When it comes to logistics, the medical supply chain is like no other. Efficiency, speed and reliability are essential parameters in every industry, but the transport of pharmaceuticals and medical devices requires much more precision, greater monitoring, tightly controlled conditions and the highest possible level of traceability. At the end of the chain are patients whose lives may depend on the right drugs or devices arriving in perfect condition, on time.
Over the years, the industry has made huge investments in cold chain capability, logistics support and much more to maintain compliance with regulations that have become increasingly stringent and more focused on issues of patient safety. Now, advances in technology have greatly improved the role that packaging solutions can play not only in maintaining the integrity of their contents but also in improving visibility, transparency and tracking.
These innovations broadly fall under the heading of smart packaging, though that term covers a great many different solutions. The challenge for the industry is not only to keep pace with recent advances in smart packaging, but to understand how best to integrate new and familiar tools to optimise the supply chain.
Smart packaging has the potential to change the game when it comes to medical device logistics, but it will take some time and effort to understand how newer concepts such as blockchain will work with tamperevident features, QR code-enabled user engagement tools and other aspects of smart packaging to create the ideal formula for supply chain integrity.
Tamper-proof and traceable
With approximately one in ten medical products in low and middle-income countries either substandard or falsified, and WHO-commissioned work estimating tens of thousands of additional deaths (e.g., malaria and childhood pneumonia) due to substandard and falsified medicines, there is clearly a strong need to secure the integrity of the medical supply chain. Add to that the financial cost of counterfeit products – analysts estimate the global counterfeit pharma trade at $200bn annually; country-level losses are hard to pin down – and the need becomes even more urgent.
Product integrity is also the platform on which patient safety is built, so any successful and robust medical device supply chain must integrate packaging that can show if its contents have been compromised in any way. That principle could manifest in many forms, but tamper-evident seals have become an important tool in ensuring that products remain unopened during transit.
There are many options that are relatively simple to adopt if the goal is to provide visible evidence of tampering to ensure the integrity and safety of medical devices and other supplies during transport and storage. These range from self-adhesive security labels that uncover a ‘void’ message or leave residue when removed, to destructible labels and barrier seal labels made with materials that break or visibly distort if tampered with.
Plastic security seals for bags, cartons and containers that make use of ‘pull-tight’ mechanisms serve the dual purpose of enabling quick removal when an item is used in an emergency, and also provide strong tamper evidence. Specialised foil seals for vials and IV ports can be used to make clear any damage if penetrated by a needle. Many are imprinted with clear messages – perhaps simply the word ‘opened’ – that are revealed when a seal is broken.
Other means of providing immediate visual or digital alerts of unauthorised access come with the use of radio-frequency identification (RFID) tags. Using near-field communication (NFC) capability, familiar to us all in our smartphones, these tags enable logistics personnel to use simple mobile scanners to track the journey of a pharmaceutical product or a medical device throughout the supply chain, from the manufacturing site into the hands of the end user.
Indeed, RFID is becoming a common feature in smart packaging because of tamper-evident features – such as fragile circuits that break if tampered with, triggering alerts in the system – and its use of unique identification and serialisation numbers to ensure that products are genuine and free from interference. Each product can be given a unique RFID tag with a unique serial number, which acts as a kind of digital fingerprint. Any product without a legitimate tag or a serial number that matches official records can be flagged as counterfeit.
As well as tracking the shipment at every stage of its journey in real time, RFID tags also provide a way of verifying a product at the point of use, as healthcare practitioners can scan the item with a reader to verify that it is genuine before use in patient care.
Clarity and compliance
Maintaining the barrier between the product and the external atmosphere is, therefore, relatively straightforward, and advances in RFID and NFC capability are making it easier to put in place a system of alerts to bring to light any threats to the integrity of the supply chain. Yet there are many other ways to build trust and reliability into the supply chain, while also ensuring that product use at the end of the line aligns with best practice.
Some methods have become very familiar even beyond the medical device sector in recent years, and QR codes are a prime example. Increasingly, QR codes are embedded into packaging to provide quick and simple links to multimedia educational content. Users can easily gain real-time access to usage instructions and compliance information, which brings noticeable improvements in patient adherence and safety.
Collectively, these innovations have brought a transformation in traditional packaging systems, which have become more like interactive platforms that support not only security and traceability, but also user engagement in the medical device industry. A more recent technological innovation, however, could have an even bigger effect on supply integrity and product traceability – namely blockchain.
Blockchain is not a completely new phenomenon. Since the advent of Bitcoin and other cryptocurrencies, we have all become familiar with the term and, to a lesser extent, the distributed ledger technology (DLT) that underlies it. What industries across the globe have struggled with, however, is how to incorporate that technology in a way that brings clear and obvious benefits to supply chain partners and end users.
In the context of digital currencies, permissioned blockchains can provide an append-only audit trail and enable smart contracts for supply-chain events, but immutability complicates error correction, and privacy/GDPR and data quality remain key constraints. Its use of distributed decentralised data sharing among a group of authorised users within a specified network means that the individual units – blocks – of transaction information are connected with other blocks that create a chain of tamper-evident data with a high degree of integrity.
As the data record is decentralised, there is no single central record that can be manipulated, tampered with or corrupted. That is why blockchain provides such great potential for better security, transparency and trust in supply chain data. To tamper with a single unit of data is virtually impossible because each one is connected to the previous one, and they are all heavily encrypted and carry timestamps. This limits the vulnerability of a blockchain record to cyberattacks and, therefore, improves data privacy.
A smarter future
The reliable and tamper-resistant record that DLT technology supports, and the way that it facilitates comprehensive recording and tracking of transactions and movements of healthcare products from manufacturers to end users, gives blockchain the potential to become an indispensable solution to support product authenticity, quality and integrity, but that is not its only benefit. There is much more scope to use its data record to improve cost-efficiency and speed.
After all, the blockchain record can readily support the automation of key processes such as inventory management and procurement, as well as logistics, thereby reducing the administrative burden and further improving patient safety. It also underpins the concept of smart contracts, which are becoming ever more prevalent.
These self-executing contracts are based on predetermined criteria, enabling tasks to be performed automatically when certain conditions are met – such as payments and shipments, and the confirmation of an item’s legitimacy to ensure compliance requirements are met.
No doubt blockchain will become a familiar feature in the supply chain in the years ahead, but there are still some issues to iron out. For example, the use of decentralised data is one of the major strengths of DLT, and the data is secured with strong encryption, but questions remain about guarantees of data privacy and confidentiality. Also, any errors made in an immutable blockchain system would create their own challenges.
The roles of blockchain and other key advances in smart packaging are not carved in stone, but their capacity to positively impact traceability, security, product integrity, patient safety and regulatory compliance means that they will continue to attract significant investment of time and money as supply chain optimisation remains firmly at the top of the industry’s agenda.
