The write stuff

Dave Taylor, VP of global products, Prisym ID, looks at the evolution of medical device labeling

The introduction of Unique Device Identification (UDI) regulations signals a major shift in the labeling of medical devices. The development of labeling solutions for the sector has been a steady evolutionary process – but not everybody has taken the journey. While some companies have recognised the benefits of introducing more scalable solutions – driven by data, not label outputs – others remain on the lower rungs of the evolutionary ladder. But the introduction of a common UDI mandate is a once-in-a-generation game-changer that gives device organizations no choice but to change.

So is your current labeling infrastructure aligned with the new UDI regulations? Moreover, is it aligned with your business objectives? Fully integrated label lifecycle management solutions not only provide a mechanism to ensure regulatory compliance, they also provide an engine for growth.

The process of evolution

Device labeling systems have been through three distinct stages of evolution. The ‘origin of species’ was largely a localised solution managed at a site level. Silo systems focused on the provision of outputs – labels – and were generally run from basic software held on individuals’ PCs. They offered little standardization and no centralized control.

Roughly ten years ago, systems evolved to provide greater regional or divisional control; operational clusters began to centralise and standardise the label design, review and approval processes. Though methodology still focused largely on the label, there was an increased emphasis on data.

The latest development is the emergence of integrated label lifecycle management (LLM) solutions that provide accessibility right across global organisations. These systems recognize that effective content management can enable standardisation and ensure that processes are controlled centrally, distributed locally and cater for local language and country-specific requirements.

All-round view

LLM is data-led, with labels considered merely the final output. The best solutions give companies a 360° view of all their data assets, enabling an integrated organisation-wide approach to production processes. They provide a centralised platform that can be leveraged across all sites, regions and divisions – and are interoperable with existing enterprise systems. These scalable web-based tools deliver complete label integrity – from data management to design and approval, through to label production and inspection – to meet strict regulatory requirements.

Labeling defects remain responsible for a high percentage of voluntary device recalls. The implications are significant; efficiency, productivity and ROI take a hit, whilst the potential damage to brand reputation is equally severe. Moreover, the financial penalties for non-compliance are unforgiving. With regulatory scrutiny intensified by the introduction of the UDI directive, the catalyst for change is compelling.

Assuring UDI compliance presents great challenges. Companies’ typical approach to the design, creation, approval, printing and inspection of labels is variable and fragmented; processes are often resource-intensive, inefficient and prone to human error. With data commonly maintained off-line and rarely integrated with other business systems, companies are increasingly vulnerable to mislabeling and voluntary recall. A broader view is required. Labeling solutions cannot sit in isolation, they must be built into a 360° view of all variable data components.

Finding solutions

But meeting the challenges of UDI does not need to be daunting. LLM solutions can facilitate a more strategic approach to the management of global data, and help companies capture, store and disseminate data quickly, safely and accurately. The benefits are significant. LLM platforms can reduce unnecessary manual checks, improve quality control by optimising automated validation systems, and accelerate products to market. Centralised data creates a platform for a ‘single version of the truth’ that can be used to generate labels ‘just in time’ – ensuring that the right information goes on the right product at the right time, every time. And holistic systems also allow for post-print verification to ensure no errors have crept into the process; vision verification solutions carry out automated audits, assuring approved imagery and data has been printed correctly on every label, as well as delivering lifecycle traceability. Moreover, LLM provides data visibility for stakeholders right across multi-national, multi-site organizations.

Inefficiency has long troubled medical device manufacturers, but the perceived trauma of change has dissuaded organisations from overhauling their systems. UDI removes the option of choice. Without standardised mechanisms, the cost of implementing UDI controls will undoubtedly be prohibitive.

The mantra is therefore simple - evolve or die. In a changing marketplace, companies must climb the evolutionary ladder and adopt integrated systems that empower multi-national workforces with data accessibility and visibility – and provide enterprise-wide operational efficiency and agility. It’s the theory of evolution, the survival of the fittest. To thrive, a Label Lifecycle Management solution may just be the natural selection.