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Improved screening of retinopathy of prematurity (ROP): development of a target product profile (TPP) for
Rebecca P Kirby1, Aeesha N J Malik2, Kara M Palamountain3
1Kellogg School of Management, Northwestern University, Evanston, Illinois, USA becca.kirby@kellogg.northwestern.edu.
Insights
Developing low-cost retinopathy of prematurity (ROP) imaging devices is crucial for underserved regions. A consensus process defined product requirements for ROP screening devices, improving access to care for preterm infants globally.
Area of Science:
- Medical Devices
- Ophthalmology
- Global Health
Background:
- Complications of preterm birth, such as retinopathy of prematurity (ROP), are increasing globally.
- ROP rates and associated blindness are disproportionately high in low- and middle-income countries due to limited resources for detection and treatment.
- Accessible, low-cost imaging devices are needed to enhance remote screening for ROP.
Purpose of the Study:
- To develop a Target Product Profile (TPP) for an imaging device to screen for retinopathy of prematurity (ROP).
- To define essential product requirements for an ROP imaging device through a stakeholder consensus process.
Main Methods:
- A Delphi-like process, including an online survey and a consensus meeting, was employed.
- Thirty-six international stakeholders (clinicians, developers, technicians) provided feedback on 64 proposed product requirements.
- Consensus was sought on requirements for a novel ROP imaging device.
Main Results:
- 36% of participants reported no current ROP screening, citing cost, lack of training, and poor image quality as barriers.
- Among those screening, indirect ophthalmoscopes were most common, followed by RetCam and smartphone-based devices.
- Consensus was achieved on 53 (83%) of the proposed product requirements, with further discussion on 11 items.
Conclusions:
- The TPP process successfully convened diverse stakeholders to establish consensus on ROP imaging device requirements.
- The developed TPP serves as a foundational framework for the innovation and development of ROP screening prototypes.
- This collaborative approach addresses critical needs for ROP detection in resource-limited settings.
Background:
As more preterm infants survive, complications of preterm birth, including retinopathy of prematurity (ROP), become more prevalent. ROP rates and blindness from ROP are higher in low-income and middle-income countries, where exposure to risk factors can be higher and where detection and treatment of ROP are under-resourced or non-existent. Access to low-cost imaging devices would improve remote screening capabilities for ROP.
Methods:
Target product profiles (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 a TPP for an ROP imaging device, collecting feedback on a proposed set of 64 product requirements.
Results:
Thirty-six stakeholders from 17 countries provided feedback: clinicians (72%), product developers (14%), technicians (6%) and other (8%). Thirty-six per cent reported not currently screening for ROP, with cited barriers including cost (44%), no training (17%) and poor image quality (16%). Among those screening (n=23), 48% use more than one device, with the most common being an indirect ophthalmoscope (87%), followed by RetCam (26%) and smartphone with image capture (26%). Consensus was reached on 53 (83%) product requirements. The 11 remaining were discussed at the consensus meeting, and all but two achieved consensus.
Conclusions:
This TPP process was novel in that it successfully brought together diverse stakeholders to reach consensus on the product requirements for an ROP imaging devices. The resulting TPP provides a framework from which innovators can develop prototypes.
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