Say yes to the US! Register now for session 4 of our internationalization program

MEDVIA announces US internationalization program for 2024: workshop series + US mission

Updated 2 April 2024

MEDVIA is pleased to announce our new internationalization program for 2024. “Say yes to the US” is a seven-part series on breaking into the US market, organized in partnership with Smart Hub Flemish Brabant and MEDVIA member Crowell & Moring.

The monthly series began in January and will culminate with a mission to one of America’s healthtech hubs in the second half of October, taking in events and visits to clusters and accelerators.

Why a program on the US?

The regulatory environment in Europe for healthtech innovations can be complicated and time-consuming, while the US is home to a large single market. This means that some start-ups should consider launching their product in the US first. Other companies will be looking to expand their market beyond Europe.

For some innovations, faster impact can be achieved in the US, and can also be more lucrative. Reimbursement policies are streamlined, making building a business case easier and faster. If you want to get your company going and raise the capital to launch in your home market, the US can be an excellent place to start.

Even for R&D companies without products to put on the market, keeping an eye on the US is important. Non-dilutive R&D funds for starters and scale-ups through government grants and funding is definitely worthwhile to follow! Every session will feature special guests who are experts in the topic.

When and where are the sessions?

The sessions take place monthly until June in either Brussels or Flemish Brabant. The final gathering, early in September, will be a preparatory session for a mission MEDVIA organizes to the US. The date for this session will be communicated soon.

The mission to the US will take place over one week in the second half of October. We are planning to select a trade show or conference that brings the most value to our members.

In the meantime, you can register for all of the sessions now! While it is the intention that you attend all the sessions – especially if you are planning to join the mission – you are allowed to register for the sessions of your choice.

Session 4: Navigating FDA regulations
25 April, 14.00-17.30
Crowell & Moring, 7 Rue Joseph Stevens, Brussels

Session 4 is dedicated to dealing with America’s Food & Drug Administration (FDA). Legal experts and company leaders will talk about FDA clearance, tips for submitting a file and explaining the key differences between Europe’s CE label and US health and safety labels.

The program for session 4

14.00  Registration and coffee

14.30  Linda Malek and Jason Johnson of Crowell Health Solutions on FDA Requirements
            Kyun Thibaut of Covartim on FDA submission process

16.00  Panel: Key Differences between CE marking and FDA certification process

16.45-17.30  Networking reception

Register for session 4 here

 

 

Future session dates and topics:

Session 5: Important regulatory & strategic considerations / Geopolitical situation, reimbursement, US healthcare system
30 May / Register here

Session 6: Forward thinking / How the US views emerging technologies, US-specific opportunities
27 June / Register here

Session 7: Preparing for mission to the US
September, date TBA

Who can attend the internationalization series?

Say yes to the US, which includes the seven-part series and the mission to the US, is open to all healthtech companies wanting to learn more about doing business in the US. Companies should be involved in R&D activities. It is possible to attend all or part of the sessions, whether or not you attend the mission in the autumn. It is also possible to join the mission without participating in the sessions. Though if plan to join us for the mission, we highly recommend joining us for the sessions!

How much does it cost?

MEDVIA members:  Free
Companies in Flemish Brabant:  Free
Members of BioWin or Lifetech.Brussels:  €175 per person per session
Others:  €250 per person per session
Exception: Session 3 takes place as part of an event hosted by the American Embassy in Belgium. Therefore, there is no charge for anyone to attend this session

Sessions are free for MEDVIA members and for companies based in Flemish Brabant. This is due to a partnership with Smart Hub Flemish Brabant. A no-show fee of €250 will apply to organizations attending for free. There is an exception for Session 3 (see above).

Anyone planning to take part in the mission is advised to set aside some €5,000 for travel, accommodation and event fees. We will communicate later about any subsidies or discounts that might be available.

Mission to US

The US Mission will take place from 16-23 October, 2024.

  • 16-19 October: Hub visit, New York City, NY
  • 20-23 October: HLTH US Conference, Las Vegas, NV

For updates on this event and to register, click here. Detailed program to come!

Previous sessions

Session 3: Choosing a landing site / Meet MEDVIA’s partner hubs
27 March, 11.00-13.45
BNP Paribas Fortis, 1 Rue de la Chancellerie, Brussels

Program, session 3:

  • Matthew Moisan, partner at Crowell & Moring’s New York office
  • State Representative Panel Discussion: Hub hotspots
    Panelists: Marine L’Herrou, Empire State Development, New York / Geert Hovens, representing the Pennsylvania Office of International Business Development / Ellen Kraft, Managing Director, Georgia Department of Economic Development / Nils Künkler, Consultant FDI European Office, Wisconsin Economic Development Corporation
    Moderator: Antje Abshoff, Managing Director International Business Development, Virginia Economic Development Partnership


Session 2:
Entry strategies and considerations
29 February, 14.00-17.30
Crowell & Moring, 7 Rue Joseph Stevens, Brussels

Program, session 2:

  • Market Entry Strategies by Lex Eley, Partner at Crowell & Moring, Washington, DC
  • Case studies panel: When and how to enter the US market
    Panelists: Peter Kinhan, CEO of Dermicus / Lex Eley, Partner at Crowell & Moring / Ward Servaes, co-founder of moveUP
  • Networking drink


Session 1:
Why go to the US?
25 January, 14.00-17.00
De Hoorn, Sluisstraat 79, Leuven

Program, session 1:

  • Introduction to the series
  • Doing business in the US and working with Americans: Real-world experiences and insights
  • Case studies panel: Why didy ou launch in the US? Featuring: Jan Verheyden, VP Partnerships at Icometrix / Kathleen Verleysen, CEO of miDiagnostics / Julien Penders, COO of Bloomlife


MEDVIA’s greater strategy

Say yes to the US is part of MEDVIA’s Tackling Global Markets strategy. This strategy is one of several we will be rolling out in 2024. What are the others? We’re glad you asked:

  • Tackling the Home Market (BE/EU)
  • The Future of Healthcare (Futureproofing the Belgian healthtech sector)
  • Money, Money, Money (Getting funding, including our project calls) 

MEDVIA will position our programming in 2024 within these strategies.

Say yes to the US is held in partnership with: