The European Parliament on Friday voted decisively in favor of a proposal to delay by one year the implementation of the EU's Medical Device Regulation. This will allow authorities and manufacturers alike to prioritize the fight against the coronavirus pandemic by continuing under current procedures. 

This means all new medical devices sold in the EU must comply with the new Medical Device Regulation (MDR) requirements. Now, most medical device manufacturers are ready to become compliant as the deadline approaches, what improvements have they benefited from by implementing EU MDR?

The first effect of the MDR directive was to force medical device manufacturers to review their artwork and labeling practices. Not only was this review forced upon the manufacturers it also came with a deadline. Reviews that were done by medical device manufacturers often highlighted areas where efficiencies and improvements could be made.

In terms of artwork and labeling the EU MDR regulation put a focus on the layouts of both labels and IFU’s. Labels needed new symbols and additional warning phrases. Where would this information come from? How would it be checked? How would it be made consistent on a global basis for a given brand or product range? After these questions came where or how will it fit on the label and probably equally importantly how will large volumes of labels be updated with the changes required?

Customers have told us they used their heightened focus on labels to remove duplicates and archive labels no longer in use, some customers removed around 20% of their labels by doing such an exercise. This tidied up their landscape and of course reduced the number of labels to be considered for updating. It was found that duplicates were usually created because a single source of truth for the label or label component was not easily accessible. Many of the archived labels were old versions of current labels. Either no version control was available, the user didn’t know how to use it or was not forced to use it. Now these challenges have been identified as our customers affected have implemented a single source of truth for the label and label components. They have made sure the source of truth supports full version control thus allowing all previous versions to be contained within the same file in the same location.

Faced with layout changes and additions to sometimes thousands or even tens of thousands of labels our customers have told us they now realize how important it is to get the changes right first time around. Several iterations for a change can be frustrating when its only one label but when its thousands it quickly becomes a serious problem. They have learned to provide the label components required from the single source of truth as discussed above and then to provide detailed brand or design guidance to the artworker to ensure the change is done correctly the first time. Customers have found these changes have made improvements in the accuracy of the label first time around leading to a much-appreciated overall business improvement.

If customers were lucky enough to have a powerful artwork management tool like Kallik’s Veraciti™ then identifying how many labels and IFU’s need to be changed under the new MDR rules was a simple task using the “where used” tools. Knowing the scale of the task even before the change project starts is a major benefit to any customer. Once the scale of the task is known a plan can be put in place to action the task. Our customers would have simply needed to guess without such a tool and in my experience any guess is likely to be wrong.

Once the scale of the task has been identified then the feedback from our customers was that many more labels were impacted than they realized. Usually, the number was in several thousands but often it was in the low tens of thousands. The only economic way to change such a large number of labels is to use templates and automated generation of the new version using computer power and associated logic. 

The Kallik customers using our automatic label generation tools have commented on how they saved the day and changed the labels well within the MDR deadline thus allowing plenty of time for review and any necessary print trials that may have been required. The overall feedback is that MDR compliance was made possible within their business due to the automatic generation tools. Now the tools have proven so useful most customers have plans to expand their use and pass on the business improvements experienced to more packaging types such as IFU’s and User Manuals.

In terms of IFU’s many of the above comments and much of the feedback applies in the same way. The challenges were similar, the tools used were similar and the same type of business improvements have been experienced. 

The further challenge with IFU’s was how to publish them and in what file format? Regulators may want the IFU in an XML format and the device manufacturers' website editor may want it in a pdf format. 

By having a single source of truth, the IFU content remains correct and compliant whilst allowing different tools to be validated to publish the IFU in various file formats. Our customers have told us that having this in the same system as the labels has made their lives much easier. Most now have decided to continue this improvement process by using the same system to control and manage their cartons as well as labels and IFU’s.  

In conclusion it's clear that the EU MDR forced changes on the medical device manufacturers but at the same time such a large scale and all-encompassing task has led to business improvements in multiple areas across many different packaging types.

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.

Our labeling and artwork experts share experience from recent customer projects and explain how medical device manufacturers can recover lost time in preparing for EU MDR labelling and IFU compliance, whilst being better positioned for the next wave of regulations.

