EU-Funded Projects

This is an exciting time for Global Heart Hub. Our organisation is continuously growing our impactful activities in the areas of advocacy, cardiovascular health awareness and patient/ public education. We work with a variety of stakeholders including patients, clinicians, academics, research institutes and industry as we strive to improve health outcomes for people living with heart disease. We recognise the importance of collaboration and welcome being involved in projects funded by the European Union as they focus on addressing health challenges through innovation and multidisciplinary engagement.

Global Heart Hub strive to ensure the patient voice is heard, represented and meaningfully engaged throughout our collaborations. We can also engage and involve our extensive network of patient organisations across the globe to communicate and disseminate project outcomes, key messages and ‘lessons learned’. Here you can have a look at the extent of our reach.

Global Heart Hub is excited to learn and grow its organisational capacity by collaborating in multi-stakeholder projects. This is a new area of work for the organisation, and we are always happy to explore opportunities for co-creation together.

Our efforts could focus on:

Communications and dissemination activities: to ensure that the project progress and final outputs are shared with the relevant patient communities, an accessible language is used and by using engaging formats which maximise reach and learning.
Facilitating the involvement of patients within the CVD community in developing and implementing the project: The patients’ contribution could vary from focus groups, survey development, research design co-creation, educational and informational material co-development, reports review and co-creation.
Participating on multi-stakeholder advisory panels: where the patient’s voice is not only required, but rather is viewed as a key element of the project itself.

These are examples with which the organisation currently feels comfortable with however we are always willing to learn, co-create and growth together. We are happy to embark on such a journey with you! Please get in touch and let’s talk!

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Current projects

HEU-EFS

Harmonized Approach to Early Feasibility Studies for Medical Devices in the European Union (HEU-EFS) is a four-year IHI research project which aims to develop a shared and innovative program entirely dedicated to conducting Early Feasibility Studies (EFS) in the European Union for medical devices.

This project is led by Bocconi’s Center for Research on Health and Social Care Management (CERGAS) and Edwards Lifesciences and it has received €10.53 million in funding from the European Commission and €8.47 million from industry partners, for a total of €19 million, as part of the Horizon program.

The consortium has 22 partners among which there are universities, hospitals, contract research organisations (CROs), patient associations, health technology assessment agencies and small- and medium-sized firms, 6 industrial partners, and an extensive Advisory Board with regulatory authorities, notified bodies and professional associations.

Global Heart Hub is part of the consortium and is teaming up with the European Patients’ Forum (EPF) to advance patient centricity in the project.

Why is the project important?

In recent years, regulators in various countries have been taking a closer look at how health technologies get approved for the market. Attention has been paid to the quantity, type and quality of evidence needed for the approval of medical devices, which has been traditionally considered weaker than for drugs and sometimes insufficient to fully ensure patients’ safety, especially for implantable, high-risk medical devices. For this reason, EU Regulations on medical devices, in-vitro diagnostics, and Health Technology Assessment (HTA) were established to promote a stricter process for clinical evidence generation before medical devices can enter the market and be used by patients.

This is where EFS come in. EFS are small-scale research studies or tests done in the very early stages of developing a medical device or treatment to see if it is practical, safe, and worth pursuing further. EFS help assess whether an idea or concept has potential before investing more time and resources into full-scale development and testing.

Currently, there are no standardised procedural rules or guidelines for conducting EFS in the EU. The ambition of the HEU-EFS project is to create a harmonised framework for the EU EFS programme. This programme is a crucial opportunity to introduce patient perspectives early on, benefitting all stakeholders involved in the development and use of medical devices.

The project website is now live and you can visit it here

Press release announcing the project launch here

More information is available here.

This project is supported by the Innovative Health Initiative Joint Undertaking (JU) under grant agreement No 101112185. The JU receives support from the European Union’s Horizon Europe research and innovation programme and life science industries represented by MedTech Europe, COCIR, EFPIA, Vaccines Europe and EuropaBio.

Disclaimer: This project is funded by the European Union, the private members, and those contributing partners of the IHI JU. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the aforementioned parties. Neither of the parties can be held responsible for them.

RESIL-Card

RESIL-Card is an EU4Health funded project managed by a consortium of four partners dedicated to enhancing the resilience of European healthcare systems in providing cardiovascular care. The project aims to develop and implement a protocol-based tool enabling cardiovascular stakeholders assess and address the gaps in care systems, ensuring continuity during crises. Global Heart Hub is delighted to support the work of the consortium in its efforts around communication and dissemination.

The RESIL-Card project will contribute to reducing the burden of CVD by identifying and defining disruptions of cardiovascular care pathways driven by the COVID-19 pandemic and the lessons learned during this crisis to ensure the continuity of CVD care in the future. By providing a resilience assessment tool and a set of recommendations for the maintenance of essential critical care that cannot be discontinued in any situation, the project supports the NCD policies and corresponding actions led by Member States, including the creation of knowledge and resources that may be used by relevant entities to develop or refine regional, national or international guidelines. Ultimately, the project will directly improve the access to care by CVD patients during and after crises, thereby reducing the burden of the disease.

The project website is now live and you can visit it here

You can read the press release here Empowering European healthcare systems: RESIL | EurekAlert!

This project has received funding from the European Union’s EU4Health work programme under grant agreement No. 101129203.