Streamlining regulatory compliance in health tech spin-offs through digital tools

By project VIADUCT

Published on 26 February 2025

Finland

Länsi-Suomi

About this good practice

Tampere Region actively supports the creation of health tech spin-offs from public research. However, these startups face significant challenges in navigating complex regulatory frameworks, a crucial step in developing compliant and market-ready products. This complexity often results in delays, increased costs, and reduced resources for innovation, creating a barrier to growth in this sector. Recognizing these challenges, Tampere University sought a solution to streamline the regulatory process.

To address this issue, Tampere University adopted a digital tool that demystifies regulatory requirements. The tool translates complex compliance standards into straightforward, actionable steps tailored to the specific needs of health tech startups. It offers a centralized platform where users can access up-to-date regulatory insights and guidance, minimizing the time and expertise needed to manage compliance. By doing so, the practice empowers startups to focus more on product development and innovation while ensuring they meet all necessary regulations.

The main stakeholders include Tampere University and health tech incubators. Beneficiaries are primarily health tech spin-offs and startups, which gain easier access to regulatory knowledge, reducing time and costs. Indirectly, this practice benefits the wider innovation ecosystem in Tampere by accelerating the commercialization of health technologies and fostering knowledge transfer between research and industry.

Expert opinion

The initiative introduces a digital tool – Entries – to help health tech spin-offs from public research navigate complex regulatory requirements in Finland. Tampere University developed this tool to simplify compliance by translating regulations into clear, actionable steps. It centralizes regulatory guidance, saving time and enabling startups to focus on innovation. Key stakeholders include the university and health tech incubators, with startups as the primary beneficiaries. The tool has demonstrated strong results, particularly through use by SPARK teams and in startup training programs. This good practice offers a scalable, transferable, and adaptable model for other European regions, especially those with dynamic health tech incubators and startup ecosystems and large research universities focused on healthcare innovation.

Arnault Morisson

Works at Interreg Europe Policy Learning Platform

Resources needed

The main costs include the maintenance of the digital tool, as well as resources for facilitating spin-off creation processes. Funding covers platform updates, regulatory expertise, and stakeholder coordination. Exact figures depend on regional implementation and specific support structures.

Evidence of success

The Entries tool has proven effective, with positive feedback from SPARK teams in Finland, who report significant benefits in understanding regulatory pathways. It is also integral to the training of Research to Business funding applicants, helping them identify regulatory obligations and constraints early in development. This proactive approach reduces compliance risks and accelerates product readiness, demonstrating measurable value in fostering successful health tech innovation.

Potential for learning or transfer

This practice is highly transferable, particularly for regions supporting innovation in regulated sectors like health tech. The digital tool simplifies compliance by centralizing complex regulatory information into actionable insights, making it adaptable across different frameworks. Its modular design allows scalability, demonstrated by features like a dashboard consolidating regulatory readiness, device classification, and risk profiles.

Key success factors include significant time and cost savings—startups have reported cutting months and hundreds of thousands of euros from their market entry timelines.

Successful transfer depends on aligning with regional regulatory environments and securing stakeholder commitment. Initiatives like the planned EU Horizon Scanning project illustrate how this tool can integrate into broader frameworks, fostering knowledge exchange and accelerating EU-wide regulatory readiness.