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.

Six 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 six 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

Want to know more?

Whether you’re in the food and beverage, pharmaceutical, medical device, chemical, or even the cosmetic industry, our experts are ready to help you transform your labeling and artwork management with the help of our innovative software, leading the way in the labeling and artwork software space. Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100.

Where are we with MDR and what do you need to know to be compliant with IVDR?

Just over 4 months on from the implementation of the EU Medical Device Regulation (MDR), there are still manufacturers failing to meet requirements imposed by the new directive. According to a recent article published by The Regulatory Affairs Professionals Society, manufacturers are struggling with concepts of basic UDI-DI, under both MDR which has applied since the 26th of May 2021, and IVDR, which will come into effect by May 2022. It is agreed amongst MedTech organizations that MDR has become a major regulatory challenge, and Kallik has experienced those issues first-hand.

Don't fall at the first hurdle

Bob Tilling, VP Global Sales, who has worked closely with medical device companies in their MDR and now IVDR projects says that the first step towards meeting compliance - organizing the artwork - is possibly one of the biggest challenges. Finding and collating the artwork is the beginning of a long project, and the time it can take to pull these together is often underestimated. 

Our experience has shown that label content is normally dispersed and stored in different spaces, with some being at agencies or third party suppliers. After getting the content together, it is then necessary to change and update artwork, which, again, takes a lot more time than is generally expected. The delay in starting these projects, along with the belief of it being a straightforward task, is the first step towards missing regulatory deadlines.

What lessons can be learned from MDR and how can we apply them to IVDR?

Similarly to MDR, experts at MedTech Europe estimate that as few as 24% of IVD manufacturers will be compliant by the time the regulation is implemented, with 17% definitely failing to be certified on time. That leaves around 59% of manufacturers with undetermined futures, all depending on what they decide to do in the next few months. 

Kallik’s Bob Tilling believes that manufacturers must act now to be able to meet the IVDR deadline and avoid the current challenges organizations are facing with MDR, even 4 months on from its initial implementation. Our experience has demonstrated that with MDR, there was not a single company or project that was completed ahead of schedule, even with the 1 year extension due to COVID. Leaving the start of the process to as late as January or February 2022 will result in missing the deadline; the time that is needed to complete the project should not be underestimated. 

To meet the deadline, medical device companies will need to partner with a labeling and artwork management software company that not only offers technology able to resolve the challenges but also has extensive experience in working in the life sciences industry, particularly medical devices.

Want to know more?

Whether you’re in the food and beverage, pharmaceutical, medical device, chemical, or even the cosmetic industry, our experts are ready to help you transform your labeling and artwork management with the help of our innovative software, leading the way in the labeling and artwork software space. Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100.

The Nordic region is a potentially lucrative area for medical device companies to expand into, with analyst research estimating Sweden alone to have a 2.7% market share of the €140bn European medical device market. But practical challenges, in particular operational obstacles on the regulatory side, have deterred many manufacturers from making the leap into this geography. Bob Tiling, VP Global Sales at Kallik, explains how effectively managing the simple device label could be key to overcoming the challenges of entering the Nordic market.

Expansion into one or even several Nordic countries may seem like a minor leap to today’s large, multinational medical device manufacturers – but business leaders with an eye on new market growth should beware the pitfalls. These range from special logistics labels on products for each healthcare association through to large-scale downstream compliance challenges. Dedicated label and artwork management software solutions have made significant strides in bringing advanced digital capabilities to bear on many of these challenges – and could yet again bring peace of mind to those exploring a push into the Nordic medical device market.

Here are my three major considerations that medical device manufacturers should focus on when weighing up expansion into the Nordics – and how technology can help solve them:

High risk, high reward? Weigh the costs vs. benefits to your business

At first glance, expansion into the Nordic market may seem like a case of ‘high effort, low reward’ for many medical device companies. The entire Nordic medical device market, for example, is smaller than the German market alone, and the Nordic market is far from the largest by value, given the relatively small populations of each nation within the region.

Yet medical device margins are significantly higher in the region when compared to most European nations and indeed to countries beyond. Nordic countries have a very high standard of living and per capita wealth is equally strong, with effective healthcare systems and high-quality products used in treatment. Healthcare spending is also typically very high as a percentage of GDP.

Expanding into or setting up in the Nordic market ultimately represents a calculated risk for many medical device companies – do they replicate compliance tasks and increase the volume of labels and assets managed internally to sell into this market, or do they cut their losses and focus on large, more lucrative targets such as Germany and the UK?