Where are we now?

Some industry observers have been suggesting that the one year delay to the EU MDR date of application has largely ‘fixed’ the labeling problem. While it is true this extension has helped some, the issue has certainly not gone away according to the device manufacturers that Kallik are talking to.

Despite some companies now being better placed to make these label changes, many others are still burning valuable time. Those having emerged from the maze of Class III device labeling know they need a better map next time. Others who are yet to start their EU MDR change project face many blind alleys. Once the labeling is done, up next are IFUs and also for some, Patient Implant Cards.

But this is not the whole picture. Many device manufacturers have miscalculated the scale of the task. Initial estimates of Class III device labels and IFUs have typically been out by a factor of three or more. 100 IFUs and 2,000 labels have become 300 and 6,000 respectively.  Ensuring compliance across labels, cartons and IFUs for every single device adds another dimension.  Extrapolate this out across Class II and Class I devices and both the second and third waves of EU MDR start to look alarming.

Realising they were facing a tsunami, some manufactures ditched their existing processes mid-stream and switched to a content driven approach. Having started to recover lost ground on labels, they’re now getting to grips with the next challenge - ‘the IFU problem’. Others are still burying their heads in the sand, but word is getting round there is a smarter option and one that places device manufacturers in a better position for managing future wholescale changes.

So what exactly is the IFU problem?

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 EU MDR much larger than first anticipated for many device companies.

There’s also another problem. Little, if any, upstream alignment exists across labels and IFUs.  Often, the first time labels and IFUs come together is at the point of packaging and shipping; this is not the time or place to be checking for consistency. IFUs also tend to be owned by artwork teams rather than labeling teams and therefore don’t change as regularly. Henceforth, there’s limited capacity for wholesale changes. Where IFU artworks are outsourced, there is the added risk that agencies lack resources to manage the changes in required timescales - if in fact they actually understand what is required?

There is more to this than most manufacturers realise. Not all IFUs will be impacted, particularly products not sold in the EU, and sorting those that are impacted from those that aren’t takes considerable time. Content from translation agencies will also need to be included, followed by several internal review and approval cycles before going to print. Add in the enormous time pressures and limited resources to deliver these sort of projects, there is a real risk of IFUs becoming out of alignment and potentially out of compliance.

Doesn’t PLM already solve these issues?

The stark reality is, in our experience, it doesn’t. There may be multiple production variants of a single label stored in PLM resulting from the need for locale specific content, different pack sizes and varying production data. Geographically dispersed factories operating a variety of labeling software solutions fail to deliver a single view of these variants. Plus, with IFUs usually arriving via a different route into Goods Inwards, PLM systems may be bypassed. Despite Regulatory being responsible for what goes on the labels, they may not have sight of the finished goods, being left to rely on the efficacy of others who are sometimes less qualified.  

Back to labels…

Despite a delayed start, it is true that some organisations are making headway transitioning from MDD to MDR. Whilst there are those that have seen MDR as an opportunity for business transformation, there are others that have tried to force feed change into already broken processes. Already reaching breaking point for Class III, these processes won’t scale for Class II and Class I devices. Many are quickly learning that it takes much longer than forecasted -  3 months to find all the impacted labels, 6 months to complete the change cycle followed by 3 months of print and publishing lead-times. That’s one year of elapsed time plus another 3 months to achieve certification. It’s simply taking too long. The worst case scenario is that some devices might not ship, disrupting global healthcare supply chains, revenues and shareholder confidence. Who is brave enough to predict what might happen?

Back to the future...

With unprecedented numbers of staff working from home via downloadable apps since COVID-19 lockdowns, resistance to cloud-based software deployments is quickly becoming a thing of the past. The use of this technology is becoming the norm for all of us. Implementation is quick and user adoption is fast and easy. Bringing all labeling and IFU content together in a single solution that fully integrates with localised print facilities and third party agencies enables globally dispersed teams to operate from a single source of truth. Not only this, they can do so safely and securely with full traceability and accountability. In a fraction of the time taken by labeling teams to extract content from legacy systems, a cloud-based solution can be operational and ready to stop the loss of time.

