The certification of a medical device can require animal testing: norms and ethical, and economic reasons impose a careful understanding of the mandatory steps for ensuring safety and efficacy of new technologies
In this context, the European Union Directive 2010/63 / EU on the protection of animals used for scientific purposes constitute a milestone, but many times there is no clear understanding of who-is-what, leading to useless experiments.
The UBORA team gave its contribution to the discussion, try to make a clarification on one of the cutting edge fields of research, Bioprinting of scaffold and living tissues, where a clear distinction between medical devices and advanced therapies medicinal products can be a first step toward the refinement of animal testing.
The UBORA team was invited to participate during the Health&Care Summer School, a training course for co-design and prototyping devices for people with disabilities, know also as careables.
The school was organized by OpenDot in the framework of the project DDMP, and presented both hands-on session and frontal classes aimed at developing in a short run functional prototypes together with and for supporting people with disabilities. In fact, the motto was “designing with, not for“, and the students worked on 3 needs-based challenges:
In this context, the UBORA team gave an overview of Medical Device regulations, and how to go through the certification process before safely deploy a medical device to patients and healthcare providers.
For us it was an extremely useful opportunity to enlarge our network of people, associations and laboratories, which work together for increasing the access to medical devices.
Research visits have been frequent during the almost 2.5 years UBORA project. At the end of April, for example, in the framework of WP2 UBORA innovation action, Prof. Torop from the University of Tartu spent a period in the Mannan’s Laboratory at KTH.
Recently (18th-21st June), also Dr. Carla Papa, from UBORA project office at the University of Pisa, visited KTH for preparing dissemination materials for promoting UBORA sustainability.
On June 11th 2019 the award ceremony of “Ingegnere innovativo” and “Bertelè” was held in Turin. The awards have been organized by the Ordine degli Ingegneri della Provincia di Torino e la Commissione Ingegneri per l’Innovazione which followed the overall operative aspetcts.
This year the Bertelè award has been won by Lucia Arcarisi who presented Palpreast. This medical device, developed using UBORA Platform, is a wearable device for breast self-examination based on tactile imaging. This simple and non-invasive procedure can be performed by lay individuals for detecting possible malignant nodules in the breast. Combined with other screening methods, the device can increase the odds of early detection demonstrating its innovative approach to prevent breast cancer.
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.