Call: Smart medical devices and their surgical implantation for use in resource-constrained settings

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Programme

Horizon Europe - Cluster 1 - Destination 5: Unlocking the full potential of new tools, technologies and digital solutions for a healthy society

Acronym

HORIZON-HLTH-TOOL

Type of Fund

Direct Management

Description of programme
"Horizon Europe - Cluster 1 - Destination 5: Unlocking the full potential of new tools, technologies and digital solutions for a healthy society"

Calls for proposals under this destination are directed towards the Key Strategic Orientation KSO-A ‘Promoting an open strategic autonomy by leading the development of key digital, enabling and emerging technologies, sectors and value chains’ of Horizon Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination should contribute to the impact area ‘High quality digital services for all’ and in particular to the following expected impact, set out in the Strategic Plan for the health cluster: ‘Health technologies, new tools and digital solutions are applied effectively thanks to their inclusive, secure and ethical development, delivery, integration and deployment in health policies and health and care systems’. In addition, research and innovation supported under this destination could also contribute to the following impact areas: ‘A competitive and secure data-economy’, ‘Industrial leadership in key and emerging technologies that work for people’, and ‘Good health and high-quality accessible health care’.

Technology is a key driver for innovation in the health care sector. It can provide better and more cost-efficient solutions with high societal impact, tailored to the specific health care needs of the individual. However, novel tools, therapies, technologies and digital approaches face specific barriers and hurdles in piloting, implementing and scaling-up before reaching the patient, encountering additional challenges such as public acceptance and trust. Emerging and disruptive technologies offer big opportunities for transforming health care, thereby promoting the health and well-being of citizens. Unlocking this potential and harnessing the opportunities depends on the capacity to collect, integrate and interpret large amounts of data, as well as ensure compatibility with appropriate regulatory frameworks and infrastructures that will both safeguard the rights of the individual and of society and stimulate innovation to develop impactful solutions. In addition to existing European Research Infrastructures, the European Health Data Space will promote health-data exchange and facilitate cross-border research activities. This destination aims to promote the development of tools, technologies and digital solutions for treatments, medicines, medical devices and improved health outcomes, taking into consideration safety, effectiveness, appropriateness, accessibility, comparative value-added and fiscal sustainability as well as issues of ethical, legal and regulatory nature.

In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health and EIT-KIC Health (under pillar III of Horizon Europe) or in areas cutting across the health and other clusters (under pillar II of Horizon Europe). For instance, with cluster 4 “Digital, Industry and Space” such as on digitalisation of the health sector, incl. health technologies, medical devices and key enabling technologies; assisted, autonomous, independent and empowered living; smart homes; decision support systems; health impact assessment (e.g. related to consumer products, working place innovation).

Expected Impacts

Proposals for topics under this destination should set out a credible pathway towards unlocking the full potential of new tools, technologies and digital solutions for a healthy society, and more specifically to several of the following expected impacts:

Europe’s scientific and technological expertise and know-how, its capabilities for innovation in new tools, technologies and digital solutions, and its ability to take-up, scale-up and integrate innovation in health care is world-class.
Citizens benefit from targeted and faster research resulting in safer, more efficient, cost-effective and affordable tools, technologies and digital solutions for improved (personalised) disease prevention, diagnosis, treatment and monitoring for better patient outcome and well-being, in particular through increasingly shared health resources (interoperable data, infrastructure, expertise, citizen/patient driven co-creation).[[Commission Communication on the digital transformation of health and care; COM(2018) 233 final.]]
The EU gains high visibility and leadership in terms of health technology development, including through international cooperation.
The burden of diseases in the EU and worldwide is reduced through the development and integration of innovative diagnostic and therapeutic approaches, personalised medicine approaches, digital and other people-centred solutions for health care.
Both the productivity of health research and innovation, and the quality and outcome of health care is improved thanks to the use of health data and innovative analytical tools, such as artificial intelligence (AI) supported decision-making, in a secure and ethical manner, respecting individual integrity and underpinned with public acceptance and trust.

Citizens trust and support the opportunities offered by innovative technologies for health care, based on expected health outcomes and potential risks involved.

Link

Link to Programme

Call

Smart medical devices and their surgical implantation for use in resource-constrained settings

Description of call
"Smart medical devices and their surgical implantation for use in resource-constrained settings"

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes.

Medical device developers provide sustainable and affordable smart active implants validated in the operational environment.
Medical professionals in resource-constrained clinical settings use sustainable and affordable surgical procedures for smart active implants.
Patients have access to sustainable and affordable smart medical devices suitable for minimally invasive surgical implantation through further clinical studies.

