Read the Conversation
Conversation highlights:
- The big opportunity Lindsay identified was reducing reliance on imported medical devices through R&D and collaboration with local institutions.
- The founding of VIVA Medical to locally produce infusion administration sets and needle-free infusion devices in South Africa, the continent's first such device.
- South Africa's robust ecosystem of medical innovation and talent, with growing support from universities, multinational companies, and international foundations, highlights the importance of increasing awareness and market penetration of local innovations in Africa.
- The need for sustainable procurement practices that favor local manufacturers, stimulate local manufacturing, and reduce unemployment in South Africa's healthcare sector.
- Advice to young healthcare entrepreneurs would be to identify clinical problems by engaging with healthcare professionals, joining local industry associations for collaboration and knowledge sharing, and focusing on solving real healthcare challenges rather than pushing products into the market.
EF: Could you elaborate on the story behind VIVA and what opportunity you see in the market?
LC: VIVA Medical was founded on solving a critical gap in the South African healthcare sector. After spending 33 years with a multinational corporation importing infusion administration sets into South Africa, I realized there was a significant opportunity to manufacture these devices locally.
The process was far from straightforward and required extensive research and development. We collaborated closely with the University of Stellenbosch and several local manufacturers who provided the technical expertise necessary to bring our products to life. Today, we work with a network of companies across the Western Cape that supply raw materials and EtO sterilising, while certain specialized components are imported. All assembly takes place at our ISO Certified Class 7 Medical Cleanroom facility in Somerset West, near Stellenbosch, where we produce 28 types of infusion administration sets, accessories, and extension sets for hospitals to deliver fluids, medications, and blood.
During our journey, we identified a further need to produce key components locally. As most components for IV sets originate from the United States, Europe, or China, we took on the challenge of developing Africa’s first needle-free infusion device. To support this initiative, we received a one-million-rand grant from the Department of Trade and Industry and the Medical Research Council of South Africa as part of the MEDDIC program.
The VIVASite™ project had started. We assembled a multidisciplinary team, including a Professor of Biomedical Engineering at the University of Stellenbosch, two mechanical engineers, a senior anaesthetist, a microbiologist overseeing quality and regulatory compliance, and me as project lead. Over two and a half years, we successfully created a prototype, which will soon enter non-clinical trials. Following that, the South African Bureau of Standards will evaluate it according to their specifications for needle-free devices, aligned with European and American standards. Once approved, we will launch Africa’s first locally developed needle-free device, named VIVASite™.
VIVA Medical’s success is built on collaboration and co-operation. VIVA Medical is a founding member of The Western Cape Medical Devices Cluster, which represents a network of 42 MedTech companies involved in the development of medical devices, vaccines in the pharmaceutical market, digital health, including wearable technologies, and the biotech and nutraceuticals market.
South Africa has a strong history of medical technology development, including the foundational work by Allan Cormack on CT scanning and innovations in surgical techniques like Dr. Selig Percy Amoils' cryoprobe for cataract surgery. These developments range from the early 20th century to more recent contributions to diagnostic equipment and devices like the Smartlock safety syringe and the LODOX X-ray system, which was developed as a spin-off from the diamond mining industry and is now featured in television programmes such as Grey’s Anatomy. Key milestones include the first successful heart transplant by Dr. Christiaan Barnard and inventions like Pratley's Putty, which was used on the Apollo 11 mission.
Cape Town continues to foster this innovative spirit through a dynamic ecosystem that connects academia, industry, and government. We work closely with the Technology Innovation Hub and postgraduate engineers at Stellenbosch University, continuously driving forward new ideas that strengthen the region’s position as a leader in medical innovation.
EF: Could you elaborate on your current priorities?
LC: VIVA Medical has been in business for 10 years, and during that time, with support from the Department of Trade, Industry, and Competition, we secured funding to achieve ISO 13485 certification. We have also been licensed as a manufacturer by SAHPRA, and at the same time, we have prepared all the documentation required for a CE mark, which has become a necessity.
We have completed all the CE documentation through our US and UK representatives, but at this stage, we lack the funding to proceed with the formal application. The plan now is to seek investors for the VIVASite™ needle-free valve and look for an investor to help finance the CE mark certification.
EF: What is your pitch to attract investment?
LC: Africa is really an untapped market. With more than 300 million people, healthcare across the continent is growing, and life expectancy is improving. South Africa is the economic driver of innovation and product development in the medical device space. So, it is only natural that there should be organic growth from South Africa into the rest of Africa.
Our plan is to launch the product here first and then expand northward into other African markets. We know there are strong opportunities, and the key is getting the message out.
The benefits are numerous for both patients and healthcare workers. Needle stick injury remains one of the biggest causes of contamination and cross-infection, particularly with the HIV and TB pandemics in Africa. Needle-free valves help reduce those injuries and, in turn, reduce follow-up costs, testing, prophylaxis, and the time healthcare workers are absent.
The benefits are all massive, both for patient safety and healthcare worker safety, besides the enormous savings to treat needlestick injuries, which are estimated at $50 Million per annum in South Africa alone. The challenge is to scale the business and gain acceptance for the device throughout Africa before targeting Europe.
EF: Do you have any special initiatives to educate the professionals, or collaborate with some institution to make them understand the difference?
