Medical device manufacturers can turn new product identifier requirements to their competitive advantage if they treat them as an excuse to make bigger changes to the way they manage label creation. Among the latest regulatory requirements vying for the attention of medical device manufacturers is the unique device identifier (UDI) – a universally accepted product identification standard. Included on product labels, it will make individual items much easier to trace as they move through the supply chain and out into the world. The FDA requires UDI compliance in the US by as soon as September 2014, with Europe to follow within the next 2-3 years, then China and the rest of the world. UDI is a positive step in improving patient safety. It will also help device manufacturers minimise risk and make any product recalls much easier to contain. But making the transition to UDI is a significant undertaking, so it is important that companies take a wider perspective - to help justify the investment required.
Why stop at UDI?
Addressing UDI traceability in isolation is a wasted opportunity. Companies that do this are failing to acknowledge other significant, related issues – issues which really they need to address with equal urgency. For most companies, simply adding UDI traceability codes when all of the underlying label management processes are a jumbled mass of complexity and inconsistency is to merely paper over the cracks. So rather than focusing solely on UDI requirements, think of this as a great time to sort out everything else too. That way, the wider benefits – and there will be many - will more than pay for any investment being made. All of the work Kallik has been doing with medical device producers not only takes care of UDI but, by centralising and automating the way all forms of product packaging, labelling and customer documentation are created, approved, delivered and managed, we consistently deliver significant cost, time and risk reductions. For companies operating internationally, and those keen to take advantage of new growth opportunities in emerging markets, this efficient adaptability (which includes the ability to cater for individual country requirements, without additional labour), offers a huge advantage. It increases visibility, ensures labelling accuracy, and makes it much easier and faster to make changes to labelling output as requirements change.
Colossal savings at Coloplast
Among the forward-thinking manufacturers that have understood these broader benefits of a unified approach to label creation and management is Coloplast. The Danish company supplies specialist medical therapy products around the world, to hospitals, institutions, wholesalers and retailers. It has production facilities in Denmark, Hungary, France, China and the US, as well as international custom manufacturing facilities. Each year, it produces around 60,000 different labels. Until recently, Coloplast’s label production processes were highly manual, spanning a series of home-grown content management systems that were not interconnected. Now, however, it has migrated its labelling artwork assets to Kallik’s powerful end-to-end enterprise artwork management solution, Veraciti™. This is now up and running across several of Coloplast’s manufacturing facilities around the world. The system connects all of the different locations, and provides full, centralised control of approved legal and regulatory labelling information, while managing all localised and translated texts for individual markets. Says Jette Byg, Coloplast’s Head of Labellng & Packaging, “When we saw Kallik at an exhibition, it brought a completely different perspective to the way we could manage our content management activities. Previously, all of our labelling and packaging content had been stored as artwork files. Every change meant starting from scratch and could take months to implement, requiring approvals of local translations from 30-40 countries. Because changes happen all the time in our dynamic market, this meant we were never in compliance - we were always behind.” A year into its labelling transformation project, Coloplast has a head start with UDI, a position many of its competitors are likely to envy. Coloplast is also taking UDI compliance to the next level, by integrating its Kallik solution with its SAP back-office systems so that it can report on its UDI traceability performance.
Unified processes make UDI automatic in the US
Another major life sciences company, which prefers not to be named, is even further along in its labelling artwork management initiative. Based in the US, it is directly affected by the UDI deadline of September 24, 2014. The company is a world leader in medical devices and implants for use in orthopaedics, neurosurgery, spinal, reconstructive and general surgery. Recently, in one of its manufacturing sites, it needed to make no fewer than 10,000 changes to labelling artwork. Traditionally this process has involved 90 weeks’ work in repeat cycles of new artworks being developed, amended and eventually signed off. By investing in a centralised content management and integrated artwork generation and system from Kallik, the company has not only prepared effectively for UDI but, in the latest application involving 10,000 artworks, has reduced the effort from 90 weeks to just 10 days. This is resulting in cost savings that could run into millions. The company is also able to get its products to market much earlier, safe in the knowledge that all labeling is fully compliant with UDI and other regulatory changes (eg. involving safety symbols used on labels).
“Kallik allows us to manage all changes and approvals centrally, in a single location,” explains David, a marketing associate at the company. “Everyone works on the same, latest version of the content, rather than a series of emails that have been sent back and forth. In terms of compliance control, our use of Kallik AMS is about managing label content across the organisation - so that we can change a symbol very quickly as these are updated, and understand where patent numbers are located as these expire.”
German medical device manufacturer stays one step ahead of regulators
The world’s leading suppliers in casting, bandaging, wound care and compression stockings, is another manufacturer to have taken a centralised, automated approach to label artwork management, which has set it in good stead for UDI compliance. The German headquartered company has implemented Kallik’s Veraciti artwork automation solution to streamline the way it manages labeling for more than 14,000 different product lines, many of which have secondary and tertiary packaging. Previously, the content for individual packaging was treated as its own artwork job. “This involved the manual collation of input via phone calls and emails from global marketing, packaging development, product development, scientific & regulatory affairs, quality management and external sources,” explains its Head of Packaging Development. Typically, it would take up to 10 goes to get artwork content approved. The Kallik system saves artwork coordinators having to ‘reinvent the wheel’ each time they need to update content, or create new labelling from scratch. Routine amendments to packaging artwork can now be done without the need to involve an agency or design team. Cycle times are being reduced substantially too - from 1-2 weeks to prepare simple artwork, to 1-2 hours now.
Meanwhile compliance with all sorts of requirements, including UDI, is much easier to manage. “What stands out about the Kallik system is its completeness,” says the Head of Packaging Development. “Given the rate at which regulation can change, the level of control provided by Kallik is vital.”
Change is the only constant
In September 2013, the industry had a further reminder of the frequency with which regulatory requirements can change - when the European Commission introduced new measures to restore patient confidence in the medical devices sector in the wake of the PIP breast implants scandal. Among the demands are clearer labelling (down to individual product level), and the EC has held up the UDI as an essential facilitator. In addition, manufacturers must have up-to-date procedures that describe all the processes that ensure regulatory compliance. So manufacturers must first get the internal controls right, and then be able to show the measures they have taken.
Getting the right help
With the first UDI deadline looming large, manufacturers can’t afford to bury their heads in the sand. Companies are likely to need a lot of help as they make the transition to new systems. Kallik provides a full toolkit as well as comprehensive migration support services, so can guide medical device manufacturers through the entire journey – both as they strive both to tick regulatory boxes, and as they attempt to achieve a good payback from their investment. As tempting as it might be to rush down the pure UDI route (if time has become an issue), this is a false economy. UDI is not the only new regulatory requirement on the agenda, and a point solution will only lead to a lot more duplication and work in the long run, without any real payback. Kallik’s approach to compliance involves working from a single approved set of master data which can be reused and repurposed with minimal effort but under strict central controls. It is only with this kind of transformation to internal processes that companies can hope to turn UDI and other regulatory requirements to their advantage.