If manufacturers conduct suitable research and can identify a strong appetite or market niche in the Nordics to position proven, fully compliant medical device ranges, there is a potentially rewarding opportunity. The short-term risk, therefore, may be comfortably worth the long-term reward – but only if manufacturers have suitable systems in place to comfortably handle country-specific labelling and artwork requirements that can be customised to effectively handle national nuances.

National nuances mean labelling is a nightmare – a wake-up call for digital management

One of the main challenges facing medical device companies looking to ‘crack’ the Nordic market is the scale of it. Spanning Denmark, Norway and Sweden, Finland and Iceland, the market is fraught with differing product preferences, healthcare system priorities and customer expectations. Each national healthcare authority is also far smaller than other European counterparts such as the NHS, and each has differing back-end processes such as those covering general management, documentation and reimbursement. Beyond this, Nordic regulation and labelling requirements also closely follow the same path as the majority of Europe – following EU directives as a core regulatory framework. This today includes the recently introduced MDR and IVDR, and formerly MDD.

As a result, medical devices sold to and used in these Nordic countries require extra labels and markings on product packaging. Some manufacturers, still conscious of their often- disruptive compliance efforts to satisfy MDR and IVDR deadlines, have opted to avoid the market for fear of replicating similar compliance burdens several times over. Again, by looking to digital alternatives to the more ‘traditional’ legacy methods of manual spreadsheets and disparate systems, this is far easier to get to grips with on a single easily managed platform.

M&A ambitions just add to the problems with onboarding challenges

Can you buy your way in? Can medical device companies looking to expand in the Nordic market instead aim to achieve this relatively pain-free through merger or acquisition? The answer is not so simple.

Manufacturers that take over existing Nordic medical device companies could face a burden similar to the scale of MDR or IVDR compliance projects – something we at Kallik have seen pose a major challenge to day-to-day operations of medical device companies of all sizes.

Significant increases in the number of assets that must be amended for rebranding product lines, newly discovered siloes of information and a scattered workforce could all threaten to make a typical acquisition into an unexpected time- and resource-consuming challenge. Add the usual M&A challenges of translating assets into multiple languages for the region, and without the right digital backbone this quickly becomes a non-starter.

Focus on digital maturity now to avoid new market ‘growing pains’

It is clear that expanding existing medical device operations into the Nordic market is far easier said than done, with downstream compliance challenges, asset management and multiple languages all obstacles to be overcome. Embracing end-to-end label and artwork management within a single digital system offers a lifeline to medical device manufacturers. It helps ease the onboarding burden by allowing companies to establish pre-set templates and layouts suitable for products being sold into each Nordic country, and bulk update existing assets for acquired product lines.

Most problems stem simply from an enforced need to manually create, update and manage labels and other product assets – a lesson industry as a whole learned during the MDR and IVDR compliance rush.

Digital alternatives offer far more than a ‘luxury’ alternative to this – they are increasingly the norm for manufacturers to weather the storm of emerging regulations, customer expectations around product traceability, and other unexpected industry disruption. Those that can deploy and maintain a truly mature digital environment for label and artwork management will be laying the groundwork to flourish in potentially lucrative markets such as the Nordics.

Want to know more?

Whether you’re in the food and beverage, pharmaceutical, medical device, chemical, or even the cosmetic industry, our experts are ready to help you transform your labeling and artwork management with the help of our innovative software, leading the way in the labeling and artwork software space. Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100.

In a world where regulations tighten, consumer demands evolve, and sustainability takes precedence, the Labeling and Artwork industry is undergoing a profound digital transformation. Our comprehensive guide (Top Tips: Your Guide to Mastering Enterprise Labeling & Artwork in 2024) delves into this revolution, offering insights from industry experts and real-world success stories that highlight the crucial role of digitalization.
 

Embracing the Digital Revolution

The shift from traditional processes to cloud-based, automated platforms in labeling and artwork management (LAM) has become a strategic imperative for organizations navigating regulatory complexities and adapting to changing market landscapes. Cloud-based solutions have emerged as the cornerstone, enabling global collaboration, instant updates, and enhanced security. According to Gartner, by 2025, an estimated 85% of businesses will have adopted cloud-based technologies into their daily operations—a trend that's reshaping the industry's standards and capabilities.
 

