From warehouse to ward: applying implementation research methods to the device identification, qualification,...

Preventing newborn deaths requires the right medical devices. However, in many countries, devices for small and sick newborn care (SSNC) are unavailable, not fit for the environment, or broken. Newborn Essential Solutions and Technologies (NEST360) is a multicountry alliance aimed at decreasing neonatal mortality in Kenya, Malawi, Nigeria, and Tanzania. The technology qualification, distribution, and management teams in NEST360 work to ensure appropriate devices are available and functional at facilities, by identifying needed technologies, sourcing suitable devices, testing them under varied conditions, establishing reliable supply chains, training staff, and maintaining the devices once installed through trained biomedical technicians. We applied implementation research (IR) to understand context, describe strategy selection, and implementation outcomes of the work designed to ensure the consistent availability of functional SSNC devices.

Between March and July 2024, we conducted 12 in-depth interviews with NEST360 team members via Zoom, and reviewed quantitative programmatic data, including device functionality reports. We applied deductive content analysis for interviews and descriptive statistics for quantitative data. Results were used to develop an implementation research logic model (IRLM) using NEST360 and United Nations Children's Fund SSNC Implementation Toolkit for contextual factors and the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework for implementation outcomes.

We identified 40 contextual factors, 78% being barriers. Twenty-one strategies were implemented to address barriers to device qualification, distribution, and management efforts, including engaging stakeholders and conducting ongoing trainings. Notable implementation outcomes included reach with 29 devices in 12 product categories qualified, and all 66 facilities received NEST-qualified devices, effectiveness, in 2024, an average of 87% of all newborn care devices were functional, including those provided by NEST360 and those sourced through existing channels, adoption with over 2476 devices installed at NEST360 sites in 2023. Acceptability was also high with country-level biomedical technicians reporting positive facility-level experiences using the devices.

The NEST360 approach to ensuring appropriate and functioning equipment for SSNC was successful through multiple strategies to address multilevel barriers. The use of IR facilitated understanding of how strategies addressed context and where change is needed. These results will be used in plans for scale-up and dissemination.