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. 2023 Nov 15;23(Suppl 2):564.
doi: 10.1186/s12887-023-04342-1.

Target product profiles for neonatal care devices: systematic development and outcomes with NEST360 and UNICEF

Rebecca P Kirby  1 , Elizabeth M Molyneux  2 , Queen Dube  3 , Cindy McWhorter  4 , Beverly D Bradley  4 , Martha Gartley  5 , Z Maria Oden  6 , Rebecca Richards-Kortum  6 , Jennifer Werdenberg-Hall  6 , Danica Kumara  7 , Sara Liaghati-Mobarhan  4 , Megan Heenan  6 , Meaghan Bond  6 , Chinyere Ezeaka  8 , Nahya Salim  9 , Grace Irimu  10 , Kara M Palamountain  11 ; TPP Survey, Consensus Meeting Participants Collaborative Authorship Group
Collaborators, Affiliations

Target product profiles for neonatal care devices: systematic development and outcomes with NEST360 and UNICEF

Rebecca P Kirby et al. BMC Pediatr. .

Abstract

Background: Medical devices are critical to providing high-quality, hospital-based newborn care, yet many of these devices are unavailable in low- and middle-income countries (LMIC) and are not designed to be suitable for these settings. Target Product Profiles (TPPs) are often utilised at an early stage in the medical device development process to enable user-defined performance characteristics for a given setting. TPPs can also be applied to assess the profile and match of existing devices for a given context.

Methods: We developed initial TPPs for 15 newborn product categories for LMIC settings. A Delphi-like process was used to develop the TPPs. Respondents completed an online survey where they scored their level of agreement with each of the proposed performance characteristics for each of the 15 devices. Characteristics with < 75% agreement between respondents were discussed and voted on using Mentimeter™ at an in-person consensus meeting.

Findings: The TPP online survey was sent to 180 people, of which 103 responded (57%). The majority of respondents were implementers/clinicians (51%, 53/103), with 50% (52/103) from LMIC. Across the 15 TPPs, 403 (60%) of the 668 performance characteristics did not achieve > 75% agreement. Areas of disagreement were voted on by 69 participants at an in-person consensus meeting, with consensus achieved for 648 (97%) performance characteristics. Only 20 (3%) performance characteristics did not achieve consensus, most (15/20) relating to quality management systems. UNICEF published the 15 TPPs in April 2020, accompanied by a report detailing the online survey results and consensus meeting discussion, which has been viewed 7,039 times (as of January 2023).

Conclusions: These 15 TPPs can inform developers and enable implementers to select neonatal care products for LMIC. Over 2,400 medical devices and diagnostics meeting these TPPs have been installed in 65 hospitals in Nigeria, Tanzania, Kenya, and Malawi through the NEST360 Alliance. Twenty-three medical devices identified and qualified by NEST360 meet nearly all performance characteristics across 11 of the 15 TPPs. Eight of the 23 qualified medical devices are available in the UNICEF Supply Catalogue. Some developers have adjusted their technologies to meet these TPPs. There is potential to adapt the TPP process beyond newborn care.

Keywords: Low- and middle-income countries; Medical devices; Newborn; Target product profile; Technology.

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Conflict of interest statement

The following authors have the following competing interests: MO and RRK are inventors of a bCPAP device (Patent US 2015/0258291 A1) and bilirubinometer device that have been licensed to 3SD; the devices are licensed at 0% royalty in GAVI-eligible countries, and the inventor’s share of all royalties have been donated to Rice University. EM holds a small portion of the intellectual property patent for Pumani on behalf of the University of Malawi College of Medicine (COM)/ Kamuzu University of Health Science (KUHeS). MB is an inventor of the BiliDx bilirubinometer and an inventor on a patent (US20120257188A1) for haemoglobin measurement. DK was employed by 3rd Stone Design, the parent company of Hadleigh Health Technologies, during the TPP process. This does not alter our adherence to BMC Pediatrics policies on sharing data and materials.

Figures

Fig. 1
Fig. 1
Flow chart summarising TPP process and level of consensus achieved for performance characteristics for final TPPs
See this image and copyright information in PMC

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