Smart medical devices and their surgical implantation for use in resource-constrained settings
HORIZON Innovation Actions
Basic Information
- Identifier
- HORIZON-HLTH-2021-TOOL-06-01
- Programme
- Tools and technologies for a healthy society (2021)
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- June 22, 2021
- Deadline
- September 21, 2021
- Deadline Model
- single-stage
- Budget
- €30,000,000
- Keywords
- Non-invasiveDigital AgendaEOSC and FAIR dataPublic healthClinical development, Phase IResource-constrainedFrugal innovationImplantDiagnostic and therapeuticSurgery
Description
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.
“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:Destination & Scope
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.
Eligibility & Conditions
General conditions
1. Admissibility conditions: described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.
Proposal page limits and layout: described in Part B of the Application Form available in the Submission System.
2. Eligible countries: described in Annex B of the Work Programme General Annexes.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding to support its participation in projects funded under the Health cluster.
3. Other eligibility conditions: described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes.
5. Evaluation and award:
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual
Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes.
Specific conditions
7. Specific conditions: described in the specific topic of the Work Programme.
Documents
Call documents:
Standard application form (HE RIA, IA) — call-specific application form is available in the Submission System
Standard evaluation form (HE RIA, IA) — will be used with the necessary adaptations
HE General MGA v1.0
Essential Information for Clinical Studies
Additional documents:
HE Main Work Programme 2021–2022 – 1. General Introduction
HE Main Work Programme 2021–2022 – 4. Health
HE Main Work Programme 2021–2022 – 13. General Annexes
HE Programme Guide
EU Financial Regulation
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Funding & Tenders Portal Terms and Conditions
Funding & Tenders Portal Privacy Statement
Support & Resources
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Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe.
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Latest Updates
We recently informed the applicants about the evaluation results for their proposals submitted under this call. The results of the evaluation are as follows:
- Number of proposals submitted (including proposals transferred from or to other calls): 84
- Number of inadmissible proposals: 1
- Number of ineligible proposals: 2
- Number of above-threshold proposals: 41
- Total budget requested for above-threshold proposals: EUR 298.969.154
Call HORIZON-HLTH-2021-TOOL-06 closed on 21 September 2021. 84 proposals were submitted. The breakdown per topic is:
- HORIZON-HLTH-2021-TOOL-06-01: 7 proposals
- HORIZON-HLTH-2021-TOOL-06-02: 31 proposals
- HORIZON-HLTH-2021-TOOL-06-03: 46 proposals
Evaluation results are expected to be communicated on Friday 28 January 2022 at the earliest.