PRODUCT AUTHENTICATION / ANTI-COUNTERFEIT
According to the World Health Organization, the number of detected cases of counterfeit medical products is increasing. High-margin, single-use or limited-use disposable medical devices can be prime targets for counterfeiters.  To protect themselves, medical device manufacturers can build product authentication or anti-counterfeit features into their products. Datakey Electronics provides medical OEMs with proven anti-counterfeit and product authentication solutions that they can implement with minimal engineering investment--minimizing risk and speeding time-to-market.
In a typical design, the medical device's controller or base unit is controlled by a microcontroller or microprocessor and the disposable attaches to the base controller unit, as indicated in the block diagram above-right.
Problem: How to add authentication capabilities to both the disposable and base controller unit while minimizing engineering costs, time-to-market and risk.
Solution: Add a rugged memory token to the disposable and a high cycle-life receptacle to the base controller unit.
 
Details: Datakey Electronics' rugged SlimLine™ Memory Tokens contain non-volatile memory with a range of security features. Medical OEMs can write a product authentication key/code along with other data to the Token. Security features and/or security measures can be utilized to ensure that the memory Tokens themselves cannot be counterfeited. Datakey Electronics also controls the availability of our products, only selling to known OEM customers.
 Datakey Electronics' SlimLine™ Memory Tokens are available with a tether, making it easy to add to most medical disposables. Also, the Memory Tokens can survive EtO and autoclave sterilization, while retaining all data.
For the base controller, Datakey Electronics offers a full line of SlimLine™ Receptacles. The Receptacles are available in PCB- and panel-mount versions, and are available with IP65 (splash proof) and IP67 (immersion) ratings. The Receptacles connect directly to the microcontroller's SPI, I2C or Microwire serial ports. Once a Token is inserted, the microcontroller communicates with it just as it would with a standard serial EEPROM that was soldered to the PCB.
When a medical device uses removable memory for product authentication/anti-counterfeit, it opens up a host of other capabilities, including: tracking (and limiting) the number of times an attachment has been used, automatically identifying the model of the attachment and uploading any model-specific parameters, uploading any calibration information that is unique/specific to that particular attachment, and recording settings and other usage data to ensure the device was used properly according to the manufacturer's instructions.
In addition, the Receptacle on the base controller can be used for secondary uses, including: in-field firmware updates, medical personnel access control, rights management, and more!
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