Human and societal systems
The human and societal systems research group focuses on medical device research, design, development and small-scale manufacturing. The CSIR has an ISO 13485 medical quality system which is a key requirement needed for European conformity and Food and Drug Administration (FDA) approvals.
The group’s capabilities are in the development of:
- High-frequency ultrasound devices.
- Ultrasonic ceramics.
- Analogue and digital electronic design and development.
- Mechanical design, development, and small-scale manufacturing.
- Software development in alignment with medical device standards (ISO 62304) and best practices. This includes graphical user interfaces, together with the back-end advanced signal processing algorithms and processes on both Windows and Android devices (Android App). With Medical machine learning work currently ongoing.
- Regulatory (South African Health Products Regulatory Authority and ISO 13485) support, guidance, and advice.
An example of a medical device designed, developed, and manufactured locally is the Umbiflow device.
Umbiflow is a low-cost medical ultrasound device, which measures the umbilical blood flow between a pregnant mother and foetus. The measurements are used to identify fetuses that are at risk of being stillborn. Umbiflow has been developed at the CSIR and has shown to reduce the stillbirth rate by 50% during clinical trials in Mamelodi, Gauteng. Subsequent clinical trials throughout South Africa’s nine provinces have shown a similar still-birth reduction prevalence when using the device
Due to the group’s experience with medical devices, an additional involvement area has been assisting organisations and small and mid-size enterprises to get their medical device products to market while navigating regulatory, clinical trial, design, development, manufacturing and distribution aspects. This has promoted medical device localisation within the country. In this regard, the group has been contracted by the Technology Innovation Agency (TIA) and the South African Medical Research Council (SAMRC) to support the Medical Device & Diagnostics Innovation Cluster (MeDDIC) programme.
During the first six months of 2020, amidst the Covid-19 pandemic, the CSIR’s industrial sensors impact area contributed to the development of the CSIR CPAP ventilator, which was adopted nationally to combat COVID-19.