LC: VIVA Medical hosts a series of Workshops to promote the safe and effective use of IV Therapy, our most recent being at the Red Cross Children’s Hospital here in Cape Town. The primary focus was to educate nurses on good clinical practice, and we emphasized the correct use of needle-free valves.
Reaching early adopters in other countries requires significant effort and resources. It is costly to travel across the continent and persuade healthcare professionals to switch from old technology to new. We see media as one way to help amplify this message.
Africa Health has always been a great opportunity for us to connect with clinical professionals from across the continent. We have leveraged the last few Africa Health events in South Africa very effectively. People leave with valuable knowledge for their countries, and we have built strong contacts through this.
EF: What advice would you give to young professionals who want to enter healthcare and build sustainable businesses, especially in manufacturing, while developing talent and independence?
LC: The first thing for anyone considering entering this space is to find a contact working in a hospital or clinical environment and learn from them what challenges they encounter daily. Being able to solve a real problem creates a business opportunity for a product. The market does not welcome products that are forced upon clinicians. That is the first stage: identify a real problem, which means you need exposure to the clinical environment.
Secondly, and perhaps even more importantly, join a local industry association. Join MDMSA, SAMED, or the Western Cape Medical Devices Cluster. Often. Attending meetings allows you to interact with specialists in polymer science, engineering, CAD design, and all aspects of medical device manufacturing, giving you access to knowledge. In the Western Cape, we take a cooperative approach. We work to support each other. This collaboration has helped new businesses start, create subcontracting, and grow together. It really comes down to being committed to sharing in the quest to help each other.
EF: You are about to celebrate 10 years of VIVA Medical. Can you share your journey and the moment you are most proud of in contributing to South African healthcare?
LC: Breaking into the market during our first five years was extremely challenging. Without ISO 13485 and the SAHPRA license, we could not bid for any contracts. My proudest moment came when we achieved ISO certification. It took three years of preparation and determination, and raising nearly half a million rand as a start-up was particularly challenging. The support we received from WESGRO and the Department of Trade and Industry through grant funding made all the difference.
Once certified, our facility was inspected by the Western Cape Department of Health and Wellness, which led to an award for a five-year contract covering 52 hospitals. We subsequently succeeded in securing a national tender that extended our reach to all nine provinces.
Local manufacturing strengthens the economy by retaining profits within the country while also creating jobs within South Africa. Many products previously sourced abroad can be produced domestically with the right support and a compelling business case.
Funding remains a challenge, but the opportunities are immense. Encouragingly, foreign companies are willing to produce their products in South Africa, and we are seeing international companies establishing operations in South Africa to produce mostly Class A products locally. There is no reason items such as syringes, gloves, gowns, sutures, tongue depressors, and feeding tubes should be imported when we can manufacture them locally.
EF: What are the three main pillars of the healthcare sector in South Africa?
LC: The first pillar is sustainable procurement. The current government procurement system relies on a preference point structure that is not sustainable. For example, tenders are often awarded on a 90:10 split, with 90 points allocated to price and only 10 points allocated for local manufacturing. This approach gives an advantage to imported products, particularly from countries such as China and India, where manufacturing costs are significantly lower.
As a result, local manufacturers are placed on an equal footing with companies that do not invest locally. This is being addressed by the MedTech Master Plan, which will identify opportunities for local manufacturers and should transform the industry to be more inclusive.
Sustainable procurement requires adjusting this system to allocate more value to local production. Businesses like ours are investing in South Africa’s industrial base, and this commitment and investment should be recognised. Victor Van Vuuren is doing remarkable work in engaging with the National Treasury to advocate for changes to the Preferential Procurement Policy Framework Act so that it better supports industrialisation in the medical device sector.
The second pillar involves greater financial support and opportunity for local manufacturers. Many companies with innovative products struggle to enter the market due to limited funding for essential requirements. The Department of Trade and Industry can play a transformative role by redirecting funds from less critical activities toward supporting the evaluation and commercialisation of locally developed products. Partnering with universities and clinicians to validate innovations and then providing seed funding for regulatory approval would help unlock significant local potential that currently goes unrealised.
The third pillar is the introduction of tax incentives for local manufacturers. South Africa’s tax rates are among the highest globally, and this discourages growth and job creation. With unemployment levels at 30%, particularly in provinces like KwaZulu-Natal, the Eastern Cape, and the Free State, there is a crucial need to stimulate regional industrial development. By offering tax incentives for companies to establish factories and create jobs in these underserved areas, the government can foster inclusive economic growth and reduce internal migration, while also upskilling the labour force to possibly enter the local manufacturing sector.
Ultimately, government spending must be more effective. Instead of channelling resources into areas with limited long-term impact, investment should focus on supporting local industry, developing manufacturing capacity, and expanding employment. This is how we build a resilient, self-sustaining healthcare industry that empowers communities and drives economic progress. The motor industry is a great example of industrialised manufacturing in South Africa and exports to the world.
EF: What would be your final message?
LC: Many South African products are designed to meet international standards. All that is needed is for hospitals to take the time to evaluate them.
For more information about us, please visit our website or take a tour of our factory and meet our team. You can join the millions of patients, hospital managers, and procurement officers who have successfully used our products. We take pride in our work.
