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.

Support Manufacturers

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.

School of Engineering, University of Warwick

This event has been cancelled and we'll let you know when it will be rescheduled.

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 ^[1], 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 ^[2]. 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.

Learning outcomes

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 ^[3], 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 ^[4]. Also in this case the target audience were early career researchers, but the focus and layout of the school were different.

Target

· 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, …).

Academics/Tutors

• 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]

School Sponsoring/Endorsement

• Warwick IAS
• IFMBE CED
• IFMBE HTAD
• EAMBES
• Warwick School of Engineering

This event has been cancelled and we'll let you know when it will be rescheduled.

This project aims to steer the discussion within the international biomedical engineering (BME) community, creating an international working group that will influence European and WHO policy on HTA of Medical Devices, with a specific focus on LMIC.

The main activities of supported by this project have been:

1) to host a meeting of an international working group, aiming to draft a white/paper on HTA of Medical devices.

2) support field studies in Benin, aiming to explore the operational condition of medical devices in a sub-Saharan country

3) support the dissemination of those preliminary results in scientific conference and discuss the preliminary findings with relevant European Institutions and with WHO.

This project has been conducted with the support of:

1) the World Health Organization (WHO)

2) the International Federation of Medical and Biological Engineering (IFMBE)

3) Warwick Impact Fund

4) EPSRC IAA