Hospitals must increase their efficiency and productivity and boost quality and safety, while containing and reducing costs. This cannot be an untaught linear reduction. For instance, the number of ICU beds per million of EU habitants was reduced of 75% in the past 30 years, also in response to the unneglectable need to invest on territory healthcare services in response to democratic challenges. This left EU Hospitals completely unprepared to the COVID-19 pandemics, proving that hospital budget cuts must be complemented with major organizational restructuring, making use of innovative technologies. We have identified 11 hospital critical challenges, which ODIN will face combining robotics, Internet of Things (IoT) and Artificial Intelligence (AI) to empower workers, medical locations, logistics and interaction with the territory. ODIN will deploy technologies along three lines of intervention: empowering workers (AI, cybernetics and bionics), introducing autonomous and collaborative robots and enhancing medical locations with IoT. These areas of intervention will be piloted in six hospitals (in Spain, France, Italy, Poland, The Netherland, Germany), via seven use cases, spanning from clinical to logistic, including patient management, disaster preparedness and hospital resiliency.ODIN pilot will be a federation of multicentre longitudinal cohort studies, demonstrating the safety, effectiveness and cost-effectiveness of ODIN technologies for the enhancement of hospital safety, productivity and quality. Use-case protocols will be approved by the local hospital ethical committees, in order to assure the highest quality of the study, while providing a pragmatic solution for the scaling-up of the ODIN technological solutions and business models in a variety of local ecosystems. ODIN vision is that as Evidence Based Medicine revolutionized medicine with data-driven procedures, so data-driven management (enabled by Industry 4.0 tech) can revolutionise hospital management.
ODIN vision is that the introduction of innovative cost-effective technologies must be accompanied by processes’ transformation, to ensure cost saving and sustainability. Leveraging on partners’ wide range of expertise and backgrounds, ODIN innovative contribution will go beyond the technical elements, contributing to prepare the EU market to the KER. As it was demostrated in 2015, management control requires interventions in three critical hospital areas: staff, technology, medical locations [5]. The ODIN pilots will leverage on these findings deploying innovative technologies and managerial solutions across three hospital spheres of operations: clinical, logistic, territorial. ODIN will enable data-driven anticipatory decision-making based on multisource connected data collection, analysis and feedback. The ODIN platform will promote the application of EBM methods and principles to hospital management, measuring the performance of deployed technologies against health and care metrics, suitable for the ODIN spheres of operation. State of the art Multicriteria Decision Analysis (MCDA) methods and tools will be used to define and validate valuable Key Performance Indicators (KPIs) and to assess the performance of ODIN platform in each sphere, as well as in their intersections. While the project partners will align demand (hospital partners) and supply (technological partners) within the project, the project management team will engage a constructive interaction with the European institutions, in order to facilitate the removal of barriers that may hinder the adoption of ODIN technologies beyond the project lifespan. In fact, the project will run a survey with European and National Bodies for Public Procurement in the healthcare sectors4 in order to identify, classify and prioritise gaps in the current procedures, which may affect the uptake of AI and robotic solutions in EU Hospitals. Moreover, ODIN will leverage ongoing contribution of project partners to European scientific societies (e.g., EAMBES), which are currently involved with EU policy-makers such as the European Parliament and the European Commission, in order to support the preparation of guidelines and clear interpretations of EU Regulations that are relevant for the ODIN technologies. This includes the General Data Protection Regulations (GDPR), for all the aspects related to the data collection, processing and sharing of healthcare works and patients. This also includes the recent EU regulations on medical devices. In fact, although the technology deployed in the ODIN project are not meant to be medical devices (i.e., are not intended by their manufacturers for the purposes defined in the Medical Devices Regulation [MDR] 2017/745 and 2017/746), they will interact with medical locations, medical devices, healthcare professionals and patients. Therefore, the potential interaction among ODIN technologies with the works, environment and patients will have to be deeply explored concerning MDR. This is particularly challenging, also because EU regulations on medical devices are in a transition period and will be enforced during the project (respectively May 2021 for MDR2017/745 and May 2023, for 2017/746). However, the project partners have huge expertise of this fluid domain and are already involved in ongoing discussion with policy-makers in EU and beyond (e.g., World Health Organization), on the evolution of these directives and their interpretation (i.e., UoW, UPM). It is also worth mentioning that all the aspects concerning cybersecurity will be addressed, according to the guidelines from the Medical Device Coordination Group (MDCG), established by Article 103 of Regulation (EU) 2017/745, specifically in terms of Information Technology (IT) Security, Information Security and Operation Security. ODIN technologies will be designed to positively impact on safety, security, and effectiveness of the healthcare technologies.
