Designing for Success: A Prospective Evaluation of Implementation Factors Affecting a Prototype Novel Medical Device in a Low-Resource Environment Using the CFIR 2.0

1 Abstract Background Implementation challenges are a major contributor to the failure of novel medical technologies in low-resource settings. Although frameworks such as the Consolidated Framework for Implementation Research (CFIR) are widely used to evaluate interventions post-implementation, their prospective application during the product development phase remains limited. Methods This study aimed to prospectively assess implementation factors relevant to the future adoption of a prototype handheld ultrasound device designed to improve congenital heart disease (CHD) screening in low- and middle-income countries (LMICs). Structured observational field notes were collected during a clinical site visit to Mongolia in May 2024. Observations were made across five hospitals and two high-level stakeholder meetings. Data were thematically analysed using Braun and Clarke’s reflexive method, followed by deductive mapping to CFIR 2.0 domains. Results The final codebook included 70 codes mapped to four CFIR 2.0 domains: Innovation, Individuals, Inner Setting, and Outer Setting. Key facilitators included high staff motivation, alignment of hospital and national goals with device priorities, and the device’s simplified screening procedure and cloud-based data transfer capability. Identified barriers included inconsistent infrastructure across hospitals, limited access to trained staff, lack of maintenance systems, and fragmented digital health records. Conclusions Prospective application of CFIR 2.0 provided a systematic method for identifying factors likely to influence implementation success. This study demonstrates the value of incorporating implementation science early in device development, particularly in LMIC contexts where design-stage decisions can determine device success. By embedding structured implementation analysis into product development, developers may improve alignment between design and setting, reduce downstream failures, and accelerate adoption of new technologies.