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.

Medical device manufacturers can turn new product identifier requirements to their competitive advantage if they treat them as an excuse to make bigger changes to the way they manage label creation. Among the latest regulatory requirements vying for the attention of medical device manufacturers is the unique device identifier (UDI) – a universally accepted product identification standard. Included on product labels, it will make individual items much easier to trace as they move through the supply chain and out into the world. The FDA requires UDI compliance in the US by as soon as September 2014, with Europe to follow within the next 2-3 years, then China and the rest of the world. UDI is a positive step in improving patient safety. It will also help device manufacturers minimise risk and make any product recalls much easier to contain. But making the transition to UDI is a significant undertaking, so it is important that companies take a wider perspective - to help justify the investment required.

Why stop at UDI?

Addressing UDI traceability in isolation is a wasted opportunity. Companies that do this are failing to acknowledge other significant, related issues – issues which really they need to address with equal urgency. For most companies, simply adding UDI traceability codes when all of the underlying label management processes are a jumbled mass of complexity and inconsistency is to merely paper over the cracks. So rather than focusing solely on UDI requirements, think of this as a great time to sort out everything else too. That way, the wider benefits – and there will be many - will more than pay for any investment being made. All of the work Kallik has been doing with medical device producers not only takes care of UDI but,  by centralising and automating the way all forms of product packaging, labelling and customer documentation are created, approved, delivered and managed, we consistently deliver significant cost, time and risk reductions. For companies operating internationally, and those keen to take advantage of new growth opportunities in emerging markets, this efficient adaptability (which includes the ability to cater for individual country requirements, without additional labour), offers a huge advantage. It increases visibility, ensures labelling accuracy, and makes it much easier and faster to make changes to labelling output as requirements change.

Colossal savings at Coloplast

Among the forward-thinking manufacturers that have understood these broader benefits of a unified approach to label creation and management is Coloplast. The Danish company supplies specialist medical therapy products around the world, to hospitals, institutions, wholesalers and retailers. It has production facilities in Denmark, Hungary, France, China and the US, as well as international custom manufacturing facilities. Each year, it produces around 60,000 different labels. Until recently, Coloplast’s label production processes were highly manual, spanning a series of home-grown content management systems that were not interconnected. Now, however, it has migrated its labelling artwork assets to Kallik’s powerful end-to-end enterprise artwork management solution, Veraciti™. This is now up and running across several of Coloplast’s manufacturing facilities around the world. The system connects all of the different locations, and provides full, centralised control of approved legal and regulatory labelling information, while managing all localised and translated texts for individual markets. Says Jette Byg, Coloplast’s Head of Labeling & Packaging, “When we saw Kallik at an exhibition, it brought a completely different perspective to the way we could manage our content management activities. Previously, all of our labelling and packaging content had been stored as artwork files. Every change meant starting from scratch and could take months to implement, requiring approvals of local translations from 30-40 countries. Because changes happen all the time in our dynamic market, this meant we were never in compliance - we were always behind.” A year into its labelling transformation project, Coloplast has a head start with UDI, a position many of its competitors are likely to envy. Coloplast is also taking UDI compliance to the next level, by integrating its Kallik solution with its SAP back-office systems so that it can report on its UDI traceability performance.

Unified processes make UDI automatic in the US

Another major life sciences company, which prefers not to be named, is even further along in its labelling artwork management initiative. Based in the US, it is directly affected by the UDI deadline of September 24, 2014. The company is a world leader in medical devices and implants for use in orthopaedics, neurosurgery, spinal, reconstructive and general surgery. Recently, in one of its manufacturing sites, it needed to make no fewer than 10,000 changes to labelling artwork. Traditionally this process has involved 90 weeks’ work in repeat cycles of new artworks being developed, amended and eventually signed off. By investing in a centralised content management and integrated artwork generation and system from Kallik, the company has not only prepared effectively for UDI but, in the latest application involving 10,000 artworks, has reduced the effort from 90 weeks to just 10 days. This is resulting in cost savings that could run into millions. The company is also able to get its products to market much earlier, safe in the knowledge that all labeling is fully compliant with UDI and other regulatory changes (eg. involving safety symbols used on labels).

