Medical Device manufacturers are operating in a constantly evolving regulatory landscape, requiring regular updates to labels, IFUs and other items of regulated content across all SKUs. We recently conducted a survey of Medical Device companies that revealed less than 8% of respondents have label management systems with the ability to initiate wholesale change across all SKUs, with 40% of surveyed companies stating that they update labels one at a time.
A single error when updating labels or other regulated content can result in costly recalls, necessitating relabeling and repackaging, in addition to the cost of reputational damage to the organization involved. In December 2020, more than 5% of Medical Device recalls were initiated due to errors in labeling according to the FDA Medical Device Recalls Database.
Overall, 15% of survey respondents expressed a lack of confidence in their ability to deliver error-free changes across their product lines, including a third of those who change labels one at a time. All respondents with a label management solution capable of mass change were confident they could execute an update to all SKUs without error.
Almost 29% of Medical Device companies who responded to the survey said that they lacked a centralized process to initiate change across all SKUs, with almost two-thirds relying wholly or partly on manual processes. All companies solely using automated software tools were confident that they could update all SKUs within a week of initiating the change process, compared to less than 45% of other companies with some indicating it could take up to a year for all changes to be achieved.
Companies lacking centralized process to initiate mass changes to labels were also more likely to doubt their ability to update all SKUs in a cost efficient or safe and accurate manner. More than 70% of respondents without a centralized process expressed a lack of confidence in cost efficiency and more than a third raised doubts about safety and accuracy.
At the latest PRISYM ID webinar on 14 December, Warren Stacey, SVP of Global Sales at PRISYM ID and Chris Heckert, Senior Director Labeling Solutions at Network Partners discussed how global labeling systems can facilitate mass change in labels and other regulated content. During the hour-long session they explored the value these systems offer to companies through reduced regulatory risk while simultaneously reducing overhead costs and improving speed to market. You can watch a recording of Push the Button on ‘Mass Change’ Content & Labeling here.