By Marty Kerluck, Kallik Business Development Manager for North America

As you may know, the rise of the US Food and Drug Administration’s new Unique Device Identification (UDI) system has been closely followed by both Kallik and our many customers in the medical devices markets (see All The Power Of UDI – In A Three Minute Nutshell’ among other blogs on this topic, for example).

We thought you would be interested in an up-close look at UDI’s impact in the US, the country most immediately in the standard’s ‘firing line’ – and where Kallik has an important presence helping companies get ready for UDI

Please extend a warm welcome to Kallik’s Business Development Manager for North America Marty Kerluck, who is well placed to tell us.

Well, what we are finding with customers opening up the Pandora’s Box of UDI is that while a lot of people have put some good thought into dealing with it well ahead of time, that still doesn’t mean it’s not presenting some issues.

For example, companies we speak to in the medical devices market seem to have been planning for it for some time; they are all geared up for putting data on to the new Global UDI Database, the GUDID for instance, they are aware there is a new barcode symbology they need to start working with, and they are gathering data the right way to share with the FDA.

So far so good – what’s to worry about? Well, it’s a problem I have kept seeing again and again in the fifteen years I have been working in this market:

They aren’t doing enough with the data when they’ve collected it – especially when it comes to utilising it for their packaging and labelling requirements.

And I fear that that is going to come back and bite – hard – if they ever get into any kind of issue as a result, such as the horrible expensive nightmare we know as a ‘product recall.’

Data has a central role beyond UDI

The issue is that the data on the label has to be not just accurate and up to date, it has to be available for a third party like an FDA if there is any kind of product problem.

In addition, if the data on the label isn’t exactly the same as the information you gave the FDA or put into GUDID, then you are going to have a big problem when it comes to building out a proper audit trail to explain what has taken place.

The only way to head off both issues is to see that the data on the label always has to be part of the data you give the FDA for your UDI obligation – they are parts of what should be one seamless whole.

What the experience of complying with UDI is showing to me is that companies are missing out on the last part of this process. They have the data, and it’s good data. The problem is that some of it is in their Oracle system, some of it is in their FDA submissions system – it’s there, but not connected up in one place.

To beat a drum that any Kallik customer will have heard us beat: they are failing to build a single source of the truth, a unified view of product data that can be closely followed and tracked.

Which is a bit odd, as the single source idea is no longer just Kallik’s when it comes to medical device data – it’s a core philosophy of the whole UDI move itself.

Kallik is the glue

So the first stirrings of UDI in the US is that people are not doing badly, far from it, there is great work being done – but that bigger data picture, the link between the back end production systems database, the FDA and the packaging and labelling front-end hasn’t quite gelled yet.

That is, of course, potentially a great opportunity for Kallik, as we are ideally placed to be the ‘glue’ to bring all that together.

But first we need to educate the market a bit more in the importance of not just collecting the right data for UDI but in managing it properly so that full integrity and safety can get embedded in the heart of not just the UDI process, but all core labelling, packaging and artwork management processes.

Marty, Kallik’s Business Development Manager for North America, based in Toronto (Canada), has an extensive track record helping companies in the medical devices and regulated industries sectors; we hope this will be the first in a regular series of dispatches from ‘over the Pond’

Please take advantage of the UDI Compliance webinar: (https://www1.gotomeeting.com/register/786791768) on 3 December 2014, at 12 Noon EDT/1700 BST and find out what you need to do to prepare for UDI compliance

By Neil Gleghorn, Co-Founder and CEO of Kallik.

We recently discussed the huge challenge that a product recall can be for a company (‘Why “Product Recall” Needs To Stop Being The Scariest Words You Know’). I don’t know if you saw it, but that turned out to be a very timely post, as the US Federal and Drug Administration has also just published some truly alarming data on why it asks medical device manufacturers to take products off the market.

The study – a Medical Device Recall Report – covers some nine years (2003 to 2012, financial year-wise) and has some frankly startling stats – starting with the very first finding: in that nine year period under scrutiny, the annual number of medical device recalls increased by an incredible 97% – so, basically doubling.

What does the FDA put this rise down to? It believes enhanced awareness by device firms – including those that were cited for reporting violations – as well as its own efforts to improve medical device safety are partly responsible.

But what may strike you most was the judgement on where the problems are coming from in the first place: “The most frequent causes for recalls are related to device design, software, and non-conforming material or component issues.”

The report states that if industry and regulators could address these problems jointly, as many as 400 recalls could be prevented each year. 400! That’s an incredible number.

