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Nelli Karhu

Senior Advisor
Terveysteknologia ry HealthTec Finland
Finland

Nelli Karhu is a senior advisor for HealthTec Finland. She has extensive experience in MD and IVD regulatory issues on both national and EU level. Before joining HealthTech Finland in 2025, Nelli worked as a Senior inspector and Section Head in the Finnish competent authority for medical devices, Fimea. Now, as a senior advisor for HealthTech Finland, Nelli supports Finnish healthtec companies with regulatory issues, as well as working for a better regulatory environment for the European healthtec sector. Nelli is a biochemist by training, with a PhD in bacteriophage structure and evolution. In addition to medical device regulatory issues, viruses, and especially bacteriophages are still close to her heart.

Aiheet

Curing the System amidst Geopolitical Trade Wars: Regulatory Reform for Better Health and Innovation

Developing Health Technology
Regulatory Landscape
5.2.2026 10:20 - 11:20 | Hall 205

In an increasingly interconnected world, the global medtech market is navigating a complex web of geopolitical tensions, regulatory reforms, and shifting trade dynamics. This panel aims to provide clarity on the evolving landscape, focusing on the intersection of regulation, innovation, and international trade.

With the European Union restructuring its regulatory frameworks, ongoing concerns over overregulation, and the shifting tariffs and policies between the U.S. and China, the medtech industry faces both significant challenges and opportunities. As regulatory bodies work to balance patient safety, market access, and innovation, industry leaders must adapt to remain competitive on a global scale.This session will explore the key forces shaping the medtech market today, including:

  • Review of the European Commission's proposed legal text in view of addressing innovation and patient health
  • The competitiveness of the EU medtech industry amidst global regulatory restructuring
  • The impact of the legislative proposal in view of shifting geopolitics, global regulatory restructuring, medical supply chains and partnerships
  • The evolving role of big tech in reshaping the healthcare landscape, from product development to patient care

Through expert insights, the discussion will highlight strategic approaches to navigating these turbulent times, with a focus on how regulatory reform can foster an environment of growth and innovation. Attendees will leave with a clearer understanding of the global medtech landscape, practical takeaways on navigating regulatory and geopolitical challenges, and a vision for the future of healthcare innovation on the world stage.