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QA/RA expert and the regulatory jungle – Radical Health retrospective

Project timeline:
months
Service areas:
Quality and Regulatory
Product development
Software development
Written by
Teija Tulinen
Innokas content creator
Innokas employee on a laptop with accompanied by "Innokas sustainability report 2024" title

Published on 2.2.2026

Europe’s complex electronics sector is a regulatory jungle, now made even denser by the rise of AI. But meaningful progress happens when experts gather and exchange perspectives. The 2026 Radical Health Festival in Helsinki created space for that – especially for Innokas, where a shared stage and live customer case with GlucoModicum and QA/RA Specialist Sandra Hänninen’s panel work and active presence drew strong interest in our regulatory know‑how.

Panel: Innovation pathways in the EU regulatory environment

Sandra’s first session of the day was the interactive panel "Creating innovation pathways through the EU policy and regulatory jungle." Using a navigation-themed format, the discussion walked participants through how AI-based medical devices move within the EU’s evolving frameworks. The group explored the current regulatory landscape and examined what responsible, forward-looking innovation can realistically look like.

Joining Sandra on the panel were lawyer Petra Wilson and Visa Honkanen from HUS, each opening with short presentations that set the stage for a wider conversation. The content of the panel included:  

  • A practical overview of the EU regulatory jungle, including the implications of the AI Act and the European Health Data Space (Petra Wilson)
  • How Finland’s largest healthcare provider balances innovation with safety, accountability, and patient trust (Visa Honkanen)
  • Shared challenges for both startups and large enterprises, with insights from Sandra (Innokas) and Joost van Kogelenberg (Philips)
  • Opportunities to strengthen Europe’s competitiveness while maintaining confidence in medical technologies

Despite this being Sandra’s first panel appearance, the atmosphere made it an approachable experience. She described the Radical Health Festival as intentionally informal and easygoing: “People can be at ease there. It was a nice atmosphere for a first panel experience. Attendees even sought out the Innokas booth afterward to continue the discussion.” Her expertise in QA/RA sparked curiosity throughout the event and opened the door to several meaningful follow-up conversations.

Sandra and Innokas software engineer Heikki Miinalainen conversing with exhibit visitors

The story behind the husky

Surprisingly, or perhaps unsurprisingly, the Innokas husky mascot was quite an eye-catcher both at the exhibit and the panel discussions. Sandra was asked to share how it reflects Innokas’ approach to partnerships right at the first panel; “A husky team has different roles that work together to navigate challenging terrain. That is how we work with our customers. We help take a product from idea to market as part of the same team,” she told the curious panel attendees.  

Panel 2: “Doctors, nurses and AI: Bridging the medical and innovation worlds”

Sandra returned to the stage in the afternoon to moderate the panel "Doctors, Nurses and AI: Bridging the Medical and Innovation Worlds." The conversation quickly moved beyond theory to show how AI is already reshaping diagnostics, care pathways, administrative workflows, and even preventive health. The panel also confronted the real pressures this rapid change puts on both professionals and patients.

With panelists ranging from European health policy advisors to innovation leaders and clinical specialists, the discussion highlighted AI’s role as a supportive, not disruptive, tool in healthcare. Concrete examples, including digital adoption experiences from Scotland, helped illustrate the opportunities and sticking points in scaling new technologies.

A recurring theme was the gap between technologists and frontline healthcare professionals. Panelists shared strategies for building trust, improving dialogue, and understanding why some clinicians view AI with confidence while others remain cautious. The session closed with a compelling look at AI in preventive care from the barriers innovators face to its potential to reduce system burdens and lower costs, as well as improve health equity.

Sandra in the "innovation pathways in the EU regulatory environment" panel (second from right) with the other panelists

A high impact event

With a central exhibition space and strong traffic around Sandra’s panels, Innokas held a visible and valuable presence at the festival. The event offered an accessible setting for open conversations and created opportunities for new connections across the health innovation ecosystem.

For Sandra, the festival was both professionally rewarding and personally enjoyable. For Innokas, it strengthened visibility in the EU health and regulatory space and gave us a chance to highlight our capability to support customers from early idea to market readiness.

If this is an area where you seek understanding and support, don't hesitate to contact us. Let's discuss if we have the know-how your project needs to succeed.

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Based on an interview with

Sandra Hänninen
QA/RA specialist
sandra.hanninen@innokas.eu

Lead Magnet: The 101 of medical technology innovation
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