Performance & Operational Characteristics for ROP Imaging Device

Written by: Carrie Noxon

As neonatal care improves worldwide, reducing the risks of disabilities and impairments becomes essential. WHO and UNICEF provide guidance on reduction of the risks of disabilities and impairments through quality inpatient care in Survive and Thrive: Transforming care for small and sick newborns. Retinopathy of prematurity (ROP) represents just such a risk that can be reduced through quality care, safer oxygen therapy, screenings, and urgent treatment.

ROP is a potentially blinding condition often affecting preterm and low birthweight infants attributed to perinatal, postnatal, and other factors including incorrect oxygen therapy dosing.1,2 ROP vision loss is usually in both eyes and irreversible. Blindness can impact all aspects of a child’s development and can have life-long consequences. Early detection and intervention significantly improve outcomes.

 TPP for ROP technologies

Routine screening for ROP with an imaging device could improve the quality of care for all babies, especially those born too soon. If detected early, ROP treatment outcomes improve significantly over outcomes from later detection.3 Therefore, developing ROP imaging technologies for use in hospital settings in low- and middle-income countries is needed for early detection and treatment of ROP worldwide.

To assist medical device developers in designing ROP technologies suitable for low- and middle-income countries, UNICEF, NEST360, and the London School of Hygiene & Tropical Medicine worked together to develop a Newborn Target Product Profile (TPP) for an ROP imaging device. TPPs are developed early in the medical device development process to define the setting, target user, and range of product requirements. A Delphi-like process, consisting of an online survey and consensus meeting, was used to develop the ROP TPP.

The performance and operational characteristics were identified through input from global stakeholders and experts.

Through quality newborn care, potential disabilities and impairments can be addressed. Technologies to assist in quality care are needed around the world, so every newborn, everywhere, has the same opportunity to survive and thrive.


  1. Kim SJ, Port AD, Swan R, Campbell JP, Chan RVP, Chiang MF. Retinopathy of prematurity: a review of risk factors and their clinical significance. Surv Ophthalmol. 2018;63(5):618-637. doi:10.1016/J.SURVOPHTHAL.2018.04.002
  2. Good WV, Hardy RJ, Dobson V, et al. The incidence and course of retinopathy of prematurity: findings from the early treatment for retinopathy of prematurity study. Pediatrics. 2005;116(1):15-23. doi:10.1542/PEDS.2004-1413
  3. Good WV, Early Treatment for Retinopathy of Prematurity Cooperative G. The Early Treatment for Retinopathy of Prematurity Study: structural findings at age 2 years. Br J Ophthalmol. 2006;90(11):1378-82.