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EF: Grace, could you elaborate on the role of the South African Medical Research Council in the market, and what are your priorities?
GB: The SAMRC, established in 1969, is dedicated to improving the health of South Africans through research, development, innovation, and technology transfer. We conduct laboratory investigations, clinical research, and public health studies, focusing on the quadruple burden of diseases in South Africa: Maternal health, newborns, child health, HIV/AIDS, TB, Non-communicable diseases (NCDs); Violence and injury.
The SAMRC’s mission is to build a healthy nation through research, innovation, and transformation, advancing health and quality of life while addressing inequity through relevant and responsible health research, capacity development, innovation, and research translation. There are about 718 employees, with slightly more than 50% funded by the government through the national treasury, and the rest funded by contract research. We operate intramural units, research units, and platforms.
I am currently a Senior Programs Manager at the South African Medical Research Council (SAMRC). I handle three portfolios at the SAMRC (MeDDIC, TTO and GHIA). The first portfolio is the Technology Transfer Office, which protects intellectual property from SAMRC-funded public research and commercializes it to benefit researchers. I am also responsible for the Global Health Innovation Accelerator aimed at growing the ecosystem through technologies impacting both South Africa and low- and middle-income countries (LMICs). Finally, I am responsible for the program called MEDDIC, which stands for the Medical Devices and Diagnostics Innovation Cluster program and is funded by the Technology Innovation Agency.
During 2023-2024 the innovation unit, managed a total of 64 (20 new and 44 ongoing innovation and technology projects), facilitating funding through grant programs for the organisations’ focus areas. We also support research capability development, providing career awards to early career researchers and postgraduates. The SAMRC prides itself on being the largest health funder in Africa, with annual revenue over one billion rand, 53% from government grants and 46.7% from contracts.
In 2022-2023, with regards to leading the generation of new knowledge, the SAMRC had 1455 accepted or published outputs by SAMRC-affiliated and funded authors Our innovation process involves identifying needs, understanding the disease burden, and setting priority areas in consultation with stakeholders. We enter strategic funding partnerships, run requests for applications, and manage a rigorous technical peer review process, involving experts from the science community, universities, and sometimes even international experts, through various committees. Once projects receive funding, product development primarily occurs.
EF: How is the national medical technology master plan impacting your work, and what grants are you working with?
GB: The Global Health Innovation Accelerator (GHIA) was established in 2014 as a partnership between PATH and the SAMRC. This collaboration is aimed at leveraging the strengths of both institutions, focusing primarily on product development. Together, they developed a suite of products and recognized the need to expand ecosystem development, leading to the creation of MEDDIC. This sub-program was designed to broaden stakeholder involvement using the triple helix model, fostering local innovation systems and facilitating access to technologies in South Africa and beyond.
MEDDIC, the Medical Device and Diagnostics Innovation Cluster, is hosted at the SAMRC and funded by the Technology Innovation Agency (TIA), a government entity under the Department of Science and Innovation. The program aims to stimulate technology innovation, encourage ecosystem development, and address significant challenges in the medical devices and diagnostics sector. It operates on a cluster and hub model with three main pillars: providing an enabling environment, localization and rapid product development, and human capacity development.
Public and private entities are involved in MEDDIC. The mission is to develop a vibrant and cohesive ecosystem where stakeholders collaborate to design, develop, manufacture, and commercialize medical devices and diagnostics with increased local content, contributing to economic development. The necessity for MEDDIC arose from a landscape analysis revealing a substantial market for medical devices in South Africa, valued at approximately 21 billion rands in 2021. Despite this, over 76% of these devices are imported, representing a missed opportunity for local manufacturers. The study also highlighted that about 90% of the market is dominated by imports. MeDDIC aims to increase the success rate of locally developed medical devices, utilizing existing capabilities and centers of excellence more effectively.
