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

BMC Pediatrics · 17 authors, 10 centres

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TL;DR

The central result was that consensus was achieved for 648 (97%) of the 668 total performance characteristics across all 15 TPPs.

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The central result was that consensus was achieved for 648 (97%) of the 668 total performance characteristics across all 15 TPPs.

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other

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pediatrics

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AI pipeline

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ORIGINAL PAPER

PMC10647088

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

BMC Pediatrics

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ABSTRACT

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. Supplementary Information The online version contains supplementary material available at 10.1186/s12887-023-04342-1. Keywords: Newborn, Low- and middle-income countries, Target product profile, Technology, Medical devices

CITATION EXPORT

Rebecca P Kirby, Elizabeth M Molyneux, Queen Dube et al.. Target product profiles for neonatal care devices: systematic development and outcomes with NEST360 and UNICEF. BMC Pediatrics. (2023). https://doi.org/10.1186/s12887-023-04342-1

AUTHORS

17 · 10 CENTRES

Rebecca P Kirby, Elizabeth M Molyneux, Queen Dube, Cindy McWhorter, Beverly D Bradley, Martha Gartley, Z Maria Oden, Rebecca Richards-Kortum, Jennifer Werdenberg-Hall, Danica Kumara, Sara Liaghati-Mobarhan, Megan Heenan, Meaghan Bond, Chinyere Ezeaka, Nahya Salim, Grace Irimu, Kara M Palamountain

1Kellogg School of Management, Northwestern University, Illinois, USA
2Department of Paediatrics, Kamuzu University of Health Sciences (Formerly College of Medicine, University of Malawi), Blantyre, Malawi
3Department of Paediatrics, College of Medicine, University of Malawi, Blantyre, Malawi and Department of Paediatrics, Queen Elizabeth Central Hospital, Blantyre, Malawi
4UNICEF Supply Division, Copenhagen, Denmark
5Clinton Health Access Initiative, Toronto, Canada
6Rice360 Institute for Global Health Technologies, Rice University, Texas, USA
73rd Stone Design Inc, San Rafael, CA USA
8Department of Paediatrics, College of Medicine, University of Lagos, Lagos, Nigeria
9Department of Paediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania
10Department of Paediatrics and Child Health, University of Nairobi, Nairobi, Kenya