May 17, 2020

Proving provenance in the drug supply chain

Supply Chain
Health technology
pharmaceutical
pharmaceutical
Adrian Clarke, Founder of Evid...
4 min
A report from strategy& last year stated that prescription drugs is the biggest global counterfeiting market by sector and that one million patients...

A report from strategy& last year stated that prescription drugs is the biggest global counterfeiting market by sector and that one million patients die every year from toxic counterfeit pharmaceuticals. Not only that, the World Health Organisation (WHO) estimated earlier this year that 1 in 10 medical products in low and middle income countries is substandard or falsified.

It is not a new problem but it is one that the industry has continually failed to solve. However, the EU’s latest approach to tackling the issue comes in the form of its directive related to medicinal products for human use and specifically section 16, which states that:

“The verification of the authenticity of the unique identifier is a critical step to ensure the authenticity of the medicinal product bearing it and should only be based on the comparison with trusted information on the legitimate unique identifiers uploaded in a secure repositories system by verified users.”

This directive is an important weapon in the fight against counterfeit drugs but it is not a simple change for organisations to implement. This is partly because of the complex and globalised supply chains that exist for the design, manufacture and distribution of drugs. It is also because the requirements for ‘comparison with trusted information’ and the need for ‘a secure repositories system’ are difficult to envisage with the current technology available.

However, a radical new technology could solve this issue if the industry is willing to embrace it.

Blockchain as a solution

It’s fair to say that the hype that surrounds blockchain at present means that it is being proffered as the solution to almost every issue within the pharmaceuticals and healthcare industries, as well as a lot of others.

However, in the battle against counterfeit drugs, these claims have strong evidence to back them up. A public blockchain is a distributed and decentralised record of information that is transparent, highly secure and immutable. Within tokenised economies, such as Bitcoin, it serves as the authoritative record of truth as to where and when digital assets have been created, transferred and currently exist.

Looking again at the EU’s directive, a couple of significant points stand out. Firstly, there is a need for “trusted information...in a secure repository system”. When you peel away the complementary or parallel technologies that often get mixed in, this is exactly what a blockchain is design to be. Public blockchains are decentralised, open-source infrastructure that incorporate cryptography and consensus mechanisms, resulting in them being highly trustworthy, secure and immutable data repositories.

See also

These characteristics are key to explaining why blockchain technology is the only viable solution to the EU’s directive. That’s because, while database tools already exist for storing information in a way that can easily be compared, they are not fit for purpose. The result is that they are mutable and they are hackable.

Immutable and unhackable

Mutability can be a very useful characteristic in software development, as it’s often the case that changes need to be made to databases. However, when using unique identifiers for medicinal products to fight counterfeiting, immutability is key.

Not only that, once these records are stored, they need to be held securely. Blockchain technology, through its decentralised consensus and cryptographic processes, makes hacking a near impossibility. When you compare this with the number of well documented breaches from centralised databases that have occurred in recent years, the same can’t be said for the technology used today.

While blockchains are clearly well suited to the EU’s directive, it is worth noting the importance of storing the right information in the first place. The whole system that the EU has envisioned relies on unique identifiers being used as the verifier of authenticity. In the globally distributed supply chains of medicinal products, there could be opportunities for dishonest parties to attempt to record counterfeit drugs as legitimate ones.

This is why the “verified users” that the directive mentions are so important. These individuals would need to have access to services that allow them to securely encrypt data and store it on a blockchain, so it can be used as proof of evidence. Not only would this make it easy for trusted parties to work with the blockchain but also make it possible for them to generate value from their data when interacting with other parties that want to access it.

Provenance proved

Undoubtedly, the eradication of counterfeit products from as complex a supply chain as exists for drugs is no small task. From the areas where raw materials are sourced, to the plants where the drugs are manufactured, the warehouses where they are stored and all the transportation points in between, there are many opportunities for malevolent forces to operate.

However, by using cutting edge verification services to ensure the right information is stored, blockchain technology can be used to establish an immutable, unhackable and secure repository system that everyone can trust.

Adrian Clarke, Founder of tech startup Evident Proof and CEO of Berkshire Cloud & former Microsoft CTO and Innovation director. Adrian has more than 20 years’ experience in enterprise cloud computing and app development, most recently as co-founder and CEO of Berkshire Cloud. Evident Proof uses blockchain technology to bring ‘trusted, distributed consensus’ to supply chain management

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Jul 24, 2021

A guide to labelling compliance for medical devices

medicaldevices
Technology
healthcare
Compliance
Susan Gosnell
4 min
A guide to labelling compliance for medical devices
Susan Gosnell, Product Manager at Loftware, explains labelling compliance for small medical device manufacturers

Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.

Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.

But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it. 

On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.

Putting a plan in place

MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.

Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance.  They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.

When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.

Why labelling in the cloud offers a roadmap forward

Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.

The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.

When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.

A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.  

Future-proof technology

The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.

While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.

Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.

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