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The Growing Importance of Quality in the Medical Device Industry

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  When it comes to medical devices, what's the cost of quality? It could be as much as $36 billion, according to research by McKinsey & Company which suggests the total direct cost of quality is between 6.8% and 9.4% of industry sales. [1]   That’s equivalent to between $26 billion and $36 billion each year. One-third of that amount is ensuring good quality, the remaining two-thirds is the direct cost of poor quality. Global sales of medical devices reached $380 billion last year, rising from $260 billion in 2006 [1]   – but during that time, the quality of these devices failed to keep pace.   The industry has realized it needs to do more to capture the value of good quality in medical devices. The growth in demand for medical devices The medical device industry is worth $140 billion in the US, making it the largest medical device consumer in the world. [2]   The industry encompasses more than 5,800 companies in the US alone (80% of which employ fewer than 5...