“Kallik allows us to manage all changes and approvals centrally, in a single location,” explains David, a marketing associate at the company. “Everyone works on the same, latest version of the content, rather than a series of emails that have been sent back and forth. In terms of compliance control, our use of Kallik AMS is about managing label content across the organisation - so that we can change a symbol very quickly as these are updated, and understand where patent numbers are located as these expire.”

German medical device manufacturer stays one step ahead of regulators

The world’s leading suppliers in casting, bandaging, wound care and compression stockings, is another manufacturer to have taken a centralised, automated approach to label artwork management, which has set it in good stead for UDI compliance. The German headquartered company has implemented Kallik’s Veraciti artwork automation solution to streamline the way it manages labeling for more than 14,000 different product lines, many of which have secondary and tertiary packaging. Previously, the content for individual packaging was treated as its own artwork job. “This involved the manual collation of input via phone calls and emails from global marketing, packaging development, product development, scientific & regulatory affairs, quality management and external sources,” explains its Head of Packaging Development. Typically, it would take up to 10 goes to get artwork content approved. The Kallik system saves artwork coordinators having to ‘reinvent the wheel’ each time they need to update content, or create new labelling from scratch. Routine amendments to packaging artwork can now be done without the need to involve an agency or design team. Cycle times are being reduced substantially too - from 1-2 weeks to prepare simple artwork, to 1-2 hours now.

Meanwhile compliance with all sorts of requirements, including UDI, is much easier to manage. “What stands out about the Kallik system is its completeness,” says the Head of Packaging Development. “Given the rate at which regulation can change, the level of control provided by Kallik is vital."

Change is the only constant

In September 2013, the industry had a further reminder of the frequency with which regulatory requirements can change - when the European Commission introduced new measures to restore patient confidence in the medical devices sector in the wake of the PIP breast implants scandal. Among the demands are clearer labelling (down to individual product level), and the EC has held up the UDI as an essential facilitator. In addition, manufacturers must have up-to-date procedures that describe all the processes that ensure regulatory compliance. So manufacturers must first get the internal controls right, and then be able to show the measures they have taken.

Getting the right help

With the first UDI deadline looming large, manufacturers can’t afford to bury their heads in the sand. Companies are likely to need a lot of help as they make the transition to new systems. Kallik provides a full toolkit as well as comprehensive migration support services, so can guide medical device manufacturers through the entire journey – both as they strive both to tick regulatory boxes, and as they attempt to achieve a good payback from their investment. As tempting as it might be to rush down the pure UDI route (if time has become an issue), this is a false economy. UDI is not the only new regulatory requirement on the agenda, and a point solution will only lead to a lot more duplication and work in the long run, without any real payback. Kallik’s approach to compliance involves working from a single approved set of master data which can be reused and repurposed with minimal effort but under strict central controls. It is only with this kind of transformation to internal processes that companies can hope to turn UDI and other regulatory requirements to their advantage.

We’ve been having a discussion about compliance: why it matters and how you can see it as not just a necessity but as a ‘mother of invention,’ – a way to sharpen up your business processes, and as a ‘free’ benefit of putting all you need in place to be compliant. Here’s another benefit that not everyone considers: compliance as self-protection. Both of the big sectors we work in, cosmetics and medical devices, have seen large amounts of consolidation in the past few years.

You will find large cosmetics companies buying niche cosmetics companies and medical device companies doing the same. In fact, a lot of the medical device sector is made up of small businesses; over the years they get acquired into larger organisations’ portfolios. When a large organization acquires the smaller one, they are not just buying the business, e.g. the IP, the customers, the assets – they are also acquiring responsibility. They are now liable for that firm’s mistakes as much as its successes. From the time you buy a company, in other words, if one of its products is in non-compliance, even though you didn't create the original labelling or manufacture it – it is still now your responsibility because you own that business.

Are you ready to cope with that? We speak to customers who say they need to reduce the risk of non-compliance on a range of products that they have just taken responsibility for. You need to be thinking this way, too – and seeing beyond the immediate benefits of any M&A and taking the long-term view. What you need is a plan that will help you get control over that new acquisition – which you can only do if you fully understand the risks, so you can plan to reduce them, and make your acquired asset fully compliant. We are finding a lot of our customers use Kallik solutions to assist with merging the acquisition into their business much more rapidly than would have been otherwise possible.

