Target product profiles for neonatal care devices: systematic development and outcomes with NEST360 and UNICEF
Authors: Kirby Rebecca P. , Molyneux Elizabeth M. , Dube Queen , McWhorter Cindy , Bradley Beverly D. , Gartley Martha , Oden Z. Maria , Richards-Kortum Rebecca , Werdenberg-Hall Jennifer , Kumara Danica , Liaghati-Mobarhan Sara , Heenan Megan , Bond Meaghan , Ezeaka Chinyere , Salim Nahya , Irimu Grace , Palamountain Kara M. ,   the TPP Survey, Consensus Meeting Participants Collaborative Authorship Group, Manasyan Albert , Worm Anna , Zuechner Antke , Chepkemoi Audrey , Tembo Bentry , Trubo Casey , Mudenyanga Chishamiso , Wald Daniel , Goldfarb David , Gicheha Edith , Asma Elizabeth , Ciccone Emily , Mbale Emmie , Gheorghe Florin , Dumont Guy , Naburi Helga , Pernica Jeffrey , Appiah John , Strysko Jonathan , Langton Josephine , Lawn Joy , Klein Kate , Kawaza Kondwani , Gandrup-Marino Kristoffer , Lloyd Lizel , Woo Kinshella Maggie , Chise Mamiki , Myszkowski Marc , Mkony Martha Franklin , Waiyego Mary , Khoory Matthew , Medvedev Melissa , Chiume Msandeni , Spotswood Naomi , Mataruse Noah , Lufesi Norman , Lincetto Ornella , Lavoie Pascal , Mbuthia Rachel , Chifisi Rhoda , Owino Rita , Moshiro Robert , Mbwasi Ronald , Akech Sam , Shah Sona , Reschwamm Steffen , Adudans Steve , Mogotsi Thabiso , Karlen Walter , Demeke Zelalem 
Published: November 2023

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 usingMentimeter™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.