Packaging, supply & logistics
solved over the subsequent decade and a half. In 2022, to give one example, staff from the UK’s Medicines and Healthcare Regulatory Agency (MHRA) seized some 285,000 counterfeit drugs medicines from addresses across the country. And if that last operation seized goods worth some £850,000, it goes without saying that the consequences of counterfeit devices are much more than financial. “The consequences of counterfeit devices pose a significant safety risk to patients including the potential to cause injury, disability or even death,” explains Dr Mark Deakes, chairman at the International Hologram Manufacturers Association (IHMA). “In addition, there is the loss of confidence in the medical device brand due to its failure to help reduce or alleviate symptoms.” Yet if Deakes lays out the scale of the problem, might he and people like him equally hold the solution? Certainly, sophisticated holograms have the potential to upend the fight against device counterfeiting – especially when integrated with other interactive features like serialisation for track and trace, they make forgery far harder. That’s before you consider the host of brand engagement and regulatory advantages holograms offer too. Not that the fraudsters must simply be defeated once, with honest insiders instead obliged to constantly update their defences as the criminals innovate in turn.
Keeping it real
As that £850,000 MHRA raid implies, counterfeit medical devices involve big money. Perhaps ironically, this bonanza is largely animated by the parallel rise of legitimate devices. Think about it like this: with Statista reporting that the global medical devices market is currently worth $510bn, a figure expected to reach almost $675bn by 2029, there’s obviously increasing room for criminals to make bank too. That’s reflected, Deakes continues, by the medical vagaries of recent years. Consider the pandemic. In May 2020, the British government announced the manufacture of 70 million face masks, each destined for put-upon health workers. With production targets like that floating about, and with politicians rushing to secure equipment at speed, it’s easy to see how fakes could slip into the supply chain.
Once you factor in the rampant popularity of new weight-loss drugs – in June 2024, the WHO warned of fake Ozempic pen devices in Britain and Brazil – and no wonder Deakes says that the proliferation of counterfeit devices has “continued unabated” even as Covid-19 has waned. No less important, of course, are the practical consequences of these crimes. That clearly starts
Medical Device Developments /
www.nsmedicaldevices.com
with health, with countless depressing examples to choose from. In Israel, for instance, fake versions of drugs used to treat diabetes left many with psychiatric conditions, after it transpired that the medicine contained high traces of MDMA. In the US, meanwhile, an influx of counterfeit KN95 masks from China left wearers vulnerable to airborne diseases like coronavirus. That’s echoed, Deakes adds, by reputation damage. “For legitimate manufacturers,” he says, “there is the loss in revenue from the impact of counterfeits, erosion of brand reputation, reduced funds available for research and development, potential legal implications, and increased costs due to the inclusion of product security authentication measures.”
Given these varied challenges, at any rate, it makes sense that OEMs should have invested so heavily in making their devices counterfeit-proof, with holograms an important tactic. Virtual three- dimensional images, they’re much harder to mimic than regular signs – obviously beneficial to anti- counterfeit teams. Not that every hologram is identical; on the contrary, Deakes describes how companies have developed a range of manufacturing options since Glaxo first used a tamper-evident hologram back in 1988. Encompassing labels, seals and hot-stamped patches, the form holograms take depends on the device it’s protecting. Yet if blister-foil packs unsurprisingly need different holograms from glass bottles, there can be no doubt about their efficacy. To explain what he means, Deakes offers the example of Biotehnos and Rompharm. A pair of Romanian companies, they noticed that sales of their (anti-inflammatory) Alflutop and (cartilage regeneration) Rumalon
The WHO has warned that Ozempic pen devices are being counterfeited.
8%
The percentage of medical devices worldwide estimated to be fake in 2010.
Medical Device Network 123
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Shutterstock.com
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