Interview with Iñaki Sádaba, CEO of iLine Microsystems: “The support of CDTI Innovación has been key to developing our own technology, clinically validating medical devices, and scaling biotechnological innovation.”
With a strong track record in technological innovation and clinical validation, iLine Microsystems, a Spanish biotechnology company specialized in Point-of-Care (POC) diagnostic devices, is advancing—supported by CDTI Innovación—the design of a portable multitest device that will enable expanded assessment of oral anticoagulation.
The progressive aging of the population and the sustained increase in the use of anticoagulant therapies are reshaping healthcare system needs. More and more patients require these treatments, a trend that is expected to continue rising in the coming years. This scenario presents a clear clinical challenge: having tools that allow hemostasis— the set of physiological processes that enable the body to stop bleeding and maintain the balance between clotting and bleeding— to be assessed quickly, reliably, and accessibly, minimizing the risk of serious complications such as hemorrhage or thrombosis.
Within this context operates iLine Microsystems, a Spanish biotechnology company specializing in the development of in-vitro Point-of-Care (POC) diagnostic devices in the field of coagulation. With nearly two decades of experience, the company has built an innovation model based on proprietary technology, clinical validation, and a clear focus on addressing real needs in clinical practice.
Among its projects is the design and development of a portable multitest device for the diagnosis and clinical management of hemostasis—a solution that will allow coagulation assessment from a single drop of blood in seconds, with analytical quality comparable to that of a laboratory.
Origin and Mission: Bringing Diagnostics Closer to the Patient
iLine Microsystems was founded in 2007 with a clear mission: to bring the diagnosis of critical coagulation parameters to the point of care, outside centralized laboratories. As CEO Iñaki Sádaba explains: “The company was founded as a biotechnology firm specialized in in-vitro Point-of-Care diagnostic devices in the field of hemostasis, with the goal of developing and manufacturing innovative and highly reliable solutions that meet current and future healthcare model needs.”
From the outset, the company committed to developing proprietary technology based on microfluidics and Lab-on-a-Chip systems. This strategic decision has enabled iLine Microsystems to maintain strong control over its developments and progressively evolve its solutions, always focusing on clinical utility, result reliability, and healthcare professional user experience.
From Early Developments to International Positioning
iLine Microsystems’ first efforts focused on monitoring oral anticoagulant therapy, an area where diagnostic speed and precision are essential to ensuring patient safety. This work culminated in the launch of the microINR system, a portable device that marked a turning point for the company.
As Sádaba recalls: “iLine’s initial developments focused on creating a portable system for monitoring oral antivitamin K (VKA) anticoagulant therapy, which led to the launch of the microINR system in 2011.”
From that point forward, the company embarked on steady growth, expanding its product portfolio, incorporating advanced connectivity solutions, and committing strongly to internationalization.
This growth has been accompanied by increased production capacity and expansion into highly regulated markets, particularly the United States, where it has obtained multiple authorizations from the Food and Drug Administration (FDA). These achievements have consolidated its position as a reference in POC hemostasis diagnostics in both clinical settings and patient self-testing.
The Support of CDTI Innovación as a Growth Lever
Throughout its trajectory, iLine Microsystems has relied on the backing of CDTI Innovación as a key agent in transforming technological developments into real clinical solutions. This support has been particularly relevant during critical growth phases, when it was essential to reduce risks, validate technology, and lay the groundwork for sustained evolution.
As the CEO highlights: “The support of CDTI Innovación was key to developing our first commercial product and consolidating the microfluidics and Lab-on-a-Chip technological base within the company.”
Beyond that first milestone, collaboration with CDTI has enabled iLine to advance in the clinical validation of its devices, strengthen reliability in real hospital environments, scale production for international markets, and facilitate entry into highly regulated territories.
In a sector such as biotechnology—where innovation cycles are long and complex—this type of public support is decisive in accelerating the arrival of innovative solutions into the healthcare system.
Toward Comprehensive Hemostasis Assessment
Building on its accumulated experience in POC device development, iLine Microsystems is now undertaking a project that represents a qualitative leap forward. Rather than focusing on a single parameter, the company is developing a portable multitest system capable of offering a comprehensive view of hemostasis.
“This new development focuses on designing a portable multitest device to evaluate patients under different oral anticoagulant treatments, increasing diagnostic capacity and clinical utility within a single POC device,” Sádaba explains.
A particularly innovative element is the development of the microDOAC chip, which will enable the analysis of direct oral anticoagulants (DOACs) from a single drop of blood in a very short time.
This approach addresses a clearly identified clinical need: there is currently no portable device capable of providing a complete coagulation assessment with laboratory-equivalent performance, positioning iLine Microsystems prominently within the POC diagnostic innovation ecosystem.
Real-Time Clinical Decisions: The Value of Point of Care
The relevance of this new device becomes especially clear in time-critical scenarios such as emergency departments, urgent surgeries, or active bleeding situations, where immediate information is essential to adjust or reverse anticoagulant treatments without delay.
“Having rapid and reliable information at the point of care is key because it enables immediate clinical decisions when time is critical,” the CEO affirms.
The project has been conceived with this goal in mind, prioritizing high clinical-impact parameters and ensuring reliable results in seconds directly within the care setting.
Integrating Complexity While Maintaining Laboratory Quality
Technologically, integrating multiple coagulation assays into a single portable device represents a considerable challenge. Miniaturization, precise handling of complex biochemical reactions, and guaranteeing laboratory-equivalent analytical quality demand highly sophisticated solutions.
Sádaba highlights challenges such as advanced miniaturization and microfluidics, ensuring laboratory-level quality and precision in a rapid automated format, and developing internal control and automatic calibration systems. Overcoming these hurdles has been possible thanks to a combination of advanced engineering, materials design, and proprietary algorithms—the technological pillars of iLine Microsystems.
Beyond Conventional Monitoring: Multiple Oral Anticoagulant Therapies
The new system expands patient monitoring capabilities by incorporating microDOAC, a test specifically designed to address oral anticoagulant treatments alternative to VKAs. This broadens the device’s applicability across a wider range of anticoagulation-related clinical scenarios, enhancing its practical utility and decision-making value.
According to the CEO, this capability will allow: “Faster therapeutic responses”
and improved management of unexpected clinical situations, reducing dependence on centralized laboratories and contributing to greater patient safety and healthcare system efficiency.
The Future of Hemostasis Diagnosis at the Point of Care
Looking ahead, iLine Microsystems faces ambitious challenges: consolidating and commercializing the new multitest platform, launching the microDOAC chip globally, strengthening its presence in strategic markets such as the United States and Asia, and integrating enhanced connectivity and clinical data management capabilities.
For Sádaba, the future of hemostasis diagnostics in the Point-of-Care field is “highly promising,” with solutions becoming “increasingly comprehensive, intelligent, and accessible.” This evolution will decisively contribute to more agile, personalized, and patient-centered medicine—bringing critical clinical information to the place and moment where it is truly needed.
CDTI Innovación
The Centro para el Desarrollo Tecnológico y la Innovación (CDTI E.P.E.) is a public entity under Spain’s Ministry of Science, Innovation and Universities. Its mission is to promote technological innovation within the business sector and ensure that Spanish companies generate and transform scientific and technical knowledge into globally competitive, sustainable, and inclusive growth.
In 2024, within the framework of a new strategic plan, CDTI provided more than €2.3 billion in support to Spanish companies and startups.
Image: iLine Microsystems production line, where POC diagnostic devices are manufactured under strict quality and control standards
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