Considering Entering the European Market?
5 Common Mistakes to avoid
Eric Rambeaux, CEO
January 9th, 2025
Europe represents 25% to 30% of the global healthcare market. It is quite a significant opportunity for non-European startups or SMEs aiming at scaling up internationally. Yet, too often, startups stumble into common pitfalls. This article outlines five critical mistakes to avoid:
1. Overlooking Cultural and Administrative Diversity
Europe does not exist. United States of America, China, Japan, France do. Europe does not. It is a political and intellectual construction. Europe has a rich history and cultural diversity but with over 40 countries, 20+ languages, and varying administrative systems, assuming Europe is a single, homogeneous market is a costly mistake.
The Pitfall: Underestimating local cultures and administrative practices as well as local business specifities.
The Fix:
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Invest in understanding Europe as such as well as the nuances of your target countries from a business, cultures and administrative standpoint.
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Engage local, country based, not “Europe Based” experts. They can help you navigate the cultural and bureaucratic maze effectively.
2. Choosing the Wrong Entry Strategy
In expanding to Europe a question that keeps coming back is whether to enter alone or through partnerships. This only the tip of the strategic iceberg. The key two questions that need to fit both the opportunity business case and company culture are:
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Level of integration: Is the company willing to delegate or does it want to be in control?
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Mode of introduction: is it a short term transaction deal or a long term structural deal (inc. greenfield / brownfield).
Each option carries its own risks and rewards, and a one-size-fits-all approach is a recipe for failure(1).
The Pitfall: Entering without a clear, fact based understanding of the consequences of this choice.
The Fix:
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Evaluate key questions before choosing your entry approach: balance the expansion opportunity with company culture, experience and objectives.
3. Neglecting Regulatory and Market Access Alignment
Securing approval (EMA authorization or CE Mark) is an important milestone. But it is only the first step. Not having a clear market access plan is the guarantee the your product will fail to reach patients effectively.
The Pitfall: Treating regulatory approval and market access as separate processes.
The Fix:
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Align your clinical plan with both regulatory and reimbursement needs. This can save significant time and resources down the road
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As long as the new European HTA in not fully in place(2), leverage benchmark countries (e.g. France), where demanding reimbursement standards often translate well across other European markets.
4. Relying on Assumptions Instead of Data-Driven Decisions
Entering the European market requires precise planning and an fact-based approach. Too often, startups rely on shortcuts or preconceived ideas about which countries or strategies will work best. Selecting UK simply because of the language for US companies or assuming that larger markets like Germany are automatically the best choice is a common mistake.
The Pitfall: Choosing entry countries based on convenience rather than best possible business case.
The Fix:
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Use a data-driven approach to prioritize markets based on factors like market size, regulatory complexity, and competitive landscape.
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Avoid generalizations. Even within a single country, regional differences can affect success. (e.g. Italy’s fragmented healthcare system or Spain’s regional reimbursement variations).
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Engage European experts with no country bias that will rely on facts. Run away from local organization or consultant that try to “sell” you a country.
5. Failing to Consider Non-Dilutive Funding Opportunities
Europe is home to a wealth of non-dilutive funding opportunities, such as grants and public funding programs. They represent a significant source of resources that must be leveraged.
The Pitfall: Overlooking these resources or assuming they’re too difficult to secure.
The Fix:
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Work with advisors or consultants familiar with country specific or European grant applications to identify funding programs improve your chances of success.
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Use funding strategically to offset R&D cost when appropriate.
Europe offers a wealth of opportunities for healthtech. However, the complexities of its diverse cultural, regulatory, and market landscapes demand a thoughtful approach.Before considering Europe, do your homework: Understand the region!! Do not get into analysis paralysis but make sure you have a clear fact based understanding before starting any implementation.
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Read more in “Jean Paul David, Comment développer les marchés internationaux – Editions Transcontinental“
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As of Jan 12th, 2025, European authorities will start to implement a European Assessment for drugs and medical devices. This will slowly as the implementation this impact this dimension (https://www.has-sante.fr/jcms/p_3545447/fr/reglement-europeen-sur-l-evaluation-des-technologies-de-sante).
#InternationalExpansion #EuropeanMarket #BusinessStrategy #HealthTech #EuropeanRegulations #MarketAccess #NonDilutiveFunding