Read the Conversation
EF: What are your priorities for 2024?
TV: One of our major priorities for this year has been to elevate the status of the MedTech sector. We are focused on educating and raising awareness about the unique characteristics and nuances of the medtech and in vitro diagnostics (IVD) sector, emphasizing that it is distinct from pharmaceuticals. The creation of a dedicated MEDTECH Master Plan and its launch in May 2024 is a giant and meaningful milestone that reflects the progress and success of our efforts. SAMED has worked tirelessly for years to establish and empower the sector’s own identity and make its unique features and contributions across the healthcare value chain clear to regulators and public and private sector funders. Often, regulations and practices designed for pharmaceuticals have been inappropriately applied to medtech, which makes them unfit for purpose.
Partnering with key government, industry, regulatory, funding and trade stakeholders in South Africa and across the continent further elevates our profile. Among the engaged international entities are USAID, AdvaMed, MedTech Europe, and U.S. Trade and Development Agency (USTDA). We have joined these influential organisations in contributing to workshops held in Kenya and South Africa to advance good medtech regulatory practices and regulatory convergence and reliance. These forums underscore the message that Africa is the next frontier, which is reflected in the increased presence of international manufacturers on the continent. We are also seeing a movement towards sharing expertise, capacity, and support across Africa to ease trade.
EF: Could you elaborate on the new MEDTECH Master Plan and what is the expected impact on the industry?
TV: The MEDTECH Master Plan seeks to provide guidance for the public and private sectors to dedicate resources and time to strengthening the sector and its growth trajectory. The plan unites health system stakeholders to give medical technology greater prominence in the economy and to benefit South African and African patients. The Master Plan’s 2035 vision is for a digitalised, integrated and cohesive ecosystem that enables, supports and encourages the development, growth, and competitiveness of the continental medtech value chains to produce reliable, safe, quality, and affordable MEDTECH for domestic and export markets. The Plan will serve as a valuable blueprint for other African countries and support the priorities of the Africa Free Continental Trade Agreement (AfCFTA).
EF: Why is data about the sector becoming so important to you?
TV: Another key area of focus this year has been developing our "Data with Integrity" platform. During and after COVID-19, we recognized how imperative it is to have accurate data in order to make critical decisions and influence policymakers. South Africa's heavy reliance on imports highlighted our lack of information on local manufacturing capacities and export potentials. This realization has driven our push towards becoming more self-sufficient, which also makes economic sense as it will help grow skills and provide jobs.
We have been working hard to gather more data about our sector, and are gradually convincing members of the benefits of sharing information. Without data, we cannot measure progress or exert influence. Ensuring we have credible data has been a top priority.
EF: What synergies can be put into play to ensure talents are paired with work opportunities?
TV: South Africa has one of the highest unemployment rates in the world. A significant priority is addressing youth unemployment. Despite having a large number of educated young people, many remain without formal employment. We have partnered with YES, the Youth Employment Service, encouraging our member companies to provide 12-month paid learning experiences for previously unemployed youth. Currently, 42 member companies are participating. While not all participants secure permanent positions, they gain critical workplace skills that enhance their employability. This initiative also supports companies to meet South Africa's Black Economic Empowerment (BEE) requirements, improving their B-BBEE scores through participation.
Since the inception of the program, we have provided over 3000 youth, 64% of whom are women, with invaluable learning experience and injected over 160 million RAND into the local economy. We urge our members to place participants in learnerships focused on critical skills, such as regulatory compliance and quality assurance—areas that are not only essential but also rapidly developing. These skills are crucial for nurturing a robust local manufacturing industry.
In addition, we have developed the first-of-its-kind YES X SAMED alumni portal to help former YES learners stay connected, access job opportunities, and continue their professional development. This amplifies the long-term impact of our programs. Those youth who are not absorbed after the 12-month learning experience can upload their CVs to our alumni portal. This portal serves as a free recruitment resource for our member companies, allowing them to access a pool of trained candidates at no cost.
While we provide youth with employment opportunities, we also ensure they gain expertise in fields that bolster the industry's growth and sustainability. Additionally, from a diversity, inclusivity, and equity perspective, we launched another first for Africa, if not the global Women Empowerment Index. Currently, we are piloting it with several members. We measure specific metrics such as women's employment, ownership, development, YES learnerships, YES youth participation, and remuneration parity. Member companies can compare their Women Empowerment Index to the aggregate and download a certificate. This certificate can be valuable in procurement discussions with both the private and public sectors.
