Page 188 - SAMRC AnnualReport 2025-26

compromising quality. With this breakthrough, ALIGN: Advancing Country-
COBA Manufacturing is setting a new standard Led Innovation Introduction
for surgical tools, combining precision, safety, and
affordability to improve surgical outcomes and through Government
patient care. Engagement and Evidence
ALIGN is a multi-country programme led by Duke
Medi-Safe Surgicals and Myco Medical’s
Innovative Safe Shave Biopsy Device University's Global Health Innovation Center
Medi-Safe Surgicals, in collaboration with Myco (funded by the Gates Foundation) and implemented
Medical (USA), has created an innovative shave in South Africa by GIPD in partnership with the
biopsy device with integrated safety features that SAMRC's Health Systems Research Unit, Cochrane
greatly decrease the risk of sharp injuries. Designed South Africa, the Office of AIDS and TB Research
for extracting skin or lesion samples for biopsy and Biostatistics Research Unit, PATH South Africa,
testing, the device keeps the razor blade securely and the Aurum Institute. The programme runs from
behind a protective guard, which extends only when July 2025 to December 2027, with a total SAMRC
the surgeon activates it. Building on Medi-Safe’s sub-award of USD 2,6 million. The programme
expertise in surgical safety – already proven by their collaborates with the national government to
three market-leading safety scalpel devices – this strengthen the systems through which new health
new innovation provides surgeons with improved products are prioritised, financed, and introduced
ambidextrous grips for better control, secure into the public health sector across four areas:
blade fixation that preserves the bowed profile of whole-of-government coordination, data-driven
the razor blade, and a pioneering safety design decision-making, whole-of-market engagement,
for shave biopsy procedures. Fully developed and and portfolio-based planning. A growing pipeline
ready for distribution in South Africa and the USA, of health innovations reaching the market in the
this device establishes a new standard in surgical coming years makes the efficiency and coherence
safety, empowering healthcare professionals with of these decision-making and implementation
confidence in precision and protection within a processes and systems more critical than ever, and
single tool. ALIGN positions the SAMRC and the products it
supports within its broader research and innovation
Rapid Point-of-Care Test for Early Detection portfolio to benefit from the evidence and tools this
of Kidney Injury in HIV Patients work is generating.
In South Africa and many other developing
countries, Tenofovir disoproxil fumarate (TDF) In the first reporting period, the project established
is a key component of HIV treatment; however, its governance structure, including a national
up to 10% of patients experience acute kidney Steering Committee and thematic working groups
injury (AKI) as a serious side effect, with current with participation from the NDoH, DSTI, National
diagnostic methods often detecting damage too Treasury, and provincial health authorities. A
late. To address this, researchers at the CSIR have landscape assessment, mapping current pathways
developed a point-of-care multiplex rapid test that for the introduction of medicines, vaccines, devices,
uses non-invasive urine or blood samples to identify and diagnostics, is in progress. This will help identify
early biomarkers of AKI within 10 minutes. Based on gaps, bottlenecks, and opportunities to build the
a low-cost, paper-based immunochromatographic evidence base and systems that remove guesswork
assay, the test is simple to use, requires no laboratory about which innovations to prioritise and how to
facilities, and is ideally suited for deployment in introduce them. Simultaneously, a local market
resource-limited settings. Multiplex prototypes with intelligence hub linked to a global platform is being
three biomarkers have already been developed and developed. The hub aims to consolidate the data
are undergoing clinical validation, positioning this decision-makers need to prioritise and plan for
innovation to transform HIV care by enabling earlier incoming health product innovations into a single,
intervention, reducing complications, lowering accessible platform.
healthcare costs, and ultimately saving lives.

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