Advertisement

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
  • 91 Downloads
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 

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.

References

  1. 1.
    Sustainable Development Goals. https://www.un.org/sustainabledevelopment/sustainable-development-goals/. Accessed May 2019
  2. 2.
    World Health Organization. Medical devices: managing the mismatch: an outcome of the priority medical devices project. World Health Organization (2010)Google Scholar
  3. 3.
    Iadanza, E., Dyro, J.: Clinical Engineering Handbook. Elsevier (2004)Google Scholar
  4. 4.
    World Health Organization. Barriers to innovation in the field of medical devices. Background paper 6. World Health Organization, Geneva (2010)Google Scholar
  5. 5.
    Malkin, R.A.: Design of health care technologies for the developing world. Ann. Rev. Biomed. Eng. 9, 567–587 (2007)CrossRefGoogle Scholar
  6. 6.
    Lustick, D.R., Zaman, M.H.: Biomedical engineering education and practice challenges and opportunities in improving health in developing countries. In: Atlanta Conference on Science and Innovation Policy 2011. IEEE (2011)Google Scholar
  7. 7.
    Malkin, R.A.: Barriers for medical devices for the developing world. Expert Rev. Med. Dev. 4(6), 759–763 (2007)CrossRefGoogle Scholar
  8. 8.
    Douglas, T.S.: Biomedical engineering education in developing countries: research synthesis. EMBC, IEEE (2011)Google Scholar
  9. 9.
    Perens, B.: The open source definition. In: Open Sources: Voices from the Open Source Revolution, vol. 1, pp. 171–188 (1999)Google Scholar
  10. 10.
    Williams, A., Gibb, A., Weekly, D.: Research with a hacker ethos: what DIY means for tangible interaction research. Interactions 19(2), 14–19 (2012)CrossRefGoogle Scholar
  11. 11.
    Niezen, G., Eslambolchilar, P., Thimbleby, H.: Open-source hardware for medical devices. BMJ innovations bmjinnov-2015 (2016)CrossRefGoogle Scholar
  12. 12.
    Gamma Cardio Soft S.r.l. http://www.gammacardiosoft.it/openecg/. Accessed May 2019
  13. 13.
    Ferretti, J., Di Pietro, L., De Maria, C.: Open-source automated external defibrillator. HardwareX 2, 61–70 (2017)CrossRefGoogle Scholar
  14. 14.
    Arcarisi, L., Di Pietro, L., Carbonaro, N., Tognetti, A., Ahluwalia, A., De Maria, C.: Palpreast—a new wearable device for breast self-examination. Appl. Sci. 9, 381 (2019)CrossRefGoogle Scholar
  15. 15.
    De Maria, C., Mazzei, D., Ahluwalia, A.: Improving African health care through open source biomedical engineering. Int. J. Adv. Life Sci. 7(1), 10–19 (2015)Google Scholar
  16. 16.
    UBORA: Euro-Africa Open Biomedical Engineering Innovation e-platform for Innovation through Education. https://platform.ubora-biomedical.org/. Accessed May 2019
  17. 17.
    European Medical Device Regulation 2017/745. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2017:117:FULL&from=EN. Accessed May 2019
  18. 18.
    International Organization of Standardization EN ISO 13485:2016 Medical devices – Quality management system- Requirements for regulatory purpose certification. https://www.iso.org/standard/59752.html. Accessed May 2019
  19. 19.
    Wilkinson, M.D., Dumontier, M., Aalbersberg, I.J., Appleton, G., Axton, M., Baak, A., Bouwman, J., et al.: The FAIR guiding principles for scientific data management and stewardship. Sci. Data 3, 160018 (2016)Google Scholar
  20. 20.
    Trimi, S., Berbegal-Mirabent, J.: Business model innovation in entrepreneurship. Int. Entrepreneurship Manage. J. 8(4), 449–465 (2012)CrossRefGoogle Scholar

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

Personalised recommendations