Scope:

“Smart” technologies, i.e. micro-electronic sensor/actuator systems provide novel functionalities to surgically-implanted active medical devices. “Smart” active implants involve microelectronic components and are placed inside the body of the patient to achieve the desired physiological response. They open up therapeutic avenues for a wide range of medical handicaps, complex chronic conditions and lesions, thanks to their integrated diagnostic capabilities, and may help addressing hitherto unmet medical needs. Challenges involved in the development of these devices include but are not limited to miniaturization, sensor robustness, wireless power supply, etc. Such devices require specific surgical implantation procedures, dependant on the type of device and on the intended use, with the successful surgical implantation and activation of such smart medical implants, being crucial steps for their functioning. The device targeted and its intended use is open for applicants to choose (e.g. orthopaedic, neural, cardiovascular, metabolic, etc.), but should at the start of the proposed work be at a TRL of minimum four and will necessitate appropriate tailored surgical procedures and interventions. Surgical conditions account for approximately 30% of the global burden of disease and have a huge social and economic impact. However, of the 300 million surgical interventions undertaken globally every year only around 6% occur in low-income countries, where a third of the world’s population lives. There is therefore a strong need for high-quality, affordable surgical interventions for implanting “smart” active medical devices suitable for resource-limited or -constrained clinical settings. Resource-constrained settings are clinical environments that are affected by limitations such as lack of medical staff, scarcity of medical equipment or medicines supply, etc. To address this gap, the sustainability of both the medical device and the applied surgical intervention, including the necessary equipment and operating skills, are essential elements. Implantation procedures should be fully compatible with resource-constrained environments and minimally invasive approaches should be favoured. Hence, research and innovation activities should comprise medical device design, regulatory work, clinical stages and developmental iterations, reaching a TRL of at least seven, and involve key medical specialists (e.g. surgeons) and/or other health care professionals, developers, patients and relevant regulatory bodies as appropriate. The work proposed should take into account the new EU legal framework on medical devices with the targeted implants meeting all the essential requirements as defined therein.

Cross-cutting Priorities:

EOSC and FAIR data

Link

Link to Call

Thematic Focus

Clustering, Development Cooperation, Economic Cooperation, Research & Innovation, Technology Transfer & Exchange, Health, Social Affairs, Sports, Digitisation, ICT, Telecommunication, Capacity Building, Cooperation Networks, Institutional Cooperation

Funding area

EU Member States
Overseas Countries and Territories (OCTs)
United States of America

Origin of Applicant

EU Member States
Overseas Countries and Territories (OCTs)
United States of America

Eligible applicants

Education and Training Centres, Federal State / Region / City / Municipality / Local Authority, Research Institution, Lobby Group / Professional Association / Trade Union, International Organization, Small and Medium Sized Enterprises, SMEs (between 10 and 249 employees), Microenterprises (fewer than 10 employees), NGO / NPO, Public Services, National Government, Other, Start Up Company, University, Enterprise (more than 250 employees or not defined), Association

Applicant details

eligible non-EU countries:

countries associated to Horizon Europe

At the date of the publication of the work programme, there are no countries associated to Horizon Europe. Considering the Union’s interest to retain, in principle, relations with the countries associated to Horizon 2020, most third countries associated to Horizon 2020 are expected to be associated to Horizon Europe with an intention to secure uninterrupted continuity between Horizon 2020 and Horizon Europe. In addition, other third countries can also become associated to Horizon Europe during the programme. For the purposes of the eligibility conditions, applicants established in Horizon 2020 Associated Countries or in other third countries negotiating association to Horizon Europe will be treated as entities established in an Associated Country, if the Horizon Europe association agreement with the third country concerned applies at the time of signature of the grant agreement.

low-and middle-income countries

Legal entities which are established in countries not listed above will be eligible for funding if provided for in the specific call conditions, or if their participation is considered essential for implementing the action by the granting authority.

Specific cases:

Affiliated entities - Affiliated entities are eligible for funding if they are established in one of the countries listed above.
EU bodies - Legal entities created under EU law may also be eligible to receive funding, unless their basic act states otherwise.
International organisations - International European research organisations are eligible to receive funding. Unless their participation is considered essential for implementing the action by the granting authority, other international organisations are not eligible to receive funding. International organisations with headquarters in a Member State or Associated Country are eligible to receive funding for ‘Training and mobility’actions and when provided for in the specific call conditions.

Project Partner

Yes

Project Partner Details

Unless otherwise provided for in the specific call conditions , legal entities forming a consortium are eligible to participate in actions provided that the consortium includes:

at least one independent legal entity established in a Member State;and
at least two other independent legal entities, each established in different Member States or Associated Countries.

Further info

Proposal page limits and layout:

The application form will have two parts:

Part A to be filled in directly online (administrative information, summarised budget, call-specific questions, etc.)
Part B to be downloaded from the Portal submission system, completed and re-uploaded as a PDF in the system

Page limit - Part B: 45 pages

Type of Funding

Grants

Financial details

Expected EU contribution per project	The Commission estimates that an EU contribution of around EUR 6.00 million would allow these outcomes to be addressed appropriately. Nonetheless, this does not preclude submission and selection of a proposal requesting different amounts.
Indicative budget	The total indicative budget for the topic is EUR 25.00 million.
Typ of Action	Innovation Actions (IA)
Funding rate	70% (except for non-profit lega lentities, where a rate of up to 100% applies)

Submission

Proposals must be submitted electronically via the Funding & Tenders Portal Electronic Submission System. Paper submissions are NOTpossible.