Bob Tilling, VP Global Sales at Kallik, shares his experience from recent customer projects and explains how medical device manufacturers can recover lost time in preparing for EU MDR labeling 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 localized 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 organizations 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 please contact Bob Tilling at Kallik, [email protected] or +44 1827 318100.