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The United States has long been medtech’s largest and most complex market. For manufacturers and distributors considering entry to the U.S. market, true and comprehensive preparation is more important than ever. This involves extensive market analysis, a deep understanding of regulatory requirements, and other potentially difficult measures. So how can you set yourself up for success?

In this three-part series, our industry experts reveal everything you need to know to enter the U.S. market and find the right partnerships for your products. You’ll learn how to conduct thorough market analysis, what regulations and certifications are required, and how to chart a successful sales and branding strategy to lay a foundation for growth.

Part 1: Understanding the U.S. Medtech Market: Look Before You Leap

Learn how to successfully enter the U.S. market, including what questions you should be asking, how to maneuver the regulatory landscape, how to manage payers, and plan for reimbursement.
Hear from Mark Lesselroth, President and CEO of BioPortUSA as he details the in-country guidance you need to succeed including:

  • The complexity and dynamic nature of the U.S. healthcare market
  • How to successfully enter the U.S. market, including what questions you need to ask before entering, regulatory requirements to be aware of, developing the right commercialization strategy, and more
  • How to create a U.S. market entry checklist
  • Managing payers and planning for reimbursement

Mark Lesselroth
President and CEO

Mark is the President and CEO of BioPortUSA, commonly known as the gateway for life science companies into the United States. He has been instrumental in securing and building relationships for massive international companies like Siemens and start-ups developing breakthrough technologies for the U.S. healthcare market. Mark excels at bridging transatlantic relations that yield positive outcomes. Mark has been a featured presenter at BIO, MEDICA, Bionnale, bw-I, Medical Mountains, MedTech Bridge, WILCO, Bio-M, GACC NY, BIO Deutschland, and Upgraded Health. He is a peer reviewer for the Johns Hopkins Bloomberg School of Public Health, and is an active participant in several life science clusters both in the USA and Europe. When he is not traveling the world, he resides in Syracuse, NY with his wife and three children. In his free time, he enjoys tennis, golf, and good food.