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.

U.S. market is attractive

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. 

Workshop

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. They will be travelling to the Netherlands exclusively to give this workshop!

The workshop is in English.

Register

You can register via this link.

Key questions addressed in the 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.

Location

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

Program

You’ll find the program below.  You can also download the program with an overview of the speakers here.