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

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 character

SUBMITTER: Kirby RP 

PROVIDER: S-EPMC10647088 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature