Target product profiles for neonatal care devices: systematic development and outcomes with NEST360 and UNICEF.
Low- and middle-income countries
Medical devices
Newborn
Target product profile
Technology
Journal
BMC pediatrics
ISSN: 1471-2431
Titre abrégé: BMC Pediatr
Pays: England
ID NLM: 100967804
Informations de publication
Date de publication:
15 11 2023
15 11 2023
Historique:
received:
24
01
2023
accepted:
02
10
2023
medline:
17
11
2023
pubmed:
16
11
2023
entrez:
16
11
2023
Statut:
epublish
Résumé
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. 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. 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). 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.
Sections du résumé
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.
Identifiants
pubmed: 37968603
doi: 10.1186/s12887-023-04342-1
pii: 10.1186/s12887-023-04342-1
pmc: PMC10647088
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
564Subventions
Organisme : Wellcome Trust
Pays : United Kingdom
Investigateurs
Albert Manasyan
(A)
Anna Worm
(A)
Antke Zuechner
(A)
Audrey Chepkemoi
(A)
Bentry Tembo
(B)
Casey Trubo
(C)
Chishamiso Mudenyanga
(C)
Daniel Wald
(D)
David Goldfarb
(D)
Edith Gicheha
(E)
Elizabeth Asma
(E)
Emily Ciccone
(E)
Emmie Mbale
(E)
Florin Gheorghe
(F)
Guy Dumont
(G)
Helga Naburi
(H)
Jeffrey Pernica
(J)
John Appiah
(J)
Jonathan Strysko
(J)
Josephine Langton
(J)
Joy Lawn
(J)
Kate Klein
(K)
Kondwani Kawaza
(K)
Kristoffer Gandrup-Marino
(K)
Lizel Lloyd
(L)
Maggie Woo Kinshella
(M)
Mamiki Chise
(M)
Marc Myszkowski
(M)
Martha Franklin Mkony
(MF)
Mary Waiyego
(M)
Matthew Khoory
(M)
Melissa Medvedev
(M)
Msandeni Chiume
(M)
Naomi Spotswood
(N)
Noah Mataruse
(N)
Norman Lufesi
(N)
Ornella Lincetto
(O)
Pascal Lavoie
(P)
Rachel Mbuthia
(R)
Rhoda Chifisi
(R)
Rita Owino
(R)
Robert Moshiro
(R)
Ronald Mbwasi
(R)
Sam Akech
(S)
Sona Shah
(S)
Steffen Reschwamm
(S)
Steve Adudans
(S)
Thabiso Mogotsi
(T)
Walter Karlen
(W)
Zelalem Demeke
(Z)
Informations de copyright
© 2023. The Author(s).
Références
Trop Med Int Health. 2013 Jan;18(1):117-28
pubmed: 23279380
Paediatr Int Child Health. 2015 Aug;35(3):192-205
pubmed: 26053669
Global Health. 2017 Aug 18;13(1):59
pubmed: 28821280
PLoS Negl Trop Dis. 2015 Jun 04;9(6):e0003697
pubmed: 26042730
Lancet. 2014 Jul 12;384(9938):189-205
pubmed: 24853593
Nat Rev Drug Discov. 2017 Mar;16(3):156
pubmed: 28209989
J Infect Dis. 2015 Apr 1;211 Suppl 2:S39-49
pubmed: 25765105
BMC Infect Dis. 2017 Nov 1;17(Suppl 1):707
pubmed: 29143620
BMC Pregnancy Childbirth. 2015;15 Suppl 2:S1
pubmed: 26390820
Med Biol Eng Comput. 2010 Jul;48(7):721-6
pubmed: 20490939
BMC Med. 2020 May 11;18(1):119
pubmed: 32389127
Lancet. 2014 Aug 2;384(9941):438-54
pubmed: 24853600