Fast-track health technology assessment for in vitro diagnostics

Abstract

The evolution of diagnostic technologies, combined with the urgent need for efficient healthcare delivery in challenging public health contexts, calls for agile and empathetic innovation. This is particularly relevant in the context of in vitro diagnostics (IVDs), which significantly impact patients, healthcare providers and the overall healthcare system. This broad reach depends on specific health technology assessment (HTA) frameworks for IVD, which are still underdeveloped. As a response to this challenge, our study seeks to document the inspiration, ideation and implementation of a fast-track HTA project for IVDs, employing a design thinking (DT) methodology. We report an iterative process encompassing different methodologies including a narrative literature review, in-depth semistructured interviews and interdisciplinary workshops. Our results confirmed the value of IVDs for different healthcare dimensions, including clinical outcomes, economic impact, operational efficiency in healthcare delivery, patient outcomes and healthcare innovation. Stakeholders proposed innovative IVD solutions, which were assessed based on their feasibility, impact and potential for commercialisation. As a result, a fast-track HTA for IVDs was selected for implementation. Following the identification of contextual challenges, specific suggestions for idea implementation were prioritised. By applying a comprehensive and multidisciplinary approach, our study offers insights into how HTA processes can be adapted to rapid healthcare innovation cycles and provides a practical roadmap for policymakers and stakeholders in the health technology sector, which is particularly relevant in an era where healthcare innovation is a key driver of economic growth and global strategic advantage.