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.

Last week’s UDIs and Traceability Conference in Brussels brought with it some excellent weather and it was a delight to experience this vibrant city in such fine conditions. However, it wasn’t just the weather that was topical. The publication of the European Medical Devices Regulation on 5th May 2017 and its impact on the industry has also been raising the temperature of the debate within some circles.

Let's recap the event

Before we get into that, we should first thank IQPC for assembling a highly relevant conference programme delivered by some of the leading industry experts in their field, including our own CEO, Neil Gleghorn. We were highly privileged to receive first hand insight from speakers spanning the regulatory, standards and device manufacturer communities including the FDA, GS1, GMDN, Teleflex, Abbott and bioMérieux to name but a few.

So what did we learn? Well, in a nutshell, it’s all about the data. The FDA for one acknowledged that not only does data have value, but structured data has increased value. It transpires that the biggest problem the FDA have experienced to date with submissions to the GUDID has been data accuracy. As UDI implementation in the US is moving closer to Class I devices an increasing number of healthcare providers are picking up inconsistencies between what’s printed on the package label and the content uploaded to the GUDID – clearly impacting compliance and traceability. Switching our focus to the European equivalent of the GUDID - The European Database for Medical Devices, (or Eudamed) we’re likely to see more of these challenges.

The newly introduced EU MDR
 

Firstly, the EU MDR directive introduces a new identifier not seen elsewhere: Basic UDI-DI. This is the primary identifier of a device model used for market surveillance and clinical investigations. The Basic UDI-DI needs to be assigned ahead of product registration and enable device traceability across all corporate functions, not just the supply chain. Secondly, we’re going to be seeing different drivers from different countries spanning data sets required for regulatory, traceability and commercial purposes. The UK NHS eProcurement Strategy, being one such example. Thirdly, all data for all classes of device must be submitted to Eudamed by May 26 2020. That’s a tough ask when the general industry consensus is a 3 to 5 year implementation timeframe.

So how does this impact device labelling? 

Despite the requirement for printing of UDIs on product and package labelling coming after the above date, we here at Kallik see little distinction between the two. Reflecting back on the FDA’s comment regarding the value of structured data it seems to make sense to apply this to attributes associated with labelling. Doing so vastly simplifies the capture, collation, approval and traceability of such content. Also, given that we’re currently waiting for clarity on the data elements required for Eudamed submission, getting started now with adopting a structured approach to managing labelling content will trigger the organisational culture changes needed to ensure readiness. In my next blog on this topic, I’ll look more at these issues and discuss how having a single source of truth for labelling content sits comfortably within an enterprise-wide data governance approach for achieving UDI compliance.

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 our previous UDI blog, we talked about the dynamic nature of labelling and artwork content. We also suggested that there could be a difference between what is classed as ‘master data’ and what might be a single source of truth’. 

In this, our third and final blog reflecting back on the IPQC UDIs and Traceability conference in Brussels last month, we’ll be discussing how adopting best practice for managing labelling and artwork related content can bring early business value to UDI projects. Before we do that, let’s return to some of the discussion points from the event around data quality. We heard from the FDA that the biggest issue in the US is the quality of data submitted to the GUDID.

UDI is not simple 

Granted that out of the 65 data attributes uploaded to the GUDID for each product, only 12 or possibly 13 are related to labelling content, but inaccuracies in product nomenclature could at best lead to expensive product recalls and at worst, patient injury and huge fines. It was also said by one prominent speaker that UDI is a company-wide project. The point made here being that UDI is not something that can be successfully implemented by one department alone, it needs executive level sponsorship with cross-functional collaboration and clear ownership.

So accepting that UDI is not simple, let’s turn our attention back to data quality in the context of labelling. Data quality is characterised by levels of accuracy, completeness and consistency (or standardisation). Having the wrong name on the wrong product is not a data quality issue, but having a misspelt product name or one obfuscated by spurious characters is. So what can be done to minimise these risks and why the attention paid here to a subset of UDI attributes rather than the majority? Well, when we questioned the FDA at the conference as to whether any penalties had been so far levied on organisations submitting inaccurate and/or incomplete data to the GUDID, their response was a simple “no.”