Cloud-based collaborative technologies also shorten creation and review cycles. Advanced software tools and techniques reduce the number of label and IFU template variants, minimising risk of errors and non-compliances from misinterpretation. In the context of MDR, this is essential. Finding impacted labels, updating content, designing new label and IFU layouts, managing translations and demonstrating 21 CFR Part 11 compliance starts and finishes here. This is where device manufacturers need to focus to economise.

And here’s the proof...

Mid sized Class III device manufacturers having approximately 350 IFUs are typically forecasting over 3,500 hours to achieve readiness for EU MDR certification based on current systems and processes.

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. More than this, it’s freed up resources to start preparing for Class II compliance.

Economies increase where external agencies are engaged. Translated text and phrases can be stored and reused. Streaming label and IFU layouts and content directly into InDesign also minimises the number of design studio iterations. Applying business rules logic to pre-populated label templates for locale specific variants reduces error-prone repetitive tasks and minimises dependence on tribal knowledge.

Finally, buying back lost time...

As Heraclitus said, "there is nothing permanent except change.” This applies to labeling as much as it does anything else. Volumes of Class II and Class I device labeling and IFU changes will have an immense impact on organisations failing to embrace change and a move towards technology based solutions.  

There’s also more to come with new regulations once again mandating labeling changes.  Brexit requires all devices shipped to the UK after June 2023 to carry a UKCA marking.  Moreover, products shipped to Northern Ireland from 1 January 2021 where conformity assessments are carried out in the UK, will need to carry a new UKNI marking. Every impacted label will need to be identified, updated and approved. Those failing to take action now, will be asking questions of themselves very soon.

Other countries are also implementing ‘EU MDR like requirements’ with China and Australia being two such examples. More are following their lead. Lost time can still be recovered, but only if organisations act now. Delaying investment until the second wave of EU MDR hits is certain to result in major disruption. Finally, following the advice of the infamous Wyatt Earp, perhaps now more than ever is the time to do it once and do it right.

If you would like to know more about how software and technology is being used by medical device companies to shorten the label or artwork change and approval process whilst maintaining compliance levels then speak to one of our experts at enquiries@kallik.com or +44 1827 318100.

A persistent challenge in highly regulated industries is getting the right label on the right product at the right time. Ever-changing regulations can make this a long and arduous task, particularly when these companies maintain the usage of outdated manual labeling and artwork management processes. It is clear that the introduction of an automated system can provide value, but the question is: how?

A quick thought experiment...

Consider a designer taking 30 minutes to create a label at $40 an hour. 1000 labels would cost $20,000 to produce conventionally. Not only can Automated Artwork Generation save $1000’s by producing labels quickly and automatically, it will get it right the first time too. This is a great advantage when it comes to responding to regulatory changes, making label changes a much more straight-forward, clean process. Furthermore, this method vastly minimises the risk of recalls, which can incur massive costs in high-stakes industries. In fact, we’ve found that in the case of many of our customers, automation has allowed organisations to reach an average label and artwork generation time of well under 60 seconds.

Real-life results

Throughout 2020, we at Kallik were able to capture highly impressive Veraciti™ user data. User data improved as the year went on, as a result of continuous development in Veraciti™ tools and technology. This, in combination with our release of Project Brief Manager 3, has allowed us to achieve spectacular results, such as a 50% reduction in project completion time at a major life science company. The very same tools and technology that delivered this incredible reduction simultaneously handled a 27% increase in the number of labels or artworks being generated by Veraciti™.

Of course, the migration of our solution to AWS has also been paramount in maximising these benefits. The added speed and security which the AWS cloud provides has aided our customers in countless ways, with enhanced resilience, full compliance with ISO/IEC standards, GxP requirements and data privacy, these benefits have had a knock-on effect.

Through the adoption of our automated platform, a leading medical device company can now process a typical monthly workload of over 8,000 artwork creation jobs at an average rate of one job per 37 seconds, in turn cutting average label and artwork project completion time from 52 to just 26 days. A major chemical company, meanwhile, has seen artwork generation times slashed by 75% over a four-month period to an average of just 12 seconds per artwork generation, with another in the oil & lubricants sector reaching just 3 seconds per task.

