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 demographic challenges. This left EU Hospitals completely unprepared to the COVID-19 pandemics.
In order to respond to this challenge the European Commission has invested 40 millions of EURO with a dedicated call, which has selected 4 projects our of 85 proposals.
Dr Leandro Pecchia from the School of Engineering at the University of Warwick, is a key member European collaborative team that has been awarded one of those 4 project, the ODIN project. The ODIN project has a total value of €13 millions for 21 partners from 11 EU countries. This project will support 2 senior PDRAs, which will join Dr Pecchia team in 2021.
Dr Pecchia said:
“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 using AI, cybernetics and bionics;
· introducing autonomous and collaborative robots for enhancing hospital efficacy and safety;
· introducing and enhancing medical locations and medical device management with IoT and video analytics
These areas of intervention will be piloted in six top hospitals in six European cities (Berlin in Germany, Paris in France, Rome in Italy, Madrid in Spain, Utrecht in The Netherland and Lodz in Poland), spanning from clinical to logistic interventions, including patient management, disaster preparedness (e.g., reorganising Hospitals in case of pandemics) 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.
ODIN vision is that as Evidence Based Medicine revolutionized medicine with data-driven procedures, so data-driven management, enabled by Industry 4.0 technologies, can revolutionise hospital management.
Beyond this project, I believe it is important to appreciate that our successes in the H2020 are the results of several factors, including vision, competence and constructive collaboration with European Scholars. This proposal in particular, is the result of the collaboration with Dr Giuseppe Fico, which visited Warwick last year as IAS Fernandes Fellow. ”
This is the 5th successful project written by Dr Pecchia and his EU partners in the past 12 months, focusing on IoT, AI, Robots and big-data for healthcare.
dr Silvio Pagliara is in the Management Committee of the Cost Action 19104 - Advancing Social inclusion through Technology and EmPowerment.
Social inclusion is an important element of well-being for people with Autism Spectrum Disorder (ASD) and/or Intellectual Disability (ID). Research has highlighted that social inclusion is facilitated through access to education and employment. Despite this, people with ASD and/or ID have low rates of participation in these domains. Research has demonstrated that Assistive Technology (AT) shows great promise in increasing participation in education and employment. Notwithstanding recent technological advances, there are low rates of adoption of AT throughout Europe by service providers, educators, employers and policymakers. There are several areas of unmet need including: high abandonment rates of AT, lack of inclusion of people with ASD and/or ID in the research process, lack of interdisciplinary and intersectoral collaboration and poor match between technology and the individual with ASD and/or ID.
The aim of the COST action is:
Build an interdisciplinary, intersectoral pan EU and beyond, network which will enhance social inclusion and empowerment of individuals with ASD and/or ID.
This will be achieved by:
Evaluating the development of novel AT by providing an interdisciplinary and intersectoral collaboration between all stakeholders using a translational approach to establish standardised practice guidelines for design, development and deployment of AT.
Creating knowledge, by providing a database of current AT technologies and their match to employment and educational contexts for users with ASD and/or ID.
Promoting the adoption of evidence-based guidelines in relation to use of AT across settings and populations and propagating the use of inclusive design and rigorous research approaches.
The lab is deeply involved in the Global response to the COVID-19 pandemic, in three main areas:
- regulatory framework for PPE and medical devices
- telemedicine for monitoring of COVID19 and to provide continuity of care to chronic patients
- AI for early detection of pneumonia
- Training, sharing of best practices
Supporting the WHO with PPE, medical devices and training/dissemination
Dr Pecchia is part of an international team of experts helping WHO in identifying essential COVID medical devices and preparing specifications for helping Hospitals/MoH, in particular in LMICs. You can find here the WHO tools onine
As trersaurer of the IFMBE CED, I am part of an international team which organised a series of webinars on COVID-19 and medical devices in collaboration with the WHO. The program is available here.
We have supported manufacturers who have been willing to convert their productions and move into PPE or Medical Devices. In particular, we have supported few manufacturers navigating the regulatory framework, informing their design with relevant harmonized standards and norms.
Telemedicine, AI and IoT
The main focus of our lab is on Telemedcine, AI and IoT for health. We have several projects in this area, which are described here. The last and wider is teh GATEKEEPER project (£20mil, 500,000 patients, 8 European NHSs). Telemedicine is a key instrument to fight COVID-19.
We have supported an Italian company to adapt their platform for COVID. This is now serving 20,000+ self-isolated patients and citizens in Rome Region, which use the platform to monitor their data, and transmit those to their local NHS Trust. Further details are available here.
