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.
The objective of the course, held on 14-18 January 2019, was to introduce the design principles of biomedical electronics and impart practical knowledge on construction and signal acquisition (details on the teaching programme can be found here). The same principles are daily applied by Mannan’s team for designing their devices on UBORA platform.
The 4th WHO Global Forum on Medical Devices, held at AMTZ-Kalam Convention Centre in Visakhapatnam (India), was a great opportunity for the over 1000 participants from all over the world to disseminate and share information on medical devices for global health.
During the forum, the UBORA delegates had the opportunity to hold a dedicated workshop on Open Source Medical Devices: safety and reliability, where the e-infrastructure was used by many participants with a different background (healthcare providers, entrepreneurs, policymakers) and origin (from Asia to America).
UBORA is a truly worldwide community of medical device developers which includes engineers, clinicians and patients, for developing needs-based medical healthcare technologies.
Recently (November 29th) we met, for example, the doctors of Zambrano Hellion Hospital in Monterrey (MX), one of the most advanced in Latin America. The discussion was focused both on high-tech medical devices and on the low resource settings, which can be found also in rich areas such as Monterrey. Open, smart and EU MDR compliant solutions can come from the UBORA e-infrastructure: a worldwide harmonized regulation is, however, necessary for increasing the access to quality healthcare.
Representatives of BME community from EU, Africa, US and Asia, of European Parliament Members (Madame Neena Gill, West Midland and Nicola Caputo, Italy), of European Commission (Mr Bernd Rainer, DG Research) took part to the meeting.
One of the topics of the meeting was how to harmonise international regulation on medical devices and medical setting across these continents, which is a key objective of UBORA.
Thinking, making, innovating, taking care, this is the mission of MAKEtoCARE18.
During the evening of October 10th, Licia Di Pietro and Lucia Arcarisi of UBORA team were protagonists of MAKEtoCARE18, an initiative promoted by Sanofi Genzyme, the Speciality Care division of Sanofi. The contest is aimed at bringing out and facilitating the creation and dissemination of innovative solutions useful for meeting the real needs of people affected by any form of disability, understood as any marked decrease in quality of life due to pathologies and/or traumatic events. The event was held at “Tempio di Adriano” in Rome, where 8 teams presented their innovative ideas.
During the contest, Lucia Arcarisi presented Palpreast, a medical device designed through the UBORA e-infrastructure. The device is a wearable stretchy top with a pressure sensing textile that is adapted to breast with an inflation system. This system applies an external pressure to simulate the hand movement that detects the presence of nodules, which are stiffer than the breast tissue. The device can be used by all women, including pregnant ones, because it’s safe, easy and does not use any radiation. Women, with high familiar or genetic onset, are the first target patient population, which have to undergo to several breast diagnostic exams.
The UBORA e-infrastructure was officially presented at the Digital Infrastructure for Research DI4R conference, held at ISCTE University Institute in Lisbon on October 9th-11th, by Prof. Andrés Diaz Lantada.
The conference was jointly organized by EOSC-hub, GÉANT, OpenAIRE and PRACE, which are some of the most important EU e-infrastructure, and represented a moment for reflecting about the sustainability of these tools which promote collaboration in the EU research community and beyond.
The intense programme can be found here, and the abstract we presented can be downloaded at this link.
The recently released UBORA e-infrastructure was presented to clinicians, who really appreciated the new “I have a needs” section, which can be the entry point for many of the design process of medical devices.
This conference session was a great opportunity for creating new contacts: Global Health Telemedicine is looking for affordable medical devices for the local point of care, and UBORA is ready for collaborating with them.
The UBORA Design School 2018 was held in the first week of September at the Conference Center Le Benedettine of University of Pisa, in Italy. More than 90 students, mentors, teachers and keynote speakers of 22 different nationalities from 4 continents animated the 5-days school on the design of open source medical devices.
Classes on design, legislation and prototyping, practical workshops on software and hardware enabling technologies were provided in the first three days of the school, while keynote speeches offered the opportunity to students to be inspired for their future careers.
The conference was articulated into 4 thematic sessions, focused on the recent developments on open source medical devices, on new methodologies for teaching collaborative biomedical engineering, on clinical needs in low resource settings and in high-income countries and on ethical problems introduced by new technologies in healthcare
During the Closing Ceremony of the conference, the preview of the UBORA e-infrastructure was presented by prof. Arti Ahluwalia, the UBORA coordinator.