Benchmarking Visit to South Africa
From May 7 to May 10, 2024, the MakBRC delegation visited Pretoria, South Africa, to explore collaborations, gain insights into certification processes, and procure materials for their laparoscopic device project. Key engagements included meetings with the South African Medical Research Council (SaMRC), Council for Scientific and Industrial Research (CSIR), and Build Volume, alongside procurement efforts at Builders Warehouse, Adendorff, and Maizey Plastics. These interactions provided critical feedback, resources, and collaborative opportunities for advancing the medical device project.
At SaMRC, Ms. Grace Baloyi detailed the Global Health Innovation Accelerator (GHIA) program’s initiatives, challenges, and achievements in fostering South Africa’s medical device manufacturing sector. The team explored potential collaborations, with a focus on replicating GHIA’s model in Uganda to enhance innovation and local production capabilities. Mrs. Baloyi also highlighted regulatory challenges and ongoing efforts to streamline approvals, providing valuable insights into South Africa’s medical device landscape.
The visit to CSIR included discussions with Mr. Kahesh Dhuness, who provided practical guidance on ISO 13485 and CE certification processes and manufacturing practices. The team gained feedback on their laparoscopic device, including addressing electromagnetic interference (EMI) and cybersecurity concerns. Opportunities for collaboration in manufacturing were identified, and next steps were outlined, including pre-manufacturing testing, preparation of assembly instructions, and capacity-building training.
Procurement efforts concluded with the decision to acquire a Formlabs resin 3D printer from Build Volume to enhance production capabilities. While biocompatible adhesives were unavailable at Builders Warehouse and Adendorff, the team successfully secured high-density polyethylene from Maizey Plastics. Overall, the visit fostered productive collaborations, strengthened technical knowledge, and laid a strong foundation for advancing medical device development and certification.
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