact Partners (MIP), a leading firm specialising in medical device regulatory strategies. The luncheon offered a platform for engaging discussion on the complexities faced by medical technology companies as they navigate the challenging landscape of U.S. market entry – while connecting over a catered menu.

The discussion focused on the “Gateway to the United States.,” with a particular emphasis on the evolving regulatory environment in the U.S. and the strategies companies need to employ to succeed across borders. Martin Gomez, Partner at Goodwin, highlighted the shifting landscape, noting that European companies are increasingly entering the U.S. market at earlier stages in their development. “We’re advising companies earlier in their lifecycle, which involves critical decisions around regulatory strategies, fundraising, and commercial hurdles,” he explained.

For many, understanding and addressing regulatory requirements early is crucial to success. Kwame Ulmer, Managing Partner at MIP, stressed the importance of having a thorough regulatory strategy. “We’ve worked with over 70 companies globally, and more than 60 percent of our clients are outside the U.S. We pride ourselves on being responsive and understanding the nuances of the FDA,” Ulmer shared, underscoring the firm’s role in helping medical device companies navigate the complexities of U.S. regulations.

Insights from industry leaders

The discussion was enriched by the experience of industry executive Martin Grasse, CEO of Gradient Denervation Technologies, a Paris-based company that specialises in medical devices for pulmonary hypertension. Grasse shared his company’s approach to U.S. market entry, stressing the importance of early FDA engagement. “We’ve always taken an FDA-first approach, knowing we’ll eventually commercialise in Europe, but the U.S. market requires a heavy lift for FDA approval,” he explained. Grasse’s company has been working closely with the FDA, engaging in pre-submission processes to understand expectations and refine their strategies.

A changing investment landscape

The conversation also delved into the evolving dynamics of medical device investments. As regulatory landscapes shift, investor expectations also change.

Grasse reflected on the differences between European and U.S. investors. “I’ve found that European investors are more open to early-stage investments without data, whereas U.S. investors often require early human data before they commit,” he said, pointing out a key challenge for companies seeking funding in the U.S. He stressed the importance of having a well-developed U.S. story, even for non-U.S. companies, to attract American investors. “It’s essential to have a U.S. presence and a clear U.S. strategy to build investor confidence,” he added.

Gomez also noted that U.S. investors are now asking for more data than ever before. “We’re seeing a trend where institutional funds are requesting more data earlier in the process, which is leading to a more fragmented investment landscape in the U.S.,” he explained.

Ulmer echoed this sentiment, pointing out that U.S. investors are increasingly looking to co-invest with other U.S. investors as a sign of credibility. “For U.S. companies, there’s a preference to invest alongside other U.S. investors, and this co-investment scenario is often seen as the dream for raising funds,” he said.

The Importance of Market Access

The panel also focused on the critical importance of having a clear market access strategy. Ulmer pointed out that simply splitting time between the U.S. and Europe is not enough. “It’s not just about being in both markets; it’s about showing that you are fully committed to each market, especially the U.S.,” he said. According to Ulmer, having strong U.S. partnerships, such as collaborations with law firms and regulatory experts like Goodwin, can help reassure U.S. investors about a company’s commitment to the U.S. market.

For companies planning to enter the U.S., the panellists agreed that establishing a solid U.S. story is key. This includes ensuring that the company has a U.S. presence, whether through a subsidiary or through U.S.-based clinical operations. Grasse, for example, underscored the importance of Gradient Denervation Technologies’ U.S. operations in Minneapolis, noting that such a presence has been essential in securing investor interest and building a successful market access strategy.

As the luncheon concluded, the audience absorbed key insights on the importance of being strategic and adaptable, especially when expanding into the highly regulated U.S. market, and learned that collaboration between regulatory experts, investors, and industry leaders is more than ever crucial for success.

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