Seeking new markets: unique opportunities for medical innovations in the US

Tightened European regulations for medical products are causing more and more companies to set their sights on the U.S. market. The workshop "How to achieve commercial viability for the U.S. healthcare market" on November 19 & 20, organized by LIOF, Brightlands Maastricht Health Campus and RQR Advisors, responds to this growing need.

"During a two-day workshop, medical companies will receive tools that will help them successfully launch their innovative products in the United States," says René Kessen, business developer and transition lead health at LIOF. In this article, he provides more insight into the format and importance of this new event.

European rules force new markets

The new European Medical Device Regulations (MDR) have created major challenges for many companies. "The MDR has significantly tightened the requirements for medical products," explains René. "Not only new products, but also products that were already on the market have to be certified. And that process is extremely slow. We know that many companies have to wait a long time to certify their new products."

Because of these obstacles, companies are looking for alternatives, and that is often the United States. "The U.S. Food and Drug Administration (FDA) has strict rules, but once you get through that certification process, the whole U.S. market is open to you," Kessen adds.

Why the U.S.?

"Since the U.S. is the world's largest healthcare market, successful access offers the opportunity for significant revenue growth. With only four percent of the world's population, it represents about half of the $8 billion global healthcare economy. In addition, FDA approval can serve as a globally recognized standard for quality and safety, enhancing the reputation of products and facilitating access to other international markets," Kessen said.

Keynote speaker: Michael Phalen

During the event, attendees will receive information from experts with in-depth knowledge of the U.S. market. One of the speakers is Michael Phalen, Chairman of RQR Advisors and former Executive Vice President at Boston Scientific. "Michael Phalen is a heavyweight in the U.S. medical industry," says Kessen. "His knowledge and experience in building companies and navigating the U.S. healthcare market are invaluable." In addition to Phalen, other experts will share their insights and advice on commercial strategies for the U.S. market.

An event that transcends borders

Although the event is initially aimed at companies from Limburg, the scope is broader. "We are also offering this workshop to companies from the provinces of North Brabant and Gelderland and the Belgian and German border regions," said Kessen. "The challenges surrounding the MDR cross borders, so it made sense to broaden our scope to companies outside of Limburg. The response from regions such as Belgian-Limburg and German Aachen has been very positive."

The workshop will be led by RQR Advisors, a consulting firm specializing in the commercial viability of health innovations in the U.S. market. RQR Advisors has offices in the U.S. and in the Netherlands. During the workshop, their experts will cover key topics and provide practical guidance for successful market entry.