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.

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.

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.

In our last blog, we discussed the need for transparency and visibility throughout the labelling process. Reducing the risk of product recalls and non-compliance being the goal. Most would agree that given a clear mandate plus an appropriate level of investment, this can be achieved. Not always easy, but certainly possible. Introducing the required cultural and organisational changes can be a different subject altogether! But what if part of your labelling processes are outsourced either because you’d prefer not to have the overhead or, like much of the life sciences industry, your supply chain spans many CMOs (Contract Manufacturing Organisations)? Now let’s add some new legislation into the mix just for fun.

If you’re a pharma manufacturer, meeting the DSCSA (Drug Supply Chain Security Act) and FMD (Falsified Medicines Directive) requirements for product and package level serialisation is probably going to be at the forefront of your mind right now. If your business is med devices, then it’s likely to be maintaining integrity of UDIs throughout the supply chain and the task of getting your labelling content ‘fit for purpose’ ahead of upload to either the GUDID or EUDAMED (or possibly both) that will be grabbing mindshare. Before we go any further, let’s look at current supply chain trends across the life sciences industry. According to a survey carried out by NICE Insight in 2016, 69% of pharma and biotech companies expected to increase their use of CMOs going forward – business drivers being to increase agility whilst reducing costs. Gaining rapid entry into emerging markets, portfolio transformation and new partnerships and alliances are contributing factors to this increasing trend. The flip side of this being the risk of non-compliance from introducing multiple potential points of failure.

So how do you maintain the integrity and accuracy of your labelling content when your global supply chain may include tens, if not hundreds of affiliates sitting between you and your end customer? How do you also validate that what your partners print on the label aligns with content submitted as part of the regulatory approvals process, including that which is required to satisfy local HA’s?

This is where adopting a cloud based labelling and artwork management solution helps to remove the barriers and disconnects that can often occur across highly fragmented supply chains. Implementation can be quick and easy and new partners can be onboarded with minimal integration effort. Suddenly, the headaches of trying to exchange and align both static and variable labelling content across 3rd party systems and processes is removed as everyone and everything is connected. Content is all held in one place – safely and securely. Every partner can be become a user of the solution and with appropriate permissions, users can review, edit or approve content. Better than this, corporate oversight becomes a given ensuring management by truth and not perception. So much for managing static content.

How about the challenge of ensuring alignment of serialisation and UDI content across highly distributed supply chains. How do you also ensure integrity of variable data at print run time with the inevitable disruptions caused by manufacturing downtime and labels that need to be re-printed for quality purposes? Well, here again having ‘variable’ (i.e. print run time) as well as ‘static’ content captured in one single place makes it easy to recover from such situations without risking duplication or inconsistencies. In our next blog, we’ll talk more about the specifics of capturing and managing variable run time data and how this might work in practice. 

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.

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.

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.

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.

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.

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.

As leaders in highly regulated industries embrace Industry 4.0 and best practice labelling and artwork, they must recognize that all stakeholders need to be fully empowered and connected at all times. Here are some of the steps that can be taken to simplify your labeling supply chain, along with some of the operational and financial benefits that this can deliver.

Frequently, global organizations are hampered in their attempts to improve supply chain efficiency. Often, this is due to multiple, localized approaches that have evolved over time to solve individual country needs despite product commonality. Alternatively, it could be the result of M&A activity, with newly acquired operations continuing to run their own discrete systems and processes. In many cases, it’s usually a combination of both.

Although not without risk and potentially being highly disruptive, moving to a more streamlined supply chain needs to be embraced if organizations are to remain competitive and reduce time to market. In their report earlier this year, the World Packaging Organisation emphasised the importance of accurate packaging and labelling and how this can contribute to overall supply chain performance. Furthermore, consolidation of multiple production facilities can only be achieved if the labeling integrity can be guaranteed at a local level. The question is, “How can I achieve this without disrupting existing supply chains?”

