Bob Tilling, VP global sales at Kallik, discusses how advanced technologies can ensure end-to-end consistency throughout the medical device labelling process, and ensure today’s pain points don’t extend into future operations.
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In today’s medical and device artwork and labelling operations, the focus rests on mitigating as many errors as possible. Relying on traditional, manual methods won’t suffice in an increasingly complicated landscape – and it’s time organisations looked to new approaches for the future to reduce risks and avoid costly mistakes. The antidote lies with technology, where the automation of tasks, such as thorough quality checks and the population of pre-approved key phrases and symbols into a single source of truth is essential. The payback in business terms is huge. In turn, these will significantly improve the processing times for thousands of products, identify mistakes before they go to market and form a master source of approved data, equipped to support medical device manufacturers in a smooth labelling process.
Communication is key – in every language
With new medical devices being trialled every day across the globe, demand for both creation and management of artwork and labelling is extremely high. Of course, major regulatory changes are also common in other industries. Kallik has seen a sharp rise in the number of major brands looking for help – one leading multinational consumer goods company currently has over 300,000 current pieces of artwork, which require up to 60,000 minor changes per year. With this sheer volume of assets, even 1% of these with an error could be a highly expensive and time-consuming task to rectify.
For pharma and medical device organisations where regulation and compliance issues are top of the agenda, companies must ensure communication across the whole supply chain – from production and storage to transport and distribution. Information must be clear, easy to read and localised in its respective language. The translation process poses a significant risk to label printing, as the upkeep of just one sentence across numerous languages is an arduous task. An end-to-end labelling and artwork management solution such as Veraciti takes approved translated data and automatically triple-checks the information before printing.
Compliance pressures squeeze medical device organisations from multiple angles
Regulatory changes affecting labelling and artwork are frequent. Previous EU MDR requirements saw Class II medical device organisations overhaul their existing labels, and upcoming IVDR regulatory deadlines in May and UKCA certification by January 2023 will see countless medical device businesses alter their labels yet again to stay compliant. While the rules are clear, the job at hand will not be an overnight fix, and organisations will need to ensure their data is in order – in advance – to succeed. The effects will be felt globally, as alongside UK businesses, those exporting to the UK will also need to ensure they are UKCA-complaint.
The global pandemic had its own role to play in accelerating these pressures. When most employees worked remotely and on alternative hours, communication became a challenge. With this disconnect hindering approval times, processes, and accuracy particularly in the first year, attention pivoted to speeding operations up efficiently and safely, using software to centralise data.
Reducing artwork approval time by 70%
Manual quality checks, in-person reviews and laborious approval processes – moving artwork through these stages has historically taken numerous weeks. The answer lies in a collaborative approach, one that provides enhanced visibility and can significantly reduce artwork approval times from an average of around 18 weeks, down to as little as five. This works in conjunction with automation – ensuring one master design label has all the populated information, to allow other future labels to use this as a foundation.
All edits and contributions can also be viewed by each stakeholder, and artwork can be reviewed the same day with the ability to add visible comments or annotations for clear communication. By using a comparison tool, any differences between two versions of a label are highlighted to ensure approvers are only reviewing the newest and latest edits, to avoid wasting valuable time analysing the entire artwork.
How one error can affect the whole supply chain… or worseErrors can be made at various stages but only around half are captured internally. Frequently, these mistakes are discovered between warehouses or in the design stages, where they must be recorded. It is software that focuses on preventative measures to these error challenges, with methods to capture errors before they cause any damage, such as professionally approved and stored data and rigorous quality control processes.
It's against a consumer-facing backdrop that we see the need for accurate labelling and a single source of truth to be so critical. With information on how to use, store and maintain medical devices all critical to the health and safety of patients, an error in printing could have severely harmful consequences. For example – ‘1-2’ tablets becoming ‘12’ subsequently presents a major risk to life.
Avoid potential future mishaps
As the market evolves, companies have increased their focus on finding an artwork and label management solution that will suit the changing needs of their business – no matter the industry.
From the building and configuration to the migration of large data, end-to-end solutions can reduce a year of integration down to three months to reduce disruption and save organisations substantial costs. Once all the content needed to create a new version of a label is decided, the information can be automatically populated into the correct fields using a set of pre-configured rules, to drive regulatory compliance across labelling and artwork management activities.
There really is no room for errors in medical device labelling. With the largest number of product errors occurring at the artwork and labelling stage, embracing a digital solution capable of preventing these mistakes before they become a significant issue is vital.