As our regulatory landscape evolves and becomes more complex, particularly with the impending product registration for medical devices and IVDs in South Africa, companies are anxious to understand related processes, the required effort, and the associated costs. Consequently, we are seeing a rise in smaller companies joining SAMED. SAMED invests in strategies and programmes that ensure the association is equally relevant to large multinational companies and smaller businesses, which are often the backbone of the economy and where true growth occurs. To address their needs, we have a dynamic programme of regular member forums on topics that matter to them and impact their businesses.
EF: Could you elaborate on the role of collaboration and fostering partnerships, especially in the Healthcare sector, and what is its impact?
TV: We conscientiously strive to collaborate and partner with our regulatory authority, SAHPRA, so that we can share our views and engage in conversations to find common ground. I believe our regulator is open and keen to partner with us, showing a desire to hear from the industry and workshop solutions with us. SAHPRA has recently reviewed the engagement structure with the industry with the aim of making it more inclusive than before.
We also need to keep tabs on developments in other African countries, as the African market opens up. The recent pandemic has sensitised countries to the importance of good governance and robust, fit-for-purpose medtech regulations to safeguard the health and well-being of their people. We are noticing an increasing number of African health ministries developing medical device regulatory frameworks. Navigating these changes requires vigilance. We co-chair the Global Medical Technology Alliance Regulatory Working Group with Mecomed and are continuously monitoring these developments and making strategic and MedTech-centred submissions and inputs to draft policy and legislation.
EF: What are the key challenges facing the MedTech sector in South Africa regarding sustainability and procurement?
TV: South African procurement legislation has been updated recently. SAMED engaged extensively with policymakers and parliamentarians to ensure that revised procurement policies take account of the specific factors that determine the quality and efficacy of the MedTech procurement process - and this is significant because our products are so distinct from other commodities the government might procure.
Being actively involved and taking a leading role is crucial, especially as we focus on the sustainability of the sector. This has been challenging for our members due to our reliance on imports and the impact of exchange rate fluctuations. Companies have faced significant pressure regarding price increases, with considerable pushback from medical funders. The costs of logistics, doing business, and issues like load shedding in South Africa have compounded these challenges. Climate change has also caused disruptions, such as those seen in KwaZulu-Natal, making environmental sustainability a pressing and increasing reality that companies must navigate.
Additionally, slow payment by the provincial departments of health has been a major issue, further affecting the broader sustainability of our sector. We have been gathering statistics from our members and sharing them with the Ministry of Health, the provincial departments of Health, and the Department of Trade, Industry, and Competition with a view to highlighting and resolving this long-standing issue. We are trying to ensure that all our members get paid on time so that their businesses and health services can continue.
EF: As a final message, how do you see South Africa becoming a Medtech hub?
TV: Despite the recent dip in our currency, locally manufactured products are a positive development because they can be exported at competitive prices compared to imported goods. Localization has come into sharp focus with the launch of the MEDTECH Master Plan. The process of its development for the past few years has enabled the gathering of key information and interviews with key stakeholders and these assets will help ensure that every part of the value chain gets included and addressed.
The plan involves not just MedTech companies but also government procurement, private hospitals, innovators, NGOs, and regulators. Implementing the plan effectively will require a dedicated secretariat and likely funding. As an association representative of importers, distributors, and local manufacturers, we fully support this plan, recognizing its importance for our country. However, we are pragmatic and understand that neither South Africa nor any other country itself can manufacture all its required medical technology. Successful local manufacturing must look beyond our borders, making cross-country and cross-border treaties, trade agreements, and collaborations essential.
We need to ensure access to appropriate quality and effective medtech for patients across Africa and avoid exacerbating barriers that hamper this access and movement. There is often criticism from local manufacturers that for others, getting products into South Africa is easy due to the absence of import tariffs, but for them, exporting to countries like Brazil, China, Russia, or Europe can be prohibitively expensive. Therefore, bilateral and multilateral government interactions between South Africa and other countries on the continent are vital to realising the promise of the MEDTECH Master Plan.