So that’s just a few insights on compliance – why we have it and why it can help you. I hope you’ve found our discussion interesting and we’d love to know your own views. Do you agree, for example, that you really aren’t compliant until you-know-what hits the fan – or that compliance is a fantastic tool to help in mergers or buyouts? Let us know.

In this guest blog, a key Kallik partner at professional services firm Kalypso shares their perspective on the importance of integration in the modern enterprise.

Why does integration matter?

If you don’t do integration right, you are failing to truly maximise the investment you have made in enterprise software, in the sense of leaving too big a gap between two very important business functions. Let’s back up a little so I can show you the basis of my understanding a little better. Kalypso is an Ohio-based consulting firm focused on helping clients to improve productivity and boost innovation. To that end, we’ve found the Kallik system a highly useful tool in our armoury, especially in the packaged goods sector. This is because packaging integrity and brand identity are becoming more and more important in this market, for all sorts of reasons – compliance being very important, of course, but many of these companies’ leadership see the need for integration between all the elements in their systems. And a lot of the time, we encounter two sorts of enterprise IT systems in those customer environments: the central corporate platforms, the Oracles and the SAPs, the classic Enterprise Resource Planning (ERP) suites at one end of the scale and at the other, the PLM, the Product Lifecycle Management applications, which can sometimes be from the same suppliers. Generally speaking, the first set of systems is there to take care of the overall business – to process orders, handle the finance side, and so on. At the other end of that spectrum, we have the smaller PLM solutions, whose main job is to manage the integration of product design. This is a very typical snapshot of a lot of the consumer goods as well as regulated industries, I think you’ll agree.

Where does integration come in? It comes in when you want to marry the two sides up – when you want to connect the data that is in the ERP system with what you have in the PLM system so as to have a properly unified single source of truth for all your product information. It is probably worth saying at this point that the tool we use to help bridge the gap between the ERP and the PLM sides of the business - by working with our PLM assets on artwork and labelling content which is then integrated to ERP - is, the Kallik Veraciti™ Labeling and Artwork Platform, which we are happy to see is fully compatible with the leading products in both sectors.

A new systematic way of working

But there are challenges on the way to achieving that desired integration – a lot of them. We can start with the human one. A lot of teams outside the IT side of a business can often end up resisting what they feel are ‘monolithic’ attempts to unify all their data and workflows: you find quite typically that the IT department want everything in SAP, which can be difficult for some people in the business given the complexity of that very rich system. That’s sometimes compounded, in our experience, by the artwork side of the house not being too keen on being expected to work with PLM-style systems, either. Sometimes, you find the artwork team is just not really that convinced of the value of working in a systematised way, be that with ERP or PLM. The next level up in terms of integration challenges is the technical aspect of the integration (between ERP, PLM and artwork and labelling). To make that work, you have to be very sensitive to the architecture underpinning the proposed joined-up system you want to see emerge here. The key here is the old adage of KISS – it really does pay to Keep It Simple (Stupid). In the past, the technical elements of an integration project might be much more nuts and bolts, to do with making two non-standard or niche systems talk together. That’s less of an issue now, as so many organisations have standardised on SAPs and Oracles, for both ERP and PLM, as well as SQL RDBMS. So the main face of integration now is that overall architecture side, we are finding. Beyond human/cultural issues and possibly technical/compatibility hassles, what other challenges are there to effective integration around the packaging and labelling process? We find the final one to often be around business process integration. How does a business process around packaging, artwork and labelling management need to be adapted for seamless integration of data to take off?

The human factor (redux)

To some extent, this hearkens back to the people issue I mentioned, but at a level of greater complexity. There are often big changes here in the work styles and daily activities of team members that need to be carefully thought through and sensitively handled; get this stage wrong and your whole effort may end up going nowhere, frankly. Make sure you build in time for people to get used to new ways of working with artwork and labelling post the introduction of an integrated process via Kallik, is my advice. And we all may have to. In the past 20 years or so we here at Kalypso have seen more and more parts of our customers having to get to grips with integration, which is now touching more and more highly creative people who haven’t been asked to deal with this sort of technology before. We need to help them get used to this and get comfortable first if we want to get the main benefits of integration here: better throughput and efficiency. No pain, no (lots of) gain? It’s easy to lose sight of why we’d want to put in efforts around integration. The truth of the matter is that there is a huge value to be gained, despite these challenges. I always point to the Kalypso customer that implemented integration via Kallik and realised a 40% improvement in turnaround due to saved time and errors as the proof point as to why we want to do this. And if we can not just produce accurate artwork assets quicker but re-use those assets throughout the enterprise, then that’s also promoting efficiency as we are clearly not re-inventing any wheels any more.

