Umbiflow, a point-of-care medical ultrasound system for pregnancy care, is currently undergoing final clinical trials and certification, with key components manufactured at the CSIR’s own pilot-scale laboratory. 

Mobile, affordable and easy to operate, the Umbiflow ultrasound system for pregnancy care was designed by the CSIR and the South African Medical Research Council (SAMRC). The University of Pretoria (UP) has conducted extensive clinical trials involving nurses and midwives at primary healthcare facilities and antenatal clinics in remote and low-resource settings. 

Jeremy Wallis, manager for industrial sensors at the CSIR, says that while Doppler ultrasound and sonar are not new technologies, their integration into a low-cost, easy-to-use device is innovative. The design has enabled a reduction in stillbirths in urban and rural environments in South Africa that lack sophisticated facilities and equipment.  

“With thousands of stillbirths recorded every year, a simpler, lower-cost tool is needed to test for any possible fetal growth restriction early on, allowing the mother to be referred to a higher level of care,” he says. “The Umbiflow ultrasound will indicate if the placenta is adequately supplying oxygen and nutrition to the fetus, determining whether referral to a hospital is needed.”  

Wallis explains that the handheld device plugs into any computer or tablet’s USB port for power and uses its own software to display blood flow in the umbilical cord as waveform graphs on the screen. Audible pulses of the blood flow can also be heard, similar to traditional sonar screenings.  

The device can also connect via mobile networks to medical experts and obstetricians elsewhere, providing real-time guidance and advice to the clinic staff conducting the tests. 

Umbiflow has been extensively tested in multiple clinical trials with nearly 20 000 patients by a team from UP. 

“Clinics using Umbiflow have seen up to a 43% reduction in stillbirths,” says Wallis, adding that it has been clinically tested in Rwanda, Ghana, Kenya and India with support from the World Health Organization. 

Wallis says that the CSIR is currently pursuing Conformité Européene (CE) Marking for Umbiflow as a prerequisite for market entry. CE is a mandatory conformity mark for regulating products sold within the European Economic Area and a range of low-to-middle-income countries, signifying that products meet high safety, health and environmental protection requirements. 

The Umbiflow manufacturing team already holds ISO 9001 and ISO 13485 certifications, along with a manufacturing license from the South African Health Products Authority. This permits the CSIR to manufacture Umbiflow probes for clinical trial use. 

Wallis says the team has recently worked on delivering 27 Umbiflow systems for UP’s latest clinical tests, funded through philanthropy.  

The devices will be used in the UmbiTshwane study at 22 primary healthcare clinics in Tshwane, as well as in the Siyakubona Study at 24 clinics in Gauteng, Mpumalanga and the Western Cape. 

Lessons learned in developing and commercialising a medical device – through the Umbiflow development and trials – are currently being shared with small businesses through the Medical Device and Diagnostic Innovation Cluster (MeDDIC) programme. MeDDIC is an initiative hosted by the SAMRC and supported by the Technology Innovation Agency and the Department of Science, Technology and Innovation. 

MeDDIC was established to help SMMEs in the medical technology sector attain certification and promote the localisation of medical device development and manufacturing.  

The CSIR operates as a technical partner for MeDDIC, which typically entails product development and testing, technical documentation, market access and compliance with the complex standards and regulations applicable to medical products.   

“South Africa has a significant dependency on importation and the sector has complex regulatory requirements,” says Wallis. “At the same time, there is significant scope for innovation in the medical sector and, in particular, for solving our unique healthcare challenges.” 

“Innovation drives local manufacturing, which creates jobs, spurs exports and foreign investment and helps the economy,” he adds. 

Wallis says Umbiflow is just one example of a diagnostic tool that is technically sophisticated, yet mobile, simple to power and easy to use by clinic staff.   

“The CSIR is also working on means of screening for illnesses such as TB, malaria or HIV/Aids, e.g., using a smartphone application. These epidemics are recognised under the UN Sustainability Goals (SDGs) with a deadline of arresting their spread by 2030.” 

A similar blood flow measurement ultrasound system is also under development for the early detection of conditions that lead to heart attacks and strokes.  

“We continue to work with the SAMRC and other agencies who mirror our mandate and commitment to provide product solutions that meet real healthcare needs in this country,” Wallis says. 
 

Umbiflow was co-developed by the CSIR and the SAMRC. It addresses SDG 3.