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.

We recently caught up with a prominent executive from the chemicals sector to find out what they think are the important trends in their industry in 2020 and beyond. What we found: a real need to simplify the complexity of labeling management in their global industry so that ever-intensifying regulatory demands don’t crunch too hard on market growth.

Trust, transparency and, above all, the safety of process/supply-chain intermediaries and consumers is of paramount importance to the global chemicals industry. At the same time, increasingly stringent regulations about product/substance-based declarations, hazard warnings, and use of mandatory safety statements and symbols is definitely taking its toll on the supplier end; there are now so many regulated elements that must be carried on product packaging and labeling that they’re potentially starting to impinge on the market’s ability to execute. A specific area of concern here is the complexity. As an industry, we have to deal not just with new international, regional or country-specific requirements but the sheer volume of required text and graphics that must now be featured on individual labeling.

To maintain market authorization in each market and to uphold brand standards and market confidence, manufacturers must have 100% control over the quality, consistency, accuracy and currency of everything that appears on their labels and the legibility/user-friendliness of that content. In 2021, chemical products will need to carry a unique formula identifier (UFI), a 16-character alphanumeric code required on the label of any products that contain a hazardous mixture, assigning almost batch-specific traceability to chemicals. This will constitute a further obligation on manufacturers and brand owners to manage on their labeling, whether their products are destined for consumers or industry.

Regaining Control

Such is the scale of the challenge that the industry has been dialoguing with regulators about alternative approaches to help ease the burden. These suggested help-mates range from the use of market-agnostic pictograms for safety advice to the option to move finer detail to product inserts or online rather than have to try to fit them on to the smallest spray-can, or tube of adhesive. In future, it is more than possible that apps and scan-able QR codes will make it easier to link physical and complementary digital labeling, reducing the need to attach so much information directly onto products.

But that’s in the future. For now, when changes to labeling are required, or if errors or omissions to printed content are identified, companies risk having to recall products or re-label many thousands of items while also setting up to dispose of all the labels and instructional materials already printed. As well as being very costly — potentially running into tens of thousands of dollars each time current labeling stock is rendered obsolete— this often runs counter to existing organizational commitments around sustainability and social responsibility.

Whether a manufacturer’s chemical products are consumer-facing or designed for industrial use, regaining control over spiraling complexity requires that labeling can be tracked and managed on a global, enterprise-wide scale, and assembled in a structured way that makes lighter work of change and variant management.

Centralizing Labeling Management Capability

To get there, streamlining requirements and boosting control must start with a clear line of sight across everything that is going out to the market, anywhere in the world. This means creating a single source of labeling truth of approved, current label components. If anything changes — to the brand, to the product or its ingredients, or to regulatory requirements — it can be managed in a controlled and robust way from a single, central vantage point.

One of the biggest benefits of imposing centralized structure and control like this: it creates certainty. Certainty that the right information is going out on every product, every time, in every market. In this way, the manufacturer is able to maintain safety, compliance and market confidence, plus reduce the risk of product recalls, fines for mislabeling, and the high cost of labeling reprinting and reissue.

A centralized labeling management capability can also stop teams starting from scratch when just a small aspect of a label, such as a logo or listed substance, needs to be amended or replaced, enabling a much more efficient change process. The ability to create standardized labeling templates and treat each labeling item as a composite of pre-approved text or artwork components, eliminates unnecessary process duplication, leaving skilled professionals free to focus more of their time on the elements that do need to change.

Sensitivity Parameters & Smart Tools

Enterprise labeling management can also help transform the processes involved, for instance in discovering label inter-dependencies if requirements or other conditions change, as all global label activity is mapped and tracked. The central platform can also be used as a reliable look-up for latest country-specific requirements and sensitivities, and to calculate quickly the ramifications of a single change request. Sensitivity parameters and smart rules can also be set to ensure that required logos and symbols are included, and that important information is displayed in legible fonts.

The verdict’s clear: through automation of your complex labeling activity, our sector’s regulatory burden can become controllable.

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 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.

It’s fair to say that COVID-19 has brought us all challenges in one way or another over the last few months. As a software implementation expert, changing our approach to remotely implement an end-to-end enterprise solution for artwork and labelling management has to be one of the biggest that I have faced (admittedly, it could have been worse).

