Bridging innovation and implementation in laboratory medicine: insights from a global survey on unmet needs and...

Technological innovation in laboratory medicine is advancing rapidly, driven by artificial intelligence, next-generation sequencing, high-resolution mass spectrometry, novel biomarkers, and decentralized point-of-care testing. However, the translation of these advances into routine clinical practice remains uneven worldwide. To explore current barriers and priorities, the IFCC Emerging Technologies Division conducted a multi-regional survey among laboratory leaders and functional unit representatives. The survey identified a persistent gap between innovation and implementation. Major challenges included unequal access to advanced diagnostics, financial constraints, regulatory complexity, and workforce preparedness. Respondents highlighted disparities in infrastructure and expertise, particularly in low- and middle-income settings, raising concerns about widening global health inequities. Economic sustainability emerged as a central barrier, with high capital costs, uncertain reimbursement pathways, and the need for robust evidence of clinical utility and cost-effectiveness. Regulatory requirements, including evolving frameworks such as IVDR, were perceived as increasing compliance burdens and potentially limiting availability of specialized tests. A significant proportion of respondents also emphasized the need for structured implementation support, including training programs (64.7%), improved access to resources (64.7%), and strengthened networking and partnerships (66.7%). A significant skills gap related to artificial intelligence, data science, and bioinformatics was also reported, emphasizing the need for competency-based education and interdisciplinary collaboration. Six strategic priority domains were identified: AI integration, genomics capacity, global harmonization, decentralized diagnostics, biomarker validation, and implementation science. Bridging innovation and implementation will require coordinated global leadership, structured support from scientific organizations, and sustained investment to ensure equitable, clinically impactful adoption of emerging technologies.