Innovative automated artwork and label management is the way forward

Organisations in highly regulated industries who are adopting automated artwork and label generation in favour of using manual processes or outsourcing design work to third parties are seeing major time and cost reductions. Through further investment and innovation, we hope that our Veraciti™ statistics will reflect these advantages even further as 2021 progresses. We are committed to providing our customers with optimal efficiency and results.

Beyond helping companies in highly regulated industries get to grips with disparate labelling and artwork processes, our findings also demonstrate the benefits of automation scale over time and as organisations grow their operations. Many of these organisations have traditionally employed third-party designers to create and amend artwork and labels to great expense, with these assets numbering in the thousands. The cost efficiencies for bringing these operations in-house and introducing automation are clear.

Automation has a critical role to play for industries such as medical devices, pharmaceuticals, chemicals, cosmetics and food & beverages, where regulations are tight and mistakes can have serious effects on brand reputation or consumer health. 

As we have seen with the rush to comply with EU Medical Device Regulations and the potential regulatory shifts of a prospective Brexit deal, the agility and centralised control of a dedicated artwork and label management solution has become a necessity for businesses rather than simply a nice thing to have; automation is the future of efficient and reliable label and artwork management.

Highly regulated industries are continually being hit with more stringent rules and changes, particularly when it comes to their artwork and labels. As product portfolios grow and businesses penetrate new markets, it becomes increasingly difficult to identify and respond to the changes that these new regulations entail in a timely manner. 

This has a subsequent impact on speed to market, for both new and existing products, and can also result in product recalls if this process is handled inadequately. While your business needs to get products to market quickly to remain competitive, it is essential that this process is also quality-driven in order to maintain regulatory compliance.

Basic artwork management is not enough

Historically, there has been a major focus within these markets on artwork management, where artworks are approved, stored in an asset manager and version controlled. However, Gartner notes that ‘what has typically been called labeling and artwork management in the past is only artwork management that governs artwork activities for the final product packaging’. 

Enterprise labeling and e-labeling technology has subsequently emerged to ‘address the distinct needs of specialized labeling, product traceability and transparency’. It has become increasingly clear that an artwork management system is not enough to achieve speed to market. 

Enterprise label management will take your business to the next level in terms of speed to market and compliance. More and more businesses are discovering the benefits of a single, end-to-end enterprise labeling and artwork management (LAM) solution that both encapsulates and compartmentalizes the entire labeling process. Compliance is guaranteed through the ability to access audits from every step of the process, identifying problems instantaneously and preventing long-term issues such as recalls or wider compliance shortfalls.

In a highly competitive business world, the ability to quickly locate labels affected by regulatory changes and make swift amendments to them is of greater significance than ever for companies that operate on a global scale. When thinking about sharpening your label and artwork management process to drive business growth, there are three key areas to focus on:

1. Structure your data to drive traceability and quality 

In order to appreciate the value of managing and structuring your data correctly, it is helpful to consider the consequences of not doing this. Imagine that you have 10,000 products in your portfolio, and 50% of these are sold in a market where you are required to place a specific regulatory symbol on all labeling. The regulator requires you to use a different version of this symbol and you have 6 months to implement this change across all of your products. How easy would it be to find all labels and artwork which use the old symbol, update them with the new symbol and send them for approval? For most organisations, just the task of finding the impacted artworks alone can take months, due to the fact that their data structures do not allow this traceability.

Data needs to be structured in a way that allows the individual elements of an artwork or label to be managed independently of the artwork itself. Phrases, translations, symbology, imagery and all other aspects of the label need to be individually stored in centralized asset and phrase managers. This enables version control of each constituent part, as well as the ability to pre-approve each component, so you know that you're building your label with correct and compliant data. The value of this method of label data storage cannot be overstated, as it provides a basis for simplifying and optimizing the rest of the labeling process. It enables common components to be standardized and reused across all artwork and labels, and getting the data right upfront means the artwork creation process is much smoother.

2. Enable collaboration across the value chain

Once all of your label components are contained within a single location, the relevant data can be structured into a label dataset. At this stage, you can select each of the components (images, phrases etc) that your label requires and determine where they appear with the confidence that each component has already been pre-approved. 

