The WHO methodology framework to assess innovative technologies for low-resource settings

Purpose To present the World Health Organization’s (WHO) multi‑stage methodology used in the 2024 Compendium of Innovative Health Technologies for Low‑Resource Settings and provide a replicable framework for decision‑makers. Methods Α five‑step process is described covering call preparation, open call and screening, multi‑domain assessment, cross‑checking and final approval, and selection. Evidence‑based assessments were conducted across six areas—clinical need, comparison with WHO technical specifications (MeDevIS), regulatory status (WHO/IMDRF), health technology assessment (HTA), health technology management (HTM), and intellectual property & local production (IP/LP)—using standardized forms and an online innovations assessment database. Evaluations were iterated with feedback from WHO staff and the Strategic Advisory Group on Medical Devices and Health Technologies (STAG MEDEV). Results In the 2023/24 cycle, 225 submissions were received; 62 technologies underwent full evaluation by multidisciplinary external panels. Following deliberation and validation, 28 technologies were listed (13 commercially available, 3 newly commercialized, 4 prototypes, 1 reassessment, and 7 minor updates), reflecting transparent criteria and consensus‑driven decisions. Conclusions The WHO methodology operationalizes rigorous, transparent, and context‑appropriate evaluation of health technologies for low‑resource settings. By integrating clinical, regulatory, economic, managerial, and IP/LP perspectives, it supports adoption decisions that balance effectiveness, feasibility, and sustainability. The standardized tools and workflows are readily adaptable by ministries of health and procurement bodies to strengthen technology selection processes.