Pre-Pandemic Working Practices

Face-to-face meetings and workshops used to play a key role in our implementation approach. The initial system design session has always been conducted in person, co-located with the customer and has given us an opportunity to dig deep into the customer process, see what they expect from Veraciti™ and document the details which will enable us to configure a site for the customer to review. Plus, we can start to build the all-important relationships with the key stakeholders we are going to be working with in the upcoming months.

Following on from this session, Veraciti is configured and we again return to the customer’s offices to present their prototype Veraciti configuration, ensuring that our understanding of their requirements is correct.

Making Remote Software Implementation Successful

The objectives of the sessions remained the same, despite them being completed remotely, so we had to be creative about how we were going to achieve this. Shorter sessions were set up allowing us to focus on specific areas of the system and in some cases we could brief the customer on activities that they could complete separately in their own time. A best practice document was shared, keeping the customer on track with any decisions made before the system design session. This was an efficient way of working and we even managed to accommodate different time zones working like this.

Clear communication and decision making at this stage is key. Given the challenges of remote communication, the emphasis was on asking more questions, ensuring both parties understood the consequences of any comments or decisions, which really helped us get to know and understand our customer and their business.

We also saw additional benefits in working this way, such as being able to bring other Kallik experts into specific sessions. Previously this has been difficult to do whilst on site because of time differences and not having specific times for each activity. With us moving to a remote working model, we had to plan the sessions very carefully to maximise efficiency, and this enabled us to invite other Kallik team members to support specific activities. By involving these other team members in this process, we definitely saw benefits later on in the project, and it actually helped to improve communication and alignment between our various teams.

Lessons To Take Forward

There were some challenges, too. Given we operate in the artwork and labelling space, we do like using paper and seeing things printed out. When reviewing more than thirty artworks as a group to identify the commonality and differences this is still the best way to work; you need to see them all laid out together, and this is difficult to achieve on a single screen. Managing this remotely wasn’t easy, and going forward we’ll be looking at introducing new tools which will enable us to achieve the same level of collaboration as though we were co-located.

At this point in time, we don’t know when we will be back to ‘normal’ or what that new normal will look like. However, I think it is so important to embrace what we have learnt during this time and look at ways we can make implementations even more effective. In-person meetings still have their place and add value to the process, but this time should be reduced and replaced with some smaller preparation activity sessions to ensure the face-to-face sessions are more focused. Through this approach, we can make best use of both Kallik and our customers' time.

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.

It is not a secret that behaviour and attitudes shift with time, but there has been a lot of hesitation from heavily regulated industries when it comes to adopting cloud-based systems, despite the huge benefits this offers. Historically, certain industries, particularly those in the regulated space, feared the cloud. They held the belief that cloud platforms can pose greater security risks than on-premise hosting, and that by performing tasks and storing data in the cloud latency issues would hinder efficiency and frustrate employees.

In 2001, Kallik took the bold and innovative step of developing Veraciti™ our enterprise labelling and artwork management solution, straight onto a cloud platform. With artwork management, labelling and printing being a critical part of the product life cycle, we needed to ensure we could guarantee both great performance and availability, as well as security. Since then, our customers, many of whom are in highly regulated industries, have reaped the rewards cloud hosting brings.

Unlike most other software providers who have only recently woken up to the benefits of cloud hosting, Kallik hasn’t needed to rebuild our solution to be cloud-compatible; we’ve been cloud native from day one. This year, given the ever increasing importance of security to all of our customers and our desire to continually innovate our product, we successfully and seamlessly migrated Veraciti to the most secure and leading edge cloud platform in the world; Amazon Web Services (AWS) supported by our partner, Navisite.

Stop being scared of cloud

One of the primary reasons why manufacturers from heavily regulated industries such as Medical Devices, Cosmetics, Chemicals and Food and Beverage are skeptical about moving key business systems to the cloud is fears over security and data protection. It is imperative for these industries that they store business-critical data and perform essential operations in the security environment possible. A study by Deloitte showed that security and data protection is the top driver for the organisations who are going ahead with the change.

