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The UBORA E-Infrastructure for Open Source Innovation in Medical Technology

  • Carmelo De MariaEmail author
  • Licia Di Pietro
  • Andres Diaz Lantada
  • Alice Ravizza
  • Mannan Mridha
  • Janno Torop
  • June Madete
  • Philippa Makobore
  • Arti Ahluwalia
Conference paper
First Online:
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Part of the IFMBE Proceedings book series (IFMBE, volume 76)

Abstract

The development of medical devices with open source and collaborative design methodologies has the potential to increase the access to medical technologies, thanks to a feasible reduction of design, management, maintenance, and repairing costs linked to the open access of device blueprints. UBORA is an e-infrastructure for the co-design of open source medical devices, which promotes the compliance with internationally recognized quality standards and regulations for safety and efficacy of devices, taking the EN ISO 13485:2016 and the EU MDR 2017/745 as inspiration. UBORA guides the user through a systematic design process, from the identification of clinical needs, of risks class and relevant standards for the device, and provides project management tools, including a repository, finalized to the preparation of the pre-production device dossier. The process is supervised by expert mentors, which ensure that safety and efficacy criteria are fulfilled. The UBORA e-infrastructure is in line with the 2030 Agenda for the Sustainable Development Goals, promoting and strengthening the initiatives of an international community of designers, healthcare providers and policy-makers, toward the reduction of inequalities in the access to medical devices.

Keywords

Open source medical devices E-infrastructure Safety Regulation 
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Notes

Acknowledgements

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 731053. The authors acknowledge all students and mentors who daily animate the UBORA e-infrastructure.

Conflict of Interest.

The authors have no conflict of interest to disclose.

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Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  1. 1.University of PisaPisaItaly
  2. 2.Universidad Politecnica de MadridMadridSpain
  3. 3.Politecnico di TorinoTurinItaly
  4. 4.Royal Institute of TechnologyStockholmSweden
  5. 5.University of TartuTartuEstonia
  6. 6.Kenyatta UniversityNairobiKenya
  7. 7.Uganda Industrial Research InstituteKampalaUganda

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