Global medical device companies are increasingly looking at labelling from a strategic perspective. They have recognized that accurate labeling is critical for maintaining compliance, ensuring brand consistency and improving operational efficiency, with all three helping to support business growth. To work as efficiently as possible, labeling needs to be integrated into an enterprise business process, as well as working efficiently with an existing solution. Below, we outline some of the best streamlined approaches organizations can implement for the long-term benefit of their business:

Adapt and adopt

Life sciences companies need to adopt processes and solutions that will enable them to respond rapidly to change and achieve actionable insights across the entire labeling life cycle. This will enhance collaboration with all relevant stakeholders and improve regulatory operations. Adopting a strategic, enterprise-wide approach to labelling will see both huge benefits, and drive value to companies. By adopting a joined-up approach to managing labeling, text, artwork, packaging and promotional materials, medical device companies will be able to ensure country-specific legislation is obeyed and labelling changes can be made quickly and accurately. There needs to be clear visibility between functions and regions, otherwise companies will struggle to achieve cost reductions and productivity that could otherwise have a positive impact on faster integration of newly acquired businesses. Improved management and visibility of labeling content also ensures better insight of compliance, which equates to greater alignment across artwork, packaging and promotional materials.

Managing deviations

Having a system that provides all stakeholders with visibility into any regulatory or market driven changes and deviations is of paramount importance to any organisation. Teams of people within an organisation are tasked daily with finding and updating phrases across all labeling documents. A solution which is capable of tracking deviations and having a traceable link back to a single master source of content both reduces the risk of uncontrolled artwork versions and simplifies updates within an organization.

Gaining efficiencies and realising cost benefits

Life science companies are obliged to prepare and submit a significant amount of labeling content before starting clinical trials. Multiple stakeholders across different departments and regions must coordinate to implement changes affecting numerous interrelated parts. This is highly resource intensive  and a time challenge for companies. This means that medical device companies need to find ways to gain efficiencies with their processes early on in the product lifecycle. But preparing artwork and labeling from structured content drives both quality and productivity, and allows all stakeholders to leverage standardized business assets, such as reusable imagery and phrases. Advances in technology and tools for labeling activities improves processes which involve the collation and storage of content. As a result, activities which typically take weeks to manage are completed within minutes.

Transparency and visibility

Ensuring transparency in labeling and preventing inaccurate or misleading content should always be a priority. If companies are to remain compliant and easily demonstrate proof of compliance, they must adopt a solution that easily integrates a number of controlled and managed data sources to transform content into compliant labeling components. 

Heavily regulated industries face ever-changing regulation and legislation. It is increasingly important therefore, to ensure your organization puts the necessary processes in place in order to remain compliant when it comes to labeling. Improving the efficiency of labeling and artwork processes across your supply chain is one way to do this. Efficient labeling review and approval process across your supply chain reduces the time taken for products to get to market, allowing for time and money to be spent on other areas of the organization. Improved visibility and traceability will also ensure that you are able to remain agile, should changes in regulations occur. So, what steps can you take to ensure your supply chain is more efficient?

1. Consistency

Supply chains across Life Sciences tend to consist of many partners including contract manufacturing organizations (CMOs). They are also tremendously intricate, containing numerous layers of wholesalers and suppliers, dependent upon receiving accurate and timely labeling content. In the end-to-end process, compliant labeling is essential to smoothing the entire flow from product development right through to customer fulfilment. Labeling is entwined with numerous parts of the development and manufacturing processes, from the product itself, the packaging materials and the bulk transporter cases. Therefore, having one single source of content that is consistent across the entire supply chain reduces the risk of non-compliance and costly product recall.

2. Visibility

In a global marketplace, ensuring labeling interoperability is crucial. With local legislations requiring adherence and local translations of the original language, utilising a master file which contains the source content throughout the organization and the supply chain is essential, as it allows you to trace back any phrase, symbol or statement type to the original single source. Visibility is also the number one measure when looking to ensure compliance throughout the supply chain. When it comes to launching new products, or engaging new partners, many organisations tend to defer to the most recently used symbol or statement, which is not always the latest approved version. There must be visibility throughout the supply chain of the most recently approved content, who it was last approved by, and when it was approved. Ownership of each individual piece of content, whether regulatory, marketing, product development, etc. also needs to be captured and clearly defined.

3. Ensuring Connectivity

Connectivity between all stakeholders is a key element of decision-making in the supply chain. By being referred back to the same single piece of labelling content, all stakeholders in the organization will know that they are always using the most up to date, approved version. This will prevent inaccuracies later down the line and avoid time wastage and risk of non-compliance.

4. Reconstruction and Reusability

The majority of label content is held in documents that can’t be easily edited, modified or reviewed, such as PDFs, printed document and emails. Ensuring that this content is made available in a granular form, broken down to a specific phrase, statement or symbol will aid discovery and simplify the review and approval process. This will allow all stakeholders to discover the latest approved content with ease, rather than having to spend time searching for and extracting content from a range of uncontrolled sources.

