GENERAL INFO

Level C: Late-Stage MedTech

At the late stage, large MedTech companies focus on full regulatory approval, market entry, and large-scale adoption. The project has moved past feasibility and clinical validation, and now the priority is to secure reimbursement, integrate into healthcare systems, and scale globally. At this level, credibility is high, but so are the stakes: global competition, complex regulatory pathways, and diverse healthcare markets demand careful strategy. Success depends on leveraging the company’s global footprint while ensuring local adaptation to hospital workflows, payer systems, and cultural contexts.

Key Milestones at This Stage

Execution of clinical pilots or multicenter feasibility studies.

Generation of clinical evidence to support MDR/FDA pathways.

Refinement of the business model and reimbursement strategy.

Establishment of strategic partnerships with hospitals and payers.

Internal preparation for manufacturing scale-up and compliance audits.

Alignment of sales and distribution channels for market entry.

 

Best Practice from the Field

A late-stage MedTech project successfully leveraged multicenter clinical trials and early engagement with payers to secure both regulatory approval and reimbursement.

By tailoring the solution to local hospital workflows and health system requirements while coordinating global rollout efforts, the team was able to achieve rapid adoption across multiple markets. This example demonstrates how integrating clinical validation, regulatory strategy, and local adaptation is critical for scaling health technologies internationally.

Pitfalls to Avoid

Avoid evidence gaps by conducting robust multicenter clinical trials and publishing results. Ensure reimbursement readiness by developing payer dossiers alongside clinical studies.

 

Enabling environment for Digital Health Innovation

Identify your national regulatory authority and how its processes align or differ from EU-wide rules.

Position yourself as an integration partner — don’t just deliver a product, help it connect with existing systems.

Learn how to prepare dossiers that speak not only to regulators but also to payers.

Offer training and ongoing support alongside technology. This reduces fear and increases adoption.

Adapt global solutions to local gaps. CEE-specific tailoring can be a strong competitive advantage.

Design products that are energy-efficient, use recyclable materials, or optimize clinical workflows. For example, a connected medical device could be built with low-power chips and packaging that reduces plastic waste. At the same time, highlight how the product reduces healthcare spending over the long term.

 

Partner with startups to co-develop and test solutions using external funding.

 

Present multi-site or multi-country impact data directly linked to public financing criteria.

 

Scouting & Recruitment of Startups

You’re managing strategic investments, long-term pilot projects, or ongoing collaborations with startups.

You need to:

✓ Identify acquisition or licensing opportunities

✓ Scale validated solutions within your product portfolio

✓ Position your company as an industry innovation leader

 

Partner with startups to co-develop and test solutions using external funding.

 

Frame solutions in terms of system-level benefits (e.g., reducing hospitalizations, supporting prevention).

Can we clearly state how our solution will reduce hospitalizations, complications, or costs?

Do we have data (or a plan to collect it) showing clinical effectiveness and cost-effectiveness?

Can we frame our product in terms of prevention or long-term system savings?

Does our solution support value-based healthcare models (measured by patient outcomes)?

Have we translated product features into policy-relevant language (e.g., fewer re-admissions, improved continuity of care)?

 

Design products that are energy-efficient, use recyclable materials, or optimize clinical workflows. For example, a connected medical device could be built with low-power chips and packaging that reduces plastic waste. At the same time, highlight how the product reduces healthcare spending over the long term.

 

Build value dossiers that go beyond regulatory compliance, including robust health economics models, cost–benefit analyses, and system-level impact projections.

Partner with hospitals to co-design outcome-based contracts (e.g., risk-sharing models where payment is tied to avoided complications or reduced admissions).

Position products in line with EU-wide VBHC initiatives (such as EHDS, Europe’s Beating Cancer Plan) to access reimbursement and scaling opportunities.

 

At this stage of maturity, stakeholders are no longer limited to running pilots — they are shaping the future of healthcare. By embedding VBHC into everyday practice, they unlock real improvements for patients, prove the value of innovation to payers, and set new standards for efficiency. Their influence goes beyond hospital walls, driving new reimbursement models and informing national and EU policy. This is where digital health becomes more than experimentation — it becomes lasting transformation with measurable impact.

 

Explicitly align market-entry strategies with policy frameworks such as Europe’s Beating Cancer Plan, sustainability targets, or national digitalization agendas.
Build policy-ready dossiers that go beyond clinical performance, highlighting contributions to cost reduction, prevention, or strategic health goals.

Collaborate with leading hospitals on pilots that generate evidence tailored for policymakers and payers, making adoption easier.

For advanced hospitals and MedTechs, success depends not only on clinical outcomes but on the ability to demonstrate how innovations advance strategic health priorities. At this level, projects stop being pilots and become recognized as building blocks of system transformation.

 

Medical validation

Build robust data collection systems into the product design, ensuring hospitals can easily track long-term usage and outcomes.

 

Business validation

Med-Techs managers provide data on operational costs and savings potential.

 

From local to international

Build a cross-border expansion plan. Partner with one hospital or distributor in each target country and assign a local lead who understands the health system.

Create a dedicated compliance team (internal or external) that monitors regulatory updates in multiple countries. Their role: track changes, update your documentation, and ensure all markets stay aligned with local requirements.

 

Build partnerships with national medical societies (e.g., cardiology, oncology).

Work with them to adapt your training materials and educational content.

Build long-term alliances with payers and policy influencers to support reimbursement.

 

Set up real-world evidence (RWE) studies across 2–3 countries. Collaborate with hospitals to collect data in routine care settings, not just controlled pilots.