MEDDIC has three main objectives. The first is to create an integrated and cohesive ecosystem supporting the development and growth of the medical devices and diagnostics sector. This involves driving policy changes, leveraging funding for specific programs, and sharing information. One significant effort in this regard was the landscape analysis, which provided a comprehensive understanding of the sector. From this, a medical devices and diagnostics portal was developed in collaboration with the Council for Scientific and Industrial Research (CSIR) to optimize resource use and share new innovations and knowledge.
The second objective is to support the localization and rapid product development of promising medical devices and diagnostics opportunities from the South African health innovation ecosystem. This involves establishing a seamless product development and manufacturing pipeline. We aim to increase the product development pipeline, support regulatory compliance, and enhance technologies, platforms, and capabilities.
In the past two and a half years, we have implemented a regulatory support program (through a MeDDIC sub-grant) in collaboration with the CSIR. This program offers technical support to entrepreneurs and innovators, guiding them through regulatory support (i.e. EU and SAHPRA device classifications); product/device development (i.e. product specification and links to service providers), and Manufacturing and Distribution support. Examples of the type of support provided include guidance through CE marking, and assembling technical files. Recognizing industry challenges with the regulator, we approached SAPHRA to address some of these regulatory issues raised by the sector. Some people had noted concerns such as never receiving feedback from the regulator despite having submitted technical dossiers. The SAHPRA-funded sub-grant for data capturing, collation and analysis aimed to improve the medical device and diagnostics sector, supporting both innovators and the regulatory body to streamline product registrations and establishment licenses to enable subsequent commercialization by the sector. SAPHRA has provided surety that it will incorporate all the suggested changes from this project to improve the communication between themselves and the medical devices and diagnostics sector as well as use the output towards finalising the online registration system for medical devices, in vitro diagnostics and establishment licenses.
Our first product development and manufacturing funding call funded four projects, averaging around 735,000 rands each, the funding cap for this call was R800,000. Subsequent calls expanded to include more projects focused on localization and increased funding, with the most recent call in 2022 funding 9 projects and raising the funding cap to one million rands per project. This call focused on localization and LMICs. It is important to note that we only fund the technology development part/ aspect of the project.
To balance funding between researchers and companies, we required university and science council applicants to partner with companies and vice versa. This approach has successfully funded 22 projects since 2021, totaling approximately 14.9 million rands.
Lastly, I would like to touch on our final objective: developing and enhancing human capital to support innovation and sustainable competitiveness in the medical devices and diagnostics sector. In this area, we are actively seeking opportunities to provide training and create partnership opportunities.
Our goal is to align with SAHPRA's requirement for all companies to be ISO 13485 certified by 2025. To support this, we aim to train graduates or assist companies in achieving this certification. This is still a work in progress, and hopefully, by our next discussion, we will have implemented the internship program.
EF: Do you have any other success stories of partnerships with key stakeholders or companies that exemplify how you are "walking the talk?"
GB: Some partnerships that stand out include our efforts with Proudly SA to increase the visibility of local products and ensure government-funded products are affiliated with their logo. We are also setting up workshops to promote local medical devices, working together to elevate the profile of these technologies.
Additionally, we are working with an organization in Kenya, the Transforming African MedTech Conference (TAMC), which aims to address regulatory challenges and develop health tech relevant to our context. They have invited us to share SAMRC's and MEDDIC's initiatives, fostering knowledge-sharing opportunities.
We are also working with the Bill and Melinda Gates Foundation on the Global Health Innovation Accelerator, aiming to replicate successful programs in other African countries. I will be visiting Uganda, Kenya, and Tanzania to verify our desktop analysis understand their sectors better, and help The Bill and Melinda Gates Foundation to decide which country to partner with.
EF: Do you have any final message?
GB: I sometimes feel that we are not doing enough but I think we are trying as long as we can get to a stage where we are making an impact in our healthcare system. The time is ripe for us to take charge and show that we are capable of providing better medtech and ultimately improving our healthcare system if we organize ourselves as government agencies. We hope to achieve all our goals by working with different stakeholders.