However, a recent survey by Inc showed that 73% of businesses admit they’re not prepared for a cyberattack and according to Gartner, public cloud infrastructure workloads will suffer at least 60% fewer security incidents than those in traditional data centers. This data is challenging the notion that on-site traditional hosting is more secure; if anything, it is leaving many companies more exposed. Cybersecurity attacks are becoming more sophisticated and without technical expertise many companies will face challenges when managing security of their local infrastructure. Today, cloud hosting platforms offer better compliance, resiliency, fewer vulnerabilities and technical innovation than on-premise hosting and should be the default approach for software hosting in the future.

Cloud drives quality and compliance

One of the biggest challenges faced by heavily regulated industries is the need to constantly comply with changing regulations. AWS is a major supplier to the regulated industries and has baked in as standard all of the necessary regulatory requirements one would seek in a hosting provider. AWS is continually monitoring the market to ensure it adapts to these requirements and is fully compliant with ISO/IEC standards, GxP requirements and data privacy such as HIPPA and GDPR. The platform also frequently achieves third-party validation for thousands of global compliance requirements. Without a cloud supplier taking steps to guarantee this level of compliance, the burden of ensuring this lies with the manufacturer.  

Downtime just isn’t an option

In today's fast moving world, many manufacturers run production around the clock across the globe, 24/7 availability of data and applications is critical.  Even an outage which lasts a couple of seconds can have dire consequences for manufacturers, delaying shipments and disappointing customers. Local hosting back-ups are normally stored in a physical location nearby. When you consider the impact of natural events such as hurricanes, earthquakes and fires, storing back-ups in this way is almost useless. By using a cloud provider such as AWS, rebounding from these sorts of catastrophic events is much easier. In two years, Amazon Web Services experienced a total of only 7.5 hours of downtime, and most on-premise hosting will never achieve this sort of availability.

Looking ahead

With more and more regulated manufacturers adopting cloud based solutions, confidence within these industries is growing and the benefits are becoming more well understood. The value of using the cloud to host business critical systems which manage processes such as artwork and labelling are clear; unrivalled security, compliance and availability are built in as standard. Cloud really isn’t something to be feared; it should be embraced. But it is essential that you pick the best provider as your partner of choice.

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 quote, ‘We have two ears and one mouth so that we can listen twice as much as we speak’ is a good place to start when looking at implementing software.

As consultants, it is our job to set up our software for our customers, considering best practice and the functionality the customer has purchased. By listening to their current issues and expectations of the system we can ensure that, where possible, we achieve their objectives, create a team approach to the project, manage expectations and enable smoother management of change.

Preparation is key to success

The initial stage of system design should never be underestimated, both in the time and effort required. The more knowledge and information shared at this stage, the more accurate the configuration and the quicker the implementation. Recently, we completed an implementation for a large medical device company and we were able to reduce the implementation timeline by four weeks due to the fact that they prepared so thoroughly for the requirements gathering process. They very clearly articulated their requirements and needs, meaning we didn't need to rework or update any configuration after the first demonstration.

Implementing a new system does not mean that a customer no longer has their day job to complete. We carefully consider this during our implementations, so we will identify any preparation that can be completed in advance of any workshops to allow this to be completed within a longer time frame. This will mean that these workshops will be shorter and more efficient. We also create and share a best practice document to keep our customers on track with any decisions made before the system design session.

Be careful what you show at first

Knowledge sharing is a two-way process, and it's important at this stage to take care not to show too much of the system;  this can sometimes constrain the thinking and discussion around requirements. The show and tell is often on a generic demonstration site, time is sometimes wasted talking about specifics being shown or the resultant artwork which will not be replicated in the customer’s specific configuration. It's easy to get the focus taken away from the concept you are trying to show and for this to subsequently influence the decisions made. For example, after we’d shown the structure of a phrase library to a customer in a test environment to illustrate the concept of the phrase library, the customer replicated this structure nearly identically. This then had to be changed when the larger audience reviewed their configuration during a demonstration as it didn’t meet their needs.

Advocate best practice

Envisioning what the system will look like from the documentation and requirements is often difficult and the real test will be during the first system demonstration. This is where we show the customer’s specific configuration for the first time. Never underestimate the importance of recording all decisions and requirements.

