The novel corona virus causing COVID-19 overwhelmed Europe and the world in just a few weeks’ time. Small and Medium-sized Entrerprises (SMEs are put at very high risk by the slowdown or shutdown of economic life in their countries – exactly those companies who ensure the development of innovative solutions urgently required for counteracting the impacts of COVID-19 and for helping to control possible future outbreaks alike. In view of this situation, accelerated uptake of innovative technologies to tackle COVID-19 is most needed. In order to give an efficient and fast answer to this challenging situation, we propose building an Innovation Hub for the addressed technologies: an innovative open access platform to offer companies and reference laboratories the capabilities, expertise, networks and services required for the assessment, development, prototyping, testing, scaling-up, pilot production and market exploitation of innovative technologies to tackle COVID-19 pandemic. This approach will be based in the Open Innovation Test Beds (OITBs) concept, to incorporate lessons learned from those Innovation Actions, reducing time for putting in place such HUB and ensuring its successful implementation for a swift impact to the current situation. Our approach will include leading applied research and innovation centers in Europe, together with entities specialized in building OITBs, and reference clinical sites. INNO4COV19 will provide funding to third parties to help them achieve the desired objectives. Presence of leading applied research EU institutions in the Consortium will help to obtain a huge impact and to find and attract innovators across Europe to offer new solutions for COVID-19 pandemic and other potential future outbreaks. Europe needs to reinforce its technological leadership and rebuild an industrial sector capable to protect our citizen’s safety and well-being, and INNO4COV-19 will help in catalyzing the change.

Over 50m people suffer from multimorbidity (PMM) in Europe. Recent reviews find that PMM experience a range of system and professional-related issues with care delivery. In part, this is because current investments in process-based delivery means delivering healthcare within single diagnoses tracks/silos. For PMMs this does not reflect real-world conditions. No technology is available today that enables the specific care, treatment, administration and support needed for this target group. Breakthrough solutions will classify the individual according to their co/multimorbidities and medications. But this needs to be developed in close dialogue between PMM, care providers and industry sectors based upon a strong demand driven approach in a PCP. Accordingly, the CareMatrix Buyers Group (SE, NO, ES) challenge the market to develop innovative technology that enables more predictive care and support benefits for PMM. This is achieved with 6 project objectives summarised as PCP: stakeholder engagement, roadmap, Call, implementation, next steps and; profiling and outreach via IFIC. The methodology can be summarised as PCP: framing actions (PCP preparation, use of UCD principles and practice); implementation actions (Phases 1-3 contract management, support, evaluation and testing) and Market Preparation actions (business development support for Phase 3 suppliers, standards, initial PPI preparation). Direct benefits include: • 20% reduction in time spent for visits to care facilities • Improvements from baseline in at least 75% of aspects of care as identified using PREM surveys • 50% fewer patient data-related incidents (increased patient safety) between organizations • No of clinical errors reduced by 30%; Underpinning the CareMatrix solution(s) with integrated innovation (supportive policy priorities, organisational and social innovations) will optimise the potential of those solutions to produce savings of 10% in health care expenditure for PMM.

TBMED will establish an open innovation testing bed specialized in the development of high-risk devices (≥Class IIb). Due to a long reimbursement processes, patient access to innovative high-risk medical devices in Europe can take four times longer than in the U.S. In addition to this, the new regulations will stricter ex-ante controls for this type of devices. This scenario represents a big challenge for European high-tech SMEs (representing 95% of the MedTech sector in Europe) to maintain their competitiveness and innovation capacity. TBMED will provide an integral service to accelerate the development of medical devices reducing time to market, covering technology development from TRL4-7 based on Quality-by-Design (QbD) concept and business management services. QbD concept enhances product and process understanding together with process control, based on robust scientific knowledge and quality risk management. Once operating (M37) the OITB will integrate: 1) an SME office that will provide business advice and IP management, 2) services on regulation, early health technology assessment advice and QbD, 3) a biomaterial synthesis lab, 4) characterization facilities, 5) a testing lab for in vivo and in vitro efficacy testing, 6) safety assessment and 7) clinical testing. Three case studies will be used to validate the concept and will help to establish the OITB: 1) An osteoinductive hydrogel, 2) Keratoprosthesis and 3) Magnetic NPs for hyperthermia. TBMED consists of 13 complementary partners composed by 1 Industry and 2 SMEs developers of 4 different medical devices used as case studies, 5 RTD institutions experts in the development of medical devices, 1 SME expert in QbD methodology, 2 RTD Institutions that will provide the access to a hospital network with experience in regulation, health technology assessment and clinical investigation design and testing and 2 consultancy (SME) experts on business plan development, IPR management and communication activities.