5. Quickly Update and Repurpose Content

Storing labeling content as digital assets allows for a more integrated supply chain making labeling more transparent to all stakeholders involved in the process whether labeling is to be printed or published electronically (e-Labeling). This approach allows you to manage all of your labeling content from one single platform making it easier to share with multiple partners whilst maintaining consistency of content across all channels. This permits greater collaboration and sharing between all supply chain players and removes, reliance on either previously printed labels or local IT solutions as being the master source which can lead to introducing inaccuracies. It is extremely efficient for all players to be able to quickly update and repurpose content for different types of print and packaging as well as electronic media and this is only possible where there is a single approved source made available to all parties Following these 5 strategies will enable your organization’s supply chain to be as efficient and transparent as possible when it comes to labelling. This will also help ensure your organization is able to quickly respond to changing legislation and in turn avoid the risk of potential fines, brand damage and disruption to product shipment.

Keeping up with changing regulations

Notwithstanding the upcoming implementation of the new EU MDR in May 2020, many organizations in the medical devices, pharmaceutical, chemicals and cosmetics industries are experiencing unprecedented demands from regulatory authorities and consumers alike. Product labeling must be clearer, more informative and published electronically in addition to print. It must also satisfy local legislation and local market requirements tailoring of labeling content to meet these demands therefore is key, as is putting the necessary processes in place to make this efficient and accurate. The problem most organizations have when implementing these processes however, is that they are often done so manually in a way which can hinder efficiency and accuracy. Procedures are often published in an array of formats and dispersed across multiple locations which can become out of date or uncontrolled quite quickly resulting in missing or inaccurate labeling. So, what’s the key to avoiding these roadblocks? It’s all about playing by the rules.  If we can automate many of the manual repetitive processes it’s likely that time savings and quality improvements will be one of the first outcomes we experience.

How can business rules help?

Think of it like a filling in an online application form – the presence of certain fields and whether these have been pre-populated or require you to input data will depend on how you have answered the previous questions. The rules engine will decide whether it needs to insert, delete or update facts in real-time, and prove you with wider benefits to your organisation including:

• Ensuring your organisation is better positioned to keep up with the pace of change
• Improving productivity and efficiency
• Ensuring compliance with policy and regulation
• Improving customer service
• Opening new revenue opportunities

What other outcomes can applying business rules help achieve for your organisation?

Minimise the level of human intervention in completing complex tasks

Needing to make repetitive ‘low-level’ decisions manually, where these could otherwise be easily automated, can lead to unnecessary errors. The end result can be costly product recalls, potential fines and brand damage through non-compliance.

Ensure content alignment across all types of labelling 


Where much of the labeling content is held in a range of documents, emails, PDFs and printed documents it can become difficult to construct, deconstruct and reuse labeling content. Transforming existing paper-based artwork management systems and processes to a new digitally-driven environment will help reduce the risk of non-compliance and costly product recalls.

Automate and simplify the capture and collation of labelling content needed to address specific product and market needs 


Digitalizing and versioning each of your labelling assets (logos, warning statements, images, etc.) will ensure each of the variable fields you may need on your labels depending on where the product is going to be sold, and which local market legislation needs to be adhered to, can be auto-populated.

Tailor the system around your own business processes

Adopting a business rules approach to labeling and artwork means that your organization is able to tailor the system around your own business processes, rather than adapting your processes to meet the requirements of the system. It will also mean that by automating manual, repetitive tasks, you will be able to free up your resources, allowing you to attend to higher value activities. 

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? 

1. 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.
2. 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.
3. 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. 

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. 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.

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.  

Ask practitioners in the cosmetics sector what they think are the drivers of change in their industry and the answer comes back pretty quickly: consumer demand for complete sourcing clarity. I recently caught up with a prominent executive from the cosmetics sector to find out more.

Today, consumers — especially Gen Z ones — are more conscious than ever about the effect of what they buy or consume on the environment. As a result, they have high expectations about the brands they buy from around transparency of ingredients and guidance on how best to safely recycle what they’ve just purchased.

This is nowhere more true in the cosmetics world, where concerns about potentially harmful ingredients or allergens and ethical concerns around the supply chain are a priority for buyers. Consumers now pay closer attention to the information provided by cosmetics brands across their labeling, from physical packaging to online resources. Indeed, being clear about these aspects is even starting to be seen as a differentiator; a 2019 survey by NPD Group found that skincare brands pledging ingredient transparency are gaining new traction in the market, over half of American women consciously now seek out skincare products that have organic ingredients, while 46% say they will only now pick products without sulfates, phthalates and gluten, a six-point increase from 2017.