The Power of Artificial Intelligence and Automation

Integrating AI-driven systems has revolutionized accuracy and speed in LAM, significantly reducing errors and facilitating swift adaptations to regulatory changes. Automated artwork creation and modification, often taking just seconds, have replaced weeks of manual revisions. The transformative impact of AI isn't just about efficiency; it's about achieving complete regulatory compliance and instilling confidence in labeling accuracy.
 

Template Technology: A Game-Changer in Efficiency and Compliance

Template technology offers agility, scalability, and compliance, leading to significant cost savings and ensuring precision in label and artwork management. Its impact extends beyond financial implications, playing a vital role in regulatory adherence, particularly in critical industries like healthcare.
 

Prioritizing Personalization and Sustainability

The demand for sustainable packaging and labeling is at an all-time high. Digital platforms are enabling businesses to swiftly adapt to eco-friendly practices through customizable, pre-designed templates, ensuring operational fluidity while meeting sustainability goals.
 

Looking Ahead to 2024

As we move further into 2024, the evolution of LAM continues to be driven by digital innovation. The strategic adoption of cloud-based solutions, AI integration, template technology, and a focus on sustainability is shaping the future of enterprise labeling and artwork management. This digital transformation isn't just an upgrade—it's a fundamental revolution that propels businesses toward operational excellence and unwavering precision in a fast-paced global marketplace.

Your Next Step in Mastering LAM

If you're eager to learn more about the digitalization of labeling and artwork or seek guidance on enhancing your LAM process, our comprehensive guide offers expert insights and success stories to guide your journey. Download the full guide here and take the first step toward mastering enterprise labeling and artwork in 2024.
 

For personalized advice and assistance tailored to your business needs, speak to a Kallik expert today by emailing enquiries@kallik.com. Your journey toward a more efficient, compliant, and sustainable LAM process begins here.
 

Download the full guide for expert insights and success stories in mastering Enterprise Labeling & Artwork in 2024.

In the dynamic landscape of pharmaceuticals and medical devices, regulatory compliance stands as a cornerstone of patient safety and well-being. Yet, ensuring compliance with evolving standards and regulations poses significant challenges for organizations worldwide. Traditional methods of producing Instructions For Use (IFUs) and Patient Information Leaflets (PILs) have often proven inadequate in meeting these demands. 
 

These documents serve as crucial sources of information for patients, providing guidance on the proper use of medical devices and medications. Inaccuracies or errors in these leaflets can have severe consequences. When it comes to pharmaceutical and medical device labeling, the risks can even be life threatening.
 

Therefore, ensuring the accuracy and compliance of patient information and instructions for use leaflets is essential for safeguarding patient health and maintaining regulatory adherence. However, with the introduction of automation in the labeling and artwork industry, a new era of efficiency, compliance and accuracy has arrived in IFU production.
 

Bob Tilling, our label and artwork expert, sheds light on the transformative power of automation in IFU production. Let's discuss some of the insights Bob has shared:
 

Addressing Regulatory Gaps 

Having anything from 100 to over 1,000 IFUs is not uncommon for a mid-sized device manufacturer. Re-writing in a style appropriate for the user, the addition of new symbology and statements, plus translation into 20+ EU languages is making the task of updating these to comply with the new EU Medical Device Regulation (EU MDR) much larger than first anticipated for many device companies.
 

The new EU MDR is significantly longer than the EU Medical Devices Directive (MDD) and will require most medical device manufacturers to update their clinical data, technical documentation and labeling which includes the leaflets.
 

Non-compliance with EU MDR labeling requirements not only puts patients at risk but also exposes organizations to legal repercussions and reputational damage. Therefore, ensuring the accuracy and compliance of patient information and instructions for use leaflets is essential for safeguarding patient health and maintaining regulatory adherence.
 

Many organizations recently have found themselves in a quandary, as traditional systems, including Product Lifecycle Management (PLM) systems, often fall short in controlling layout and content. Veraciti emerges as a beacon of hope, offering a comprehensive solution that not only manages content but also controls layout, ensuring compliance with regulatory standards.
 

Streamlining Processes, Eliminating Errors

The traditional approach to IFU production often involves a laborious process that involves input from several stakeholders across the globe. This decentralized approach not only consumes time but also increases the risk of errors. By using an automated enterprise labeling software, such as Kallik’s Veraciti, you can revolutionize this process by automating the generation of the leaflet from a pre-approved single source of truth with pre-approved, automatic translations available too, eliminating the need for manual intervention when creating and updating the leaflets. 
 

