Transporting medicine from the pharmaceutical factory to pharmacies is a $78.8 billion industry, globally. Traditionally, only the cold-chain (refrigerated) portion of the total biopharma/supply chain – estimated to be a $12.6 billion market – was monitored for temperature and humidity. With the introduction of biologic based drugs, expansion of international drug trade, and new regulations requiring stricter oversight of drugs during transportation, though, both the cold-chain portion and the non-cold-chain (ambient) $66.2 billion part of that supply chain will have to be monitored closely in the coming years. This new reality gives companies great opportunities to provide highly integrated, more carefully controlled drug supply chains. Fortunately, the electronic technology that enables the Internet of Things (IoT) can implement very effective tracking and environmental regulation systems.
In-Transit Medication Management Solution for Improved Supply Chain Visibility
Renesas has developed a reference solution for in-transit medication management (ITMM) which enables data logger manufactures to achieve quick time to market. This solution can be thought of as an advanced data logger which enables the supply chain to be compatible to Drug Supply Chain Security Act (DSCSA). This ITMM solution is backward compatible to traditional hand-held scanning systems.
The Renesas ITMM solution has multiple sensors, to track: temperature, humidity, GPS location, tamper, shock and pressure. These parameters are displayed on the onboard display in human readable, and barcode format. A primary cell battery powers the ITMM module, and Bluetooth® low energy technology is used to communicate to a mobile phone. USB port is provided for data transfer or firmware upgrade. Push buttons and LEDs provide HMI functionality to the solution.
|Fuel Gauge||Accurate measure of the battery charge to avoid shutdown|
|USB||Standard micro-USB for data transfer and firmware upgrade|
|Alert||Out of range event in transit|
|Push Buttons||Toggle between human readable & bar code format on display, scan through different parameters displayed on the screen|
|LEDs||Power & Battery level status, Bluetooth© connection and activity status, General ITMM solution status|
|Bluetooth||Secure, reliable and low power method to communicate to the mobile device|
|GPS||Track location history for the medicine|
|Temperature/Humidity/Pressure/Shock Sensor||Ensures medicine has not been subjected to extreme conditions|
|Tamper Sensor||Displays various sensor data in bar code format which can be read by traditional hand held scanner|
|E-ink Screen||Standard micro-USB for data transfer and firmware upgrade|
|NFC tag or Barcodereading||Mobile app enables the mobile device to read NFC tag or bar code so that information at medicine package level can be combined with data logger data (GS1-GTIN format)|
|Mobile App||Forms Data base of Medicine information from labels, GPS history, Sensors data and has capability to report suspicious drugs to FDA|
On the mobile phone side, the user has the ability to scan NFC tag, linear, or 2D barcode on a medicine package. This would help identify the medicine being tracked. When the medicine package is ready to be shipped, user has to arm the ITMM solution via the mobile app. At the destination, user can disarm the solution via the mobile app, and be alerted of any tamper event. The data log from onboard sensors can be transferred to the mobile app via Bluetooth® low energy technology. Additionally, alert levels for different sensors can be set, sensor data log displayed, medicine package identity and location history tracked. Contact FDA button is provided to report suspicious activity.
This solution showcases the Renesas Synergy™ Platform, featuring the Synergy S3 MCU; the RL78/G1D MCU; and the USB Charger IC. Renesas Synergy is a complete and qualified platform that accelerates embedded development, inspiring innovation and enabling differentiation. The RL78/G1D is an industry-leading, true low power MCU featuring Bluetooth low energy technology (v4.1). Renesas has a portfolio of power management ICs.
Customers have the option to use Wi-Fi, LoRa or cellular technology for connectivity instead of the provided Bluetooth low energy technology. The mobile app can be further enhanced by providing back-end connectivity to a cloud platform and building a dashboard on the cloud. This dashboard can be a single point of interaction between the manufacturers, third-party logistics providers, distributors, and dispensers.
Renesas Electronics America and CRATUS Technology, Inc., partnered to define, design and implement the In-Transit Medication Management (ITMM) reference design. CRATUS developed the hardware, firmware and mobile applications using Renesas' Synergy microcontroller platform as well as other wireless and analog functions from Renesas offering. This platform employs CRATUS expertise in sensors and sensing systems, power management and wireless communications in data logging applications which monitor and protect valuable and volatile assets.