Sweden - Stockholm Advanced Medical Therapies & MedTech Ecosystem

Sweden

Sweden – Stockholm Advanced Medical Therapies & MedTech Ecosystem

Stockholm's Advanced Medical Therapies & MedTech Ecosystem brings together clinical, academic and industry partners to advance ATMPs and medtech from R&D through EU regulatory approval to clinical use.

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Ecosystems

Sweden – Stockholm Advanced Medical Therapies & MedTech Ecosystem

The Stockholm Advanced Medical Therapies & MedTech Ecosystem is an innovation ecosystem based at Campus Flemingsberg in southern Stockholm, Co-Lead between the Flemingsberg Science Foundation and Karolinska Institutet.

The campus co-locates Karolinska Institutet, KTH Royal Institute of Technology, Södertörn University and the Swedish Red Cross University College with Karolinska University Hospital Huddinge, placing clinical care, biomedical research and engineering within walking distance of each other. Roughly 20 research infrastructures and a comparable number of life science companies operate on site, with laboratory capacity at Novum. Our focus is translating advanced therapy medicinal products and medical technology into clinical use, spanning preclinical development, regulatory strategy under the EU MDR, IVDR and AI Act, clinical validation, and manufacturing scale-up.

Objectives

To shorten the path from research to clinical use. Move advanced therapy and medical technology projects from preclinical development into clinical evaluation faster, by making Campus Flemingsberg's research infrastructures, clinical expertise and manufacturing capacity accessible through a single point of entry.
To build regulatory readiness in early. Bring MDR, IVDR and AI Act expertise to bear while projects are still being designed rather than after development is complete, so that regulatory strategy shapes evidence generation instead of retrofitting it.
To connect academic groups with companies that can carry results forward. Match researchers at Campus Flemingsberg with SMEs, manufacturers and clinical partners capable of taking a validated result to patients, and reduce the number of promising projects that stall for want of an industrial counterpart.
To establish Flemingsberg as a clinical validation site for international partners. Offer partners access to Karolinska University Hospital's clinical environment and Sweden's health registries for real-world evidence generation, and use that capability as the basis for cross-border collaboration.
To develop the workforce the sector will need. Train researchers, clinicians and engineers in the combined technical, clinical and regulatory competence that advanced therapies and AI-enabled devices demand, drawing on the education programmes of the campus institutions

Key Links

Karolinska Institutet

Flemingsberg Sciense Foundation

KI-SMAILE core facility

Karolinska University Hospital

Royal Institute of Technology

Sodertorn University

Novum Research Park

Videos

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Ecosystem Coordinators

Fernando Seoane

Professor in Biomedical Engineering with a position as Senior Lecturer at the Department of Clinical Science, Intervention and Technology – CLINTEC, Karolinska Institutet