‘Serious and adverse’

And these problems need addressing – as the product recall numbers include a very worrying proportion of ‘class 1’ level incidents, that’s to say a situation in which there has been deemed a reasonable probability that use of or exposure to a product will cause “serious adverse health consequences or death.”

To take just one year at random, FY2011, there were no less than 50 such incidents – as well as over 1,500 ‘class IIs,’ which is to say “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences.”

Though a Class II is where such dangers are deemed unlikely, we still see 70 of those in the year we picked, 2011. That’s of less interest, maybe, to this data: that class I recalls were just 1% of 2003 recalls in FY 2003 (7 recalls), but that number had crept up to 5%, or 57, in FY 2012. Most Class I recalls were in the anesthesia, cardiovascular, chemistry, and general hospital specialties, says the study, while the radiology, orthopedic, general hospital, and cardiovascular areas had the most Class II recalls.

Okay – those are the big worrying numbers. What can we ascertain about recalls that can help us prevent them? The FDA study says that reporting gaps play a significant part: “During the study period, 364 establishments [representing 2% of the medical device firms registered with the FDA] were observed to have 21 CFR 806 reporting “deficiencies,” for example.

Meanwhile, software errors – especially in radiology devices – played a huge part, with system compatibility (interoperability between treatment planning and treatment delivery systems), user interfaces (human factors), and dose calculation (clinical decision support software) coming out as the most frequently cited causes of FDA-mandated recalls, accounting for more than two thirds of such.

Labelling – an area you need to focus on!

Finally, the study lists the main reasons for recall in the 2010-2012 timeframe. And guess what? Labelling comes up again and again, e.g. ‘labelling mix-ups/errors’ were defined as the cause of 99 recalls, ‘error in labelling’ behind 59, ‘packaging’ comes in at 58, ‘labelling design’ problems were behind some 48 recalls, ‘false and misleading labelling’ for 39 – the list goes on!

In fact, packaging and labelling issues (these are defined as ‘labelling mix-ups, packaging, packaging design/selection, expired dating, labelling design, labelling false and misleading, or error in labelling and so on) are given as the cause for recalls in no less than 13% of all the 2010-2102 cases.

If you still don’t think labelling matters, then I think you need to take that argument up with the FDA.

I don’t think they’ll be that sympathetic to your argument.

What about you? Sobering stuff.

By Ashley Goldie, Sales and Marketing Director, Kallik.

Today’s blog is all about a brilliant resource on the Web which we think you could get a lot out of.

Swiss pharmaceutical company, Roche has put up a short video on YouTube (called ‘UDI – How a barcode contributes to patient safety’) which explains everything you need to know about Unique Device Identification, or UDI, a regulation that’s been pushed through by the US Federal Food and Drug Administration.

We’ve talked a lot about UDI in these Kallik blogs (e.g. ‘Could Hassles Like UDI Actually Be Blessings In Disguise?’) as we think UDI is a huge challenge for the medical devices sector. That’s because it will have a big and beneficial – if challenging to begin with – effect on patient acceptance with devices from the safety point of view.

I’ve taken a couple of minutes to summarise the video to help work out what the main points are: we hope you find it useful.

“Hi, I’m the new UDI barcode. Soon you’ll be able to find me on all medical devices such as instruments and diagnostic tests.

“Now, you’re probably wondering what that acronym means. UDI stands for unique device identification. In the future, every medical device and diagnostic test across the globe will have to be identified uniquely. This is the result of a new legal regulation that offers a lot of benefits.

“This is how it works: A barcode like me will be present on the packaging of every medical device and diagnostic test. When you scan me, you will immediately get product info like item number, batch number and expiration date.

“I am also able to link you to a global database that contains additional product information. For example, safety information, regulatory status, storage conditions, allergy information and my manufacturer’s contact information.

Entire shipping history

“So the UDI system consists of me, the barcode, and the database where the additional information is stored. You can also use me to track the entire shipping history of the product.

“Come and join me on my journey! My journey through the supply chain begins at Roche, the manufacturer. Here, I am printed onto the medical device or diagnostic tests packaging. At this point, all information about the product is already in the global database. Hidden inside me, there is also a global trade item number – GTIN for short. It comes from a globally uniform range of identifiers that standardises all item numbers so every product of the same model has the same number. This makes the reordering medical devices or diagnostic tests easier, because they can now be uniquely identified by their GTIN number.

“The GTIN also makes my journey super easy to track. Whenever I am scanned somewhere along the supply chain, for example by a shipping agent on my way to the hospital, this info is saved right up to the lab or clinic where the product is currently located.

