The European Framework Programme for Research & Innovation represents a key funding source for Health-related R&I. The previous Framework Programme, entitled Horizon 2020, ran from 2014 to 2020 and had a total budget of € bio. 77 [1]. Horizon 2020 was conceived as a policy instrument to implement high-level policy initiatives, such as the Europe 2020 strategy and the Innovation Union. For ease of reading, the terms Medical Technology and Biomedical Engineering are simply expressed as MedTech, and for Research, Development and Innovation the short term R&I is used.

Overall, 1961 R&I projects in the MedTech field have been supported under Horizon 2020 with a total EU contribution of over € bio. 3.2. This figure is based on actual projects that have been identified following a keyword search on data available within the Commission’s internal Common Research Data Warehouse, which is the basis for the publicly accessible database CORDIS [2]. Horizon 2020 consisted of 3 main pillars [3], with MedTech R&I supported by all three in almost equal shares: € mio. 1130 under pillar II “Industrial Leadership” (LEIT), € mio. 1037 under pillar III “Societal Challenges” (SCs) and € mio. 1001 under pillar I “Excellent Science”. The classical collaborative R&I had its main home under the SCs and there it was obviously the SC on Health (SC 1) which was the primary source of funding for MedTech R&I with € mio. 922, followed by the SME-instrument with € mio. 456, supporting individual SMEs under pillar II (LEIT). Equally single entity funding came from the European Research Council (ERC) under pillar I with € mio. 390, stemming from fully bottom-up calls. To these funding figures added on other schemes like the “Future and Emerging Technologies” (FET; pillar I) with € mio. 322, the “Marie-Sklodowska-Curie” (MSCA) fellowships (pillar I) with € mio. 287, the “Nanotechnology, Materials, Processes and Biotechnology” (NMBP) subprogramme (pillar II) with € mio. 205 and the “Innovative Medicines Initiative 2” (IMI2) Joint Undertaking with € mio. 100. This financing of MedTech R&I has been completed by the scheme on “Fast-Track-Innovation” (FTI; € mio. 74.5), the ECSEL Joint Undertaking (€ mio. 39.2) and the activities on “Widening” (€ mio. 38). From this analysis one can see that - next to the collaborative funding schemes - the support of individual entities, be it to rather basic R&I (e.g. ERC-grants or MSCA-fellowships) or to more applied R&I (e.g. SME-instrument), played an important role and its increase is even more visible when looking at the evolution over the different Framework Programmes [4].

The 1961 projects have been screened for their clinical relevance again with the help of keywords and, thus, 227 projects were identified to include either a clinical study or a similar work strand exhibiting clinical value. These 227 projects had a total budget of over € mio. 691, which is app. 22% of the total budget devoted to MedTech R&I under Horizon 2020 and with MedTech targeting a therapeutic use taking the lead from diagnostic when it comes to clinical relevance (Table 1). When looking to the type of MedTech that received the biggest share of R&I funding, the In-vitro-diagnostics (IVD) with over € mio. 175 have not only taken the lead in the “Diagnostic”-category but also overall, followed closely by Implants in the “Therapeutic”-category with € mio. 130 (Fig. 1). All three pillars of Horizon 2020 provided the funds to the clinically relevant MedTech R&I projects, with pillar II Industrial Leadership on top (total € mio. 389) and with the SME-instrument being the most prominent funding source for MedTech R&I (€ mio. 264) next to the ICT-, NMBP- and FTI-subprogrammes. This is followed by pillar III Societal Challenges (total € mio. 237) including SC1 “Health” (€ mio. 198) and the Innovative Medicines Initiative 2 (€ mio. 27) and completed by pillar I Excellent Science (total € mio. 65). The contribution by IMI2 is remarkable, since the primary goal of this Joint Undertaking is the enhancement of pharmaceutical R&I. No surprise is the considerable portion of funding coming from the “Future and Emerging Technologies” (FET) - section under pillar I (€ mio. 33), whereas the contribution from the “Marie-Sklodowska-Curie-Actions” (MSCA) is (€ mio. 29). A graphical representation of these findings is given in Fig. 2.

