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

19 november 2024 - 20 november 2024
Locatie
MECC, Maastricht

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 through the button below.

Register

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.

The workshop is in English.

Day 1 | 19 November

08:15Registration

09:00Welcome & Overview
Rudiger Mees

09:15USA Commercial Viability: What is it and how do I achieve it?
James Sargent

10:30Break

10:45Perspectives from the C-Suite: How do I get the attention of a strategic buyer?
Mike Phalen

12:00Lunch

13:00The Physician's Perspective: Improving quality of life in a profit-driven healthcare system
Kelvin Hensler, M.D.

14:15Break

14:30Marketing & Regulatory Claims: Aligning the FDA Strategy with Commercial Opportunity
Laurie Lewandowski & London Krueger

16:30End

 

Day 2 | 20 November

09:00How do I get Paid? Unlocking the coding, coverage, and reimbursement mystery
Jay Stracke

10:30Break

10:45Cap table considerations
James Joslin

12:00Lunch

13:00Case Studies: Working through 3 founder fact patterns*
RQR team and Attendees
(*) case studies selected from questionnaires completed by attendees at conclusion of Day 1

16:00Networking

17:00End

 

Register

You can register through the button below.

Register

Who can participate?

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).

Costs

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.
About RQR Advisors

The workshop is led by RQR Advisors, an advisory firm specialized in the commercial viability for the U.S. market of early-stage health innovations. RQR Advisors has offices in the U.S. and in the Netherlands. In this twoday workshop, the experts from RQR Advisors address key topics that characterize the U.S. market and that are crucial to prepare for. For more information, go to www.rqrcapital.com.

Source: LIOF