GENERAL INFO
Startups at this stage have validated their solution, secured early traction, and are ready to grow. The focus now shifts to regulatory compliance, first sales, and international expansion – turning a promising prototype into a sustainable, scalable business. This phase is where clinical validation meets commercial reality. Success depends on aligning clinical data, regulatory approvals, and business strategy across diverse health systems.
Key Milestones at This Stage
- Medical validation completed
- Business validation completed
- Regulatory approval submitted or obtained (e.g., CE mark, FDA, DiGA)
- Expansion into 1–2 international markets with strategic localization plans
- Integrated evidence package compiled for investors, hospitals, and regulators
- These achievements signal market readiness and position the startup for sustainable growth or acquisition.
Best Practice from the Field
A diabetes monitoring solution used pilot data to demonstrate clinical value, supporting regulatory approval in Germany and informing strategies for adoption in other European healthcare settings. Careful alignment of clinical requirements and regulatory standards across countries helped accelerate its broader rollout.
Pitfalls to Avoid
Treating payers only as buyers → Instead, engage them early to shape reimbursement and implementation strategy.
Fragmented evidence → Create a unified evidence base that meets the needs of investors, regulators, and healthcare providers.
Scaling without adapting → Don’t assume success in one country guarantees adoption in another. Local health systems matter.
Compliance with the legal framework
Takeaways for Startups:
Map CE marking requirements early and integrate them into development and clinical evaluation plans.
Understand local procedures for device registration and market access in each target CEE country.
Leverage EHDS to collect standardized, interoperable data to support clinical validation and scaling.
Product design
Design flexible solutions with modular architecture so they can integrate with multiple hospital IT systems.
Start collecting data early, even from small pilots. Evidence of cost savings and better patient outcomes is powerful.
Spend time with clinicians. Understand their pain points before suggesting solutions. This builds trust.
Use agility to your advantage. Focus on niches where large players may struggle to adapt.
Financing
Apply to programs where challenges are clearly defined upfront.
Highlight in your application how your solution directly addresses a hospital need (e.g.,“reduces readmissions for COPD by 15%”).
Prepare basic validation evidence (even small case studies) to stand out.
Apply for small grants or join accelerator programs to build your first proof of concept including both envisaged medical impact as well as market access.
Publish pilot data in peer-reviewed journals or white papers to strengthen credibility with payers.
Business validation
Your solution is validated, and you’re working on sales, scaling, or reimbursement.
You need to:
✔ Secure market access
✔ Build implementation plans
✔ Strengthen your business model
From local to international
Secure IP rights across the EU (via EUIPO) and confirm your CE mark covers all product versions. Prepare a “compliance folder” with all documentation ready for regulators abroad.
Build a regulatory timeline for the countries you want to enter. Include milestones like “submit dossier Q3, ” “pilot required Q4,” “expected approval Q2 next year.” Keep it updated to anticipate delays.
Before launching abroad, run a small pilot in one hospital.
Sign a formal partnership agreement with a foreign hospital to co-develop clinical evidence.
Strengthen credibility by publishing pilot results in peer-reviewed journals. Even small studies in recognized journals (e.g., JMIR mHealth or Frontiers in Digital Health) boost international trust.