GENERAL INFO
Early-Stage MedTech
At the early stage, MedTech companies are in the conceptual or prototype phase, exploring how their technology can fit within healthcare. Their main challenge is to translate technical innovation into clinical value and demonstrate early feasibility. This requires close collaboration with clinicians, hospitals, and innovation hubs to ensure alignment with medical workflows, regulatory pathways, and market needs. Building trust and credibility is crucial at this level.
Key Milestones at This Stage
Development of a functional prototype that demonstrates proof-of-concept.
First clinical or user validation with healthcare professionals or small focus groups.
Initial mapping of regulatory requirements (MDR/FDA classification).
Securing a Letter of Intent (LOI) or preliminary collaboration agreement with a hospital.
Beginning to explore intellectual property (IP) protection strategies.
Best Practice from the Field
Leading MedTech organizations often establish innovation fast-track units with dedicated budgets and streamlined approval processes. These units allow project teams to bypass layers of bureaucracy and test the feasibility of solutions with hospitals in a matter of months. By combining the agility of a startup with the resources of an established company, such teams can accelerate go/no-go decisions, rapidly prototype and pilot new solutions, and expand collaborations with healthcare providers across regions.
Pitfalls to Avoid
Over-bureaucratization – Corporate procedures can delay validation and decision-making.
Create dedicated “fast-track” teams with autonomy for early projects.
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.
This refers specifically to established MedTech corporations, as early-stage startups operating in the medtech space are considered separately in this document.
Convert technical benefits into practical hospital terms (e.g., “saves 15 min per nurse per shift”).
You’re beginning to explore collaborations with startups and external innovators.
You need to:
✓ Define focus areas and scouting criteria
✓ Understand early-stage startup needs
✓ Set up internal processes for evaluating opportunities
Scouting & Recruitment of Startups
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)?
Preparing hospitals through workshops
When engaging with early-stage companies that might purchase your product or services, focus on practical benefits that are immediately relevant to them. Instead of saying “our platform uses AI, ” highlight tangible outcomes: for example, “our tool reduces time spent on manual data entry by 20 minutes per patient.” Emphasize how working with your startup can be low-risk and mutually beneficial, providing efficiency gains or early access to innovative solutions without requiring large upfront investments.
Medical validation
Identify everyday users such as nurses or clinicians as early design partners. Shadow them during their daily work to understand real workflows.
Write one-page “user sheets” for the two people who will interact most with your product.
Include their daily routine, main challenges, and what would make their work easier.
Host demo days in hospitals. Bring your device, let clinicians test it for 30 minutes, and record their feedback. Example: a nurse testing a wound-care device points out that gloves make the touchscreen hard to use — you fix it before scaling.