One way is to eliminate as much complexity at the local level as possible by transitioning from ‘tribal knowledge’ to formal processes. Rationalizing stock down to a minimal quantity of graphically consistent labels is the first step. You then need to look for a solution with in-built flexibility to accommodate local language and branding variations that link back to master content managed centrally. This will drive down complexity across the print supply chain and reduce the amount of time spent unnecessarily managing duplicate content. Migrating to a new cloud-based platform that simplifies connectivity with local print resources also means that much of this consolidation can be achieved ‘off-line’, without risk of disruption to existing production processes. This also unlocks your supply chain, simplifies late stage printing and enables you to collaborate with multiple partners whilst improving labeling accuracy.

Where adopting this approach, we’ve also seen organizations being able to increase artwork production capacity without increasing numbers of staff. This being due to the vast reduction in the number of label layouts being managed. Having the ability to ensure exact placement of graphics also makes it possible to leverage greater return from investment in print plates through their re-use.

Consolidation of label creation around a global master file also simplifies change management. The almost constant stream of updates driven by country-specific regulatory changes and differing language combinations that global organizations often experience can be managed as ‘business as usual’. This also makes it much easier to demonstrate compliance against approval processes, eliminating the need to trawl back through email and country-specific documentation to find the necessary supporting evidence.

Forthcoming regulations (including the new EU MDR regulations coming into force May 2020) require labeling content to be published electronically in addition to print. As companies seek to continuously differentiate themselves in established markets as well as gain entry into new territories, the increase in both volume and complexity of product and market variations will have a direct impact on labelling. Transforming existing paper-based legacy artwork management systems and processes to a new digitally-driven environment are two concepts that can, in fact, work together to help highly regulated industries reduce the risk of non-compliance and costly product recalls.

Firstly, all parties or stakeholders, including regulatory, marketing and manufacturing must have access to the same system that masters the content – this means they must have access to the correct level of permissions in order to edit, modify and review the labelling content as needed. Secondly, when much of the labelling content is held in a range of documents, emails, PDFs and printed documents, it can become difficult to construct, deconstruct and reuse labelling content. These organizational challenges, therefore, need to be overcome, calling for the digitization of all labeling assets. Labeling and artwork processes have tended to be seen as more of a cost overhead rather than a core business activity. This can lead to systematic failures due to a lack of clear ownership, loosely defined decision-making processes and too much reliance on ‘tribal knowledge’. In other cases, need to make repetitive ‘low-level’ decisions manually, where these could otherwise be easily automated can lead to fatigue and unnecessary errors. The end result can be costly product recalls potential fines and brand damage through non-compliance.

This is where the ‘business rules’ approach comes in – managing the decision-making process as a set of business rules allows for more responsive changes or additions to processes as this can be undertaken by business users as opposed to writing code. Whilst we could choose to implement a standalone business rules engine to automate many of the existing manual driven processes that often exist, we would still be left with the challenge of discovering and extracting the source content needed for each label variant. The way we can overcome this is by digitalizing and versioning each of our labeling assets (logos, warning statements, images, etc.) and ensure that these are easily discoverable. We can then configure our business rules engine to find, and subsequently populate, each of the variable fields we may need on our labels depending on where the product is going to be sold and which local market legislation needs to be adhered to.

Much of the medical device industry is quite rightly focused on understanding the impact of the legislative framework and being in a state of readiness to populate the EU equivalent of the GUDID, this being EUDAMED (European Database on Medical Devices) by May 2020. In addition, implementing the upcoming European Unique Device Identifier will require considerable investment and strategic planning for many organisations, so now is a good time to consider options for process re-engineering. At Kallik, we see the EU MDR as an opportunity for organisations to review the effectiveness of their current labelling and artwork processes and how digitising supply chains can strengthen compliance and simplify evolution toward e-Labeling. 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.

Adopting labeling digitalization enables more robust regulatory submissions and ultimately increases the transparency of enterprise-wide review and approval processes. This can simplify the integration of extended supply chains and shorten time to market during periods of mergers and acquisitions.

