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A public consultation process is now open for a new Target Product Profile being developed by @WHO @ConceptFNDN and @BurnetInstitute for obstetric ultrasound devices that best meet global health needs. Submissions close 13 March. Find out more at 👇https://t.co/WTgPvXyQlV
— Burnet Institute (@BurnetInstitute) February 13, 2023
The market for ultrasound devices is rapidly expanding, particularly as technological advances allow for smaller, cheaper, and more portable devices to be developed. However, no publicly available guidance currently exists on the characteristics that ultrasound devices must possess to meet minimum and optimal requirements for obstetric use. The World Health Organization (WHO) has identified this as a priority area for Target Product Profile (TPP) development.
The WHO defines a TPP as a document that describes the minimum and preferred (or optimal) characteristics of a target product, aimed at a particular disease or condition. TPPs are a well-recognised strategy to promote development of innovative medical products, such as devices, diagnostic tests, and therapeutics, in addition to guiding their implementation and procurement. Typically, they specify the key characteristics that a health product must address, such as (but not limited to) clinical indication, target population, desired efficacy, safety, formulation/presentation and stability and storage. TPPs are an important resource for multiple stakeholders in the R&D pathway, including funders, researchers, product developers, manufacturers, and regulators.
This project aims to develop a new TPP for obstetric ultrasound devices, to assist in driving the implementation of the WHO 2022 recommendations on antenatal care for a positive, person-centred pregnancy experience and guiding procurement of new devices for obstetric use.
To achieve this, we will conduct a mixed-methods study which will be guided by an expert advisory group of independent experts. Key stakeholder interviews, an international online survey and public consultation will be used to understand and incorporate the views of relevant stakeholders into TPP development.
July 2022 – March 2023
For any general enquiries relating to this project, please contact:
Principal Research Fellow; Deputy Discipline Head, International Development; Co-Head, Global Women's and Newborn's Health Group
To create and translate knowledge into better health, so no-one is left behind.
85 Commercial Road, Melbourne
VIC, 3004, Australia
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