With the EU MDR looming, medical device organizations have an opportunity to improve organization-wide best practice, rather than seeing achieving compliance as a short-term business overhead. Enforced compliance such as this gives medical device organizations the chance to organize and cleanse their labeling data and in turn create downstream value now rather than later. Many organizations lack corporate oversight of their labeling estate and there are many reasons why this is the case. 

The opportunity to put things right

Whilst there is no quick fix to the discovery, audit and update of labeling artworks dispersed across multiple sites, we see EU MDR as an opportunity to put things right. Implementing a cloud-based solution to ‘connect the disconnected’ is the approach we would recommend to take control of your labeling data now ahead of the next wave of regulatory changes. Failing to comply with EU MDR regulations can have huge consequences on your medical device organization, which may result in costly product recalls, and delays in the distribution of products in Europe. 

Bob Tilling, Sales Director at Kallik says, “The most important thing to ensure compliance is to ensure you have a thorough understanding of the requirements. The biggest challenge is the scale of the task – you must investigate how many pieces of artwork you have to change and then create a plan to move through them. Once you’ve identified these, you need a project to make these changes, approve them, and pass them out to subject experts for verification that the changes are correct.” 

Employing a joined-up, cloud-based labeling and artwork management solution therefore, can ensure you are using the changing regulations to your advantage. This approach has a number of benefits:

It connects historically disconnected people and processes: a cloud-based solution makes storing, versioning, and modifying existing label layouts to accommodate new symbology and statements required for EU MDR a much simpler task.

Increases traceability: each label is visible to all stakeholders and simplifies collaboration, change, and compliance.

Reduces the impact of future regulatory and organisational-driven labeling changes: each impacted label can now be quickly identified, updated and re-printed along with a complete audit trail of changes making it easy to demonstrate due diligence to regulatory bodies when requested.

Adopting a cloud-based approach better equips medical device organizations to respond quickly and efficiently to future changes in legislation, new market opportunities, and simply the daily labelling challenges in bringing new products to market. 

“It’s all about connecting the disconnected. You’ll have master labeling and artwork assets in a variety of artwork management systems – all of which are disconnected. By having a joined-up, cloud-based artwork management system all of these things get joined up, from their very creation, to the changes required for MDR, right up to the label being attached to the product in the factory,” Bob explains. 

At Kallik, we have responded to this challenge with our, cloud-based solution, Veraciti™. Once brought under control, Veraciti's ‘where-used’ capability makes it quick and easy to identify and update individual labelling assets and to produce time-stamped audit reports at the touch of a button. The cloud-based nature of the solution means it is quick to adopt across the broader organisation and by manufacturing partners. This means that in times of uncertainty, revisions and updates can be made in confidence as and when is needed.

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.

With May 2020 just over one year away, the clock is ticking on the need to ensure compliance with the EU Medical Device Regulation (EU MDR). The new regulations can be seen as not only a requirement, but a method of survival for medical device organizations, with key implications on product and package labeling.

What are some of the key EU MDR regulation changes?
 

• The need to provide more clinical evidence to get products to market
• A requirement for greater data transparency
• Performance monitoring pre-and post-market
• New risk classification system
• Reduced time for reporting from 30 to 15 days
  
   

Bolster your compliance processes

Bob Tilling, Sales Director at Kallik advises that the most important thing to ensure compliance is having a thorough understanding of the requirements – “You then need to investigate the scale of the task, look at how many pieces of artwork you’ve got to change and then come up with a plan to move through them,” he explains. If you haven’t started preparing, it’s imperative that you begin to bolster your medical device organisation’s compliance processes, with requirements to even reclassify your products. The inability to prove the required level of clinical evidence and correct labeling will ultimately prevent your products from getting to, and remaining on the market, and failing to comply can result in losing your licence to trade in Europe.

Create downstream value
 

The EU MDR can in fact provide medical device organisations with the opportunity to improve organisation-wide best practice, rather than viewing achieving compliance as a short-term business overhead. Enforced compliance such as this provides the opportunity to organise and cleanse labeling data, and in turn create downstream value, now rather than later.

Addressing key challenges
 

The key barriers facing medical device organisations is a lack of transparency, a plethora of structured and unstructured data, and the absence of a single view of approved labelling content. These challenges prevent key team members from accessing version-controlled data, increasing response time, and limiting organisations’ ability to make informed decisions. As Kallik’s CCO David Bennett explains, “Without a 360 vision of your whole real estate of labeling, it’s impossible to tell when a regulatory change impacts and where it impacts.”

How you can prepare: become an evidence-led organization
 

Employing a single, joined-up, cloud-based labeling and artwork management solution will allow medical device organisations to store product information in a central data platform. This will allow for a quick and effective response to future changes in legislation, new market opportunities, and simplify the daily labelling challenges in bringing new products to market. Kallik’s Veraciti™   solution is a comprehensive, unified, cloud-based Labeling and Artwork Management solution which is infinitely scalable. Its ‘where-used’ capability makes it quick and easy to identify and update individual labelling assets and to produce time-stamped audit reports at the touch of a button.

Plan and prepare for the impact and uncertainty of the EU MDR with Kallik’s Veraciti™ solution. Get in touch with the team to find out how your organization can benefit here.  

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.

