Breaking Down Bottlenecks in Healthcare Start-up Commercialisation

On 30 September, the Medical University of Gdańsk hosted an inspiring edition of EIT Health Morning Health Talks, focusing on one of the biggest hurdles faced by healthcare start-ups: “Bottlenecks in Commercialisation: Challenges Facing Healthcare Start-ups in Entering the EU Market.” Given that international expansion remains one of the toughest challenges for start-ups from Central and Eastern Europe (CEE), the event drew strong interest from innovators, healthcare professionals, and investors eager to explore solutions and learn from experienced voices in the ecosystem.

Common Bottlenecks Across Ecosystems

Dr. Natalie Walsh, Director of Entrepreneurial Development at the University of Galway (Ireland), opened the discussion by outlining the key bottlenecks early-stage healthcare ventures face — challenges that, interestingly, remain consistent across both emerging and mature European innovation ecosystems.

Beyond the fragmentation of EU markets, regulatory complexity, and country-specific reimbursement systems, Natalie pointed to a critical challenge: the growing demands for clinical evidence and the difficulties start-ups face with Health Technology Assessment (HTA) processes.

For many early-stage companies, the interpretation and cost of meeting clinical evidence requirements remain unclear. To address this gap, the University of Galway launched its Trials Accelerator under the new Institute for Clinical Trials. The initiative supports researchers and entrepreneurs through early-phase clinical research, evidence generation, and market readiness — offering access to experts in methodology, evidence synthesis, and health economics, as well as connections with clinical partners and grant-writing support.

Investor Insights: Turning Innovation into Impact

Adding an investor’s perspective, Sára Melicharová, Fund Manager at Life BioCEEd Medical Investments, provided an insightful overview of what makes (or breaks) a healthcare start-up in the eyes of venture capitalists. She began with a striking comparison: Europe produces twice as many scientific publications as the rest of the world, yet only 25% of global biotech start-ups originate here.

From an investor’s point of view, start-ups in the CEE region often face six recurring weaknesses:

• Weak value proposition
• Regulatory unreadiness
• Poor team readiness
• Clinical data gaps
• Lack of a go-to-market plan
• Funding gaps

Too many start-ups, she explained, focus on technology over real-world problems. Many pitches fail to articulate a clear clinical need or market demand. Globally, 42% of start-ups fail because there is no proven market need. Melicharová urged innovators to reflect on two key questions:n “Can I explain the value in one sentence? Is it validated by clinicians or buyers?” True innovation succeeds not through technology alone, but through solutions that seamlessly integrate into healthcare workflows.

Navigating Regulation and Evidence

Healthcare start-ups entering the EU market face an average delay of two to three years compared to those in the United States, largely due to regulatory and reimbursement barriers. With 27 EU member states operating under diverse frameworks, navigating certifications like CE marking, EMA/CTA approvals, and HTA assessments can be complex and time-consuming.

Start-ups often underestimate classification and certification requirements, resulting in delays and costly rework. “The right certification isn’t just a regulatory formality,” Sára noted. “It’s the essential first step toward commercialisation.” Her key advice: “Work with regulatory and HTA experts early. Don’t try to save money on this expertise — it pays off later.”

The Importance of Team and Data

From the investor’s standpoint, many early-stage ventures demonstrate strong technical expertise but often lack experience in healthcare markets, data analysis, and regulatory compliance. Building a multidisciplinary team is not optional — it’s critical to commercial success. “Innovation in healthcare is never a solo mission,” Sára emphasised. “It’s teamwork.”

Access to quality clinical data remains another systemic challenge. Underestimating evidence requirements can hinder certification, HTA approval, or investor confidence. Melicharová suggested that start-ups identify their data challenges early by asking: Will the necessary data be accessible? How can it be structured and used effectively within the rules? –  Having clear answers — and data-skilled team members — greatly improves a start-up’s credibility and readiness for investment.

Strategic Planning and Investor Expectations

A recurring issue among healthcare innovators is the lack of a clear go-to-market strategy. Many founders progress without fully understanding who their buyers are, who approves the product, or who makes the final purchasing decision — often not the same person in healthcare settings.

This lack of clarity, combined with long regulatory timelines, can lead to capital burnout. In fact, the failure rate of healthcare start-ups is two to three times higher than in other tech sectors.

To avoid this, founders should provide investors with a realistic overview of validation, certification, and revenue timelines, making it clear why healthcare innovations require longer runways. As Melicharová summed up: “Investors don’t look for perfection — they look for clarity. Real-world solutions, built for healthcare realities, backed by a committed, multidisciplinary team.”