It’s been widely acknowledged and accepted by leading thinkers in the pharma industry that, in comparison to other industries such as automotive and retail, it lacks the vital innovative and modern methods that are being encapsulated by the fourth industrial revolution, Industry 4.0. It is all too common-place in the industry to see high inventories, slow responses to demand changes and stock-outs, which contribute to a high cost base and more importantly, a number of missed revenue opportunities. This is an approach which sees many of the well-established players in the industry remain stuck in the past. It is synonymous with highly risk-averse industry and shows the reluctance to move away from legacy infrastructure. However, without change, the industry will be challenged in meeting the quality risk management approach set out in ICH Q9.

What also needs to be considered is the swiftly changing workforce dynamic. Baby boomers have shaped the systems and processes that underpin drug approvals, manufacturing and distribution processes. By doing this, to a certain extent, has helped this generation protect their positions, by continuing to use legacy paper-based processes that simply don’t integrate in the web-enabled world. But this is a dated, old-fashioned approach that has fallen behind the new-age of working. This generation of workers has extended the life of these systems and processes, through the blockbuster driven industry growth period of the late 20th and early 21st century. But that era is now over as we move towards much more tailor-made treatments. Another dynamic created by this environment is that it tends to foster a culture of ‘individual knowledge’ as opposed to ‘organizational knowledge’.  The pharma industry, by nature, tends to attract and retain individuals with deep levels of knowledge and expertise, sometimes at the expense of creating a more open, collaborative environment.

Global connectivity and instant communication is an essential and expected part of our everyday life. Systems such as legacy and monolithic cannot compete with predictive, intelligent web-enabled applications and are rapidly becoming unfit for purpose. Generations Y&Z as well as Millennials are being actively targeted and employed as an attempt to develop and modernize the industry. Adopting this fresh approach will lead to new collaborative, data, social and mobile driven work practices being embraced. This however does not come without its challenges, as without the investment towards the technologies and disciplines, there is the risk that this new workforce will end up feeling isolated and unempowered.

Labeling: new processes, new mindsets

A connected workforce is of paramount importance when discussing the core of any new information-enabled enterprise. The pre-requisites for this to happen are already within our day-to-day living and working environments. We use the internet, social media, apps and mobile smartphones almost without thinking. Both consciously and unconsciously, we have already begun to embrace the modern-day technologies available to us. Information and data are crucial to any such enterprise. But if we can’t access, manipulate, re-purpose and report on this data, it really does have limited value. This is the current situation we are in, with data being locked down in such examples as PDFs, emails and word documents. Labeling, when considered as a business application, is no different to this. Guidance on GxP data integrity published by the MHRA on March 9, 2018, talks about the need to design systems and processes to assure data integrity, leading to improved levels of compliance and more robust data governance.  This same data (or a subset of it) will be available for multiple purposes: research, submissions, approvals manufacturing and printing.

And, with new collaborative cloud-based technologies, it can also be shared with partners, suppliers and end-users via mobile and web technologies. We have a lot of locked-in data that needs to be released if we’re going to empower the new workforce. The benefits of doing this will stretch beyond labeling of course, but labeling is a great place to start, as it allows us to introduce new technologies and processes that can have an immediate impact on the bottom line. This not only increases clarity as to who is the curator of the data and who has the authority to share, but also increases traceability as it becomes much easier to find where data has been used. Even if something is not right, we can understand the impact and correct it straight away. With improved levels of data integrity, data accuracy is improved, is easier to share, and more visible for the purpose of reviewing and approving prior to it appearing on product and package labeling. But from a financial and efficiency perspective, the multi-purpose use of data lowers the risk of product recalls, has greater levels of collaboration across supply chains and increased accuracy.

Due to the data only ever existing as a single entity, this streamlines the process, rather than having multiple instances of the data shared across different documents, emails, PDFs and spreadsheets, with no clear ownership. Potentially, staff turnover will also be reduced as the workforce can crossover skills from their personal lives into the workplace. This would look to re-energize the workplace and revitalize other functions. Departments will be able to see what can be done with business benefits becoming visible through transparent reporting. By embracing better quality risk management, increased levels of data integrity and a shift in organizational culture, the pharma industry will be much better positioned not only to respond effectively to new legislation, but to build a sustainable business in the new area of patient-centric medicine. Simplified systems and processes will bring new levels of transparency to labeling and artwork leading to reduced risk of non-compliance through an increasingly engaged and motivated workforce. 