We have supported the Bangor Hospital (NHS north Wales Trust) in respond to the NHSx call for COVID-19. With this call, the hospital will use an App and a wearable sensor to monitor, at home, cancer patients. This will ensure them the continuity of care, while keeping them at home, minimizing hospital accesses as much as possible.
AI for pneumonia detection via symptoms
We are developing an AI system to detect pneumonia from symptoms. This is not COVID specific because data on COVID are not available yet. We are using a dataset from Bosnia (one of the LMIC I have been working with) learning how to distinguish pneumonia from bronchitis and normal influence, but we believe the work we will produce can be then adapted for COVID if/when data will become available.
COVID and LMICs
The one described above are all Global Challenges. Our activities are directly/indirectly the result of our experiences in previous EPSRC GCRF and IAA funded projects. We were considering these topics for limited resources settings (i.e., telemedicine, AI, minimum requirements, regulatory framework, heath technology assessment…) and to many extends a pandemic crisis create a situation that is, de facto, a limited resource one (not enough beds, not enough devices, not enough experiences staff…)
Here our latest publication on similitude between COVID-19 and LMICs, in regard to the limits of current international regulatory frameworks for PPE. The same probably applies to medical devices. Here the paper.
In May 2019, the World Health Assembly of the World Health Organization (WHO) decided to start working on a free international nomenclature of medical devices, including IVDs, for facilitating and harmonising the work of regulators, procurers, supply and user around the globe. According to the WHO, this nomenclature must be a "Public Good", not subject to copyright, freely accessible to everyone, and designed to consider the real need of healthcare professionals (e.g., nurses, clinical engineers), facilitating their daily work. For instance, WHO considered aligning the nomenclature with the International Classification of Diseases 11th Revision (ICD11). This does not seem to be the case for the 2 major international nomenclatures: GMDN, developed by the European GMDN Agency, which is widely used internationally and UMDNS, developed by ECRI.
The European Union has decide to change its official nomenclature adopting the Italian nomenclature, which will be renamed EMDN (European Medical Devices Nomenclature).
However, a lot of work remains to be done, in order to male this nomenclature accessible and universal, especially to protect users from LMICs.
In order to offer a support to WHO and to the EU Commission, the EAMBES set a working group. This presentation will offer a preliminary view of the conclusions achieved from this working group.
The University of Warwick is hosting the first meeting of this working group, which will kick-off meeting the Task force in March 2020.
Experts from 8 European Countries will join this meeting, which will result in a recommendations that will be presented to the European Parliament and to the World Health Organization (WHO).
PLANNED FOR Summer 2021 - Summer School on design of medical devices resilient to low-resource settings.
School of Engineering, University of Warwick
In light of the United Nations Sustainable Development Goals, there is clear need for a novel generation of experts trained to design medical devices responding to real needs of low-and middle- income countries (LMICs) and in particular Sub-Saharan Africa.
This school aims at gathering world leading experts in medical device design, 3D-printing, Artificial Intelligence (AI), Health Technology Assessment (HTA), clinical engineering, device management, regulations and ethics who will inspire a multidisciplinary pool of Early Career Researchers and PhD students from high- and LMICs to work together facing global health challenges.
In a series of frontal classes, tailored workshops and hands-on sessions, attendees will learn-by-doing the main workflow for designing medical devices and how to make them resilient to limited resources settings and sustainable. This will include methods for need assessment, risk analysis, application to real life scenarios, global regulatory frameworks, ethical issues, principles of local and circular design and manufacturing, health economic methods and tools.
Leveraging on previous experiences , the participants will be split into groups, assigned to different projects and required to design a functioning prototype with the help of tutors and mentors. We can anticipate that the prototypes will be based on the use of low-cost plug-and-play electronic development kits (e.g., Arduino), smartphones and 3D printing and manufacturing as per our previous experience . Attendees will be briefed in advance, provided with reading material and video-tutorials in order to make the school the most effective possible. The best project will be awarded a prize (subject to budget availability).
The training will be held on the newly refurbished clinical engineering lab and of the Engineering Building Space. The Engineering Build Space is more than just a 3D printing facility, it’s probably one of the best equipped academic maker space in the UK. This was designed and realized in 2018 as realization of learn-by-doing multidiscipline pedagogic philosophy. Together with the pre-existing designing spaces it position Warwick as one of the best places in the world where such a school can be conceived and hosted.
