GENERAL INFO

Early-stage represents the earliest phase, when ideas are being shaped, assumptions are tested, and potential users are first engaged. You are likely at early-staeg if you are still exploring your concept, conducting initial clinical interviews, and assessing clinical relevance. Success at this stage is not just about building a product—it’s about generating trust, evidence, and strong partnerships that will support future pilots and scaling. This phase focuses on transforming a concept into a validated prototype, preparing for clinical testing, planning funding strategies, and engaging the broader healthcare ecosystem.

Key Milestones at This Stage

• A Minimum Viable Product (MVP) is ready for pilot-level testing
• Initial clinical interviews with doctors, nurses, or patients are conducted to gather real-world feedback
• A Letter of Intent (LOI) or similar agreement is signed with a clinical partner

These milestones demonstrate early traction, ecosystem interest, and a commitment to user-centered design.

 

Best Practice from the Field

An early-stage startup validated their product by combining mock-up demonstrations with structured clinician interviews before seeking funding. This approach helped them identify usability issues and improve alignment with hospital workflows—boosting their chances of successful pilot funding.

Pitfalls to Avoid

Avoid developing features in isolation without clinical input, as this can result in solutions that don’t fit real-world practice. Engage clinicians and patients early and regularly to ensure your product meets actual needs. Additionally, don’t underestimate the complexity of healthcare regulations—seek guidance from regulatory experts early on to prevent costly delays later.

 

 

 

Compliance with the legal framework

• Learn MDR classifications, determine if your product requires CE marking, and map certification pathways early.
• 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.
• Instead of asking hospitals to change workflows for your tool, adapt your solution to existing processes.
• Appoint one innovation lead — a doctor, manager, or IT specialist — whose official role is to coordinate all digital health projects.

 

Financing

• Assess your maturity. If you only run one-off pilots, you’re at the nascent stage.
• Apply for small grants or join accelerator programs to build your first proof of concept.
• Start by documenting all ongoing innovation projects and identifying overlaps.
• Set aside a small but dedicated annual budget for pilots. This shows staff and startups that innovation is not a “one-off project” but a permanent hospital activity.

 

Matchmaking between hospitals and start-ups

Share even small data points with stakeholders to build trust. Example: “In our pilot with 10 patients, 7 reported increased adherence to treatment.” Be transparent about limitations and the level of documentation — honesty and robust processes help overcome distrust among hospitals and patients.

 

Medical validation

You have a prototype or MVP (Minimum Viable Product) and want to validate the need and usability.

No clinical testing yet.

You need to:

✔ Confirm the problem

✔ Test technical and clinical feasibility

✔ Get early user feedback

 

Early-stage startups often require more guidance from clinicians to adjust their solution for real-world hospital use and to define relevant outcome measures.

Experienced startups can co-design clinical protocols and proactively propose KPIs.

Innovation hubs coordinate communication and help structure data collection templates to ensure consistency across sites.

 

Before engaging users or hospitals, verify whether your product already has CE marking (Conformité Européenne). If not, any testing in a clinical setting can only be conducted within a clinical investigation framework, following the Medical Device Regulation (MDR) requirements — including a clinical trial plan and ethics approval.

 

Draw a 2×2 grid on paper. Write down the names of 5 people you know (e.g., a doctor, nurse, patient, manager, insurer) and place them on the grid. Circle the top two you need to talk to first.

Before finalizing your product, meet with one clinician and one patient group. Show them your prototype (even on paper) and ask: “What’s missing for you?”

 

Technical integration

Early-stage startups often need to adapt their software to interoperability standards (e.g., HL7 FHIR).

 

earlyHTA

An early health technology assessment analyzes the potential cost-effectiveness, safety, and patient outcomes to support future reimbursement discussions.

Startups shall provide clinical and usage data.

 

 

Market potential validation

Startups shall prepare investment and reimbursement arguments.