Increasing Demand for Rapid HTA and Evidence Synthesis Among MedTech Startups

Across Europe, early-stage medtech and digital health companies are facing increasing pressure to demonstrate value earlier in their product development cycles. This shift has led to a substantial rise in demand for rapid HTA, rapid literature reviews, and targeted evidence synthesis, particularly among startups preparing for investment rounds, regulatory submissions, or early market access discussions.

According to industry observations, interest in rapid assessment approaches has grown by more than 30% since 2024—an upward trend driven by accelerated innovation cycles, expanding digital health markets, and evolving payer expectations.

Why medtech startups are turning to rapid evidence generation

Unlike traditional pharmaceutical development, medtech innovation—especially in digital health, diagnostics, and devices—typically moves at a much faster pace. As a result, early-stage companies often require quicker, more flexible approaches to assess and demonstrate the value of their technologies.

Several key factors explain this growing demand:

1. Investor expectations for early evidence

Venture capital and strategic investors increasingly seek robust, data-driven evidence before committing funding. Rapid HTAs and targeted reviews allow startups to:

• validate their clinical and economic value proposition,
• map unmet needs and comparator technologies,
• and articulate a credible market access pathway.

This can significantly strengthen investor presentations and due diligence packages.

2. Earlier engagement with payers and HTA bodies

As the EU HTA Regulation moves closer to implementation, companies are preparing earlier for discussions with health systems. Rapid evidence synthesis helps innovators:

• understand country-specific reimbursement environments,
• identify evidence gaps,
• and anticipate the expectations of payers across Europe.

Startups developing AI-driven diagnostics and digital therapeutics are particularly active in this area.

3. The need to refine product strategy and positioning

Rapid assessments provide valuable insight into:

• how their technology compares with existing alternatives,
• what real-world data will be needed later,
• and which clinical outcomes are most relevant for HTA decision-makers.

This insight allows teams to tailor product development and trial planning to align with future market access requirements.

4. Accelerated regulatory pathways

Regulatory frameworks for digital health and novel diagnostic tools—such as the EU MDR, IVDR, and emerging AI regulations—are increasingly encouraging early clinical and economic evidence generation. Rapid HTAs help startups understand how regulatory and HTA expectations intersect.

What rapid HTA typically includes

While rapid assessments vary depending on the technology and client need, they often include:

• targeted literature review of clinical effectiveness and safety,
• assessment of comparators and standard of care across key markets,
• early economic insight (e.g., cost drivers, potential value proposition),
• identification of evidence gaps and feasibility of future data collection,
• mapping of reimbursement landscapes and potential barriers.

These deliverables usually have a turnaround time of 4–8 weeks—significantly faster than full HTA or systematic reviews—making them attractive for early-stage companies with tight timelines.

Strong growth in digital therapeutics and AI-based diagnostics

The steepest rise in demand comes from:

• digital therapeutic (DTx) developers,
• AI-enabled radiology and pathology tools,
• remote monitoring platforms,
• and highly specialized diagnostic devices.

These domains often encounter rapidly evolving evidence requirements and high scrutiny from payers. Rapid synthesis helps them stay competitive and aligned with emerging standards.

Challenges startups face when generating rapid evidence

Despite the benefits, startups often encounter obstacles such as:

• limited internal expertise in HTA or health economics,
• absence of clinical data beyond pilots or feasibility studies,
• difficulty identifying appropriate comparators across countries,
• navigating inconsistent reimbursement pathways.

As a result, many companies seek external support from specialized consultancies to fill methodological and capacity gaps.

IS4Health’s perspective

The increasing demand for rapid HTA and evidence synthesis reflects a broader shift toward evidence-led decision-making in the medtech and digital health ecosystem. At IS4Health, we are supporting startups by providing:

• rapid literature reviews,
• early economic assessments,
• tailored HTA guidance for digital and AI-driven technologies,
• and clear recommendations for next steps in evidence generation.

This ensures that innovators have the right information at the right time—whether they are preparing for investor discussions, regulatory interactions, or early market access strategy.

We expect this trend to continue rising through 2025, driven by evolving HTA standards, fast-paced digital innovation, and more stringent payer expectations.