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Manufacturing is a very broadly defined activity, encompassing everything from purchasing to a Quality Management System (ISO 13485). To consider manufacturing as a whole it is helpful to look beyond specific sets of materials and processes that lead to single products. Being able to view manufacturing as a system provides a useful way of identifying which factors, whether internal or external, are important, and which processes need to be kept in-house and which need to be outsourced. 



When considering manufacturing of medical devices in South Africa it helps to have some context of manufacturing.

In 2009 the South African medical device industry was estimated to be worth $700 million. Large multinationals dominate the import market as well as manufacturing of disposable products. Local manufacturers make up less than 5% of an industry that has a forecasted CAGR of 7.5% to 2013. These manufacturers exhibit a high degree of diversity, competitiveness and ultimately instability with the majority being limited to one or two products. The local  market therefore lacks both depth and breadth in the face of international trends which show that companies with single product portfolio's are  unlikely to survive 5 years of operations.

Based on the current state of medical device manufacturers, md2m evaluates each new device and assists entrepreneurs/organizations in determining the most appropriate manufacturing and market access strategy.