A recent survey by PRISYM ID of medical companies in Europe and North America has identified some of the key issues for packaging and labeling operations in the complex and changing medical device market, with label defect control as one of the top issues currently facing almost 40% of medical device and pharmaceutical companies.
In addition, for 40% of medical device respondents, UDI compliance posed a significant challenge. With the new UDI regulations for Class III devices requiring compliance from Sept. 24, 2014 and the Class II requirements to follow in 2015 and 2016, this challenge is expected to escalate. For 58% of respondents, language management within the labeling process presented its own challenges. The report concluded that a substantial percentage of medical device manufacturers are facing consequential issues of time and money loss, unnecessary waste, reputation risk, and potential patient safety concerns.
The results of these findings are not particularly surprising, according to PRISYM ID, but what is a concern is that 40% of those surveyed still do not have a solution in place to control these issues. The company notes that a streamlined end-to-end label lifecycle management solution that enables companies to effectively manage data and ensure a single version of the truth is vital to help reduce unnecessary product recall, increase profit and improve supply chain efficiency.