Packaging, supply & logistics
The growing challenge of combating substandard and falsified medical products
“The presence of substandard or falsified (e.g., counterfeit) medical products in the supply chain has become a persistent concern, creating the potential for injury and costing facilities time and money. When addressing this challenge in 2026, organisations must consider the
potential impact that developments at the US federal level could have on their efforts. Decreased international cooperation along with workforce reductions could hinder efforts to safeguard the global supply chain. As a result, healthcare organisations themselves may have to shoulder more of the burden.” – Rob Schluth, principal project officer of device safety, ECRI
Infrastructural outlay is equally important
Davis highlights that infrastructural outlay is an equally important consideration for medtech companies investing in smart packaging technology, and that being able to “adapt and adjust within the infrastructure a company already has” often proves easier than trying to make big changes quickly. For inventory tracking technology to work effectively, control towers that integrate data from different systems and other platforms are needed to “make this information usable” and bring it into a useful, holistic view, Davis notes. “Effective data integration, getting the data right, and being able to use the data in an effective manner is half the challenge with some of these technologies,” Davis adds. Regarding usability, a UDI, for example, that is buried in a “format a hospital’s system can’t easily scan doesn’t help anyone”, Lynch notes, reflecting the interplay between technology and system adoption, as the value in smart packaging is that it can serve to “make authenticity verifiable at the moment of use, not just recorded somewhere”. In consulting with clients, Davis also stresses that smart packaging technology outlay must match a company’s actual business need, and that not all companies will “need the Ferrari when a Ford will do”.
A company can spend millions on a “fancy tool that nobody uses”, Davis says, so in considering how packaging technology can drive supply chain and other efficiencies, they need to make sure a given technology is “really answering the needs of the business”. In OrthAlign’s particular case, it is implementing RFID technology into its packaging for geo-tracking in a “measured manner”. “As a privately held company, we’re running on venture dollars, so we have to be very careful from a cash flow standpoint,” Nandi notes. “With that in mind, these kinds of projects take a bit longer for us than some of the larger players in the medtech industry, with our approach being to target our high-volume accounts as well as our high-dollar finished goods and work our way down for the biggest dollar impact.”
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Packaging a “first line of defence” against counterfeit risk
Another piece of the supply chain puzzle where packaging technology plays a role is mitigating counterfeit device risk.
The non-profit ECRI ranked substandard or fraudulent medical devices and supplies fourth among its top health technology hazards in 2025. In 2026, it ranked the related category of substandard and falsified medical products third. Lynch describes packaging as the “first line of defence” against a counterfeit or diverted device entering a hospital’s inventory. “A UDI, tamper-evident feature, or authentication mechanism embedded at the packaging level is often the only thing standing between a legitimate product and a fraudulent one at the point of receiving,” says Lynch.
These protocols can also help eliminate the unwitting sale of failed goods, a pertinent issue in light of a recent case in which two lots of Dexcom’s G7 continuous glucose sensors earmarked for destruction were stolen and resold through unauthorised channels, with sales traced to Pharmsource.
Meanwhile, the UK Medicines and Healthcare products Regulatory Agency (MHRA) recently secured convictions in a long-running case involving falsely CE-marked baby feeding devices. On 23 September 2026, Kenneth George Harrison was sentenced at Manchester Crown Court to a three- year prison sentence, suspended for three years. The sentencing date for Medicina remains pending. According to Lynch, counterfeit device risks are exacerbated by fragmented hospital supply chains, with many vendors using “inconsistent packaging and labelling formats” that create blind spots. “A hospital that can’t easily verify what it received, or where a given unit has been, has an inventory visibility gap before it has a counterfeit problem,” Lynch notes.
Acknowledging that counterfeit risk is an omnipresent issue in the medical device industry, Nandi highlights that while location tracking for oversight into whether a device “wound up in a place that it wasn’t supposed to” won’t completely mitigate counterfeiting, it can serve as “one more barrier” to preventing it. For the medtech industry, supply chains are growing increasingly complex, with numerous stakeholders involved. It’s no longer just about tracking finished devices. Smart packaging, applied in a way that makes sense for an individual company, can not only improve supply chain oversight to help companies respond to potential issues, but also prove an effective tool in meeting evolving regulatory requirements and reducing the threat and potentially profound consequences of counterfeit devices entering an end user’s inventory. ●
www.medicaldevice-developments.com
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