The school will be mainly focused on the design of medical devices, and to explore the use of local manufacturing methods to make this design sustainable in LMICs and limited resources settings. Learning outcomes will include:
- Deepen regulatory requirements for medical device design
- Learn methods and procedures for medical device design
- Learn how to generate relevant evidence in medicine and biology
- Learn how to apply methods and tools for need-analysis and context-driven medical device design
- Learn how to assess, in a very early stage, the potential impact (e.g., prospective cos-utility) of medical devices
Novelty of training
The combination of different pedagogic methods (frontal classes, tailored workshop and hands-on sessions) along with the focus on contextual and frugal design of medical devices resilient to LMICs will offer an unprecedented multidisciplinary learning opportunity. The number of attendees will be limited and the participants will be organised in groups. Candidates will be carefully selected to guarantee that in each groups there is sufficient knowledge of fundamental topics (e.g., biology/medicine, coding, 3D manufacturing, electronics etc.). Each group will be assigned a medical device, and groups will have to deliver its final design, possibly also a working prototype, by the end of the school. Frontal lectures will be reduced to the minimum possible, but all the lectures will keep working with the different group basing on their own area of expertise (e.g., risk assessment, trial design, clinical engineering, regulatory science, health economic, human factors, mechanical/electronic manufacturing etc.). Each group will be assisted by tutors and will be assigned a virtual budget to spend for 'buying', consultants' time, to prepare a technical file for their medical device, and for manufacturing the working prototypes. All the prototypes will be finally tested against relevant international standards for medical device safety, using the ABSPIE equipment.
The Applied Biomedical Signal Processing eHealth (ABSPIE) Lab had already organised the first International Summer School on Health Technology Assessment , which was then adopted as model from the International Federation of Medical and Biological Engineering (IFMBE), which is now regularly running those training events internationally, every two years . Also in this case the target audience were early career researchers, but the focus and layout of the school were different.
· PhD students or early career researchers interested in medical device and global health.
· Candidates with interest/experience in medical devices design will be given priority
· a number of places will be reserved for attendees coming from other than engineering disciplines (i.e., social sciences, philosophy, liberal arts, medicine, …).
- Dr Leandro Pecchia, School Director
- Prof Francesco Cappuccio [epidemiology of cardiovascular disease, global health]
- Dr Simon Leigh [Additive Manufacturing]
- Dr Alessia Maccaro [Bioethics, Philosophy]
- Dr Sam Agbroko [Electronic Engineering]
- Prof Daniel Clark [Clinical Engineering]
- Dr Almir Badnjevic [Medical Device metrology]
- Prof Arti Ahwulalia [PI UBORA project – Biomedical engineering]
- Dr Carmelo De Maria [PI UBORA project – Biomedical engineering]
- Dr Simone Borsci [Human Factors]
- Dr Sudesh Sivarasu [Medical Device Design]
- Prof Daton Medenou [Biomedical Engineering]
- Miss Philippa Makobore [Electrical Engineering]
- Prof Stefano Severi [Biomedical Engineering]
- Dr Ernesto Iadanza [Clinical Engineering]
- Davide Piaggio [Medical Devices in LMICs]
- Dr Silvio Pagliara [Assistive Technology]
How to apply?
A call for applications will be issued in February 2020.
The main objective of the Project is to create a GATEKEEPER, that connects healthcare providers, businesses, entrepreneurs, elderly citizens and the communities they live in, in order to originate an open, trust-based arena for matching ideas, technologies, user needs and processes, aimed at ensuring healthier independent lives for the ageing populations. By 2022, GATEKEEPER will be embodied in an open source, European, standard based, interoperable and secure framework available to all developers, for creating combined digital solutions for personalised early detection and interventions that:
- harness the next generation of healthcare and wellness innovations;
- use innovative technology to cover the whole care continuum for elderly citizens, including primary, secondary and tertiary prevention, chronic diseases and co-morbidities;
- support value generation through the deployment of advanced business models based on the Value-Based Healthcare paradigm, which represent the state of the art method for Health Technology Assessment (HTA) of medical devices.
GATEKEEPER ambition is to demonstrate its value by scaling up, during a 42-months work plan, towards the deployment of solutions that will involve 40.000 elderly citizens, supply and demand side (authorities, institutions, companies, associations, academies) in 8 regional communities, from 7 EU member states.
Dr Leandro Pecchia, who coordinated the writing of the proposal with Dr Giuseppe Fico (IAS Fernandes Fellow at Warwick and Assistant Prof at UPM) and Medtronic in 2018, will be the PI for Warwick and the scientific responsible for the large scale pilotes in collaboration with 43 partners from 7 member states.