Who are the key stakeholders?

The ecosystem is co-led by Karolinska Institutet and the Flemingsberg Science Foundation. Its stakeholders fall into five groups:

• Academia and research. Karolinska Institutet, KTH Royal Institute of Technology, Södertörn University and the Swedish Red Cross University College, together with the research infrastructures on Campus Flemingsberg, some [20] facilities supporting basic and translational research, including laboratory capacity at Novum. Karolinska Institutet also contributes dedicated core facilities, among them SMAILE for medical AI, digital health and regulatory competence.
• Healthcare. Karolinska University Hospital Huddinge, providing the clinical environment in which technologies are evaluated, alongside clinical research capacity within Region Stockholm.
• Industry. The life science companies established on campus, spanning advanced therapies, medical devices and diagnostics, from early-stage SMEs to established manufacturers.
• Public sector and funders. Region Stockholm and its Life Science Office, Huddinge and Botkyrka municipalities, and Hemsö as property owner and developer of the campus.
• Networks. Swedish Incubators & Science Parks, and the ATMP Flemingsberg and Life Science Cluster Flemingsberg initiatives through which much of the collaboration currently runs.

What are the main objectives of your ecosystem?

Our objectives as an ecosystem are:

• 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

Why do you want to join the Global Health Connector Network of Ecosystems?

The Stockholm Advanced Medical Therapies & MedTech Ecosystem is well connected within Sweden but works too little across borders. Joining the network is a way to change that.

We are looking for:

• Clinical validation partners in other health systems, so that therapies and devices developed here are tested in more than one setting.
• Co-applicants for Horizon Europe and EIT Health calls, where consortia drawn from a single region rarely get through.
• A practical comparison of how other ecosystems apply MDR, IVDR and the AI Act, since interpretation still differs between countries.

What we offer: Karolinska University Hospital as a clinical validation site, Swedish national health registries for real-world evidence, and manufacturing and scale-up capacity on campus. Karolinska Institutet also brings regulatory and medical AI competence through its SMAILE core facility, which supports MDR, IVDR and AI Act compliance for AI-enabled devices.
We would rather build a few collaborations that run than a long contact list.

Who is missing from your ecosystem in terms of stakeholders?

While the ecosystem already brings together academia, healthcare, research infrastructures, public actors and life science companies, we see several stakeholder groups that need to be more strongly represented. These include MedTech and ATMP companies with development and manufacturing capabilities, CDMOs and scale up partners, notified bodies and regulatory experts, HTA and reimbursement organisations, investors, patient organisations and international clinical development partners.

Strengthening these connections would help us close important gaps between research, validation, regulatory approval, manufacturing, market access and ultimately patient implementation.

We are particularly interested in stakeholders that can help promising academic innovations move beyond proof of concept and become solutions that can be tested, scaled and implemented in healthcare.

We want to strengthen the ecosystem by involving stakeholders who can help move promising research and technologies from validation to implementation and market access. The most important missing or underrepresented groups are:

• Health technology assessment bodies and payers, to bring reimbursement, health economics and adoption requirements into development earlier.
• A broader range of MedTech companies and industrial partners with experience in product development, quality systems, manufacturing and international market entry.
• Notified bodies and regulatory specialists who can support early planning for MDR, IVDR and AI-enabled medical technologies.
• Investors, corporate partners and experienced entrepreneurs who can support commercialisation, scale-up and international growth.
• Patient organisations and end-user representatives who can contribute to needs assessment, co-creation, usability and implementation.

Which ecosystems are you looking to collaborate with?

We are looking to collaborate with ecosystems that complement the clinical, scientific and innovation capabilities available in Flemingsberg and Stockholm. In particular, we are interested in:

• Advanced therapies and regenerative medicine ecosystems with capabilities in process development, manufacturing scale-up, clinical trials and market access.
• MedTech, diagnostics and medical AI ecosystems that combine engineering, clinical validation, regulatory expertise and implementation in healthcare.
• Hospital-based innovation ecosystems that can act as cross-border clinical validation partners and support testing in different health systems.
• Ecosystems with strong HTA, payer and procurement engagement, enabling earlier planning for reimbursement and adoption.
• Ecosystems experienced in EU collaboration, including Horizon Europe and EIT Health consortia, that are seeking Nordic academic, clinical or industry partners.

Our preferred collaborations are practical and outcome-oriented, for example joint validation projects, consortium building, company-to-company matching, researcher and clinician exchange, and shared learning on regulation and implementation.