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Portable Data Carrier Solutions For Embedded Engineers
Applications For Medical & Other Embedded OEMs - Part I
Datakey Electronics' rugged portable memory systems are ideal solutions for a variety of applications, including:
All of the topics listed above find application in embedded electronic devices across a variety of industries, including medical devices. This quarter's E-Newsletter addresses these topics in the context of medical electronic devices, but are equally applicable for other markets as well. This issue looks at the first three applications mentioned above. Next quarter's E-Newsletter, coming in Q1-2010, will look at the four remaining applications.
Product Authentication / Anti-counterfeit
 It seems like no industry is immune to counterfeit products, and according to the World Health Organization, the number of detected cases of counterfeit medical products is increasing. The problem of counterfeit medical products is first and foremost a concern for the safety of patients, but it is also a concern for the original equipment manufacturers (OEMs) who manufacture the genuine medical products, as it affects their bottom line.
It would not be uncommon for a medical device manufacturer to sell a product at or below cost when that product utilizes a limited-use, disposable attachment that is sold in high quantities. In this scenario, the manufacturer could sell the base unit at a loss, but could more than make up for that loss through the sales of higher-margin attachments. This is a well-known sales model that has been used for years by razor manufactures ("give away" the razor and make your profit from sales of the blades) and ink-jet printer manufacturers ("give away" the printer and make your profit on the ink). One potential problem with this sales model is that the high-margin attachments become targets for counterfeiters.
 So, how can medical device OEMs protect against counterfeit attachments for their medical devices? If the base unit of the medical device contains a microcontroller or microprocessor, the solution can be as simple as adding a Datakey Electronics SlimLine™ Token to the attachment and a mating receptacle to the base unit. The EEPROM-based SlimLine Token (shown here with a cut-away view of the memory IC) can be tethered to the attachment and contain a product authentication code. This code can then be read by the base unit's microcontroller/microprocessor; if it is not valid, the device doesn't function. Datakey Electronics offers memory tokens with a variety of security features from: industry standard serial EEPROMs (with Microwire, I2C or SPI interfaces), to EEPROMs with unique, unchangeable serial numbers, to CryptoMemory® EEPROMs utilizing Atmel's symmetrical dynamic mutual authentication with 64-bit cryptographic keys. Datakey Electronics also offers custom Tokens giving you the ability to choose the security IC of your choice.
On the base unit of the medical device, all that is needed is a low-cost receptacle. Unlike RFID solutions, no expensive transceiver circuitry is required. The Datakey Electronics Receptacle would connect directly to the microcontroller's Microwire, I2C or SPI port. If the medical device requires a wash-down capability, we offer receptacles with IP65 (splash proof) and IP67 (immersion-rated) ratings. We also offer receptacles that reduce electro-magnetic emissions (EMI).
But what if your medical attachment requires sterilization? No problem! Our rugged memory tokens can survive EtO and autoclave sterilization! Unlike other memory devices, like SD cards and USB flash drives that are designed for light-duty consumer applications, Datakey Electronics SlimLine Tokens are made using an extremely rugged composite plastic material utilizing solid over-molded construction. They can stand up to the harshest environmental requirements including: extreme temperatures, water (immersion), chemicals, ESD, shock & vibration, and yes, sterilization!
What would prevent a would-be counterfeiter from also producing a counterfeit token? The first road block a counterfeiter would run into is that the SlimLine Tokens utilize Datakey Electronics' unique interface design and form factor. They cannot simply buy them from a store or online like they could buy a microSD card, for example. Further, Datakey Electronics controls the availability of our products, only selling to our known list of OEM customers and new, qualified OEM potentials. This keeps our products out of the hands of would-be counterfeiters. Additional measures can be taken in how the data is stored on the token (e.g. encryption, false data, etc.) to provide further protection if desired.
Usage Tracking / Limit Use
 Another common need for medical devices with disposable attachments is to track and limit the number of uses of the disposable attachment. Perhaps the attachment is only meant to be used a single time. Or perhaps the attachment is a filter that can only be used for a certain number of hours. Adding a SlimLine Token to the attachment (via tether or integrated into the attachment) can solve this problem. The re-writeable, non-volatile memory can record and track the usage information--allowing the medical device to confirm that the attachment is still within its usable life and rendering it useless when it is not.
You may be wondering what happens to the memory token after the attachment has been used the prescribed number of times. In most cases, the token's fate is the same as the attachment's. If the attachment is discarded, the token is typically discarded as well. The low cost of the SlimLine Tokens used in these types of applications allows them to be disposable. If recycling is desired, the data on the token can be erased and the Token can be re-sterilized and used again. Also, it should be noted that all SlimLine Tokens are RoHS-compliant.
Calibration Uploads
 Some medical device attachments have calibration information or other parameters that must be input into the base unit of the medical device. This information could be as simple as a product identification code. That is, a single base unit may accept a number of different attachments. Somehow, the base unit needs to know which model is attached. Instead of relying on medical personnel to enter the model, a memory token that is physically tethered to the attachment can store model information and/or the parameters associated with that model of attachment. This allows the medical device to "self-configure" based on the attachment it detects via token insertion--eliminating the possibility of data entry error.
Other medical products may have more complicated calibration information that may be unique to every attachment produced (instead of sharing the same parameters across a given model). In these cases, as part of the manufacturing process for the attachment, these parameters can automatically be written to the token--thereby eliminating the risk of error that comes with manual data entry and assuring the calibration data used is correct.
The case study shown above-left provides an example of a Datakey Electronics customer who uses a tethered SlimLine Token to store detailed calibration information. In this case, the medical system is used by cardiologists who specialize in treating heart rhythm problems. The system includes a catheter (the disposable attachment) that utilizes a proprietary wire mesh balloon to measure and calculate the electrical fields in the heart of the patient. Made up of 64 unique, non-contact electrodes, the catheter must be calibrated with the precise x-y-z coordinates of each electrode. This information, along with other proprietary information, is recorded to a tethered SlimLine Token, which is then sterilized along with the catheter assembly. To learn more about how this customer used a disposable memory device from Datakey Electronics to record calibration information for their catheter, please download the case study.
If you have an embedded system that could benefit from using a portable data carrier system and you would like to learn more about Datakey Electronics' OEM-focused portable memory solutions, please contact the factory or your local Datakey Electronics representative.
Datakey Electronics Engineering Contacts:
Brian Mishuk, brianm@datakey.com 1-952-746-4066 x348
Paul Plitzuweit, paulp@datakey.com 1-952-746-4066 x325
CryptoMemory is a registered trademark of Atmel Corp. |