Remember, the customer isn’t always right! I’m not for a minute suggesting that they are wrong, only that we are the experts in the use of our system and, on occasions, decisions made without having that detailed understanding of the software might not serve the customer well in the long term. We can also provide perspectives on how other organisations effectively manage similar processes, and advise what we think may work best for the customer. It is important to discuss these options to reach an agreement which will ensure best use of the system once the customer goes live.

As mentioned before, the more effort put into ensuring the system is designed correctly, the more efficient the following stages of the project will be and the quicker we will achieve ‘go-live’ of the solution. We want our customers to realise the business benefits of using our solution as quickly as possible, and for the solution to serve their needs for the long term. That is our goal.

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.

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.

Each year, new regulations come into place and the existing ones continue to tighten. As a result, organizations in highly regulated industries require high levels of quality assurance throughout their entire labeling and artwork process, yet very few are able to maintain a well-managed process from start to finish. 

Most companies continue to neglect the important final segment of the labeling process: printing, opting for manual processes that leave this stage vulnerable to countless errors. So, how can highly regulated industries optimize their factory printing process to avoid falling at the final hurdle?

The complex labeling and artwork process

One of the struggles experienced by companies in highly regulated industries is the complex multi-layered packaging and distribution process of products. For example, two or more individual products packaged together may constitute a ‘kit’, which requires its own unique device identifier (UDI). 

These same products may also be sold individually, requiring a separate UDI for these instances. When factory print solutions are disconnected from the rest of the process, there is a heavy reliance on the knowledge of the print operators to ensure that the correct label is applied to both the packaging of the kit as well as its individual components. 

This process has to be repeated for the inner label, outer label, box label, carton label and patient label, making it incredibly easy to mix them up, as well as being a lengthy process. 

Manually identifying the correct label leaves great margins for human error, even amongst the most skilled and experienced operators. Reliance on emails, printed documents and other uncontrolled forms of communication not only leads to oversight and errors, but also makes it incredibly difficult to demonstrate a clear audit trail underpinning proof of compliance.

The consequences of doing it wrong

Despite efforts to maintain high levels of quality control, errors still occur. This is primarily due to the fact that, in most organizations, factory printing is generally a manual rather than an automated process. Even when mistakes are rare, in such high-stakes industries, every mistake matters. The consequences of getting it wrong are significant, for both the organization and the end-user. 

A labeling error such as the incorrect dosage information on the instructions for use of pharmaceutical products or medical devices can lead to a patient injury or even be fatal. The result of manual processes is often an increased likelihood of these types of errors and subsequently recalls. It is reported that labeling and packaging mistakes account for between 35% and 40% of all errors seen by the FDA. These are not only costly, but also damaging to a company’s share prices, reputation and public confidence.

The disconnection between the upstream label approval process and the downstream printing process leaves labeling projects prone to errors that could be completely avoided by an intelligent, end-to-end system. A print operator manually mistyping a batch number or an expiry date by just one incorrect character can have a major impact. 

Similarly, patient specific products can require an input of up to 50 digits by the print operator to generate the correct label, and one error can lead to the wrong label or the wrong information being used. These risks are unnecessary. Connected systems can simply calculate and populate these details automatically, removing the chances of such errors occurring.

How can your organization optimize the factory printing process and minimize errors?

It is clear that the ideal solution is therefore an automated factory printing process, where the operator follows a set workflow and the only choice they need to make is what task to complete next. It is a powerful competitive advantage to have a tool specifically designed to tackle the many challenges presented by strict, ever-changing regulations. A centralized solution that connects the process from artwork creation to factory printing provides numerous benefits to organizations, including  reduced risk of errors, proving compliance and accelerating speed to market.

The benefits that an end-to-end labeling and artwork management software can provide to organizations in highly regulated industries do not stop here. For more information on the benefits of ditching manual processes when it comes to factory printing, you can read our recent white paper here. This explores the risks of a disconnected system in further detail,  as well as explaining what an automated labeling and artwork management software actually is, what it means to have one implemented and how it can give your company a strong competitive advantage.

To learn more about how Kallik can help your business to optimize its factory printing process, you can get in touch with us at enquiries@kallik.com.