How to achieve commercial viability for the U.S. healthcare market

LIOF, Brightlands Maastricht Health Campus and RQR Advisors are organizing an exclusive two-day workshop to prepare medical companies for the U.S. market. The U.S. market is attractive to European manufacturers of medical products due to its extensive healthcare expenditure and strong demand for advanced products and technologies. Due to the challenges on the European MDR-regulations, more and more medical companies consider going to the U.S. market parallel to or even before the EU market.

With the U.S. being the largest healthcare market in the world, successful access offers the opportunity for significant revenue growth. With only four percent of the world's population, it represents roughly half of the $ 8 trillion worldwide health care economy.

Additionally, FDA approval can serve as a globally recognized standard for quality and safety, strengthening the reputation of products and facilitating access to other international markets.

For European manufacturers of medical products it’s crucial to thoroughly prepare for the U.S. market due to the FDA's strict regulations, which require extensive documentation and clinical data. Good preparation is crucial to manage the high costs and complex procedures of approval and market entry.

In this two-day workshop, American experts from RQR Advisors address key topics that characterize the U.S. market and that are crucial to prepare for. And they'll come to the Netherlands especially for this workshop!

• Is there a market need for the technology and the various layers of the competitive landscape?
• Will healthcare companies and consumers believe they need the technology?
• Is there a pathway for coding, coverage and payment?
• How does the founder align the marketing claims with the regulatory claims and then choose the correct regulatory pathway?
• Are there key opinion leaders who will champion the product?
• Will medical societies adopt the new technology as the new standard of care?
• Is there a strategic buyer thas has an unmet need for the product in its existing portfolio?

By understanding and addressing these questions at an earlier stage in the development pipeline, founders and investors can decrease the risk of failure and increase the likelihood of success.

The workshop will take place at the congress center MECC Maastricht.

You'll find the program here.

All SMEs in the medical sector with the ambition to bring their medical innovation to the U.S. market.
This workshop is particularly for SMEs from the south of the Netherlands and the surrounding border regions in Belgium (provinces of Limburg and Liége) and Germany (StädteRegion Aachen).

The costs for participating this workshop are dependent on the number of participants per company:

1 participant: € 300,- p.p.
2 participants: € 275,- p.p.
3 participants: € 250,- p.p.
> 3 participants: € 225,- p.p.
The ticket price is including taxes and ticketing service fee.

LIOF uses Eventbrite for the registration and payment of tickets for the workshop. After placing your order you will receive a receipt from Eventbrite​​​​​​​.

Cancellation policy

In case you cancel your order:

• Latest on November 8th, LIOF will refund the costs except for the ticketing service fee;
• After November 8th, there will be no refund.

Host or Publisher LIOF and Brightlands