Technology & Innovation

Smart Packaging and Anti-Counterfeit Technologies

To combat the severe health risks of counterfeit diabetic test strips and the economic loss from grey market diversion, manufacturers employ a Defense in Depth strategy combining physical, digital, and electrochemical technologies.

  • Physical Security: Utilization of holograms, color-shifting inks, and tamper-evident seals on vials and boxes to facilitate visual verification.
  • Supply Chain Serialization: Adoption of 2D DataMatrix barcodes and Unique Device Identification (UDI) allows for item-level tracking, helping to identify diverted goods and automate recall management in compliance with FDA and EU regulations.
  • Intrinsic Authentication (DRM): The most effective barrier is the integration of proprietary electrical signatures directly onto the strip. Modern meters use AC Impedance Spectroscopy to analyze the electrode materials and conductive patterns; if the strip's electrical profile does not match the OEM specifications, the meter locks out the user. This technology simultaneously blocks dangerous counterfeits and legitimate third-party generics.
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Smart Packaging and Anti-Counterfeit Technologies for [Diabetic Test Strips](/sell-diabetic-supplies)

Manufacturers deploy a Defense in Depth strategy to combat counterfeit diabetic test strips. This approach integrates physical, digital, and electrochemical technologies to ensure authenticity and safety.

Physical Security Measures

Manufacturers use holograms, color-shifting inks, and tamper-evident seals to enable visual verification of authenticity. These features make it harder for counterfeiters to replicate packaging.

Supply Chain Serialization

2D DataMatrix barcodes and Unique Device Identification (UDI) facilitate item-level tracking. This technology helps identify diverted goods and automate recall management, ensuring compliance with FDA and EU regulations [1].

Intrinsic Authentication (DRM)

Manufacturers integrate proprietary electrical signatures onto the strip. Modern meters use AC Impedance Spectroscopy to analyze electrode materials and conductive patterns. If the strip's electrical profile does not match OEM specifications, the meter locks out the user [2]. This technology effectively blocks counterfeit and unauthorized strips.

[1]: FDA. (2020). Unique Device Identification (UDI).

[2]: EU. (2019). Medical Device Regulation.

References

  1. Paper-based electrochemical biosensors: From test strips to wearable devicesSource
  2. Drug Supply Chain Security Act (DSCSA)Source

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