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Assisting new entrants to the medical device market

Publication Date: 
Friday, December 17, 2021

Medical Device and Diagnostic Innovation Cluster (MeDDIC) programme

The CSIR is assisting new entrants to the medical device market with product lifecycle management support.

The medical device innovation process follows a path from concept creation through to design and development, including the necessary technical and clinical testing phases, design transfer for manufacturing, manufacturing, and post-market surveillance activities. This requires product lifecycle management support to assist new entrants into the market.

Medical Device and Diagnostic Innovation Cluster (MeDDIC) programme

The CSIR is assisting new entrants to the medical device market with product lifecycle management support.

The medical device innovation process follows a path from concept creation through to design and development, including the necessary technical and clinical testing phases, design transfer for manufacturing, manufacturing, and post-market surveillance activities. This requires product lifecycle management support to assist new entrants into the market.

The CSIR and the South African Medical Research Council joined forces with the Technology Innovation Agency (TIA) and established a service intervention initiative as part of TIA’s Technology Cluster Innovation Programme. This enables the CSIR to serve the South African medical sector – through the Medical Device and Diagnostic Innovation Cluster (MeDDIC) programme – to help grow the local medical device sector.

The national initiative helps drive technology localisation and alleviate common industry challenges, thereby lowering the barriers to innovation in the medical sector. This is enabled through the provision of specialised regulatory and technical support, as well as business-enabling services, including access to a network of product development service providers and linkages into government’s small business assistance programmes.

The CSIR team performing this role is strategically positioned to assist in this field as a result of its long-standing experience in medical device development and its certification to both the International Organization for Standardization (ISO) 9001 and ISO 13485 (medical device) quality management standards.
 

MeDDIC programme services

  • Medical device technology development under ISO 13845
  • ISO 13845 (medical device ISO standard) quality management system support
  • Medical device contract manufacturing under ISO 13845
  • Configuration management of developed device products and development of a manufacturing data pack
  • Medical classification/standards identification support
  • Medical product regulation (product master file development)
  • South African Health Products Regulatory Authority-approved process support
  • Access to a network of contacts for clinical testing
     

Under the MeDDIC programme, the CSIR has, to date, engaged with 18 small, medium and micro enterprises to provide relevant support.