Collaboration is key here; stakeholders across various teams such as product, marketing, regulatory and legal may be required to contribute to the label dataset. Automated routing should be in place to ensure that the people who need to give their input or approve artworks are given the opportunity to do so. Furthermore, the system you use for this needs to be readily available across the globe with 24/7/365 uptime to ensure that all timezones are catered for; cloud hosting makes this possible. 

Preventing delays at the artwork creation and approval stages is paramount to speed to market, and digitizing the data collation and approval process ensures that new artworks get to the relevant approvers as soon as possible. If the data is correct the first time and it goes straight to the people who need to see it, your new label will require far fewer rounds of approval. Speed to market is not just about how quickly the label itself is changed; it is ensuring that approvals are correctly executed the first time around too.

3. Automate traditionally manual & time consuming processes

Of course, speed to market can be improved beyond centralizing the process to one end-to-end system. Having all of your labels in a central location is one thing, but finding every label that uses a specific component is another. 

The enterprise labeling solution you choose needs to enable you to easily identify all labels that are affected by changing regulations. Take the example of the post-Brexit change from the CE mark to the UKCA mark on products sold on the UK market: the affected labels can be identified automatically through setting a simple search criteria. Perhaps in this instance the search would include (1) All UK labels (2) containing the CE mark component. This sort of search function can return search results in a matter of seconds, giving your company an accurate representation of the task at hand. 

Apply this process to tens of thousands of affected products that would otherwise need to be identified manually, and the value of this function becomes very clear - even finding just 100 impacted labels manually is an incredibly time-consuming process. In the pursuit of speed to market, the ability to easily locate labels with any given components is essential regardless of your company size.

Another clear way to speed up the process of getting a product to market is to automate artwork creation. Many businesses outsource their label artwork to external design teams, disconnecting an otherwise streamlined, end-to-end process. In the case of technical labels predominantly found in the chemical and life science industries, labels can be generated completely automatically with the right LAM solution; once the relevant components are chosen, the software will create the label for you using pre-defined templates. New artworks can be created in seconds, instead of weeks.

Digitizing your labeling and artwork management process will support revenue growth
 

An intelligent enterprise labeling and artwork management solution provides numerous competitive advantages across highly regulated industries. Kallik’s market leading solution, Veraciti™, is already helping our customers across medical devices, chemicals, cosmetics and food & beverage industries achieve huge efficiencies in their labeling processes. At Kallik, we’ve seen our customer’s project completion times cut in half, with an average label and artwork generation time of less than 60 seconds, monumentally improving speed to market. Find out more about our impressive statistics here.

Medical device manufacturers, pharmaceutical firms, chemical and cosmetics companies use Kallik to deliver trust in their labeling, confidence in their brand and integrity in their process. If you want to find out more about how we can support your label and artwork management transformation in your business, please get in touch at beth.peckover@kallik.com. We’d be more than happy to help.

After a one-year postponement, EU MDR is now set to come into force in late May. With the new rules regarding labeling and packaging officially set for 26 May 2021, some manufacturers of the most critical Class III devices are still struggling to ensure full compliance before the cut-off.

Looking further afield to the next wave of MDR requirements, Class II devices – such as catheters, syringes and teeth implants – will have to conform to the same label and packaging regulations as Class III. Manufacturers of these devices would be wise to not postpone preparations for their own 2023 deadline, especially given the various challenges and pitfalls that have been laid bare by the initial compliance push.

Failing to act now is a costly mistake

As a field leader in label and artwork management for highly regulated industries, our team understands that many organizations are still far behind the curve on their compliance journey – both in getting to grips with the significance of the work required and then actually put these changes into effect.

This is not a case of simply shifting internal goalposts – there are major drawbacks to failing to meet these new regulatory deadlines. At the financial level, non-compliant manufacturers will not be allowed to sell their products into the EU market, with some minor exceptions for critical supplies. Non-compliant businesses could also be placed on a watchlist to be inspected and audited, affecting brand confidence and in turn share price.