Dealing with Multiple Market Contexts

Clearly, the public is paying very close attention to product information, and know what’s in products and how ‘natural’ they are — research which often starts online. It’s a trend that regulators are supporting too: they are putting more and more pressure on brands to ensure they provide complete, accurate and up-to-date information on all of their products, and that they make no unauthorized or false claims about them.

This ends a long period of self-regulation, and authorities have signalled they are going to be more proactive in keeping consumers safe. The challenge for international cosmetics leaders, is that this changes decades of practice, especially around labeling. There’s a big push now to keep it consistent, transparent, consumer-friendly and on message, which can be tricky if each market has its own special regulatory requirements, different cultural reference points and ways of wording safety messages.

So ensuring that each product carries exactly the right label content for the intended market and target consumer group is the mission now, from eye liner to sunscreen. Unless the cosmetics company has a clear line of sight across both evolving market requirements per country and how these affect each product and its different forms of labeling/customer information, however, the risk of wrong or out-of-date information getting through could be significant. Risks to consumer safety, reputational damage, potential fines and loss of revenue if products are rejected or withdrawn from affected markets all need to be avoided...

But labeling encompasses a lot! It’s everything stated on the product itself, which could be designed or embossed directly onto a bottle to promotional inserts in magazines and product information published online. This adds up to a lot of collateral to coordinate and control for accuracy, currency, quality and compliance. But if these different elements are handled by different teams, or wheels have to be reinvented time and again, the demand on resources but also the danger of something going wrong are considerable.

Centralized Quality Control

To alleviate spiraling workloads, mitigate risk and keep pace with evolving requirements without compromising label quality, cosmetics brands should consider introducing some form of central control and visibility across everything that is going out to the market, anywhere in the world. This means creating a single source of labeling truth that acts as the foundation for all forms of future labeling, so if anything changes — to you as a company, to the product or its ingredients, or to regulatory requirements — this can be managed in a controlled and robust way from a single, central vantage point.

Hence the useful approach of centralizing and organizing the construction and quality control of global labeling. When introduced correctly, this can also help transform the processes involved, for instance in discovering label inter-dependencies if requirements or other conditions change, as all global label activity is mapped and tracked. And great shortcuts like ‘phrase managers’ for different languages can reduce the translation burden too, by eliminating repetition of routine tasks such as the construction of common directions for use in each target language/country.

Offering What The Ethical Consumer Is Demanding

In cosmetics, the ability to treat each labeling item as a composite of pre-approved text or artwork components eliminates unnecessary process duplication, leaving your skilled professionals free to focus more of their time on the elements that do need to change. As well as substantially reducing the safety implications, cost and reputational damage associated with product recalls, doing your product labeling will help to safeguard the brand and maintain public confidence in the quality and safety of its products — as we’ve seen, increasingly an operational necessity in our highly competitive, global market.

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

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

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

Regaining Control

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

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

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

Centralizing Labeling Management Capability

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

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

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

Sensitivity Parameters & Smart Tools

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

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

As someone with extensive experience of delivering transformation and change in both financial services and life sciences, I recognize many parallels in the challenges and opportunities facing both industries. Both markets are heavily regulated and traditionally conservative in their approach to modernization, for example, yet both are being disrupted and are facing pressure to deliver improved productivity, speed of turnaround, and cost efficiency.

Therefore, change is imperative. Banking has come a long way here; what were once long-winded processes around opening a new account or setting up regular payments can now be managed simply, speedily and securely from a handheld device. But the life sciences industry, and indeed many other strictly-regulated markets, could also benefit significantly from equivalent innovation.

Take the current complexities of global product labeling. Why shouldn’t these be reduced to more coordinated, streamlined and automated processes — those that can be tracked and managed via a handheld device — even on the daily commute, in some instances? Right across the label creation process and out to labeling approval and even distribution, including that of electronic/online information for patients, there is enormous scope to do things in new and better ways.

Your 2020 Priority Needs to Be User-Oriented Improvement

If the life sciences industry is serious about delivering a more user-centric experience, not just in look and feel but in teams’ ability to execute their duties more intuitively and easily, a more app-oriented user experience could be a real game-changer. The problem is that true user-centricity remains the exception rather than the rule in many aspects of business, with regulations and internal system requirements more likely to dictate any improvements to the way things are done. In turn, this compromises the potential for impactful transformation.

However, with the right coordination and controls behind the scenes, app-driven labeling management could genuinely empower label creators, approvers and distributors to complete their work far more spontaneously, effectively and immediately. This could include everything from quickly determining precisely which mandatory elements need to appear on a label to instantly calculating how the impact of any changes of circumstance might cascade across global operations — even all the way out to visualizing finished output, assessing exceptions, and processing approvals on the go.

If brands, in no matter what sector, really want to push boundaries, drive progress, and accelerate time to market, with so much now digitally possible, enterprises really ought to make user-oriented improvements a priority in 2020.

The best starting point: being willing to view and do things differently.

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.