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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Target product profiles for neonatal care devices: systematic development and outcomes with NEST360 and UNICEF
BMC Pediatrics, Volume 23, Article 564, Year 2023
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Description
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. © 2023, The Author(s).
Authors & Co-Authors
Molyneux, Elizabeth M.
Malawi, Zomba
University of Malawi
Dube, Queen Felix
Malawi, Blantyre
Queen Elizabeth Central Hospital Malawi
McWhorter, Cindy
United States, New York
Unicef
Bradley, Beverly D.
United States, New York
Unicef
Gartley, Martha
United States, Boston
Clinton Health Access Initiative, Inc.
Oden, Zillah Maria
United States, Houston
Rice University
Richards-Kortum, Rebecca Rae
United States, Houston
Rice University
Liaghati-Mobarhan, Sara
United States, New York
Unicef
Heenan, Megan
United States, Houston
Rice University
Bond, Meaghan M.
United States, Houston
Rice University
Ezeaka, Chinyere Veronica C.
Nigeria, Lagos
University of Lagos
Salim, Nahya
Tanzania, Dar es Salaam
Muhimbili University of Health and Allied Sciences
Irimu, Grace W.
Kenya, Nairobi
University of Nairobi
Palamountain, Kara M.
United States, Evanston
Northwestern University
Statistics
Citations: 2
Authors: 14
Affiliations: 10
Identifiers
Doi:
10.1186/s12887-023-04342-1
ISSN:
14712431
Research Areas
Health System And Policy
Maternal And Child Health
Study Design
Cross Sectional Study
Study Approach
Quantitative
Study Locations
Kenya
Malawi
Nigeria
Tanzania