For those Class II manufacturers caught up in the rush to comply by 2023 and eager to avoid the consequences of non-compliance, there’s three key takeaways businesses should note based on the efforts Class III manufacturers are having to make to meet their May deadline:

1. The scale of the task must not be underestimated

As the pool of devices in Class II broadens – to the extent that Class II is further divided into IIa and IIb devices – so does the scale of the tasks involved for compliance.

Businesses that are yet to begin their compliance process will first need to identify how many labels and artworks exist within the organization. Many business leaders underestimate the quantity of assets, and this task will typically unearth siloed data, labels and artworks that immediately increases the scale of the compliance work.

Manufacturers operating facilities and systems on a global level will find they must also contend with challenges such as asset translations for each device into every applicable target market language. This adds a further level of complexity to label and packaging compliance tasks – the EU alone, for example, has 24 official languages, leading to further translation expense and the risk of ‘doubling up’ translations.

Businesses that grow through mergers and acquisitions will also see the complexity and scale of compliance tasks increase, as product lines and further data siloes are absorbed that require all the above tasks to be worked through from scratch.

2. Relying on manual processes is no longer feasible - automation holds the answer

With the Class III deadline just two months away and many organizations still struggling to get their label and packaging operations over the compliance finish line, it has become apparent that relying on manual work and processes is no longer sufficient. The cost of hiring extra staff – or simply the operational cost of diverting existing capacity and finances – to complete repetitive tasks is slow, prohibitively expensive and outdated.

Automated label and artwork management solutions now offer a modern, future-proof lifeline to help businesses manage all assets from a centralized location hosted in the cloud. Automation eliminates the need to manually search for, identify and edit assets to ensure compliance, with features such as artwork generation saving significant time and eliminating the need to involve costly third-party design agencies. Simply put, automation gets the task right first time, every time – there is little scope for human error to be introduced into the process.

Indeed, the most advanced providers of automated solutions are already exploring ways to streamline remaining bottlenecks such as de-duplication and translation checks by introducing advanced technology to improve efficiency. At Kallik for example, we’re already building strong academic partnerships to explore the application of AI for this purpose.

3. Looking ahead: Future industry and business shifts will pose similar challenges

There will be major medical device regulatory changes in each of the next four years – so medical device manufacturers cannot afford to sit back and wait their turn to comply with each one.

Looking beyond further phasing in of MDR, UKCA marks must be placed on medical devices destined for the UK market from July 2023. Companies that find they barely scraped by to comply with a previous round of regulation will be hard-pressed to repeat the same process for fresh rules.

Pandemic disruption is no excuse to kick the can. The shift to remote operations and cloud-based solutions has been far smoother than expected, with in-house technical experts and external consultants both adapting to remote compliance tasks and in particular software implementation.

Don't delay - get compliant today!

Making the early switch to automated label and artwork management solutions such as Veraciti™ not only lessens the burden of future regulatory compliance, it also delivers long-term business improvements. Significantly cutting outsourced design costs, automated artwork generation and comprehensive audit trails are just some of the benefits provided by a centralized, cloud-based solutions.

But these solutions are no overnight fix – they require buy-in and support from in-house teams throughout the deployment and onboarding stages, spanning several months. This is why it is vital medical device manufacturers act now and begin the process of mapping out compliance roadmaps and planning a technology-led, long-term solution.

Want to know more about how automated label and artwork management solutions can help your business comply with EU MDR and future industry regulations? Get in touch with us at enquiries@kallik.com or +44 1827 318100.

To find out more about how automation can streamline your labeling process to comply with new medical device regulations, you can also download our white paper here.

For medical device manufacturers, the compliance deadline is looming for the European Union's In Vitro Diagnostic Regulation (IVDR) for critical in vitro devices used to detect life-threatening diseases. It comes into force in May 2022 replacing the In Vitro Diagnostics Directive (IVDD), and is designed to enhance the safety, effectiveness and traceability of all in vitro devices currently sold or intended for sale in the EU market.

Over 80% of devices that previously did not require certification under IVDD will be covered by IVDR certification, so that means a lot more work for device manufacturers.

The new regulation is closely linked to the EU Medical Device Regulation (MDR), which is currently coming into force for multiple classes of medical devices. For those manufacturers that have already completed initial projects to comply with MDR by May 2021, it may be tempting to sit back and delay their IVDR efforts. But there have been significant lessons learned from MDR compliance attempts, not least the scale of these compliance tasks and the wide-ranging impact regulation has on end-to-end operations.
 

