Clinical Packaging RFID

Before discussing Clinical Packaging, RFID let’s see the current scenario. Billions of dollars are spent each year on medical research. But evaluating the drugs designed in laboratories around the world is an imprecise science. Two pharmaceutical companies are now testing a new blister packaging system that records when people take medication and sends that information to readers using radio frequency identification technology.

Information Mediary Corp. (IMC) and Shorewood Packaging, a business of International Paper, developed the smart packaging technology. IMC CEO Michael Peterson declined to reveal the names of the two pharmaceutical companies at this time, but said the trials are expected to be completed by the end of year 2003.

About 40 percent of patients don't take their medication as prescribed, according to IMC. In clinical trials, that can make it difficult to determine the effectiveness of some drugs that must be taken at specific intervals. The new Med-ic ECM (for Electronic Compliance Monitor) is designed to solve the problem.

The smart packaging combines IMC's "sensor grid technology" and a proprietary process of printed conductive inks in Clinical Packaging, RFID is very useful. When a patent breaks open the blister packages -- individual foil wrappers for pills -- a signal is sent to a microprocessor that records the date and time.

IMC says the Med-ic ECM packaging can be tailored to specific clinical requirements, such as monitoring the temperature, vibration, humidity, radiation, light or shock to which the package might be exposed. The company could also add beeps or a tiny light to alert the patient when it is time to take a pill.

Let’s see some real life examples of Clinical Packaging, RFID implications. Cypak has developed blister packaging in which conductive inks are used to print circuits on the plastic bubbles that hold pills. When a patient breaks open the blister to take a pill, a microchip in the package records the date and time. This can be checked against the timing required by the drug regimen.

The packaging in Clinical Packaging, RFID can also include a keypad, so patients can input information, such as whether or not they are feeling better after taking the pills. Then, when the patient visits a doctor's office or clinic, the package is placed on a close-proximity reader, and the information stored on the microchip is transferred to a PC. Certus, a drug-testing company, is currently testing the technology.

Jakob Ehrensvard, Cypak's CEO, says the technology adds a couple of dollars to the cost of blister packs. The reader costs about $10. The reason it's so inexpensive is data can only be transmitted a quarter of an inch or less. This limits interference and enables the electronic components to be far simpler than those used in Clinical Packaging, RFID readers.

Ehrensvard says he looked at RFID, but it was too expensive. Since the readers need to be given away, and each patient might need one, the readers had to be very cheap for the system to make economic sense for a drug company. Cypak developed an electrostatic communication system that requires very little power and enables the circuits and antenna to be printed with nonmetallic ink.

One key to Cypak's technology is the microcontroller has an encryption engine and can store 32 KB of data, including encryption keys, so it can ensure the integrity of data. For example, information about a clinical drug trial could be downloaded from the packaging, sent across the Internet and decrypted by a drug company's host computer.

Cypak is also looking at other applications. One is a smart card with a keypad. The system can be used for access control, where the unique identifier on the card is stored in an encrypted form. The user has to enter a PIN to activate the card, which adds an extra level of security.

Another interesting application is parcel authentication. Cypak is doing a pilot study in which the microcontroller in the parcel stores confidential data and encryption keys that are used to verify that the package sent is the package that arrives in Clinical Packaging, RFID system. The system can also monitor whether the package has been tampered with or damaged. (If the printed circuits are broken when the package is dropped or opened, that would be recorded in by the microprocessor.)

Ehrensvard says Cypak is in discussions with a number of companies, but so far, none has committed to using the technology. Cypak is an engineering company and plans to develop applications, based on its technology, for lager firms.