GENERAL INFO

 

Mid-Stage MedTech

At the mid stage, large MedTech companies have already secured internal approval and funding for a new project. The focus shifts from feasibility to clinical validation, market testing, and preparing for regulatory approval. This stage is critical for demonstrating real-world clinical benefits and health-economic value, which will determine whether the project can move forward into late-stage development and scaling.

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.

Use the committee to ensure your validation metrics match payer and hospital needs.

 

Move beyond “selling devices” — offer co-investment in pilots.

Example: Provide your device at reduced cost for 6 months in exchange for being listed as a partner in a reimbursement dossier.

 

Build cost–benefit scenarios based on hospital accounting data (e.g., “reduced bed days by 12%, saving €25,000 annually”)

 

Scouting & Recruitment of Startups

You’re actively participating in open innovation calls, challenges, or co-development pilots.

You need to:

✓ Structure partnerships and engagement models

✓ Provide technical and regulatory support

✓ Align startup activities with internal R&D

 

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.

 

Business validation

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

 

From local to international

Select 2–3 target countries. For each, research: their top health priorities, reimbursement

system, and key national programs (e.g., oncology in Czechia, digital chronic care in Finland).

 

In your first foreign market, hire or partner with a local regulatory consultant who understands national interpretations of MDR.

 

Adapt your solution to local IT systems and reimbursement pathways.

 

Secure distribution agreements with local companies that know procurement rules and hospital networks.

 

Build a multi-country evidence package. Combine results from pilots in 2–3 countries into one document that compares outcomes.