On September 22, Kevin Grygiel, VP Strategic Accounts & Partner Ecosystem, PRISYM ID, moderated a panel discussion at the 11th Annual Medical Device and Diagnostic Labeling Conference, alongside Dawn Fowler, Director of UDI/Master Data Management at Masimo, Anoop Padival, Senior Manager for Strategic Global Labeling and Regulatory Affairs at AbbVie and Debra Horn, Labeling Specialist II, Global Labeling at Smiths Medical. Here is Kevin’s review of the discussion.
Medical device manufacturers face the challenge of efficiently managing increasingly high volumes of data relevant to product labeling in a vast array of different forms. On any given medical device label there are warning indicators, various symbols, expiration dates, production information and much more. Having all this information at our fingertips is both a blessing and a curse – healthcare professionals and patients are more informed than ever before and consequently have greater confidence in products, but the process of managing label content and the underlying datasets is a complex task for any regulated organization.
Manufacturers are therefore increasingly looking to their labeling system as a potential central repository for regulated information, giving them greater flexibility and allowing them to get products to market much faster. Considering the growing volumes of label data that needs to be managed; the rapidly shifting regulatory requirements and divergence between different countries means that it is almost impossible to rely on manual systems and procedures. This is especially true when you consider the natural overlap with other forms of product information like Instructions for Use (IFUs) or patient implant cards.
Never is this more evident than when it comes to handling a mass change event, like updating the address for an authorized representative across dozens of SKUs. If you’re manually scoping the required changes rather than using a purpose-built labeling system with mass change functionality you’re embarking on an inherently risky journey and it’s going to take considerably longer. A Global Labeling System (GLS) can spot potential changes near instantaneously with 100% confidence, whereas a time-intensive manual scoping exercise always concludes with someone muttering “Hopefully we found everything”.
Data management can be further complicated if you have distinct teams managing different aspects of product information, for example having a separate team manage IFUs from product labels, each of them using siloed systems.
In addition to running a gauntlet attempting to keep datasets synchronized, potentially you’re going to have costly duplication of efforts. A prime example of this would be translation management – shifting to a GLS would allow for standardization of common phraseology and streamlining of the whole process using phrase tables which eliminate the need to repeatedly commission translations.
Ever-increasing levels of product data can of course also present challenges in a physical sense – the size of your product dictates the maximum size of a label that can be affixed, and various internal stakeholders are all competing for ‘their content or data’ to make the cut. Consider the introduction of the new UKCA conformity marking for the UK following Brexit, another symbol and address that needs to be accommodated to ensure compliance – if you’re tight on space, what information is going to make way for it?
All of these decisions on what to include and not include on each type of label need to be recorded and justified so that when faced with an audit you can easily explain the rationale. You never want to give an auditor the perception that a decision was made without full consideration. Having a set of policies that dictate your approach to different scenarios makes your decision-making easier to defend while also streamlining those processes. Each policy should be based on regulatory interpretations agreed upon between all relevant teams so if an auditor comes knocking you can present a consistent narrative. Of course, your policy documentation should be constructed so that they can easily understand the thought processes that are followed to make decisions.
There is certainly nothing to suggest that the introduction of new sources of data is going to slow. In addition to more granular requirements in many countries, there is demand for greater transparency throughout the whole supply chain which is leading to an avalanche of data to incorporate. Medical device companies need to continuously tailor and upgrade their data management processes, ensuring they have the flexibility within their systems to guarantee compliance as the global web of labeling regulations gets ever more complex and sources of data ever more numerous.
About the author
Kevin Grygiel, Vice President of Strategic Accounts & Partner Ecosystem, PRISYM ID
Kevin Grygiel is Vice President of Strategic Accounts & Partner Ecosystem at PRISYM ID. He has over 15 years' experience in software development and implementation, helping to deliver complex and personalized business solutions to Life Sciences customers.
Kevin has a proven ability to focus, align and build effective teams with an uncompromising regard for customer impact. He also has the ability to conceptualize, develop and deliver innovative solutions and services that address and resolving enterprise-wide business needs resulting in a high degree of customer loyalty and retention.