Measuring the clinical impact of Artificial Intelligence in the biotech sector: a comprehensive view from Vicomtech

Digitalisation in the healthcare and biotech sector is advancing rapidly, and artificial intelligence (AI) plays a key role in the development of new products, process optimisation, and improved efficiency in the health field. For companies creating innovative solutions in this sector, it is not enough to measure the technical performance of their technologies. It is essential to assess their real impact on clinical practice, on the health of patients, ensuring that their products and services generate tangible value that improves care quality and health outcomes.

From technical validation to clinical validation

The development of an algorithm for the healthcare sector does not end with its training and testing phase in controlled environments. Its validation must include different stages, aligned with technology development cycles, to ensure its effectiveness under real conditions. First, retrospective validation is carried out using historical data or a prospective observational study is conducted to collect new data, followed by testing in simulated environments and, subsequently, in real clinical settings under the supervision of healthcare professionals. At each of these stages, not only is technical performance key, but also the interpretability of the algorithm, its ability to integrate into clinical workflows, and its impact on medical decision-making.

Measuring the clinical impact of health algorithms: beyond accuracy

For AI to deliver value in healthcare, it must translate into concrete improvements: faster and more accurate diagnoses, more efficient care times, and ultimately better health outcomes. This is only possible if a multidisciplinary approach is taken from the outset, combining technology with the experience of clinicians and biotechnology experts.

At Vicomtech, we have a team of engineers and biologists specialised in multimodal artificial intelligence applied to health and biotechnology, integrating diverse data sources such as medical imaging, omics, clinical data, and biomarkers to develop advanced AI models and digital solutions. We work closely with experts in health regulation and clinical professionals to ensure that our technologies are not only innovative but also applicable and validated in real-world settings.

Strategic partnerships and regulatory compliance

The clinical impact of algorithms also depends on their proper implementation and acceptance within the healthcare sector. That’s why at Vicomtech we establish strategic collaborations with hospitals and healthcare product and service companies, enabling us to validate our technologies in real scenarios and adapt them to the needs of the healthcare system.

Likewise, regulatory compliance is a fundamental pillar of our approach. We hold ISO 13485 certification, which enables us to develop health technologies under the highest quality standards, ensuring their safety and effectiveness. This commitment to regulation not only strengthens the trust of healthcare professionals and patients in our solutions but also facilitates their implementation in clinical environments and their integration into medical workflows.

Conclusion

The true value of AI in biotechnology and healthcare lies not only in its technical performance but in its ability to improve care and clinical outcomes. To achieve this, a comprehensive approach is essential—one that covers everything from design and validation to real-world application in hospitals and clinics, always involving multidisciplinary teams and complying with regulations.

At Vicomtech, we collaborate with biotech companies to develop AI-based technologies that can be applied to personalised medicine and advanced diagnostics. Thanks to our expertise in multimodal AI and our ISO 13485 certification, we ensure these solutions are not only innovative but also meet the regulatory standards required for their later adoption in clinical settings. This approach enables biotech companies to accelerate the transfer of their developments to market, minimising risks and optimising efficiency in the clinical validation process.