The real deal: How counterfeiting is being fought within the medical device sector

Counterfeit medical products pose a serious threat to the health of patients worldwide, as well as to the brand recognition of medical device manufacturers. Helping fight the counterfeiting epidemic with their collaborative system Plastiward are specialty chemical company Clariant and security provider SICPA. MPN reporter Reece Armstrong finds out more about the companies’ efforts to fight counterfeiting.

Speaking to us was Clariant’s head of Global Healthcare Polymer Solutions Steve Duckworth and SICPA’s director of New Channels and partnerships Yann Ischi.

According to Ischi the collaboration came about thanks to the synergies that both companies bring to the fight against counterfeiting, notably by bringing a “system or solution to the market to help fight counterfeiting” in the plastic medical devices sector.

Plastiward was announced at the end of 2016 during CPhI Worldwide and also presented at CPhI India. The decision to introduce the system in India relates to the country’s own developments in the medical device and pharmaceutical markets. In particular India’s medical device ‘market is placed at somewhere between $4.4-7 billion’ Duckworth tells me.

“We launched Plastiward at the end of last year at CPhI. That was with a deliberate intent because India is an important marketplace not only for domestic consumption but it’s also an attractive marketplace for people starting to produce devices there” he says.

The rising market in India means medical devices there are at risk of being counterfeited just as others around the world are. “India also represents an important source of many off-patent/ generic drugs; also under the same threat of counterfeits as 'patented pharmaceutical” Duckworth continues. The companies hope that Plastiward can help stem the problem and make drugs and devices safer around the world.

Plastiward works by using proprietary taggants developed by SICPA which are delivered to Clariant’s Mevopur production plants. The taggants are then embedded into polymers used in medical devices and pharmaceutical packaging where they can be monitored in real-time using SICPA’s deployment and monitoring platform. 

“The whole idea here is to help pharma and medical devices companies bring safe medicines to the market; and the key idea is really to bring protection as close as possible to the drug. By embedding our security technology directly into the polymers used to produce plastic medical devices, we get that security very close to the medication. With our system, we also put in place a whole monitoring system allowing for real-time detection. What makes our approach unique is that risk management features at the heart of our process.” Ischi says.

The ability to monitor products in real-time is also hugely beneficial, according to Duckworth who explains that whilst taggants already exist, companies are hindered by the time it takes to collect the data on products from the field which then have to be sent in for analysis to determine if they are real or fake. This longer time lapse means that there’s more chance of counterfeit medical devices reaching patients and potentially putting their lives at risk.

Duckworth said: “The quicker you can authenticate the quicker you can get real-time data and the quicker you can take action. One of the major advantages you see from the Plastiward system is you’re able to go into a warehouse to detect any issues and back in the HQ you’re able to see in real-time where the problem has occurred, and then take action.”

But whilst Clariant and SICPA are aware of the issues of counterfeiting, I ask whether the general public are conscious of the dangers that it poses to them.

Ischi says: “Most of them are not. It’s a huge issue and a number of pharmaceutical companies are actively creating awareness around that. What we’re doing is giving the pharmaceutical companies the means to do something about it on the outside as part of their mission to bring safe medicines to the patient.”

It’s unsurprising considering the sophistication of some of the counterfeit products. Duckworth explains the difficulty of the situation, saying: “You have copies which are extremely difficult to detect and often even somebody who is skilled like a doctor cannot really tell the difference. So this is quite scary. There are numbers that are floating around, they say between 6%-8% of all medical devices are fake.”

The risk of encountering a counterfeit medical device increases with the rise of chronic diseases such as diabetes or asthma, Ischi explains to me: “Importantly, chronic diseases like diabetes or asthma, where people will use devices again and again all through their lives, increase enormously the chance to encounter a counterfeit, especially if you travel and you don’t know the place where you buy your drugs or your devices. The awareness of population is rising as is the demand for a very strong monitoring system.”

But to simply have one solution to challenge counterfeiting isn’t good enough and Clariant realises this. Both the EU Falsified Medicine Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA) will strengthen the monitoring of medical devices and pharmaceuticals across the world. Clariant and SICPA’s contribution is a system that intends to support these laws going into place.

“One of the things that’s quite clear with anti-counterfeit technology is that there is no magic bullet. I think most people who are the experts on this realise that you have to have a kind of layered approach,” Duckworth says.