The strategic project OSASUN KM0 has officially concluded, successfully completing more than two years of collaborative R&D focused on the development of a technological and procedural framework for the design, manufacturing and secure lifecycle management of proximity (Km 0) medical devices.

OSASUN KM0 has been developed within the HAZITEK Programme for the Support of Business R&D, with funding from the Basque Government and the European Union through the European Regional Development Fund (ERDF/FEDER) 2021–2027. The project has brought together eight Basque companies from the health sector, with the collaboration of the Tekniker technology centre, a member of the Basque Science, Technology and Innovation Network (RVCTI).

The project consortium has been formed by: Mizar Health, BIOLAN Microbiosensors, BIOLAN HEALTH, Unikare Bioscience, SABELEC HEALTH, iLine Microsystems, IHS WEILING S.L. and Ayesa, combining industrial, biotechnological, electronic and advanced engineering capabilities to address the main challenges of the medical device sector in an integrated manner.

Throughout the project, the participating entities have worked in a coordinated way to respond to the key technological and regulatory challenges currently facing the medical device industry, anticipating the entry into force of major regulations such as the European Artificial Intelligence Act (EU) 2024/1689, as well as the strict requirements on functional safety, cybersecurity and interoperability derived from the MDR and IVDR regulations.

Key outcomes of the project include:

  • the development of secure hardware and software platforms designed under a safety by design approach,
  • new technological building blocks for the safe integration of artificial intelligence in medical devices,
  • advanced monitoring, diagnostic and treatment solutions, including photonic, electrochemical and intelligent electrotherapy technologies,
  • tools for manufacturing and validation processes oriented towards zero defects,
  • and systems for the secure management of the medical device lifecycle, including traceability and resilient software updates.

The progress achieved has enabled the validation of real use cases in laboratory environments, demonstrating the industrial applicability of the OSASUN KM0 approach and its contribution to accelerating the development of medical devices compliant with the highest regulatory standards.

With the completion of the project, OSASUN KM0 leaves a strong legacy in the form of a shared framework of knowledge, technologies and methodologies, allowing participating companies to reduce technical and regulatory risks, shorten development times and strengthen their competitiveness in both national and international markets.

Furthermore, the project has made a significant contribution to reinforcing the technological sovereignty and biosanitary ecosystem of the Basque Country, in alignment with the Personalised Health strategy of PCTI 2030 and laying the foundations for future collaborative innovation initiatives in the field of intelligent, sustainable and patient-centred medical devices.