Software quality and device recalls

Published: October 8, 2018

The definition of medical device has expanded quite a bit in the past decade. Not only do wheelchairs, imaging equipment and pacemakers qualify as medical devices, but so do health monitoring apps and digital health trackers. Thanks to the advancements of the digital age, 'hospital at home' is the trend. The industry is moving towards a connected care environment where devices that capture data, applications that derive insights from that data, and apps that deliver personalized suggestions have become the critical driving factors. Nevertheless, the industry is also fueled by globalization, competition, and demand for more advanced treatments. Sensors are at the heart of every device, from small bandages to implants.

The flip side

The recent Stericycle Recall Index report shows that the United States, the largest medical device consumer and manufacturer in the world, has faced 343 device recalls in the first quarter of 2018 alone, involving 208 million units. Unsurprisingly, software issues such as bugs, false results, and network connection issues were the major reason behind the recalls. Issues like disparity in patient data, displaying incorrect test results, and loss of reports could lead to consequences ranging from wrong clinical decisions to even death.

A recall not only puts the brand value at risk, but also pinches the pocket of the manufacturers due to lawsuits, reimbursements, wastages, etc. According to a McKinsey report, the industry spent a whopping US $36 billion on quality control in 2017, one-third of which went toward ensuring good quality and the remainder being the direct cost of poor quality.

Please read full article here: Health IT Outcomes

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