Periodic Reporting for period 2 - UBORA (Euro-African Open Biomedical Engineering e-Platform for Innovation through Education)
Reporting period: 2018-02-01 to 2019-06-30
The project aims at creating an EU-Africa e-Infrastructure, UBORA, for open source co-design of new solutions to face the current and future healthcare challenges of both continents, by exploiting networking, knowledge on rapid prototyping of new ideas and sharing of safety criteria and performance data. The e-Infrastructure will foster advances in education and the development of innovative solutions in Biomedical Engineering (BME), both of which are flywheels for European and African economies. It is conceived as a virtual platform for generating, exchanging, improving and implementing creative ideas in BME underpinned by a solid safety assessment framework founded on European medical device directives.
UBORA (“excellence” in Swahili) brings together European and African Universities and their associated technological hubs, national and international policymakers and committed and credible stakeholders propelled by a series of Design Schools and Competitions.
Specific objectives are:
• to create UBORA, a web-based platform for co-design and sharing data and blueprints of biomedical devices after vetting by trained biomedical engineers;
• to generate and upload a complete set of open access projects, data on performance and safety, and designs of biomedical devices to the platform;
• to empower innovations in healthcare, sustained by a solid academic background in BME.
Final Period: Conclusions of the action
The main output of the project is the UBORA e-platform and its established community of users. These users from different countries have benefited from the design competitions, the schools and the resources available in UBORA to build expertise and know-how in safe medical device design. They have the capacity to propel the vision of health equity through the open source paradigm using UBORA as a resource. The impact and potential of UBORA and the depth and breadth of work done can only be truly appreciated by visiting the e-platform as a user and interacting with other users and mentors. Therefore, we encourage readers of this summary to discover and interact with the UBORA community online (https://platform.ubora-biomedical.org/).
UBORA has a solid basis for its future management and exploitation as an educational and design platform. In particular a new Teaching/Learning methodology developed in the project based on the CDIO educational model empowered by a strong focus on Clinical Needs Identification, standards and regulatory compliance.
Finally, ten Open Source Medical Devices (OSMDs) have been developed by the consortium partners. The devices come complete with pre-production documentation, in a format ready for streamlined scaling up to manufacture as certified devices following the fabrication guidelines. Projects range from assistive technologies, devices for emergency situations, to devices for monitoring, for prevention and sanitation. These projects provide reliable solutions to well-identified clinical needs, exploiting conventional and advanced materials and both traditional and new production processes.
UBORA (“excellence” in Swahili) brings together European and African Universities and their associated technological hubs, national and international policymakers and committed and credible stakeholders propelled by a series of Design Schools and Competitions.
Specific objectives are:
• to create UBORA, a web-based platform for co-design and sharing data and blueprints of biomedical devices after vetting by trained biomedical engineers;
• to generate and upload a complete set of open access projects, data on performance and safety, and designs of biomedical devices to the platform;
• to empower innovations in healthcare, sustained by a solid academic background in BME.
Final Period: Conclusions of the action
The main output of the project is the UBORA e-platform and its established community of users. These users from different countries have benefited from the design competitions, the schools and the resources available in UBORA to build expertise and know-how in safe medical device design. They have the capacity to propel the vision of health equity through the open source paradigm using UBORA as a resource. The impact and potential of UBORA and the depth and breadth of work done can only be truly appreciated by visiting the e-platform as a user and interacting with other users and mentors. Therefore, we encourage readers of this summary to discover and interact with the UBORA community online (https://platform.ubora-biomedical.org/).
UBORA has a solid basis for its future management and exploitation as an educational and design platform. In particular a new Teaching/Learning methodology developed in the project based on the CDIO educational model empowered by a strong focus on Clinical Needs Identification, standards and regulatory compliance.
Finally, ten Open Source Medical Devices (OSMDs) have been developed by the consortium partners. The devices come complete with pre-production documentation, in a format ready for streamlined scaling up to manufacture as certified devices following the fabrication guidelines. Projects range from assistive technologies, devices for emergency situations, to devices for monitoring, for prevention and sanitation. These projects provide reliable solutions to well-identified clinical needs, exploiting conventional and advanced materials and both traditional and new production processes.
The main results at the end of the first 13 months were:
• Design Competition 2017, with over 110 projects submitted.
• Design School 2017, held at Kenyatta University from 12 to 15 December.
• Release of the alpha version of the UBORA e-platform.
• Publication of the Kahawa Declaration, which outlines the principles for the democratization of biomedical technology, recognizing it as a key to equitable healthcare.
• Sustained dissemination to multilevel stakeholders.
In the second period, the main activities were:
• The UBORA Design Competition and School 2018, held in Pisa in from 3rd to 7th September 2018.
• The First International Conference Collaborative Biomedical Engineering for Open Source Medical Technologies was held on the 1st and 2nd September 2018, at the same venue of the School, with over 100 international delegates.
• Official release of the UBORA e-platform to the public at the Design School and its subsequent maintenance and improvement.
• Sustained dissemination to multilevel stakeholders.
• The realisation of 10 completely documented OSMDs ready for manufacture as certifiable medical devices, available as a public document.
Exploitation and Dissemination of Results
Given that sustainability was a key long-term objective from the beginning of the project, a great deal of emphasis was given to widening the UBORA community and to the dissemination of the open source paradigm, with safety and efficacy as the guiding criteria for designing biomedical devices.
