From innovation to clinical impact: TNO and Orikami accelerate the path from digital biomarker development to healthcare implementation

Digital biomarkers offer significant opportunities for healthcare: from remote patient monitoring to more personalised treatment and deeper insights for both clinicians and patients. Yet the step from innovation to clinical implementation remains complex. Developers of digital health technologies face fragmented infrastructures, lengthy validation trajectories, and strict requirements around safety, privacy and certification. At the same time, researchers and healthcare organisations are operating in an overcrowded technological landscape, with limited options for scaling and insufficient structural embedding in care pathways.

For researchers, this ecosystem poses a major challenge. They need reliable, standardised ways to safeguard data quality during studies and pilots, without becoming dependent on fragmented tools, experimental software or commercial platforms that limit scientific flexibility. This leads to the risk of fragmented, manually combined solutions that are neither scalable nor reproducible. TNO and Orikami offer a future-proof alternative that combines scientific freedom with technical certainty.

It is precisely at this intersection that the TNO Digital Biomarker Lab and Orikami join forces. By combining scientific depth with a certified and scalable technical infrastructure, the collaboration makes digital biomarkers faster to validate, more robust to use, and broadly deployable in real-world settings.

Complementary expertise as an accelerator

The strength of the partnership lies in its complementary expertise. TNO continuously develops and validates new digital biomarker innovations. By embedding these developments in a mature infrastructure from the outset, the steps from development and validation to implementation and market adoption are significantly accelerated. Orikami provides the robust technical foundation: a certified, scalable infrastructure and extensive experience in commercialisation and implementation within healthcare systems.

Through this collaboration, TNO offers the Remote Data Collection Platform, built on an Orikami-licensed foundation and further developed within TNO. This modular research platform is specifically designed for data collection in studies using wearables, sensors and digital questionnaires. The result is a unique combination: scientifically grounded, technically mature, and immediately applicable in both research and clinical contexts.

An important principle is the avoidance of vendor lock-in. Researchers and healthcare organisations must remain free to choose the tools, devices and analytical methods they prefer. The shared infrastructure is therefore modular, open and extensible. It supports Bring-Your-Own-Device scenarios, enables simultaneous connection of multiple sensors, and remains fully independent of any single supplier. This strengthens scientific reproducibility and supports sustainable scaling.

From pilot to practice

A well-known challenge in digital biomarker projects is the transition from pilot to long-term implementation. What works in a small, controlled study often proves difficult to scale or integrate into daily practice. The collaboration between TNO and Orikami recognises this issue and incorporates it explicitly from the start.

Early phase — development and validation

TNO develops and validates digital biomarkers within concrete research and care contexts. This includes not only scientific justification and clinical relevance, but also explicit attention to data quality, usability, interoperability and future real-world use - embedded directly into study design and data plans.

From validation to implementation-ready solutions

The joint goal is to develop standardised digital biomarkers that are ready for implementation: not only scientifically validated, but also proven to function reliably within a scalable, professional implementation environment. As a result, organisations can scale responsibly without re-engineering solutions or becoming dependent on a single vendor.

For researchers, this ensures that results do not remain stuck in pilot form. Digital biomarkers developed within research projects can transition into broader use without rebuilding, preventing valuable insights from being lost and increasing real-world healthcare impact.

Reducing complexity as a condition for success

Digital biomarker studies are inherently complex: multiple data sources, diverse devices, and high demands on usability. The collaboration between TNO and Orikami reduces this complexity and supports researchers, clinicians and healthcare organisations on several levels:

• one certified platform for data collection
• support and flexible configuration tailored to any study design
• integration of multiple wearables and data sources
• secure storage and transparent data governance

Reliable data quality is essential for scientific research. Working with one standardised platform reduces error sources, improves protocol adherence and leads to more consistent datasets. This strengthens reproducibility and reinforces the scientific foundation of digital biomarkers.

Secure, flexible and future-proof

The collaboration combines technical certification with scientific safeguards. Data is stored securely, encrypted and governed according to strict access and retention policies. The platform is fully compliant with, and where relevant exceeding, GDPR requirements.

The solution is also highly flexible: suitable for small pilots and large multicentre studies, supporting both consumer- and medical-grade devices, and applicable across a broad range of conditions and populations.

Building the digital biomarker ecosystem together

The impact of this collaboration extends beyond individual projects. By sharing infrastructure, knowledge and standards, TNO and Orikami ensure that organisations no longer need to reinvent the wheel. Research resources can be used more effectively, validation trajectories accelerate, and a solid foundation is created for scalable implementation in healthcare.

Looking ahead, both organisations aim to further expand joint projects, apply their work to new conditions and deepen collaboration with national and international healthcare networks.