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Companies’ continued reliance on manual processes and disparate labelling systems often culminates in pricey product recalls. In 2018, the return of over a million units and 9% of all medical device recall events were due to labelling issues. Organisations are known to spend as much as US $350,000 for every global label change. However, despite opportunities to de-risk the process through automated technologies, many persist with archaic methodologies that leave them vulnerable to human error. This absurdity is as unsustainable as it is avoidable.
As global regulations stiffen and the cost of noncompliance climbs, manufacturers must find a method to end the madness. Those who do will not only remove risk from their business, they will unlock the potential for additional cost savings that could transform the bottom line.
Labelling errors are a recurring reality for medical devices. The scale of the problem has barely shifted since 2012 when, just like now, around 10% of product recalls were label related. However, as label content becomes more complex with the introduction of new regulations, this figure will only increase if companies do not proactively review and strengthen their labelling infrastructure. The telltale signs of suboptimal operations are evident in the most prevalent causes of labelling recalls.
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