My final comment, then, is that for any sort of company that has a lot of investment in packaging and labelling, that needs to get them right or done better, integration – for all the organisational, and, to a lesser extent these days, technical challenges it creates, it really does have to be the face of the future. I wish you good luck with all your integration efforts!

Transparency and visibility – most would agree that both are essential for accurate insight of any enterprise-wide process. Labelling and artwork management is no different. More often than not, it’s the lack of tools and not the lack of intent that’s the problem. In our last blog, we spoke to you about the problems caused by poor oversight and the need to better manage the constant flow of changes coming from multiple sources. Addressing these issues is the key to better management of corporate labelling activities that by nature, are often complex and highly dispersed. Lack of accurate insight, process delays and re-works aren’t problems that labelling and artwork teams should learn to live with because with the right approach they can be fixed. Also, identifying the bottlenecks and taking corrective action to shorten the labelling cycle is not just a technology issue. It will require commitment and personal ownership. Some changes may feel uncomfortable, but this is better than allowing problems to fester, compromising best business practice.

We’re probably all guilty of getting email attachments and forgetting to do our due diligence – reading the content, taking action, sharing with others and filing appropriately. When it comes to labelling and artwork, the issue is compounded by the sheer number of people and tasks engaged in the process. More rules and procedures are not the answer. What’s needed is to automatically capture all actions taken by contributors and reviewers as they complete each of their tasks. This enables the move from managing by perception to managing by facts. Also, if robust processes are in place and people realize they are being monitored – albeit in an ethical way – they are more likely to complete tasks on time. Being able to drill down and produce a report that shows who received a piece of text or image for approval and when, makes it’s easier to identify and fix issues that may be causing costly delays. Such a capability has value at a high level and in terms of detailed insight, giving you a 50,000 foot view of your overall labelling processes, spotting where the disconnects occur, and then being able to hone in on the precise problem and determine what the hold-up is, why and how best to move forward. Is it a process issue? Is it an individual problem? Or is the challenge departmental?

Having this level of insight makes it easier to fix the problem and fosters a culture of accountability. It’s no secret that every day spent waiting for documents to finalize labels or tackle labelling changes is a capital loss for a life sciences company. So companies can’t afford the hold-ups that occur because of poor process or lack of accountability.

What needs to happen to bring about better, more efficient processes?

The first thing you need to do is to store all labelling as structured content. For example, the phrase "not suitable for children under 12" constitutes an individual asset. If translated into a different language this would be classed as another asset, each being individually version controlled. In this way, all actions associated with any piece of content are captured, giving a comprehensive audit log of any changes. Every interaction is timestamped including when an artwork or asset transitioned from one person to another. Let’s go back to an issue we raised in the last blog: that changes represent between 75% and 90% of labelling activities. Now imagine you’ve approved and stored the phrase, “not suitable for children under 12” but that phrase now needs to change to “not suitable for children under 15”.

Clearly all impacted labels need to reflect the change – including localised translations. The problem is how do you know where that phrase appears, and how are you going find that information? Done manually this can take months and you’ll never be sure that all impacted labels have been updated. If everything is stored as a unique traceable asset, you can then find it immediately. Changes can be made simply and quickly. You will then be in a much better position to demonstrate compliance without the overhead of pulling together disparate pieces of evidence contained in documents, emails and attachments.

That’s the type of issue that typically keeps regulatory affairs executives up at night wondering, Questions such as: “Did I also change those labels for Argentina, was the translated phrase approved and how can I demonstrate this to the auditors?” They struggle constantly with unknowns and uncomfortable uncertainty. Accurate reporting of approval and review processes, encouraging accountability and being able to manage data as structured content will give regulatory affairs executives peace of mind and, perhaps, put a stop to those sleepless nights.