Commercialisation & Distribution

Commercialisation & Distribution

Counterfeiting medical devices: a bitter pill for the sector to swallow


Following last year’s seizure of more than $51-million-worth of counterfeit medicines and medical devices, Tim Congdon, European Business Development Manager at CCL Design UK, discusses the impact counterfeiting is having on the medical device industry, and what can be done to slow the alarming rise in counterfeit goods


The business of counterfeiting medicines and medical devices is growing worldwide at an alarming rate. Fraudulent drugs and devices can harm or kill millions around the world and inflict serious damage on the brand names and bottom lines of major manufacturers. Policing efforts have claimed some victories, most notably Operation Pangea X in 2017, which involved Interpol, the World Customs Organization (WCO) and customs and security forces in more than 123 countries. The effort resulted in the seizure of more than $51-million-worth of counterfeit medicines and medical devices and the shutdown of over 3,500 illegal websites in 2017. However, in an ideal world, medical device manufacturers do not want to get to a position where counterfeit versions of their products are being uncovered by the likes of Operation Pangea. But what more can they do to reduce their counterfeiting risk significantly?

Preventing counterfeiting

One way in which counterfeiting can be reduced is by using brand protection and authentication. Medical device manufacturers can work with specialists to develop innovative ways to design labels, ranging from tamper-evident box seals to highly complex multi-layer authentication labels. Decorative brand labels can also double as both identifiers and functional anti-counterfeit solutions – by including both overt and covert security features built into the design. In short, products must remain easy to authenticate, but almost impossible to copy. The uptake of these anti-counterfeiting solutions are growing rapidly with the Global smart label market valued at $5.68 billion in 2017, and this market is expected to double in size, to reach a value of $11.34 billion by 2023.

But, outside of brand protection and authentication solutions, what more can be done? At the 9th Annual Anti-Counterfeiting Forum, at BAE’s headquarters in Hampshire earlier this year, a key topic was the importance of knowing your supply chain and putting processes in places to reduce the threat of counterfeiting. One commentator at the Forum said that ‘blind trust in your supply chain is not enough, and suppliers and distributors should stop relying on signed documentation only to confirm legitimacy.’

Being on the same page

Part of the solution is to provide guidelines to customers on how to detect counterfeit products. These guidelines could include a list of authorised resellers, and details around the security aspects of the product. It is also important to supply some examples of ways in which counterfeit products can be discovered. For instance, this can include misspellings on the product or its packaging, codes that don’t match (ie between the component and the assembly code), and finally, part-specific requirements such as humidity may be missing on a counterfeit item.

For those manufacturers that are exporting widely out of the UK, it’s worth considering working with Customs and Border Protection to register Intellectual Property Rights with them. And, when exporting to the US, it is vitally important that the Underwriters Laboratories Inc (UL) mark is achieved. The UL mark is the most recognised safety certification mark in the world, and it has been a product safety leader for over 100 years – widely acknowledged for its safety standards, integrity, and independence. The UL mark is also particularly recognised in the US by consumers, regulatory authorities and the insurance industry and UL can enforce standards on behalf of manufacturers.

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However, you can take all the above precautions, but without using anti-counterfeiting solutions you can still leave yourself open to potential abuse. This threat has led to the development of a range of options for manufacturers. These options include specially designed labels, ranging from tamper evident box seals to highly complex multi-layer authentication labels and decorative brand labels. In short, products must remain easy to authenticate, but almost impossible to copy.


Tim Congdon

Some examples of these products include Videomark – a highly overt security feature that has several covert layers built in. To achieve this unique overt feature a photopolymer film is utilised during the bespoke manufacturing process, which allows us to create 3D images and depth that cannot be achieved with traditional Holographic techniques. As such there has been no successful attempts at copying the Videomark product by counterfeiters. Security Labels (overt/covert) range from a box seal to a label with up to 20 different overt and covert security features. We use customised manufacturing equipment to produce complex products in volume.

Secure Track is a proprietary track and trace intelligent printing solution. Secure Track was designed specifically for the printing of code management solutions, including serialisation, encrypted security codes and customised coding algorithms. It also provides complete traceability through the supply chain process and offers anti-counterfeit, brand protection and product verification capabilities.

When searching for a manufacturer to provide an anti-counterfeiting solution you need to ensure that all their products are designed, developed, and manufactured within a secure facility, ensuring all materials are closely controlled. The actions we have taken to comply with this level of security has ensured that there have been no successful attempts at copying our more advance products.

About the author

With well over 100 years experience between us, we've been around the editorial and medical blocks a few times. But we're still as keen as any young pup to root out what's new and inspiring.

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