Setting a course for IVDR compliance
 

Manufacturers that fail to ensure compliance with new regulations face losing revenue, market share, and even irreparably damaging brand reputation by exposing consumers to harm. Device manufacturers will need to start to plan now to deliver full compliance ahead of the IVDR deadline. This must span initial assessments to identify affected assets and project scale, processing label and artwork changes to satisfy new requirements and deploying fit-for-purpose technology to help automate compliance actions.

There are four critical focus areas where medical device manufacturers can take positive strides to ensure IVDR compliance:
 

1. Get to grips with the scale of the task as soon as possible
 

When working with medical manufacturers to reach MDR compliance, Kallik has often found that changes needed to span multiple sites, geographies and over 150,000 assets in some cases. It’s crucial that initial assessments capture the scale of the changes required, and that means being able to identify exactly how many devices and associated labels and artworks exist across global operations.

Complexities are introduced when data is housed in legacy systems, across disconnected regional offices and departments or scattered assets. Product translations and global supply chains can significantly add time and complexity onto a project. For example, amending individual phrase translations on each device in a product range for each of the EU’s 24 official languages threatens to add substantial time to compliance efforts.

Add in the possibility of further M&A activity bringing in new product lines and asset libraries and this issue is multiplied further.
 

2. Prioritize asset consolidation and standardization
 

Once all information siloes have been unearthed, before actioning label and artwork changes, manufacturers should look to consolidate all assets into a single, central source. Attempting to manage editing, review and approvals processes across multiple systems and departments is both highly inefficient and runs the risk of introducing costly version errors and further delays.

This is where businesses need to lean on an off-the-shelf label and artwork management solution that incorporates a single, centralized asset library to contain artwork, logos, phrases and other critical product data. Automated capabilities, such as those provided by the Kallik Veraciti™ label and artwork management (LAM) platform, aid with the extraction of content from data siloes and legacy systems, including supporting the subsequent standardisation and loading of data into a central cloud-based solution.

Consolidating all assets into an easily accessible ‘single source of truth’ significantly eases the monitoring, editing and management burdens when compared to attempting to do so across multiple systems and geographies.

3. Get down to the detail with a helping hand from LAM technology

Once existing assets have been consolidated, manufacturers can begin to enact the changes that must be made to each label and artwork.

There are many factors to consider here, from label sizing and placement, to warning symbol positioning and Unique Device Identifier (UDI) inclusion – and these can be further complicated by country-by-country requirements.

This is another situation where the consolidation of assets into a single LAM solution yields dividends. The Kallik Veraciti platform provides a powerful ‘Where Used’ feature that enables users to rapidly identify all labels affected by a minor design change and take action accordingly. Combining this capability with approved label templates within the LAM solution means users can effortlessly make changes to all labels in a product range – eliminating the need to manually identify and update each impacted asset.

4. Automation eliminates manual processes to ease the compliance workload 

As many businesses experienced during the initial MDR May 2021 compliance push, relying purely on ‘traditional’ methods and updating assets through manual work and processes has become increasingly unviable. These have been found to be typically slow, costly and risk introducing human error.

Deploying a cloud-based, centralized solution with a high degree of automation eliminates the uncertainty of manual processes. The result is an efficient operation, following best-practice procedures, providing a pre-defined outcome.

Modern LAM solutions offer a greater amount of automation and more importantly, the potential for future efficiencies through for example AI integration. Such solutions harness rules-based automation to eliminate the need to manually search for, update and republish assets to ensure compliance, and deliver significant cost and capacity savings that scale over time.

Start automating now to steal a march on EU IVDR
 

With IVDR coming into force in May 2022, medical device manufacturers still have time on their side if they act now. Automation holds the key to ensuring they have the agility, adaptability and accuracy required to meet new regulations, and this comes by putting a dedicated label and artwork management platform in place to underpin their compliance efforts – now and into the future.

Want to know more about how automated label and artwork management solutions can help your business comply with IVDR and future industry regulations? Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100.

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.