Read the Conversation
Conversation highlights:
- Strategic Shift to Innovation. UCT’s 2030 strategy marks a transition from research to an innovation-driven model, integrating entrepreneurship, technology transfer, and applied impact across the biomedical landscape.
- Homegrown Solutions Accelerated by COVID. The pandemic catalyzed South Africa’s MedTech ecosystem, proving its capacity for large-scale production through the National Ventilator Project.
- South Africa’s AI Leadership and Regulation. South Africa leads the continent in defining responsible innovation—balancing opportunity with transparency and oversight.
- Building a Collaborative Ecosystem. New frameworks are fostering collaboration, quality control, and infrastructure growth for a resilient MedTech industry.
- Focus on Practical, Scalable Innovation. True impact lies in scalable, user-centric solutions that strengthen primary and secondary care systems. Sustainable growth depends on investing in deep tech while ensuring accessibility through public sector pathways.
EF: Could you elaborate on the trends you are identifying in the market and what opportunities you see currently?
SS: From my role as South African Research Chair in Biomedical Engineering and Innovation in DSTI/NRF, I see several trends and opportunities. We recently launched our 2030 strategy at our university, which includes a pillar on innovation and entrepreneurship. This marks a clear shift from purely research-focused work to one that integrates research, innovation, and entrepreneurship.
From a medical technology perspective, in South Africa, the turning point came with the COVID-19 ventilator shortage, which led to the launch of the National Ventilator Project.
In just four to six months, approximately 20,000 ventilators were manufactured and distributed across South Africa. It was a significant milestone for medical technology in South Africa, as it upped the value and risk management nature of the products we can produce.
What is currently optimistic is that South Africa is one of the first African countries to put forward an AI draft for regulations. Dr. Boitumelo Semete-Makokotlela has done a fantastic job, and SAHPRA has released the draft. South Africa now stands as a forerunner on the continent with its draft statement and policy on AI in medical devices.
When it comes to Pandemic Preparedness, the National Institute for Pandemic Preparedness (IP3) and Prevention for pandemics is a ten-university collaboration established in South Africa, initiated by the National Research Foundation. Additionally, the institute features two integrated platforms: one for cross-cutting technologies and another for enabling environments. There’s growing support for infrastructure development, and that commitment is expected to transform how South Africa approaches medical technologies and local production.
In 2022–2023, SAHPRA introduced a requirement that significantly changed how manufacturers operate and are perceived in South Africa. The new rule compelled many local producers to meet international quality standards, such as ISO 13485. This represents a major milestone, as it places quality standardization at the center of the regulatory framework. This shift reflects a more industrialized mindset, which is vital for South Africa and the continent.
EF: How can we incorporate AI responsibly for innovation?
SS: Nowadays, with a smartphone, tablet, or laptop, anyone can use AI tools to assist them and operate at the same level as advanced developers.
The challenge now lies in regulation and oversight. We're moving from software as medical devices (SaaMD) to AI as medical devices (AIaaMD). That shift is happening drastically as we speak. AI is most readily adopted in areas where processes can be repeated and automated.
People can use their cell phones to detect what's on their nails and see how much blood is in their bodies. It is in identifying practical solutions that meet our region's needs. Even as a simple screening/triage tool, it has real potential to save lives.
AI has its risks. We need to create transparent sandboxes where we can observe how data is generated, how it evolves, and how systems respond to those changes. As a continent, we need a unified African medical agency to establish our own AI-based regulations and standards.
Another major concern is the risk of deskilling the population. AI can create its own sophisticated algorithms, but managing how they’re used and controlled is where the true challenge lies. Once we establish strong governance frameworks, we’ll be in a far better position to close existing gaps.
EF: How do you position yourself as a partner of choice when it comes to fostering these types of collaborations for clinical and trial-ready solutions?
SS: Our objective is to become a one-stop solution, where partners can have a tailored end-to-end solution.
Globally, approximately 90–95% of product innovations fail, with an even higher rate reported across Africa. One key issue is the tendency to focus almost exclusively on product design and development. Still, there are multiple layers to consider, including human factors, risk management, verification and validation, clinical assessment, regulations, local manufacturability, market research, intellectual property, and R&D investments. Equally important is the actual adoption of these medical technologies by public and private healthcare systems. Each of these dimensions requires dedicated controls and specialized expertise.
It's an ecosystem that needs to be built, and that's where the real challenge and opportunity lie. It's not just one value. Each phase has its own value, and it is necessary to progress through it. Numerous interventions are required from one phase to the next.
Developing a typical medium-risk medical device can take about six years and cost around 12-25 million, depending on its risk classification. The challenge in Africa is that investors are often risk-averse, making it difficult to fund early-stage medical technologies.
In the past, our work has focused mainly on assistive technologies, which are generally low-risk. The focus has now shifted to more complex, high-investment technologies. Developing these devices requires hundreds of millions of rands of investment. We need to strike a balance that allows innovation in both high and low-risk medical technologies to grow sustainably.
You can’t grow a sector with only low-risk devices. That’s the key difference we must recognize. For real economic growth, we need to invest in deep tech, as it is now moving toward AI enablement. That’s where the real opportunity lies, integrating AI into deep tech devices to make them clinically and surgically relevant and more useful in practice.
We view ourselves as individuals or teams that can solve problems that can be effectively translated into clinical practice. We're not focused on a technology push; we're focused on user-centric innovation.
Patients are the primary beneficiaries of medical technologies, but doctors, clinical setups, and hospitals are the actual users of these technologies. That is because they are the ones who authorize the medical device that can be put on the patient. That's why our focus needs to be balanced.
Innovation must fit into a system where the right people can use it, authorize it, and afford to keep it in practice.
EF: What is the conversation we need to have in the sector that we are not currently having?
SS: We need to have a transparent conversation on how decisions are made about innovation selections or innovation prioritization. We can't focus on creating new Da Vinci Surgical Robots when our basic X-ray machines are not working. That's the mindset shift we need to focus on, strengthening the foundation before building upward.
Primary and secondary care are under the most strain, and this is where improved systems could have the greatest impact. Simple things, such as effective appointment systems, proper record-keeping, and good patient monitoring, could prevent most emergencies before they even occur. That's where our attention should be: building dependable systems that keep primary health centers running efficiently and consistently.
Streamlining referral systems between primary and secondary care could have a profound impact. For citizens in rural areas, the terms primary, secondary, or tertiary mean little; they simply want access to a hospital. As a result, many patients go directly to tertiary hospitals for conditions that could be managed at the primary level. Introducing clarity and structure into this system is essential.
From an innovation perspective, South Africa is highly advanced. However, the regulation of medical devices still presents significant opportunities. The DTIC MedTech Master Plan, led by Vic Van Vuuren, is beginning to address this by focusing on the local manufacturing of higher-value devices, reflecting a forward-thinking vision for the sector.
The conversation now needs to progress toward action. We must consider how to support local development and production of medium-risk, high-value medical devices that can drive both economic and industrial growth. For Africa to truly localize medical technology production, access to high-quality testing and certification centers is crucial. Without this infrastructure, the region will remain limited to low-risk device production and miss the vast potential of medium- and high-risk markets.
Another major issue that is rarely discussed is public sector procurement. We need to focus on developing a proper framework for public sector translation. We cannot discuss it without considering access to technology through the public sector. Ignoring that means leaving out a big part of the population that relies on public systems.
This is the conversation we need to have with policymakers. As a university, we can only do a certain part of that, or certain elements of it. However, it's a broader ecosystem issue. When discussing responsible medical technology, we must also consider public sector translation as part of that responsibility.