People often ask why we stress the difference between a document-oriented way of looking at managing your product and brand information and a ‘data’ one. It’s a great question, and can best be answered like this: you’re a manufacturer of a single product line. Let’s say you’ve had some success, and your product is sold in 10 countries. It gets a bit complicated now, but not unrealistically; let's say your product comes in three sizes, or versions. Even at this level of simplicity, you have potentially 30 different labels (10 countries, three different iterations) to worry about and change. Now, here’s the issue. In a document-centric world, where people are managing document files in the same computer system, that’s 30 separate items you are managing. Granted, 90%, maybe 99% of the content in all of those word documents is the same as in the other 29 Word documents, which means the same data is duplicated many times.

What happens when you hand over those 30 documents, even if they are almost all identical, to an in-house graphics department or a third party to build artwork? First, artwork gets created at least two or three times. So, for each of the 30 artworks, I’ve now got 30 additional documents telling me what to change. But here’s the thing, the problem on label number one is also wrong on all other 29 labels… so, I've got to change 30 Word documents and make the same change separately to each one. If they then get changed twice, or should I say ‘only’ twice, you’ve gone from having 30 documents to having 90 documents. And the reality is that when somebody reads a document that has been through three sets of changes, as they are only human, something they were happy with in the first version and passed, they now see in the third version and decide that it is wrong. They tell the designer to change it, they make the change, but the 29 labels are now out of sync.

This happens every day of the week. It happened in your office today! Remember, I’m only talking about one product here, but I have still ended up with 90 documents in circulation that can all potentially go out of sync. Add to that the files on the designer’s Macintoshes, and I’ve got another 90 Mac files on top of the 90 Word files in play. That’s what happens when you focus on documents. We work with clients with thousands of products. That’s thousands of documents going wrong all over the place… thousands of files that need to be tracked down and updated separately with the vital textual change from the latest legal directive from the EU. The problem with the way the Word, email or document-centric approach works is that you have to duplicate the data everywhere. This is simply unmanageable – and while it’s bad enough at one product, think 1,000 products or 2,000… Next time, we're going to present the other approach – the data one, which I think you will agree is a lot less confusing and difficult to manage and get right.  

When it comes to the medical devices supply chain, it can often seem to be made up of a series of isolated steps from product development through to the patient or healthcare provider. Labeling digitalization across the supply chain therefore, can help build a more integrated, fully transparent supply chain for all involved in the process. As a result, this can help organizations move beyond compliance, to drive wider company improvement.

Consistency is key

From product development, right through to customer fulfilment, labeling is an essential element to ensuring the process runs completely smoothly. The supply chains of Life Sciences are highly complex, made up of multiple tiers of suppliers and wholesalers. Therefore, in order to optimize the elements of the labeling content associated with medical device products – labeling that’s associated with a product or attached to the product, the packaging materials or the bulk of the shipper cases – a single source is key to ensuring all parties involved can access the most up to date content files. A consistent, single source of content that can be used from submissions through to design and production across the supply chain is the most important element. This ensures that all individuals in an organization are sure they are using the most up to date, approved version of content.

What challenges face digitalising the supply chain?

Accessing the original source of content that was used to compile a larger, often undigitalized PDF, email or printed format, document is one of the biggest challenges facing the medical devices industry. Finding multiple instances of the same content across different factories and facilities can make it difficult for specific phrases, statement or symbols to be reconstructed or reused when needed and also compromise compliance. Therefore, ensuring your labeling and artwork processes are consistent and interoperable is key. This can be achieved by carrying out the following:

• Ensuring all source label content is in a digitalized format and held in a master file
• Allowing all appropriate parties to access, edit, modify and review this master file

Following these steps will allow your organization to create a fully transparent supply chain, which will also allow for collaboration between more specialist partners and providers.