Funding and project numbers of different types of clinically relevant medical technologies under Horizon 2020

Contribution in € mio. of the different sections of Horizon 2020 to MedTech R&I

The translational value of all these projects is difficult to estimate, firstly because the majority of these projects have ended only recently or are still ongoing, and secondly because the implementation or uptake of an innovative technology into clinical practice takes in general several additional years [5, 6]. Nevertheless, a further screening on these projects for their potential impact in economic and scientific terms was performed; for the direct economic impact a search on patents filed by these projects and for the scientific impact an analysis of the publications submitted by these projects was done. This analysis revealed that 37 of these projects excelled in their scientific output, having either published in top-ranked journals or exhibiting a high number of citations, and 39 projects had filed more than 2 patents. When looking to the combination of both categories, publications and patents, however, 3 projects were found, which can certainly be called outstanding in their short-term impact (see also Table 2):

The brain-computer interface technology developed within BrainCom may revolutionise speech restoration; through thousands of tiny sensors, it can read and decode non articulated speech in real time. The BrainCom technology has potential to advance rehabilitation solutions for restoring speech and communication capabilities in disabled patients, using innovative technologies that can decode neural activity and predict continuous speech.

The project ArrestBlindness addressed Corneal Blindness through different therapeutic and surgical approaches and has brought another option to clinical application in corneal transplantation; one of the project’s biggest outcomes was the optimization of a Bioengineered Cornea®, which enabled to restore vision of 20 blind patients.

The Colodetect project developed a novel blood test that detects colorectal cancer at an early stage; Colodetect® was clinically tested and validated in a large and diverse cohort of patients. Direct comparison with colonoscopy data demonstrated 81% sensitivity and 85% specificity, higher than the commonly used diagnostic faecal occult blood test.

The mention of the results obtained from these 3 projects are just an indication of the value the EU-funded R&I projects have and provide a hint as to what kind of impact all the other 224 projects may have on the long-term. It can also be seen from the tables and the graphical representations that MedTech R&I has been funded from across the different sections of H2020, a finding which is not surprising owing to the breadth of MedTech products by their nature. Moreover, it shows that both open instruments (like FET or SME) and targeted calls (like SC1-Health) are needed to provide the funding eco-system for innovative ideas and breakthrough technologies to advance on their path towards translation into clinical practice or a medical product.

The current R&I Framework Programme entitled “Horizon Europe”, that covers the period from 2021 to 2027, has a similar structure as the previous one, notably with the three pillars on “Excellent science”, “Global challenges” and “Innovative Europe”. It is equipped with a total budget of € bio. 95,5 and has as primary drivers the tackling of Climate Change, the support to achieve the UN’s Sustainable Development Goals and the boosting of the EU’s competitiveness and growth [7]. The Public-Private Partnerships are maintained as Joint Undertakings, there are new schemes of Horizon Europe like the so called “Missions”, with the one addressing Cancer being the most prominent in the health domain; the major part of collaborative R&I activities dedicated towards health are supported by the “Health” Cluster of pillar II and all activities related to growth and competitiveness are combined under pillar III, with the SME-oriented activities covered by the “European Innovation Council” (EIC). In Horizon Europe the support to MedTech R&I is again provided across the three pillars. A recent novelty is the introduction of the “Transition”-scheme under EIC (next to the “Pathfinder and the “Accelerator”), which is also open to consortia (not only single entities) and will support innovation activities to translate technologies from the lab to the relevant application environments [8]. It might in the future serve to bridge gaps from proof-of-concept activities to clinical validation for MedTech R&I and hence complete the opportunities offered by the Health Cluster [9]. However, the latter will nevertheless remain a key source of funding for translational MedTech R&I, owing to the provision of project budgets large enough to cater for clinical studies conducted by multidisciplinary consortia that are collaborating towards specific goals, which are defined in the expected outcomes of the calls opened in the Health Cluster under Horizon Europe. Since collaboration with industries has been shown to increase the likelihood of regulatory approval of the developed MedTech innovations [10], the “Innovative Health Initiative” [11], successor of the IMI2-Joint Undertaking - now having all health industry sectors as members (not only the pharmaceutical industry) and thus acting cross-sectoral [12], might also play a key role in the translation of MedTech R&I into clinical applications and benefits for patients.