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Despite numerous efforts by many stakeholders, Uganda still has one of the highest maternal and infant mortality in the world with the maternal and infant mortality rates being 336 deaths per 100,000 births, and 55 per 1,000 live births, respectively as of 2016. Access to quality maternal and neonatal healthcare is being stretched by lack of access to trained health professionals with doctor to patient ratios in Uganda being 25 times higher than the minimum recommended by the WHO. The biggest percentage of Uganda's population live in rural communities where access to specialised care is a major challenge due to long distances to big health facilities. Approaches such as education, advocacy, increasing access to medicine and skilled birth attendance have been used to improve outcomes. However, many mothers in Uganda and other Low and Middle Income countries are dying due to conditions such as postpartum haemorrhage, preeclampsia and malaria, whereas neonatal mortality is mainly due to conditions such as pneumonia, sepsis among others. What is very evident is the clear need for early diagnosis, better access to therapy and improved monitoring. There is therefore an urgent need for innovative, cost effective and sustainable context specific approaches to healthcare delivery, which can reduce maternal and neonatal mortality within a resource limited healthcare system. Appropriate technological innovations present an opportunity to i) deliver economic and efficient improvements in maternal and neonatal outcomes at scale, ii) replace existing technologies which are not designed for the Ugandan healthcare systems and environment, iii) reduce waste and iv) drive local economic growth. Uganda is uniquely placed in SSA in that, driven by academia and supported by the Government, it is expanding local research and technical expertise in biomedical engineering, healthcare diagnostics and technologies and healthcare innovation. We propose to capitalise on a new strategic collaboration between the University of Makerere Biomedical Engineering Unit and College of Health Sciences, and the University of Edinburgh to strengthen capacity for our proposed interdisciplinary Centre of Design, Innovation and Translational Excellence (CITE), initially focused on maternal and neonatal health. Our medium to long-term aspiration is to act as a hub to build innovation and capacity in the region, to act as a blueprint to stimulate innovations beyond maternal and child health and to expand our technological and research expertise to become the leading centre for academic excellence and innovations in biomedical engineering in sub-Saharan Africa. Our initial broad objectives are: (1) To map existing knowledge about the systems and processes for clinical evaluation of locally made Investigational Medical Devices (IMD) amongst key stakeholders in Uganda; (2) To strengthen local research capacity through training on clinical trial design for investigational medical devices and medical writing for the regulation of such devices. Training seminars, sponsorships to attend good relevant courses and exchange bench-marking visits between Makerere and Edinburgh Clinical Trials Units are some of the activities aimed at achieving this objective. The output of this objective is develop a critical mass of Ugandan researchers knowledgeable in IMD trial design, with specific expertise on trials in maternal and neonatal health; and (3) To establish a multi-disciplinary network with the expertise to develop a draft regulatory framework for Investigational Medical Devices, bespoke for Uganda.
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