They said they recognised the enormity of the task for some companies (particularly as we move through Class II to Class I devices) and are preferring to take a supportive rather than a vengeful approach. This would not be the same for inaccurately labelled products – this we can be sure of! It is understandable why the majority of the industry is focused on getting submission data right first as the EU MDR calls for all attributes relating to every class of product to be uploaded to Eudamed by 26 May 2020. But like the FDA, plus given the enormity of the task facing manufacturers selling into the EEA, it’s likely the EMA will go for a ‘soft’ rather than ‘hard’ enforcement. However, the problem the industry is trying to solve is not ‘just’ submitting the right data in the ‘right’ format to either the GUDID and/or Eudamed database, it’s much broader than this. It requires (as one speaker from the industry asserted) corporate level sponsorship, executive oversight and buy-in from all stakeholders. So back to labelling and artwork.

The opportunity in UDI
 

At Kallik, we see UDI as an opportunity to jump start implementation of best practice for UDI compliance. By first getting to grips with discovering, standardising and nominating stewardship of each of the attributes that constitute a product label, you’ve taken the first steps towards implementing a robust data governance framework. This will also provide ‘advance standing’ for broader UDI compliance. Everyone from regulatory through to supply chain has a role to play in labelling, so why not start here and use this as a pilot for rolling out the policies and procedures needed for the broader suite of attributes required for UDI?

The great thing about taking this approach is that it will demonstrate clear productivity gains for labelling and artwork processes and potentially de-risk your broader UDI project. None of the above requires you to rush out and invest in an IT solution may in the end turn out as not being fit for purpose. A better approach is to first look at where your priorities lie, understand who owns your data and what needs to be done to make it UDI ready. Focusing first on the subset of data required for labelling is likely to make this much more manageable. If you do decide to explore this as an approach, we here at Kallik would be delighted to support you throughout your journey.

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.

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

What are some of the key EU MDR regulation changes?
 

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

Bolster your compliance processes

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

Create downstream value
 

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

Addressing key challenges
 

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

How you can prepare: become an evidence-led organization
 

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

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

Want to know more?

Whether you’re in the food and beverage, pharmaceutical, medical device, chemical, or even the cosmetic industry, our experts are ready to help you transform your labeling and artwork management with the help of our innovative software, leading the way in the labeling and artwork software space. Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100.

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

A Shock to The System?

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

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

Labeling Moves to Center Stage

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

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

Control & Visibility Are Your New Watchwords

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

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

… But Integrating and Harmonising Processes Takes Time

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

Change Is Now Here for Good

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

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

Want to know more?
 

Whether you’re in the food and beverage, pharmaceutical, medical device, chemical, or even the cosmetic industry, our experts are ready to help you transform your labeling and artwork management with the help of our innovative software, leading the way in the labeling and artwork software space. Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100.

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

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

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

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

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

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

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

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

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

Stay safe and we will get through this together. 

Want to know more?

Whether you’re in the food and beverage, pharmaceutical, medical device, chemical, or even the cosmetic industry, our experts are ready to help you transform your labeling and artwork management with the help of our innovative software, leading the way in the labeling and artwork software space. Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100.

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

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

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

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

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

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

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

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

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

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

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

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

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

Want to know more?

Whether you’re in the food and beverage, pharmaceutical, medical device, chemical, or even the cosmetic industry, our experts are ready to help you transform your labeling and artwork management with the help of our innovative software, leading the way in the labeling and artwork software space. Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100.

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

Where are we now?

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

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

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

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

So what exactly is the IFU problem?

Having anything from 100 to over 1,000 IFUs is not uncommon for a mid-sized device manufacturer. Re-writing in a style appropriate for the user, the addition of new symbology and statements, plus translation into 20+ EU languages is making the task of updating these to comply with EU MDR much larger than first anticipated for many device companies.

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

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

Doesn’t PLM already solve these issues?

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

Back to labels…

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

Back to the future...

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

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

And here’s the proof...

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

Through adopting our approach, creation of multiple language EU MDR compliant 30 page IFUs is down from 3-5 hours to just 30-40 minutes with the time taken to generate individual labels reducing from 1 hour to around 10 minutes. With 350 IFUs and 10,000 labels, 5 person years of lost time has been recovered just for Class III devices alone. More than this, it’s freed up resources to start preparing for Class II compliance.

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

Finally, buying back lost time...

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

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

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

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