Understanding the Path to U.S. Market Access
International med tech companies have a chance to expand their presence within the world’s largest healthcare market (the USA); however, they face considerable obstacles. According to experts at LSI Europe (a medical device and diagnostics development consulting firm), access to the U.S. market is only possible through successful commercialisation through a structured commercial strategy, regulatory planning and execution.
Essentially, companies new to doing business in the U.S. should give careful consideration to the following potential pitfalls early in their journey:
(1) building the right internal organisational structure;
(2) defining the gaps they will have in their key management positions; and
(3) determining the post-FDA commercialisation readiness of the company.
Most med-tech start-party companies incorrectly believe that developing superior technology is sufficient for success; they grossly underestimate how important it is for them to be commercially ready.
Regulatory Considerations for U.S. Market Access
When companies enter the U.S. healthcare market, they can create or select a regulatory plan to achieve their product through regulatory strategy. Companies must determine which of the two regulatory strategies will be their priority in obtaining both U.S.-based FDA approval or European-based MDR certification.
Some key observations to note include:
1. FDA 510(k) pathways are generally quicker and more cost-effective than MDR certification in Europe
2. MDR certification in Europe can require a much longer and more expensive process to obtain than the FDA
3. Companies should engage the FDA through Q-sub meetings to help determine and reduce any uncertainty of their approval strategy
4. Obtaining direct regulator feedback will assist in refining their overall approval strategy
5. U.S.-first strategies are becoming increasing the popular choice of Med Tech innovators.
The regulatory strategy selected by companies is going to directly correlate with the speed of entry into the market by Med Tech devices in the U.S.A.
Economic Differences: Selling in the U.S. vs. Europe
The economic environment in the U.S. differs significantly from Europe, especially in healthcare purchasing behavior. While European systems prioritize cost control, the U.S. market focuses more on revenue generation and innovation adoption.
Key differences include:
- U.S. hospitals focus on revenue growth, not just cost reduction
- European healthcare systems prioritize efficiency and budgeting
- U.S. buyers are more open to adopting innovative med tech devices
- Key opinion leaders (KOLs) strongly influence purchasing decisions
- Faster adoption cycles in the U.S. compared to Europe
These dynamics make the U.S. an attractive but highly competitive market for medtech startups.
Building the Right U.S. Team
Establishing a robust localized foundation is critical for achieving success in the United States as many companies from outside the U.S. will find out the hard way when their initial effort to run their operations in the U.S. from their global headquarters fails miserably due to a lack of understanding and/ or inability to be physically present and operate their business without a localized presence.
- Establishing an effective local presence requires the following:
- Hiring experienced, seasoned U.S.-based commercial leadership;
- Establishing a dedicated local on-the-ground sales force;
- Utilizing local industry networks to help accelerate the company’s entry into the local market;
Recruiting local senior executives who have experience in the medical tech space and are familiar with the local market;
Having alignment between global and U.S. corporate methodologies;
Local management teams make it increasingly easier for medtech startups to exponentially grow and excel in their utilization of and resolution of the complexities associated with the U.S. healthcare delivery system.
Achieving a Successful Exit in the U.S. Market
The majority of companies are focused on acquiring or exiting U.S. from their perspective. The issue is that the level of expectation from investors has shifted greatly over the past several years.
Some of the significant points to take from this include:
– Revenue traction before acquisition is critical
– Early commercialisation of your product increases interest in potential investment
– Continuously executing well will establish a level of trust with strategic buyers
– The use of KOL’s (Key Opinion Leader’s) to help establish your credibility in the marketplace
– Competitive pressure can help provide acquisition offers
– Conference representation will support you in establishing your strategic positioning
The most innovative medical technology companies focus on their ability to be both innovative and execute successfully in order to provide maximum potential for exit.
Long-Term Strategy for U.S. Market Success
To achieve long-term success in the US Health Market, a company must first have an effective plan for US Market Entry; be successful at executing that plan; and maintain a disciplined process to ensure continuous alignment between the company’s innovation strategy and its commercial strategy.
Companies that do not consider U.S. expansion early in the development cycle will often find themselves struggling to catch up with their competition.
Some of the key strategic priorities for companies pursuing U.S. healthcare commercialization are:
- Plan for U.S. market entry during early phases of development cycles.
- Align regulatory and commercial strategies.
- Develop strong relationships with stakeholders in the U.S. healthcare market.
- Increase the company’s presence within the medical tech industry.
- Ensure that companies have a path (e.g., scalable) to support growth for medtech startups.
A disciplined approach to execution will allow companies to take full advantage of the world’s most competitive healthcare market.
Industry Insights from LSI Europe 2026
During LSI Europe 2026, experts within different sectors stressed that there is no one-size-fits-all approach to succeeding in the United States market. Nevertheless, companies who aim for regulatory certainty, possess effective leadership and are commercially prepared will greatly enhance their chance of success.
In addition, the participants agreed that the market access should be treated as a fundamental strategic priority and not simply as an afterthought by foreign entities entering the United States particularly in the rapidly evolving medical technology sector.