On February 6th, Carmelo De Maria and Licia Di Pietro were hosted by WeMake within the cycle of webinars on digital social innovation, in the framework of DSI4EU project.
During the webinar, Licia and Carmelo, covered a crucial issue for those who in the world of Makers and Fablabs are dealing with the development of medical devices. The main contents of the new European Regulation on Medical Devices was presented in a simplified way with particular attention to their classification and the procedures envisaged for CE marking.
Moreover, they presented several case studies developed using the UBORA platform in order to demonstrate the easy to use of the e-infrastructure to design medical devices compliant to the current European Regulation.
Starting from the webinar, WeMake team, with the help of the UBORA team developed the infographic “Open Source Medical Devices — a visual guide for makers”. This guide aims to provide the Do-It-Yourself communities with an easy-to-use and step-by-step documentation on how to go from a prototype of an open care device to a product that can be compliant with regulations and, therefore, ready to get to the market.
The UBORA e-infrastructure provides a structured framework for the development of an open source medical device from the identification of the clinical need up to the crowdfunding stage, sustaining the entrepreneurship spirit of BME innovators.
An example of this complete route is represented by Palpreast, a wearable device for breast self-examination. The team, supported by the innovation programmes PhD+ and Contamination Lab of the University of Pisa, was presented in front of a community of investors during the stage of C-Lab tour in Pisa, on 7th June 2019.
The UBORA e-infrastructure was presented, on June 5th at Politecnico di Torino, during the annual conference of GARR, the ultra-broadband network dedicated to the Italian research and education community. GARR is part of the European National Research and Education Networks (NREN), an international network, working together on research and development projects.
The Conference was an important opportunity to discuss the initiatives of the European Open Science Cloud and better understanding the importance of FAIR data management, which has a central role in UBORA.
The Industrial Engineering School at Universidad Politécnica de Madrid (ETSII-UPM) is performing a strategic actuation to make Spanish engineers aware of the relevance of engineering practice to achieve the Sustainable Development Goals (SDGs). In connection with SDGs 3 on “Good Health and Well Being” and 4 on “Quality Education”, an interview with Prof. Andrés Díaz Lantada, leader of UPM within UBORA, has been published. In the interview, Andrés has presented UBORA as a paradigmatic example of how industrial and educational innovation can be combined for the development of open-source medical devices. UBORA devices developed at UPM and presented in the UBORA Design School in Pisa have been also features as some of the most innovative examples of engineering systems developed by UPM students in the last years.
Communication is the basis of problem-solving. For biomedical engineers communicating with doctors, nurses and physicians is essential to understand real issues in healthcare facilities and create increasingly performing devices. On this basis, the “Needs-based medical design – Call for ideas” events have given the opportunity to students of the Master Programme in Biomedical Engineering of University of Pisa to exchange ideas and suggestions for new projects.
The first meeting was held at Cisanello Hospital on March 22nd, with the participation of Dr. Paolo De Simone and his Hepatic Surgery team, Dr. Pugliese, a specialist in Cardiology, and Dr Sani, responsible of Medical Devices Management. More than 30 students and 8 senior engineers actively discussed with the specialists on liver transplantation, heart rate monitoring and orthopaedics.
The second, held on May 10th, was instead focused on dialysis, with the participation of dr. Aldo Casani from the NOA Hospital in Massa.
WHO estimates that today, more than 1 billion people need one or more assistive products. With a global ageing population and rise in noncommunicable diseases, this number will rise beyond 2 billion by 2050, with many older people needing two or more products as they age.
Licia Di Pietro, UBORA team member, is spending a period of 3 months at the WHO Headquarters in Geneva as an intern. She is involved in the activities of supporting the work of the GATE based in the Department of Essential Medicines and Health Products.
The GATE initiative has only one goal: to improve access to high-quality affordable assistive products globally. To achieve this, the GATE initiative is focusing on five interlinked areas (5P): people, policy, products, provision and personnel.
During her internship, Licia is supporting the development of Assistive Product Specifications and mapping need for assistive technology using existing population data sources. In particular, she is involved in a study conducted between WHO Headquarters and WHO EURO, where WHO Headquarters led the estimation of the prevalence of functional limitations across all 4 countries and mapping potential AP of benefit and WHO EURO led the implementation and follow up of the rapid AT capacity assessment.
Successful teams emerging from the design competition will have one team member invited to a one-week design school featuring an innovative Conceive Design Implement Operate (CDIO) instructional framework empowered by the UBORA an e-infrastructure for the co-design of open-source medical devices.
It is a two-stage competition: the first-stage deadline is on April 1st 2019.
For submission procedure, evaluation criteria, scholarships, and other important dates please refer to the Competition page on ABEC website.
Prof. Andrés Díaz Lantada featuring UBORA as model for BME Education
Prof. Andrés Díaz Lantada has been invited by the organizing team of the Biodevices 2019 to give a keynote lecture. The topic of the lecture has been “Project Based Learning and Biomedical Devices: The UBORA Approach Towards an International Community of Developers Focused on Open-Source Medical Devices”. In the lecture, Andrés reviewed different approaches to BME education and highlighted the UBORA educational model, in connection with open-source medical devices, as paradigmatic initiative pursuing the transformation of the medical industry and innovation through education.
Interesting discussions and contacts, in connection with the sustainability of the UBORA project and with the expansion of the UBORA community, had been motivated by the presented keynote speech. Future activities for expanding UBORA into Middle East and Central Asia are being analyzed, on the basis of the contacts and synergies established in the Biodevices 2019 Conference. Besides, Andrés Díaz Lantada will be chairing the Doctoral Consortium of the Biodevices 2020 Conference to be held in Malta, in which UBORA devices will be also presented.
Prof. Alice Ravizza featuring UBORA as a resource for safe medical
Prof. Alice Ravizza, UBORA consultant, presented at Biodevices 2019 an innovative approach (in fact a methodology) to the promotion of safe-by-design medical devices, in which human errors during the use of medical devices are taken into account along the whole development and medical device life-cycle. UBORA devices, such as the “Palpreast” system for breast cancer detection (University of Pisa) and composite material splints for safe sport practice (Universidad Politécnica de Madrid), were featured as safe medical devices, in which usability risk assessment during the design stage has helped to enhance final performance and overall safety. The UBORA e-infrastructure guides medical devices innovators and developers in the safe engineering design of medical devices and motivates them to consider medical device usability and the user environment throughout the development process.
In the context of the activities for promoting the UBORA platform and importance of harmonization of medical device regulation, an UBORA workshop was held at University of Bologna, the oldest University in Europe, on February 26th.
The workshop, hosted in the course Biomedical Engineering for Developing Countries, thanks to the invitation of professor Stefano Severi, was organized in two sessions. In the morning we presented the UBORA design methodology, starting from clinical needs and putting emphasis on standards and regulation. The importance of harmonization of medical device legislation, in the context of global and local healthcare challenges, was one of the themes of discussion. In the afternoon, after an overview of the European Medical Device Regulation 2017/745, the students had the opportunity to do guided exercises on the classification of Medical Devices using the tools provided by the UBORA platform.