Key dissemination in the 2nd period:
• presentation of UBORA at the 4th WHO Global Forum on Medical Devices (Visakhapatnam, India, 13th -15th December 2018);
• publication of a position paper “Safe innovation: On medical device legislation in Europe and Africa”, on Health Policy and Technology (7 (2) 156-165 2018);
• preparation of a Handbook on Open Source Medical Devices, to be published by Springer Nature by the end of 2019 (contract signed);
• planning of a special issue on Open Source and Collaborative Project Based Learning, for the International Journal of Engineering Education (23 papers, to be published in Sep-Oct).
An exploitation strategy towards sustainability based on the outcomes of these and other dissemination activities led to a consensus for the foundation of a non-profit organization (UBORA AISBL) for the management of the e-platform.
Finally, the UBORA consortium undertook a series of actions for fostering harmonization in medical device regulation, considered as instrumental for ensuring the safety of patients and healthcare providers and for enabling virtuous and fair competition within the healthcare industry.
• Design Competition 2017, with over 110 projects submitted.
• Design School 2017, held at Kenyatta University from 12 to 15 December.
• Release of the alpha version of the UBORA e-platform.
• Publication of the Kahawa Declaration, which outlines the principles for the democratization of biomedical technology, recognizing it as a key to equitable healthcare.
• Sustained dissemination to multilevel stakeholders.
In the second period, the main activities were:
• The UBORA Design Competition and School 2018, held in Pisa in from 3rd to 7th September 2018.
• The First International Conference Collaborative Biomedical Engineering for Open Source Medical Technologies was held on the 1st and 2nd September 2018, at the same venue of the School, with over 100 international delegates.
• Official release of the UBORA e-platform to the public at the Design School and its subsequent maintenance and improvement.
• Sustained dissemination to multilevel stakeholders.
• The realisation of 10 completely documented OSMDs ready for manufacture as certifiable medical devices, available as a public document.
Exploitation and Dissemination of Results
Given that sustainability was a key long-term objective from the beginning of the project, a great deal of emphasis was given to widening the UBORA community and to the dissemination of the open source paradigm, with safety and efficacy as the guiding criteria for designing biomedical devices.
Key dissemination in the 2nd period:
• presentation of UBORA at the 4th WHO Global Forum on Medical Devices (Visakhapatnam, India, 13th -15th December 2018);
• publication of a position paper “Safe innovation: On medical device legislation in Europe and Africa”, on Health Policy and Technology (7 (2) 156-165 2018);
• preparation of a Handbook on Open Source Medical Devices, to be published by Springer Nature by the end of 2019 (contract signed);
• planning of a special issue on Open Source and Collaborative Project Based Learning, for the International Journal of Engineering Education (23 papers, to be published in Sep-Oct).
An exploitation strategy towards sustainability based on the outcomes of these and other dissemination activities led to a consensus for the foundation of a non-profit organization (UBORA AISBL) for the management of the e-platform.
Finally, the UBORA consortium undertook a series of actions for fostering harmonization in medical device regulation, considered as instrumental for ensuring the safety of patients and healthcare providers and for enabling virtuous and fair competition within the healthcare industry.
Impacts and progress beyond the state of the art
Open source medical devices (OSMDs) are bound to reshape the biomedical industry in the next decade by letting stakeholders play more relevant roles in the conception of innovative healthcare technologies. We expect that the UBORA e-platform and community will enlighten the path towards affordable, safe, regulation-compliant and accessible healthcare technologies for all. UBORA has already made a considerable impact on professionals involved in healthcare and the way in which educators in the ABEC community and universities in Spain, Italy, Estonia and Sweden transfer their knowledge to students.
Progress
Besides the UBORA platform, which is unique for its emphasis on quality, safety and innovation through collaboration and sharing, the following features are novel and represent notable advancements with respect to the state of the art:
• Definition of a teaching/learning and design methodology based on the Conceive-Design-Implement-Operate (CDIO) paradigm. This educational model was refined and specialized with a strong focus on standards and regulations and particularly on ISO Standard 13485 for sustaining the development of OSMDs.
• The establishment of a community of users and the training of engineers and biomedical workers as well as the dissemination of good biomedical practice exploiting open source paradigms and based on safety by design.
• The enrichment of UBORA’s database through the development of innovative medical devices following the above-mentioned methodology, comprising device classification, needs assessment, collaborative device design, external expert mentoring, material and resource identification and exploitation planning.
Open source medical devices (OSMDs) are bound to reshape the biomedical industry in the next decade by letting stakeholders play more relevant roles in the conception of innovative healthcare technologies. We expect that the UBORA e-platform and community will enlighten the path towards affordable, safe, regulation-compliant and accessible healthcare technologies for all. UBORA has already made a considerable impact on professionals involved in healthcare and the way in which educators in the ABEC community and universities in Spain, Italy, Estonia and Sweden transfer their knowledge to students.
Progress
Besides the UBORA platform, which is unique for its emphasis on quality, safety and innovation through collaboration and sharing, the following features are novel and represent notable advancements with respect to the state of the art:
• Definition of a teaching/learning and design methodology based on the Conceive-Design-Implement-Operate (CDIO) paradigm. This educational model was refined and specialized with a strong focus on standards and regulations and particularly on ISO Standard 13485 for sustaining the development of OSMDs.
• The establishment of a community of users and the training of engineers and biomedical workers as well as the dissemination of good biomedical practice exploiting open source paradigms and based on safety by design.
• The enrichment of UBORA’s database through the development of innovative medical devices following the above-mentioned methodology, comprising device classification, needs assessment, collaborative device design, external expert mentoring, material and resource identification and exploitation planning.