Something that the recent COVID-19 pandemic has demonstrated is that the biohealth sector demands to incorporate innovation in an agile, effective and safe way. The development of medical devices for patient monitoring and diagnosis in both home and hospital settings is vital and necessary to meet the new needs of a society where aging and the lack of birth rate are leading the way.
Manufacturers of these types of devices have seen how the new European Medical Device Regulations: 2017/745 MDR and 2017/746 IVDR that came into force in 2022 have meant an increase in the requirements to be met in terms of design, development and manufacture of these medical devices. These regulations, which are stricter than previous directives, require medical devices to meet very high quality standards and functional safety levels. Devices already on the market must be recertified in accordance with these requirements, which forces healthcare companies to adapt their product design and development processes.
This, logically, translates into an inherent increase in the quality, safety and efficacy standards of medical devices, but at the same time, it entails an overexertion in the design, manufacturing, verification and validation processes of any device.
For this reason, it is necessary to define and implement technologies, tools and processes to speed up the development of medical devices, from conception to the verification and validation phases, covering the entire life cycle of the device and always maintaining the strictest safety and efficacy standards, as required by current regulations.
The OSASUN KM0 project was born as a response to these challenges. The project is a continuation of the OSASUNBERRI project, an interregional collaborative initiative for innovation and investment in the health industry KM0. The project aims to continue joining forces with the main medical device companies in the Basque Country to collaboratively create a km0 framework that provides technical and procedural solutions for future developments of safe medical devices with embedded technology.
The final strategic objective of the project is the research and development of technological and procedural blocks (framework) to enable and accelerate the development and management of the life cycle of embedded medical devices that guarantee their functional safety and respond to the diagnostic and treatment needs of the health sector. All this, aligning the development to the technical requirements of the new regulations and under the km0 philosophy.
Finally, the research carried out in this project will also contribute in the future to Osasun Poloa, a node that will allow companies in the health sector to develop and validate their medical devices. Thanks to the outputs generated in this project, this pole will be able to start with a clear identification of the needs to be met by the pole in order to respond to the medical device manufacturers in the Basque Country.
THE PROJECT
For the achievement of the OSASUN KM0 project, a consortium has been formed by 10 Basque companies, leaders in their sector and representing the sectors of activity linked to the health industry in the Basque Country. MIZAR HEALTH is the company leading the consortium, which is completed by: BIOLAN, BIOLAN HEALTH, UNIKARE, SABELEC, ILINE, IHS and IBERMÁTICA. In order to achieve the technological objectives, the project benefits from the knowledge and collaboration of different agents of the RVCTI, such as: TEKNIKER, INSTITUTO IBERMÁTICA, BC MATERIALS, GAIKER, UPV/EHU and MONDRAGON UNIBERTSITATEA. The project kicked off in April last year and the eight work packages into which it is divided intend to cover with a 360º vision and from a transversal point of view, all the necessary aspects to cover the technological needs and regulatory requirements during the life cycle of a medical device of these characteristics.
The project began last year analyzing from a holistic point of view the technological and procedural requirements of the proposed use cases to subsequently, within WP2 led by UNIUNIKARE, define the blocks that will make up the KM0 framework. UNIKARE, in turn, also leads WP3, which continues its work to identify and implement technological blocks for patient monitoring, diagnosis and treatment. IHS is leading WP4, which aims to address medical device engineering and all aspects related to functional, safety and regulatory requirements associated with the integration of hardware platforms, BSPs, OS and AI models into medical devices in compliance with functional, safety and regulatory requirements. MIZAR HEALTH is leading WP1 and WP5, the former focused on the coordination, management and dissemination of the project as leaders of the consortium, and WP5, which focuses its efforts on the manufacturing and validation processes of medical devices. To this end, work is being done on modeling for validation of engineering, procedures and preventive tools and solutions for verification and / or quality control. IBERMATICA leads WP6, which focuses its efforts on the interoperability and cybersecurity of medical devices, currently a crucial point in the development and commercialization of such systems. ILINE is leading WP7, which aims to complete the framework with tools that provide support throughout the life cycle of the medical device, improving traceability and updating systems. Finally, WP8, led by MIZAR HEALTH, will focus in the last half of 2025 on the validation of the different technological and procedural blocks defined as a KM0 framework in a laboratory environment.
Joining forces and generating projects through collaboration between the healthcare system, the scientific-technological system and the business fabric is vital to meet the challenges posed by a highly changing and demanding sector such as the healthcare sector, where regulatory changes constantly strain the ability of medical device manufacturers to adapt. Fortunately, the promotion of innovation through the development of frameworks such as the one being developed in the OSASUN KM0 project, serves as a driving force to address these challenges in an agile and effective way, facilitating the incorporation by manufacturers of technological innovation, significantly improving the processes associated with verification and validation, and therefore having an impact on increasing the quality, safety and efficacy of the devices marketed.
