Turning Divergence into Advantage: U.S. Market Entry Strategies for Irish Life Sciences Companies

AGG International practice chair and leader of the Island of Ireland practice, Mike Burke, authored an article for Ireland Inc. examining how Irish life sciences companies can capitalize on regulatory differences when expanding into the United States.

Rather than viewing divergence between European and U.S. regulatory frameworks as a barrier, Mike explains how companies can use strategic planning to create business advantages and accelerate growth.

“The U.S. system also rewards early, structured interaction through mechanisms such as pre-IND and similar meetings, so teams may need to build sustained regulatory dialogue — and the internal resources to support it — into the business plan at a much earlier stage,” said Mike. “Irish life sciences companies can turn this divergence into an advantage by using sequencing strategically. For some Class II devices, a CE-first strategy allows earlier commercialization in Europe, generation of real-world performance data, and refinement of health-economic evidence before tackling a 510(k) or De Novo submission in the United States.”

For life sciences companies considering U.S. expansion, understanding the interaction between regulatory requirements and business strategy can influence market access, fundraising opportunities, and operational efficiency. Mike provides practical guidance on how companies can evaluate those considerations before entering the market.

To read the full article, please click here.