“The UDI also helps to tackle the issue of product counterfeiting. Patient safety is, of course, top priority and the UDI helps here too. For example, if there is a product issue the devices and diagnostic tests that need to be recalled can be easily identified.”

The video then ends like this: “I help make important information easily accessible, contributing not only to compliance and efficiency, but also to patient safety. I must admit, it all makes me quite proud. UDI – Unique Device Identification.”

I agree! What do you think?

 

Kallik has launched a new resource centre for medical device companies having to deal with changes in regulations.

The medical device sector is used to dealing with legislation and meeting tight compliance demands. Nonetheless, it’s currently facing a perfect storm of compliance changes for which manufacturers need to be prepared.

The US Food and Drug Administration (FDA) has now issued a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. It also applies to certain combination products that contain devices and to devices licensed under the Public Health Service (PHS) Act. The Year 1 deadline is24 September 2014 and it is expected that similar regulations will follow in Europe and then the Rest of The World.

Kallik’s customers are already addressing these challenges and are sharing their experiences in The Kallik Medical Device & UDI Compliance Resource Centre. The centre includes case studies, news stories, blogs and webinars – all designed to help those affected by the changes understand and navigate through the UDI compliance maze. Bookmark this page and keep checking back for updates.

By Neil Gleghorn, CEO and Founder of Kallik.

To conclude our run of case studies of firms that have worked with Kallik to achieve two powerful, inter-related benefits: get up to speed for all things compliance, especially the imminent UDI legislation out of the States and improve labeling processes at the same time to achieve greater internal business efficiencies.

We’ve told you about a great Danish example (‘Using Compliance To Your Advantage – 1: Coloplast’) and a great US example too (‘Using Compliance To Your Advantage – 2: A US Life Sciences Leader’). I want to briefly, please, now turn to another Kallik success story – a German firm that is one of the world’s leading suppliers in casting, bandaging, wound care and compression stockings.

Why? Because this company is yet another manufacturer that’s taken a centralised, automated approach to label artwork management as a way to prep for UDI compliance.

Like the other customers discussed, it’s done that by going for the award-winning Kallik artwork automation solution to streamline the way it manages labelling for more than 14,000 different product lines – many of which have secondary and indeed tertiary packaging requirements.

Previously, the content for individual packaging was treated as its own artwork job – a process that involved the manual collation of input via phone calls and emails from global marketing, packaging development, product development, scientific and regulatory affairs, quality management and external sources. As a result, typically it would take up to 10 go-rounds 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 one to two weeks to prepare simple artwork, to one to two hours. Quite an improvement, I’m sure you will agree!

Meanwhile, compliance with all sorts of requirements – including UDI – is much easier to manage. “What stands out about the Kallik system is its completeness,” this company has told me. “Given the rate at which regulation can change, the level of control provided by Kallik is vital.”

A full toolkit to help you do the same.

A great case study. But what is the real significance of it – and the other two engagements that we have talked about?

As stated, last September 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 new codes are clearer labelling (down to individual product level), while manufacturers must be able to prove they have up-to-date procedures that describe all the processes that ensure regulatory compliance. This has been put in, of course, to help us all as consumers – but in practical terms it means manufacturers must first get the internal controls right, and then be able to show the measures they have taken.

Dealing with Brussels and UDI is therefore going to take work. The good news is that Kallik provides a full toolkit as well as comprehensive migration support services to help medical device manufacturers through the entire journey – as you strive to tick regulatory boxes and as you look to achieve a good payback from investment in tightening up your internal processes around content creation and labelling.

To sum up: tempting as it might be to rush down the pure UDI box-ticking route, this is a false economy. UDI is not the only new regulatory requirement on the agenda – which means a point solution just to tide you over will only lead to a lot more duplication and work in the long run, without any real payback.

So why not look at a fresh approach to compliance that involves working from a single approved set of master data that can be reused and repurposed with minimal effort, under strict central controls but with maximal payback?

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.

What do you think?

 

 

International regulatory requirements are becoming ever more stringent in the medical device sector. Organisations that apply point solutions for each new mandate may be creating unnecessary work and cost for themselves. Neil Gleghorn, managing director of artwork management firm Kallik, believes there is a better way.

To read the full article, please visit PMP News: http://www.pmpnews.com/www.pmpnews.com/article/Viewpoint-New-Global-Medical-Device-Regulations-Burden-Opportunity-140603

 

By Neil Gleghorn, CEO and Founder of Kallik

Having a busy Q2? We certainly are here at Kallik – especially around helping customers deal with their regulatory obligations.

