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Digital maturity is paramount in highly regulated industries, and we’re going to explain why


Of course, your first question might be: what is digital maturity? When we talk about digital maturity, we’re talking about how your business operates. So what does it mean for your business to be digitally mature? A digitally mature business is one which moves its operations from manual processes to digital, automated processes. We’re going to talk about it in the context of what we know best: the labeling and artwork management (LAM) process. After all, when it comes to LAM, digitization is crucial - particularly for medical device manufacturers.


Until recently, labeling had seldom been seen as its own discipline. However, with the recent implementation of EU MDR and upcoming IVDR deadlines, medical device organizations are now realizing that digitalization of the labeling process must occur in order to remain compliant. Manual processes have become too time consuming and prone to human error, and up to a third of medical device organizations have unfortunately learned the hard way that regulatory deadlines are simply no longer achievable using traditional methods. 


6 steps your business can take to become more digitally mature (and why you should take them)


Whatever the size of your business, becoming more digitally mature comes with countless benefits. We’ve broken down the process of digitizing your LAM to just 6 key steps:


1. Consolidate


Label data is often held in varying systems across the business, but it is crucial that data such as phrases, translations, and symbols are all easily accessible for seamless label transitions in the event of regulatory changes. Subsequently, each of these components need to be consolidated into one centralized, digital source of truth. Albeit time consuming, this is an essential step towards digital maturity - little technological deployment or integration can occur without it.


2. Structure


Once all of your label data has been consolidated, your business can switch to a centralized digital system with structured and controlled datasets. Having this ‘single source of truth’ allows for the scaling up of further features and integrations, boosting the efficiency of your business. Approval workflows can then be implemented for updates to datasets and traceability on a global scale can be considered to ensure the consistency of label content. This structured approach can also help to drive the reuse of label data.


3. Exploit


With all assets in a central repository, your business will then be able to exploit this data to achieve complete regulatory compliance. This is of critical importance in the medical device industry with the MDR and IVDR changes occurring over this decade. For multinational organizations, this can be duplicated on a global scale by pre-approving compliant assets to be reused in all geographical locations.


4. Automate


With this library of pre-approved assets, labels and artwork can then be automatically generated using the right software, cutting creation times from days or hours to mere seconds. This comes with vast cost reductions, as well as increased speed to market, often eliminating the requirement for third-party design agencies. Bottlenecks and the risk of human error are also eradicated as pre-approval ensures that automatically generated content is compliant.


5. Distribute


At this stage, all assets are now suitable for publication. Distribution of the final approved label or artwork must now be controlled effectively, with traceability of the entire process. From basic black and white shipping labels to a pre-press ready file being sent to a third-party printer, labels and artworks should be firmly linked with upstream creation and approval processes. 


6. Insight


This centralized solution and its associated capabilities lay the foundation for new high-level business insights, enabling medical device manufacturers to refine business processes. As a result, data can be analyzed and actioned, and you can improve the upstream process to optimize your ROI.


For further information on how to implement these 6 key steps, you can read our digital maturity white paper here.


So why is it essential?


The benefits speak for themselves, but it’s not just a choice, it’s a necessity. Centralizing all of your data provides a level of ease of access that can save months of company time. Label alterations as a result of changing regulations go from mass projects to relatively easy tasks the further you climb the digital maturity ladder. From this central hub of assets, labels and artworks can then be automated. Automation rapidly reduces time-to-market, with project completion time going from months or years to a matter of days. This is crucial following the era of COVID-19, where products need to be approved and available on the market as quickly as possible, without compromising on safety. In the medical device industry, regulatory compliance is therefore non-negotiable. The consequences of errors in labels or IFUs can include costly recalls and, on the more extreme end, endangerment of patient safety. It is vital for brand reputation that these risks are minimized. Pre-approval of assets ensures that compliance is seamlessly achieved. Traceability is also integral, which is far more easily achieved with the connected approach that digitizing your LAM provides. Finally, this process enables intelligent business insights to further optimize your business operations. Medical device manufacturers simply cannot afford to miss out on this.


Imagine a single, cloud-based LAM solution that can achieve all of these things. At Kallik, we don’t have to! Our software, Veraciti™ is an end-to-end solution that enables you to manage all of your label and artwork data from one central location. Here are just a few of our key features:


   -  Data migration services
   -  Centralized asset and phrase management for all label and artwork data
   -  Automated and semi-automated artwork generation
   -  Secure AWS cloud access 24/7
   -  Approval workflows and pre-approval of assets
   -  End-to-end auditing
   -  Comprehensive business intelligence and reporting


To find out more about how we can help your business with labeling and artwork management, contact us and we’d be more than happy to help. You can also visit our industry specific pages to find out how Kallik optimize the LAM process for each industry.


Gurdip Singh