Medical Device manufacturers are operating in a constantly evolving regulatory landscape, requiring ever-growing investment to ensure they remain compliant. In addition to implementing changes across all SKUs to reflect updated regulations, one of the greatest challenges is delivering country-specific labeling, catering to the often-competing demands of different regulatory regimes.
During a webinar on 14 December, I was joined by Chris Heckert, Senior Director Labeling Solutions, Network Partners for a discussion about how global labeling systems can facilitate mass change in labels and other regulated content. Together we explored the value these systems offer to companies through reduced regulatory risk while simultaneously reducing overhead costs and improving speed to market.
The webinar followed a recent survey by PRISYM ID which revealed that almost two-thirds of Medical Device companies rely wholly or partly on manual processes to initiate wholesale changes across all labels, IFUs and other items of regulated content. When asked about their confidence in existing processes, over 15% expressed a lack of confidence that they could deliver error-free changes across their product lines. Less than 8% had a system capable of delivering mass change and more than 40% said a mass change event would take at least a month to implement.
"I contend that you shouldn’t ever need more than six people in your entire labeling department for a global organization. If the system is doing all of the work, then what you’re doing is managing the system. Your headcount can come down. Your changes can be made very quickly and you’re able to get into markets much sooner thanks to your global labeling system.”
Chris Heckert, Senior Director Labeling Solutions, Network Partners
One of the key benefits we discussed was how a global labeling system with mass change capabilities can unlock label postponement thanks to the ease of implementing country-specific labels for SKUs. Labels can be printed on-demand in a distribution center once the eventual destination has been determined, reducing waste and requiring less stock to be kept on hand while maintaining confidence that labels are fully compliant. This also significantly improves the speed to market when releasing an existing product to a new territory.
We both acknowledged that migration to a global labeling system is a lengthy process, however, we also both in agreement that the reduced regulatory risk and calculated ROI combined with future-proofing will far exceed the cost of change. For example, I highlighted the need for honesty in organizations about the of time and cost involved to manually revise a single label - a process that might take two minutes on paper can take days or weeks if you are waiting for someone to be available to act.
You can watch a recording of Push the Button on ‘Mass Change’ Content & Labeling here.
About the author
Warren Stacey, SVP Global Sales, PRISYM ID
Warren Stacey is the SVP Global Sales at PRISYM ID, responsible for leading and driving results from the global sales team. He has a detailed knowledge of the regulated content and label management industry and is committed to empowering global pharmaceutical, clinical trial and medical device companies to overcome operational challenges and achieve excellence at speed.
Warren is passionate in identifying and securing new business opportunities, whilst building business within our existing global client base to create year on year revenue growth. His belief in delivering market leading products to gain customer satisfaction is infectious and result’s in PRISYM ID having an enviable blue-chip customer base which is rapidly growing.