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.

Want to know more?

Whether you’re in the food and beverage, pharmaceutical, medical device, chemical, or even the cosmetic industry, our experts are ready to help you transform your labeling and artwork management with the help of our innovative software, leading the way in the labeling and artwork software space.

Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100.

In 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!

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.

Every day it seems we see more and more articles published promoting the benefits of embracing digital transformation across healthcare supply chains. Few, if any however, seem to provide much insight on how to ‘digitally enable’ labeling and artwork processes to embrace this revolution.

What actually is a digital transformation in the healthcare industry?

Before looking at this specific challenge in more detail, let’s reflect on what a ‘digital transformation’ in healthcare means and who it impacts. Firstly, no one would dispute that we would want patients to be the greatest beneficiaries both at the diagnosis or treatment stage. After all, we are all likely to find ourselves at the receiving end of healthcare provision at some point in our lives.

Secondly, there are the healthcare providers. It’s possible that the traditional patient-doctor relationship will cease to exist as we each become better informed. We’re also likely to see an increasing level of diagnosis and treatment delivered electronically. Mobile and wireless applications are already transforming the role of healthcare provision in patient monitoring and treatment as reported by the Financial Times (2017).

Thirdly there are the manufacturers to consider. Both Pharmaceutical and Medical Device companies are experiencing disruption caused by the digital transformation in healthcare, both in areas of diagnosis and treatment. A recent study carried out by Roland Berger (2016) estimates the value of digital healthcare products and services to exceed USD200bn by 2020, growing 20% per year. In their article entitled ‘ Six ways digital is changing the pharma & healthcare industry’, Econsultancy (2017) suggests that consumers are becoming ever more motivated by finding the best treatment and the cheapest price.

Steps to digitally enable labeling and artwork processes

If we are each in agreement that we are in the midst of a digital healthcare journey, we need to ask ourselves what steps we’re taking to digitally enable our labeling and artwork processes. Without doing so, we risk jeopardising the agility of our healthcare supply chains and ultimately, patient outcomes. But it’s not just the digitization of supply chains that will be disrupted, if unable to quickly and accurately persist electronic product and prescribing information across multiple channels, healthcare providers and ultimately their patients are likely to look to more enabled suppliers for their medicines and devices.

This is one reason why here at Kallik we’ve always believed that the best way of managing labeling content is as a library of re-usable digital assets. Securely managing all product and prescribing related information in a single version controlled environment enables unlimited composition, re-use and printing of any type of label anywhere. Furthermore, your labelling becomes ‘channel agnostic’, that is it can be delivered through multiple channels (web, mobile, social) as well as via the more traditional paper-based means of presentation.

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.

Understanding EU MDR

Europe’s medical device regulations are changing, bringing about some of the most substantial shifts to the ways in which manufacturers bring their devices into the EU market, and how compliance must be maintained throughout the product lifecycle. The regulations strive to increase the traceability and safety of medical devices in the EU market, expanding on requirements including product classification, own brand labelling, regulatory submission evidence, and post-market surveillance. 

Although EU MDR came into place in May 2017, medical device organizations have until 2020 to transition completely. Despite this, there is still an overwhelming 78% of organizations who do not currently have sufficient understanding of the requirements. Failing to produce accurate, MDR-compliant labeling and patient information could cause delays in market entry or even product recall. It is imperative, therefore, that organizations begin reviewing their labelling ‘real estate’, documentation, and system processes to ensure compliance with new, more complex regulations. So, what are some of the key changes you need to be prepared for?

Device warnings and precautions

Previously, all written warnings and precautions relating to a device were detailed in the Information for Use (IFU), however, new regulations state that these must now be present on a label in text form. This will bring translation into the mix – requiring ‘clearly comprehensible’ labeling in the intended user or patient’s national language. In addition, this also brings about the issue of designing labels with adequate space for new information – especially with some languages requiring more than others.

EU UDI: tracking and tracing 

As part of the MDR, a Basic UDI-DI is being introduced. This refers to the relationship between what is a family of products that may otherwise appear to be unique individual products e.g. if one product in a family has manufacturing defects and needs to be recalled, the Basic UDI-DI shows this relationship. The Basic UDI-DI itself doesn’t appear on the label, but an organisation must be able to identify and trace all other related products as a result of querying the UDI on the label via the EU UDI database (EUDAMED), in turn creating a more secure global supply chain. 

This relationship is something that medical device manufacturers will need to capture and make available for on-demand searches by patients, providers, and notified bodies with the ask made much simpler by connecting previously disparate labelling processes.

How can you prepare? 

See it as an opportunity - The challenge many organisations face is a lack of tools, systems, and processes to be able to dynamically identify and update product labelling in suitable timescales. All, of course, whilst retaining fluidity, compliance, and avoiding disruption of supply chains. Although challenging, the EU MDR should be seen as an opportunity for organisations to review the effectiveness of their current labelling and artwork processes, and how digitalising supply chains can strengthen compliance and simplify evolution toward e-Labelling.

Develop a clear strategy  - Creating a clear strategy across your organisation for implementation will make the process of preparing your labelling infrastructure simpler. It is important to carry out an assessment of your current processes and documentation to determine which elements must be modified to meet the new regulations – these may include Quality, Regulatory, Operations, Supply Chain, Legal, and R&D. Engaging all teams will ensure a collaborative, more streamlined strategy and robust implementation is achieved.

Adapt your processes - Adopting a joined-up, cloud-based labelling and artwork management solution is a key way to ensure an organisation is prepared to manage the EU MDR’s regulation and compliance changes in a more efficient manner. A platform such as this allows all users to access labelling and artwork assets via a single, centralised system, giving them full line of sight across all data assets. In addition, this platform will allow for up-and-coming changes to be managed in a fast and efficient way, future-proofing an organisation’s labelling systems in all territories.

With May 2020 fast approaching, it is imperative you act now. Assess your labelling and artwork real estate and ensure you have the operational agility to prepare for change. The implications of the inability to market your medical device products in the EU can have huge ramifications on your organisation. The countdown has begun. 

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 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.

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.

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.