In recent years, and particularly after the COVID-19 pandemic, the healthcare sector in Euskadi has been compelled to strengthen its industry by fostering strong synergies among different stakeholders. This has enabled the region to reduce reliance on external entities for the effective and efficient development, manufacturing, and commercialization of medical products. The development of medical devices for patient monitoring and diagnosis, both at home and in hospitals, has become vital and necessary.
The increased standards of quality, safety, and efficacy for medical devices demand additional efforts in the design, manufacturing, verification, and validation processes of any new product. Therefore, it is essential to define and implement technologies, tools, and processes that streamline the development process from conception to verification and validation phases, covering the complete product lifecycle while maintaining the highest standards of quality and safety, as required by current regulations.
The OSASUN KM0 project was created in response to these challenges. Under the umbrella of the OSASUNBERRI collaborative initiative, a consortium has been formed, comprised of eight leading Basque companies in the Euskadi healthcare sector, which represent different links in the health industry’s production chain.
The main goal of the OSASUN KM0 project is to build a close, efficient, and comprehensive healthcare sector, and to develop an advanced healthcare system in our community. Among its participants is BIOLAN HEALTH, which specializes in the development and manufacturing of a new generation of advanced biosensors aimed at the diagnosis and monitoring of chronic diseases, medications, and therapies.
BIOLAN HEALTH focuses on the development of rapid and reliable Point-of-Care (PoC) devices and systems based on biosensor technology for in vitro diagnostics. They offer cost-efficient solutions for monitoring and detecting key health parameters, facilitating effective decision-making in diagnosis, prevention, and health monitoring. Their products are primarily based on enzymatic biosensors and lateral flow immunoassays.
BIOLAN HEALTH’s enzymatic biosensors combine the high specificity of enzymes with the advantages of electrochemical methods, such as ease of use, sensitivity, and compatibility with screen-printing techniques, enabling mass production of miniaturized, low-cost devices. These biosensors face challenges such as batch-to-batch reproducibility in industrial-scale manufacturing, the establishment of efficient quality control systems, and compliance with the new IVDR regulations for in vitro diagnostic devices.
In collaboration with BC MATERIALS, a leading technology center specializing in high-quality interdisciplinary research for the development of functional, multifunctional, and active materials capable of addressing a wide range of technological challenges, BIOLAN HEALTH will work within the OSASUN KM0 project to improve the reliability of its biosensors. This will be achieved through research into new functional materials that enhance both the quality and functionality of the biosensors, while simultaneously optimizing production processes to achieve greater repeatability, allowing them to meet stringent quality standards.
The collaboration between the healthcare system, the scientific-technological system, and the business fabric is crucial to tackling the challenges of a highly dynamic and demanding sector like healthcare.
Investing in a local healthcare industry enables us to be better prepared for future challenges, strengthens R&D strategies, and enhances the km0 health value chain. This not only increases competitiveness and growth but also contributes to building a healthier society.