When medical products are transported, they cannot be exposed to any conditions that impact on their quality for the entire time they are in shipment. This concerns temperature above all. Excessive coldness or warmth may significantly reduce the shelf life of medicines, vaccines, or biotech products or even make them unusable. The rules for shipping these products were tightened even further in the EU at the beginning of 2017: According to Good Distribution Practice (EU GDP 2013/C 343/01) Chapter 9, wholesalers must, among other things, provide evidence that the permitted temperature range was complied with for the entire duration of the shipment.
Until recently, pharmaceutical companies had worked with logistics service providers for this, with the latter transporting medical products in trucks and containers with stabilized temperatures. However, this method is not cost-effective as most medicines are not sensitive to temperature at all, yet are nonetheless shipped using this method to satisfy GDP requirements. With the modum.io solution, this burden is rendered unnecessary as pharmaceutical companies can now still provide the evidence required by GDP.
On-board temperature logger
The centerpiece of the modum system is a temperature logger that monitors the temperature during transport. Before shipment, the user sets the permitted temperature range, i.e. sets the maximum and minimum values for an alarm, using a dashboard on any PC or laptop, and also specifies the measurement intervals and certain other criteria. If the medicines are being packed for transport, the logistics employee scans the shipping information, e.g. the tracking number, and puts the logger inside the package with the medicines. The scan process can also be done using NFC for automated packing. Simultaneously, the back end calls up a program code in the blockchain for the delivery. This code is called a smart contract.
Evidence provided automatically
Thanks to this process, past and current temperature data for the entire duration of the shipment can be called up locally by the logger. When the goods reach their destination, the smart contract stores an unmodifiable "yes" or "no" in the Ethereum blockchain depending on whether the temperature limits were complied with or not. On top of that, there is a hash for the measurement data and metadata, and a link to the customer's measurement data. The recipient can read the data via BLE for this without having to open the package.
The modum system ensures compliance with GDP at various levels:
- The logger itself displays when the temperature range is exceeded using three LEDs (active, measuring, and warning).
- The connected smartphone app provides a graphic illustration of the data and any violations of minimum/maximum temperatures, even if the smartphone is not connected to the Internet. The sender additionally receives a message if a minimum or maximum value is exceeded so that he/she can check it immediately and respond appropriately.
- The measurement data and metadata recorded are presented graphically on the front end, with only authorized persons being allowed access. They allow people with technical responsibility for the system to monitor, compare, and evaluate their operational processes.
- The authenticity and conformity of the data are confirmed in the back end. This anonymized analysis can be seen by anyone and cannot be modified or deleted.
Serial production product with nRF52832: Faster connection and data transmission
On the first few prototypes used in the three pilot studies, modum.io had a built standard sensor tag based on the SimpleLink by Texas Instruments, which supports BLE 4.2. To increase the speed and reliability of the connection, Rutronik recommended replacing the standard sensor tag on the product in serial production with the nRF52832 SoC by Nordic Semiconductor, as Rutronik had had good experience with the latter. Its ultra-low-power SoC supports BLE 5, which almost doubles the maximum data transmission rate compared to Bluetooth 4.2. Consequently, large quantities of data can be sent in a short amount of time and the electricity consumption required for transmitting quantities of data is also reduced. Furthermore, the nRF52832 also supports ANT and proprietary 2.4 GHz applications. Thanks to the integrated NFC tag, it also allows fast out-of-band (OOB) pairing so that the logger can be used in highly automated, industrial settings.
The pharmaceutical industry as a blockchain enabler
Serial production has now commenced and market entry in Switzerland is expected for the first quarter of 2018. However, this system for the pharmaceutical industry is just the beginning for modum.io, and is also the ideal blockchain enabler. This is because the industry has the highest standards when it comes to product safety, security, and stability, and requires highly automated, cost-efficient logistics solutions. After successfully proving the system in the pharmaceuticals sector, modum.io can now scale it to other markets.
What is a blockchain?
The blockchain is a technology through which transaction data are condensed into blocks and saved on a decentralized network in a way that cannot be modified. Numerous blocks are listed one after the other in a logical sequence of transactions, forming a chain. Each transaction contains a time stamp and hash link, which ensures that they match only with the previous transaction. Since the data are stored on every computer and hard drive within the network, subsequent manipulation or deletion of entries is noticed immediately and can therefore be ruled out. A consensus mechanism serves to confirm the integrity of the transactions. Any data, contracts, documents, computer programs, or currency values can form part of the blockchain's content. A prominent representative, which enables the embedding of independent programs, is the cryptocurrency Ethereum. It supports so-called smart contracts.
How blockchain technology is revolutionary:
- Security: It provides a technical basis for trust that previously required a trustworthy intermediary, e.g. a bank or notary. As a result, companies, organizations, or people who do not know each other can process transactions directly with each other without any risk.
- Traceability and transparency: Every stakeholder can see and follow each individual transaction on the chain at any time. This is how blockchains ensure a high degree of security and allow automatic presentation of evidence of meeting regulatory requirements. This transparency includes all businesses and components within the network.
- Speed and automation: A transaction can be defined as a trigger for another transaction. For example, payment can be made automatically when goods have been delivered as requested. The process runs faster, more simply, and without the risk of manipulation.
- The system works globally and independently of platform and software.