The SMART-HEALTH-4-ALL project aims to contribute to the sustained development of the national Health sector, in particular of Medical Technologies, seeking in a structured and concerted way, to increase its capacity to meet the challenges it currently faces in a highly competitive and dynamic global market, with increasingly informed and and with increasingly informed and demanding consumers. The project arises, therefore, as a result of a strategic reflection reflection carried out by the main national stakeholders, highlighting the Health Competitiveness Hub, the business community, universities business community, universities, technology centers, among others, who consider it urgent to invest in differentiation, focusing on the presentation of products and technologies with high added value, processes and innovative methodologies, to respond to the latest trends in the sector and assert itself in the global market.
The SMART-HEALTH-4-ALL project presents itself as a truly mobilizing R&D project that seeks to address the main challenges of the entire value chain of the Medical Technologies sector, by carrying out a structured set of R&D activities organized into 5 PPS oriented to the creation of new products/services or processes of high technological content, in several areas, from the creation of an Ecosystem SMART-HEALTH-4-ALL (Test, Validation, Evaluation and Procurement of Medical Technologies), Personal Health Devices (shoes for diabetic foot and armband for rehabilitation of shoulder or knee injuries, Mobile Health Apps (Brain Diagnosis and biosensors), Home Health Devices (furniture with sensing and monitoring properties and pillow for monitoring sleep quality) and Medication Management Devices (individual management of medication in any environment and Adaptive and Intelligent control for Automated Delivery Systems / Medication Preparation.
The project aims to consolidate an R&DT ecosystem dedicated to the diagnosis, monitoring, and cognitive intervention in the main neurological diseases, providing it with the necessary technology for the implementation of differentiating services. Based on three main problems identified in the previous section, the following achievement objectives were organized concerning the requirement in the context of Research & Technological Development of the consortium:
O1. Construction of a translational ecosystem, supported by the latest information technologies and hardware elements, dedicated to cognitive health in the context of neurodegenerative diseases that encourage collaboration between different actors (patients, family members, patient associations, professionals, clinical services, hospitals, and pharmaceutical companies) within the chain of care for the main neurodegenerative diseases;
O2. Based on early experimental work, the aim is to design, develop and validate a medical device for tracking, monitoring, and cognitive assessment. This medical device will consist of two major components, a component for acquisition, conditioning, and processing (with artificial intelligence algorithms for filtering and preparing physiological data) of biosensors (backend); and a software component that includes applications for the patient, healthcare professional and others (frontend);
O3. Carry out the scientific validation studies (clinical trials) that support the CE certification process as a medical device and the construction of the respective technical files. Perform all steps of medical device certification with INFARMED and an entity certified for that purpose.
With the conclusion of the project, the objective was achieved:
- Development of digital tools for tracking and monitoring cognitive decline.
And results achieved:
- Construction of prototype versions of new features of the BrainDiagnosis tool;
- Validation of BrainDiagnosis with end users;
- Preparation of technical documentation and quality management system for certification of the medical device.