Medical Device Link.

TRACK AND TRACE

ORBID’s 2DMI can be marked directly to medical devices, even implantable titanium screws.

Now that FDA’s bar code rule for reducing dispensing errors is law, there is some discussion as to whether the very same codes can be used for anticounterfeiting. Trouble is, says Gregg Metcalf of Nosco Inc. (Gurnee, IL), bar codes can be duplicated.

“In most instances of counterfeiting,” says Metcalf, “people are counterfeiting the bar codes on packaging.”

Adding variable information, either to the bar code itself or to the label in the form of other codes, can make it a little more difficult to pass a counterfeit off as authentic. “Printing variably strengthens the ability to add a unique identifier to the package,” says Metcalf.

“But counterfeiters can still mimic serialization,” he continues. “We see it in other industries, especially luxury and IT goods. Human-readable numbers are being duplicated.”

As an additional means of coding for anticounterfeiting, Metcalf says that Nosco has licensed a proprietary coding technology from ORBID Corp. (San Francisco).

“I would rather use proprietary technology and be able to control who reads it,” says Metcalf.

The technology is the ORBID 2DMI coding system, a web-like graphic that can encode serial numbers, production dates, or company identification numbers in unique, serialized fashion. According to ORBID, the ORBID 2DMI is “scalable and can be applied to almost any surface, including rough, curved, or flexible surfaces where other codes cannot be used.” Special proprietary ORBID software encrypts any data and retrieves that data upon scanning.

Other features, according to ORBID, include the following:

• Data capacity ranges from 7 to more than 30 decimals, and it is even higher with stacked 2DMI codes.

• Sizes range from 10 µm to as large as needed.

• Less than 10% contrast is required for scanning.

• Multiple marks can be applied per second.

• Codes can be read at speeds of up to 12,000 per hour on industrial lines.

• Codes can be scanned omnidirectionally.

• Using proprietary software, parent-to-child relationships, such as with a case-to-content relationship, can be tracked.

Kevin Simmons, vice president of ORBID, calls 2DMI “a cost-effective piece in a layered product security approach. Our code is an internal track-and-trace mechanism for authentication.”

He adds that he asks brand managers to ask themselves, “How can I create a chain of custody?” The smart brand owner develops a global track-and-trace solution that has multiple components, he says. These include:

• Overt and covert solutions.

• Bar codes.

• Human-readable codes.

• Radio-frequency identification (RFID).

• A proprietary code.

The vector-based 2DMI code from Orbid can be applied to a variety of surfaces and can be read in low-contrast environments.

In November 2005, Nosco and ORBID began a pilot testing end-to-end authentication using a real-time Web-based application. End-users log into the system, explains Simmons, and authenticate products bearing the ORBID code using a Web camera. “If an imager reads bitmaps, our software can help the reader decipher the code,” says Simmons.

A major orthopedics products company is already using ORBID 2DMI codes in a direct-part marking application for reconstructive facial screws, says Simmons.

“This application allows them to authenticate and track and trace their products anywhere in the world using a range of widely available and inexpensive imagers. It also allows them to control batch information and inventory control on the smallest of products,” he says.

Metcalf says customers are looking at the technology for “a lot of different things—warranties, drug registries, and track and trace. Some users will mark overtly, while others will covertly.”

Some companies aren’t yet ready for the investment of capturing data throughout the whole supply chain. “But you can deploy track and trace for just critical events,” says Simmons. “Today, you may want to capture data for reconciliation involving breakage or pilferage. Later, you may want to have products authenticated at the time of use.”

Adds Metcalf: “We can mark packages with a proprietary code and it can lay dormant until the customer is ready. It depends on what they are trying to protect.”