Capacity building for a Centre of Design, Innovation and Translational Excellence (CITE) for clinical trials of healthcare technologies in SS Africa

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.

Great strides have been taken to reduce global maternal and neonatal mortality. However, due to numerous factors such as limited access to resources including funding, healthcare providers among others, means that maternal and neonatal mortality have remained stubbornly high in sub-Saharan Africa. Advances in technological innovations, including contextually appropriate devices coupled with mobile health technologies offer the opportunity to improve healthcare outcomes in maternal and neonatal health. For instance, improved and timely diagnostics, therapy and monitoring can improve outcomes for mothers with conditions such as preeclampsia, postpartum haemorrhage and pneumonia and hypothermia for neonates. In Uganda, researchers, students and innovators have developed many contextually appropriate solutions with some winning international awards. such devices include: (1) Maternal (postpartum haemorrhage (PPH) Wrap (https://challenges.openideo.com/challenge/reproductive-health/ideas/maternal-wrap-a-first-aid-postpartum-hemorrhage-belt); (2) The EPED strip: The Early Pre-Eclampsia Detection strip (https://bigideascontest.org/winners/early-preeclampsia-detection-strip/); and (3) Mama Ope a smart jacket for early diagnosis and monitoring of pneumonia in children aged between 0 and 5 years (http://mamaope.com/en/). Such great innovations have found a great challenge in translation to useful products due to limited capacity in clinical evaluation and translational expertise in the country.

Our aim is to strengthen propose our proposed interdisciplinary Centre of Design, Innovation and Translational Excellence (CITE) in collaboration with University of Edinburgh. We propose to map existing knowledge about the systems and processes for clinical evaluation of locally made Investigational Medical Devices (IMD) amongst key stakeholders in Uganda and to strengthen local research capacity through training on clinical trial design.

This project will equip Ugandan medical technology innovators in maternal and neonatal health, with knowledge on how to design effective clinical trials for their innovations, and also build a network of stakeholders that will form a local framework for regulation of innovations to ensure smooth transition to market.


The impact can be summaries as (a) deliver economic and efficient improvements in maternal and neonatal outcomes at scale, (b) replace existing technologies which are not designed for the Ugandan healthcare systems and environment, (c) reduce waste and (d) 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 .

In detail, the impact for the proposal is summarised as below;

i) Impact in clinical trial expertise
Knowledge will be used to inform trial design for funding applications for technologies at highest technology readiness level (TRL, i.e. post-partum haemorrhage wrap, electronic gravity feed infusion system and Mamaope). Dissemination of knowledge more widely across SSA via the global trials network to inform trial design for other IMD made outside Uganda, and for IMD used for other clinical applications

ii) Impact in Medical Device Regulation Capacity Building
An approved draft framework detailing the pathway for investigational medical devices from idea to market in Uganda. Dissemination of knowledge more widely across SSA via the global trials network to inform trial design for other IMD made outside Uganda, and for IMD used for other clinical applications.

iii) Impact in fostering new interdisciplinary collaborations
We will deliver a comprehensive network of key stakeholders involved in the design, development and delivery of IMD for maternal and neonatal health by M12. Future impact: We aspire to have our draft pathway ratified into law 12M after completion of this project. This would be transformative, not only unblocking the pipeline for technologies for maternal and neonatal health, but more widely across technologies for other indications.

i) Impact in public engagement
Innovations going through a streamlined process of clinical trials and device regulation. Future Impact: Innovations reaching the target population.

ii) Impact for Industry
Showcase a maternal and neonatal IMD to potential investors at conference. Future impact: Use CITE as a platform to facilitate wider engagement with other international initiatives including NEST360, Gates Foundation.
iii) Economic impact
Immediate result: We will empower innovators with the skills to accelerate their innovations towards the clinic to reduce maternal and neonatal morbidity (by M12).
Future impact: We aspire for innovators to establish economically sustainable MedTech business to build wealth and expertise in the local economy.