Breaking Language Barriers, Ensuring Consistency

When it comes to IFU leaflets, it’s crucial that the information can be correctly understood by patients and healthcare professionals all over the world. Veraciti revolutionizes this process by enabling organizations to swiftly generate IFUs in multiple languages, all within a matter of seconds. This groundbreaking capability eliminates the necessity for linguistic expertise, a significant obstacle particularly for non-native speakers who may struggle with language nuances.

Unlike competitors who rely on less accurate methods like Google Translate, Veraciti offers pre-approved translations derived from a single source of truth, ensuring consistency and accuracy across all IFUs. This not only streamlines the process but also reduces the workload, as organizations no longer need to create separate IFUs for each language, enhancing accessibility. The ability to swiftly generate accurate translations is a game-changer, empowering non-native speakers to access vital medical information with ease and confidence, ultimately contributing to improved healthcare outcomes on a global scale.
 

Making the Move to eIFUs (Electronic IFU)

In today's fast-paced digital world, the transition from traditional paper-based IFUs to electronic formats marks a significant leap forward in efficiency and accessibility. Electronic IFU leaflets offer a long list of benefits, including streamlined access, enhanced user experience, the ability to deliver multilingual content seamlessly and not to mention the sustainability benefits. Furthermore, when regulations are updated and the information required on IFUs changes with them, this then can mean that organizations need to change thousands of labels to stay compliant. With electronic IFUs, the process is far less time consuming and involves far less waste. As Peter Muller explains in Med-Tech Intelligence: “Paper-based IFUs/PILs are printed in bulk leading to waste when product/manufacturing information or safety advice needs to be updated. There may also be a level of risk to patients if they are accessing information that has been superseded.”
 

With this rising demand for electronic IFUs, organizations are increasingly turning to automation. Unlike traditional methods that rely on manual processes and paper-based documentation, Veraciti empowers organizations to generate IFUs in electronic formats, including XML files. This capability not only ensures compliance with regulatory standards but also opens up a world of possibilities in terms of accessibility and integration. With Veraciti, organizations can create IFUs that can be downloaded as XML files, enabling seamless integration into websites and digital platforms. By harnessing the power of automation and electronic IFUs, organizations can navigate the complexities of regulatory compliance with ease while delivering an unparalleled user experience to their customers.
 

Case Study: Empowering Össur With Greater Control

Our collaboration with Össur, a leading provider of Class II medical devices, exemplifies the transformative impact of automation in IFU production. Össur faced numerous challenges, including disparate legacy systems, delays in product launches, and limited control over IFU assets. With the implementation of Veraciti, Össur achieved remarkable results, consolidating IFU phrases into a centralized system, enhancing visibility, and streamlining the approval process. The ability to pre-approve phrases and standardize IFUs has not only improved efficiency but also ensured compliance with regulatory requirements. You can read more about how we helped Össur here.
 

Success Story: Keeping People Safe with Cardinal Health

In our collaboration with Cardinal Health, a global leader in healthcare services, we have witnessed firsthand the critical importance of accuracy and compliance in IFU production. By providing solutions that streamline the compliance process and eliminate errors, we have helped Cardinal Health navigate the complexities of regulatory standards, particularly in the context of MDR compliance. 
 

As Bob Tilling aptly puts it, "The ability to pinpoint necessary artwork modifications swiftly and accurately is instrumental in not just compliance but also in ensuring accuracy in crucial elements such as Instructions for Use (IFUs)."
 

Safeguarding Lives, Ensuring Compliance

Through adopting our approach, creation of multiple language EU MDR compliant 30 page IFUs is down from 3-5 hours to just 30-40 minutes with the time taken to generate individual labels reducing from 1 hour to around 10 minutes. With 350 IFUs and 10,000 labels, 5 person years of lost time has been recovered just for Class III devices alone.
 

In conclusion, automation in IFU production is a game-changer for compliance, accuracy and efficiency. By leveraging the power of technology, organizations can streamline processes, eliminate errors, and ensure compliance with regulatory standards. Our partnerships with Össur and Cardinal Health underscore our commitment to empowering organizations with complete regulatory confidence. 
 

Want to see the power of cloud-based labeling and artwork management software for yourself? Whether you’re in the food and beverage, pharmaceutical, medical device, chemical, or even the cosmetic industry, our experts are ready to help you transform your labeling and artwork management with the help of our innovative software, leading the way in the labeling and artwork software space. Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100.