The objective of the HELoS CSA is to support the Health.E Lighthouse Initiative Advisory Service (LIASE) in its ambition to accelerate innovation in medical devices (“Moore for Medical”). Health.E will accelerate the innovation in medical devices and systems by stimulating the development of open technology platforms and standards , thereby moving away from the inflexible and costly point solutions that presently dominate electronic medical device manufacturing. Open technology platforms, supported by roadmaps, will generate the production volumes needed for sustained technology development, resulting in new and better solutions in the healthcare domain. Health.E will: • Translate the needs of medtech and pharma into ECS opportunities; • Build on the ECS Strategic Research Agenda and identify the gaps; • Stimulate initiatives: towards open technology platforms and standards for medical devices; to anticipate the requirements for regulatory, Notified Bodies, clinical trials and market access; to better apply to the current care practices, necessary conditions for market access. • Connect to European initiatives and relevant communities including PPPs such as ECSEL, IMI, Eureka, and relevant industry associations In the HELoS CSA, three main components are identified that need to be connected in order to address the complex issue of innovation in the medical industry: • Connecting existing networks: ECSEL projects, (inter)national and regional projects and initiatives; • Addressing and connecting scientific/technical issues and non-technical aspects e.g. legal, regulatory, standardization, ethical, economic (cross-cutting issues); • Extending the network of stakeholders and markets across Europe (spreading excellence, facilitating international collaboration, new applications); • The dissemination of the results of this initiative to the stakeholders and the general public.

EU-TRAINS aims to reinforce the supply chain on sensors for biomechanics and cardiovascular system real-time monitoring targeting applications in the fields of fitness and healthcare. It leverages from the strength of EU digital microsystem and design to support a 100% made-in-Europe supply chain of solutions which encompass smart-textile integration as well as advanced AI-based edge-cloud data processing. In details the following outcomes are foreseen: - Textile integrated electronic systems for real-time monitoring of hearth, respiratory and movement parameters on-the-air and in-water through an interdisciplinary approach; - Semiconductor technologies which allow the re-use of micro-nano systems both in the sports and in the healthcare sectors; - Miniaturized devices allowing the capturing of bio-chemical parameters able to withstand harsh ambient conditions such as salt fogs, chlorine, detergents, high and low temperatures, etc. The following key activities are targeted: - Development, prototyping and demonstration of versatile sensors with edge AI features for improved precision and reliability, that can also be integrated in textiles as well as in smart wearable wrist-watches and in sport equipment and gears targeting also underwater applications; - Cloud-edge Artificial Intelligence combined approaches for reliable diagnosis of body parameters. This will comprise sensor’s self-learning, remote update, multi-sensing approaches based on sensor arrays; - Novel materials that support electronics printing in textiles with stretchability and self-healing capabilities. Societal benefits are foreseen in the transition to a healthier lifestyle by promoting regular physical activity through affordable tools and services for a large audience, including people with disabilities. Moreover, this will impact the smart/remote-healthcare sector which will benefit of the availability of low-cost microfabricated solutions for intelligent, versatile, connected body sensors.

The goal of EnSO is to develop and consolidate a unique European ecosystem in the field of autonomous micro energy sources (AMES) supporting Electronic European industry to develop innovative products, in particular in IoT markets. In summary, EnSO multi-KET objectives are: • Objective 1: demonstrate the competitiveness of EnSO energy solutions of the targeted Smart Society, Smart Health, and Smart Energy key applications • Objective 2: disseminate EnSO energy solutions to foster the take-up of emerging markets. • Objective 3: develop high reliability assembly technologies of shapeable micro batteries, energy harvester and power management building blocks • Objective 4: Develop and demonstrate high density, low profile, shapeable, long life time, rechargeable micro battery product family. • Objective 5: develop customizable smart recharge and energy harvesting enabling technologies for Autonomous Micro Energy Source “AMES”. • Objective 6: demonstrate EnSO Pilot Line capability and investigate and assess the upscale of AMES manufacturing for competitive very high volume production. EnSO will bring to market innovative energy solutions inducing definitive differentiation to the electronic smart systems. Generic building block technologies will be customizable. EnSO manufacturing challenges will develop high throughput processes. The ENSo ecosystem will involve all the value chain from key materials and tools to many demonstrators in different fields of application. EnSO work scope addresses the market replication, demonstration and technological introduction activities of ECSEL Innovation Action work program. EnSO relates to several of the Strategic Thrusts of ECSEL MASP. EnSO innovations in terms of advanced materials, advanced equipment and multi-physics co-design of heterogeneous smart systems will contribute to the Semiconductor Process, Equipment and Materials thrust. The AMES will be a key enabling technology of Smart Energy key applications.