When we spoke before, (‘Compliance Only Ever Matters If You Need To Demonstrate It!’) we started to flag up the importance of new compliance changes coming your way. The one to keep your eye on closest is the US Food and Drug Administration’s unique device identifier (UDI) – a universally accepted product identification standard.

Set to be included on product labels, UDI has been architected to make individual items much easier to trace as they move through the supply chain and enter the marketplace. UDI comes into force in the US as early as September, with Europe expected to follow suit within the next two or maybe three years, then China and the rest of the world.

We see UDI as a very positive step in improving patient safety; it will also help device manufacturers minimise risk and make any product recalls much easier to contain. But getting set for UDI is a significant undertaking from the supplier point of view.

Actually, if you only put budget in to deal with UDI – you might be making a bit of a mistake. Why? Addressing UDI traceability in isolation could well be a wasted opportunity – as merely adding UDI traceability codes into your labelling process when all your underlying label management processes are a mass of complexity and inconsistency is probably just papering over the cracks.

Really, you need to rationalise those processes. UDI could be a good basis for a business case for doing just that; think of it as a great time to sort out everything. The wider benefits of sorting out this spaghetti and getting more efficient – and there will be many – will more than pay for any investment you need to make.

In fact, all of the work we’ve been doing with medical device producers is designed to not only take care of UDI but make a lot of other improvements at the same time.

This is done by centralising and automating the way all forms of product packaging, labelling and customer documentation get created, modified, approved, delivered and managed.

That means you will recoup significant reductions in your cost, time and risk factors around both artwork management/labeling and in areas like UDI.

Increase your visibility into compliance and other processes

For anyone in the medical devices sector operating internationally, or for those keen to take advantage of new growth opportunities in emerging markets, this efficient adaptability – which offers you the ability to cater for individual country requirements, without additional labour – offers a lot of competitive advantage.

That’s because it increases visibility, will guarantee labelling accuracy, and make it much easier and faster to make changes to labelling output as your specific requirements (or external compliance directives) change over time.

To help prove this, in the next few blogs I’d like to walk you through some interesting case studies of organisations we’ve worked with who’ve done just that.

– Labelling content & Artwork management leader Kallik’s AMS360™ software is proving vital for medical devices firms who need to meet critical compliance directives

 Tamworth, UK April 14, 2014 – Labelling Content & Artwork management leader Kallik has announced it is offering an advanced labelling and packaging solution to help organisations in the medical devices sector meet a ‘perfect storm’ of compliance changes.

The news is significant as much of the market is believed to be lagging in preparing for regulatory changes, including the US Food and Drug Administration’s imminent unique device identifier (UDI) product identification standard. To be included on product labels, UDI will make individual items easier to trace as they move through the supply chain and beyond. 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.

The solution has been shown to help firms get set for UDI – as well as improve internal systems, help customers meet their regulatory requirements and improve profitability at blue chip sector customers such as Colloplast, BSN, and many others.

Apart from UDI, 2014 is going to be dominated by pressure from buyers for higher quality at lower costs, increased M&A/consolidation activity, accompanied by more and more need for internationalised/global products and marketing solutions – all of which means an integrated approach to Labelling and Artwork Management is critical.

Medical device manufacturers will benefit from a robust, transparent process in place to deal with these pressures, say experts.

For Neil Gleghorn, Chief Executive Officer of Kallik, “Rather than thinking of UDI labelling as a challenge, think of it as an opportunity to improve all your labelling processes.

“By centralising and automating the way all forms of product packaging, labelling and customer documentation gets created, approved, delivered and managed, we are helping customers consistently deliver significant benefits of cost, time and risk reductions.

“It also increases visibility, ensures labelling accuracy – while also making it much easier and faster to make changes to labelling output as requirements change.”

About Kallik

Kallik is a global provider of software solutions that simplify complex artwork management, generation and approval challenges for regulated industries.

Kallik’s systems help these organisations to reduce the risk of product recall, guarantee product and brand consistency, mitigate risk and reduce costs.

Based on technologies using a structured data-centric approach, Kallik’s solutions leverage and repurpose content to automatically generate artwork.  This enables businesses to remove duplication, track content and rapidly change messaging to respond to new market and regulatory challenges.

Formed in 2001, Kallik’s founders and senior management team have a rich heritage in the packaging and labelling industry. The flagship AMS360™ Automated Artwork Management solution was devised based on this insider knowledge of the sector and today underpins the businesses of companies including Sealed Air, Estee Lauder, Coloplast, Integra, Mary Kay and Unilever.

More at www.kallik.com or follow us on Twitter @KallikAMS