ABSTRACT: MEDICAL DEVICES MARKET ACCESS STUDY
The South African medical devices sector is reportedly worth R21 billion (2021), however, it contributes only 0,3% to the global market. In addition, approximately 90% of medical devices that are used in South Africa are imported. In 2022, the Localisation Support Fund commissioned a study to understand the barriers to market access for local medical devices manufacturers in South Africa. The study was undertaken by Healthvalue Consulting and was implemented in two phases. Phase 1 examined the local device manufacturing value chain in order to identify specific barriers to entry, whilst Phase 2 concentrated on developing a set of commercially enabling recommendations on how these market access barriers could be addressed.
Phase 1 involved an analysis of the South African medical devices market in order to identify a set of key factors that present challenges for local device manufacturers. These culminated in a set of challenges organized in a set of themes as follows;
· Market Access- Cooperation/Alliances/Centralization
· Funds (Private and Public)
· Compliance (Local/Global)
· Go to market- Commercial
· Innovation- Incubation
· Supply Chain
Phase 2 focused on commercial enablement by considering the challenges within the broad themes as outlined in Phase 1 to present a set of recommendations in support of the local medical device manufacturing sector. It is worth pointing out that the recommendations are systemic interventions that require the efforts of various stakeholders across government and business in order to be adequately addressed the challenges identified in Phase 1. In this regard, the LSF has identified those recommendations that are in the purview of their mandate and has begun to recommend them in furtherance of the local device manufacturing sector’s competitiveness.