As many in the sector know, from this year all new medical devices sold in the EU must comply with new Medical Device Regulation (MDR) requirements. But how well prepared are manufacturers as the deadline approaches, and what challenges remain that you maybe haven’t reckoned with?

A Shock to The System?

Let’s be honest: many medical device manufacturers have been caught off-guard by just how demanding a process change this fundamental is proving to be. Preparing for MDR has been a colossal catch-up exercise for many, as until now, certainly as compared to the pharmaceutical and biotech sectors, the medical device industry has been operating under a more relaxed device identification, traceability, and product lifecycle monitoring and reporting regime.

This, added to the relative size of many of the firms involved, has meant processes such as global labeling management have not been a board-level priority — but that must now change, as disjointed approaches to preparing different types of labeling output does not lend itself well to the kinds of controls the EU is now asking for.

Labeling Moves to Center Stage

Incidents like the PIP breast implant scandal of 2009/2010 triggered all the new safety measures coming through, and this is what MDR is designed to avoid. But in the event of a safety scare and potential product recall, it will no longer be sufficient for patients and their medical consultants or pharmacy outlets to know which type of device has been affected — it must be possible to swiftly pinpoint and track down faulty batches of product in the market, for targeted remedial action. This is only realistic as a response if you have consistently reliable labeling.

To learn more about how companies are taking advantage of EU MDR to enhance their labeling processes download our white paper here.

Control & Visibility Are Your New Watchwords

Manufacturers cannot hope to keep on top of product identification and traceability, or manage this business process with enough efficiency, if they do not have clear visibility, control and systematic coordination across everything included on or with their products. And sorry, that’s through every channel, in every market.

The only way to ensure consistency and reliability is to have a single global source of labeling ‘truth’ that all market-facing materials flow from; one definitive place to update and check everything which any authorised team can access, anywhere in the world, supported by appropriate controls governing who can do what to, and with, the content assets.

… But Integrating and Harmonising Processes Takes Time

Arguably, the most significant impact MDR will have for the sector is around the scale of work involved. Many companies have drastically underestimated this, but the danger for companies who have left MDR preparations until the eleventh hour is that you will be  forced by time pressures to do the minimum required for compliance, potentially compromising the internal business benefits.

Change Is Now Here for Good

Another sobering realisation: regulatory disruptions are not a one-time event. Any companies that haven’t taken the time to do things properly this time around face having to go through new upheaval next time new international requirements are introduced. And don’t forget that from May 2021 unique device identifier (UDI) codes/detailed product serialisation information will have to appear on all product labeling, a move which could well present further challenges for device manufacturers lacking a structured way of managing this.

So we have some challenges, yes. But it’s important to keep in mind the bigger picture here which is the job we all have around ensuring patient safety and trust. The requirements of MDR are just one part of this wider vision, so manufacturers should not limit their efforts to overhauling their approach to global labeling management by just looking at these specific requirements alone.

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 UK has just over 8,000 ventilators, significantly fewer than the 30,000 the government estimates are needed to cope with the fallout from the peak of the Coronavirus epidemic. Clearly, the race is on for medical ventilator specialist manufacturers to ramp up production.

Manufacturers are being asked to close the gap, with firms like Dyson, Airbus, GKN, Rolls Royce, Megitt and others working on partnering with medical device manufacturers on new designs to meet the huge and unprecedented demand for the units.

But the danger is that these new entrants, very welcome as they are, may struggle with a key process: getting the product and package labeling elements correct and aligned with NHS needs.

And the inability to prove the required level of clinical evidence and correct labeling will ultimately prevent the new ventilators from getting to the NHS staff who need them in a timely manner, and time is of the essence.

What we can do as a supplier is to offer our expertise on this aspect. That’s because we have accumulated a great deal of experience in the medical device manufacturing space. We’ve helped our customers deal not just with national/international requirements, but the large amount of required text and graphics that must now be featured on individual labeling.

Based on our exposure to these issues, there are a number of practical measures you can take, in order to help you mount the quick and effective response to the current crisis required and get the new machines into the NHS in a timely, safe and acceptable manner. These are:

• Ensure that you are aware of the Government’s new regulatory exemptions as it relates to medical device manufacture during the current situation.The FDA has also updated their policy based on the current COVID-19 situation.
• Get up to date on which regulations you still need to comply with, namely EU Medical Device Regulation (MDR), US Unique Device Identification (UDI), and global product serialisation — but note that the former, which is formally due to take effect from 26 May 2020, may well be delayed, as the medical technology industry is lobbying for it to be postponed. This is a fast changing area, but we can help here, e.g. share current legislation information, best practice, and provide advice on how to navigate the rules with you if you’re not familiar with them.
• Leave nothing to chance. To meet the tough deadlines and ensure nothing derails your manufacturing schedule, introduce a Corrective/Preventative Action process (CAPA) to quickly identify any potential non-conformity or issue to quickly respond to issues wherever and whenever they might occur to assure the problem can never be experienced again.

Kallik is working hard to ensure that all of our customers are able to continue to perform their essential labeling and artwork management processes during this uncertain time. If you are looking to take new ventilators or other medical devices to market faster during this time by automating your labeling lifecycle, Kallik can get you up in running in weeks, not months. 

We are also proud to be a UK listed supplier, helping the public sector during the coronavirus COVID-19 outbreak.

Stay safe and we will get through this together. 

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 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.