Advancements in medical technology have revolutionized early disease detection, enabling faster and more accurate diagnoses. Among these innovations, in vitro diagnostics (IVDs) play a crucial role in analyzing biological samples—such as blood or tissue—to identify diseases, assess risks, and monitor treatments. However, despite their potential, many IVD solutions face significant barriers to adoption, including lengthy evaluation processes and a lack of recognition for their impact on healthcare efficiency and cost reduction.

To address this challenge, NOVA IMS, through the Health & Analytics Lab, in partnership with Roche Diagnostics, has developed an innovative model to accelerate health technology assessment (HTA) for IVDs. The findings, published in the prestigious BMJ Innovations, were led by Guilherme Victorino, Filipa Coelho de Sousa, Carolina Vasconcelos, and Pedro Simões Coelho from NOVA IMS, in collaboration with João Cordeiro and Joana Alves from the National School of Public Health at NOVA University. The study introduces a faster, more efficient framework for assessing the feasibility, impact, and integration of new diagnostic technologies.

Despite their proven benefits, IVDs often encounter obstacles in reaching clinical practice. Unlike pharmaceuticals, which have well-established approval and assessment pathways, IVDs lack standardized evaluation methodologies, leading to delays in implementation and limiting access to potentially life-saving innovations.

Current HTA processes are often slow and bureaucratic, failing to keep up with the rapid pace of technological development. Additionally, healthcare decision-makers struggle to measure the economic and clinical impact of IVDs, making it difficult to prioritize their adoption within healthcare systems.

The study led by NOVA IMS applies Design Thinking, a user-centered methodology that fosters collaboration among key stakeholders to develop practical and effective solutions. Through in-depth interviews and workshops with health professionals, policymakers, and industry experts, the research identified key barriers and developed a streamlined HTA process tailored to IVDs.

The proposed model follows a four-phase structure to enhance the evaluation and adoption of new diagnostic technologies:

1. Structured Submission – New diagnostic technologies undergo a formal submission process, covering technical, clinical, and economic criteria.
2. Multidisciplinary Assessment – A specialized committee evaluates the benefits and challenges of each innovation, ensuring a transparent and rigorous process.
3. Decision & Funding – The model streamlines negotiations to facilitate faster decisions on implementation and funding.
4. Continuous Monitoring – Once in use, real-time clinical data is analyzed to ensure ongoing effectiveness and safety.

The study’s findings suggest that this new framework can significantly reduce the time required for medical innovations to reach healthcare systems, making cutting-edge diagnostics more accessible and improving patient outcomes. The Design Thinking approach stands out for actively involving key stakeholders, ensuring that proposed solutions are aligned with real-world healthcare challenges.

With this research, NOVA IMS reinforces its commitment to innovation in healthcare, demonstrating how data-driven decision-making and collaborative problem-solving can reshape how new technologies are evaluated and implemented.