The aim of the KardiaTool project is to translate a laboratory proven concept of a saliva biosensor to the clinical practice for addressing the priority needs in personalized HF diagnostics and therapy monitoring at the point of care. The KardiaTool platform includes: (i) An easy to use portable POC device (KardiaPOC) with a disposable Lab-on-a-Chip (LOC), for the non-invasive, rapid and accurate qualitative and quantitative assessment of HF biomarkers, from saliva samples. KardiaPOC device will integrate a variety of sensors, actuators, Microelectromechanical systems (MEMS), micro-electronics, bio-chemicals and functionalized magnetic nanoparticles (MNPs), onto a disposable, low cost LOC. (ii) A decision support software (KardiaSoft) based on predictive modelling techniques, that analyzes the POC data and other patient’s data, directly added by the healthcare professionals, and delivers information related to HF diagnosis and therapy monitoring. The innovation lays in the incorporation of four novel saliva biomarkers that have been proven in a laboratory setting and bring a new promising concept for addressing the priority needs of the clinical arena. KardiaPOC will provide the capability of simultaneously extracting key information from the saliva biomarkers: (i) NT-proBNP, (ii) TNF-a, (iii) Interleukin- 10, (iv) Cortisol. It is expected that identifying a comparable source to blood, for biomarker information, such as saliva, that is cost effective, less invasive, more convenient and acceptable for both patients and healthcare professionals would be beneficial for the healthcare community. The challenge of KardiaTool is: (i) to translate a laboratory proven concept of a saliva biosensor into an MNBS platform, for HF diagnostics and therapy monitoring, at the point of care, following GLP (ii) to validate the MNBS platform through pre-clinical and clinical testing following GCP and (iii) to industrialize the outcomes following GMP towards progress to marketization

WiBEC (Wireless In-Body Environment Communications) is an Innovative Training Network for 16 young researchers, who will be recruited and trained in coordinated manner by Academia, Industry, and Medical Centres. This training will address the Social, Health, and Technology challenges of the H2020:Wireless In-Body Devices. WiBEC’s main objective is to provide high quality and innovative doctoral training to develop the wireless technologies for novel implantable devices that will contribute to the improvement in quality and efficacy of healthcare. Two devices will be used as a focus for the individual researcher’s projects; cardiovascular implants and ingestible capsules to investigate gastro intestinal problems. These devices will enable medical professionals to have timely clinical information at the point of care. The medical motivation is to increase survival rates and improvement of health outcomes with easy and fast diagnosis and treatment. The goal for homecare services is to improve quality of life and independence for patients by enabling ambient assisted living (AAL) at home. In this particular ETN, inter-sectoral and multi-discipline work is essential, as the topic requires cooperation between medical and engineering institutions and industry. This aspect is fulfilled with the participation of two reference hospitals, two medical device manufacturers and three top ranked universities in Europe, covering complementary aspects of the in-body wireless device field. Concerning future employment perspectives; surgery and medical assistance is rapidly becoming more technological than it is today, and a large number of experts combining engineering and medical skills will be required in Europe to enable novel paradigms like AAL to be realised. The ESRs who join this ETN will acquire diverse skills that will enable them to occupy privileged positions to join and promote EU leadership in ICT for Health.