According to the World Health Organization (WHO), an estimated 35-40 million people around the world require prosthetics and orthotics, and millions more need medical devices and implants to restore their bodies’ functionalities. What’s more, these numbers are only bound to increase as the global population continues to grow and age.
But while medical devices are highly regulated and controlled, the volume of counterfeit and fake medical implants on the market continues to rise, posing a significant health risk for patients and reputation threats for manufacturers.
In this guide by the product authentication experts at Authena, you’ll learn more about how technologies such as IoT devices and blockchain can help reduce the risk linked to counterfeit medical devices and boost patient safety. Let’s get started.
To understand the need to stop the market of fake medical devices and implants, it is important to clarify what medical implants are and how they are defined and regulated by the Food and Drug Administration (FDA).
The FDA defines medical implants as devices or materials that are implanted within or outside the body to restore hindered functions, replace milling limbs, or improve mobility and health. Medical implants such as prosthetics can replace missing body parts, while other devices, such as pacemakers, are implanted to control and monitor body functions (i.e.: heartbeats).
Medical implants can be made using a wide range of materials, such as skin, bone, body tissues, metal, plastic, and ceramic. Although some are permanently fixed, others can be removed as needed.
Even highly regulated medical devices come with some risks for the patient, including complications that might arise when inserting or extracting the device, infections, and defects.
The medical implant manufacturing industry is a highly regulated one, and each device is thoroughly tested and assessed before being released into the market. What’s more, most medical devices carry a serial number that is associated with barcode labels present on a patient’s medical file. This system allows healthcare providers to rapidly identify the implant and patient at any time.
Nonetheless, while many manufacturers today imprint a serial number on their devices, there is no standardized system to rely on.
As we have seen above, the volume of medical devices in circulation is rising. And, just like in the case of any other market, exponential growth comes with a heightened risk of fake products and counterfeit. In 2010, the WHO estimated that around 8% of all medical devices on the market were counterfeit, but actual and more recent numbers are likely to be higher due to the growing demand for medical implants.
What’s more, the threat of counterfeit prosthetics, medical devices, and implants is made even greater by the rise of eCommerce and the unprecedented pressure that today’s demand has put on the global supply chain.
It has never been more important for manufacturers and distributors to assess the security of medical implants in circulation in today’s market. However, as the global supply chain and distribution system continues to expand, it has become all the more difficult to track, trace, and safeguard each medical item throughout its journey from producer to patient.
Luckily, new technologies such as Blockchain and Non-Fungible Tokens, paired with IoT devices can help.
Blockchain infrastructures allow manufacturers and healthcare providers to access an immutable and transparent record of transactions, which can help them prove the authenticity of each item.
New estimations show that around 10% of Americans are likely to require at least one medical device to be implanted in their bodies during their lifetimes. On the other hand, it is believed that only around 0.5% of these devices meet regulatory standards set by the US.
For patients, having a fake device that has not been properly tested and does not meet the highest manufacturing standards can lead to significant health threats and complications.
For manufacturers, fake medical items circulating under their brand name can cause significant financial losses and reputation damage. Following a scandal, non-genuine medical devices can lead to recalls, public safety issues, and costly lawsuits.
Given the devastating impact that the circulation of fake medical implants can lead to, it is crucial for manufacturers and distributors to prevent counterfeiting and guarantee the authenticity of their medical devices.
At Authena, we have developed a portfolio of customizable systems based on blockchain and IoT that allows manufacturers to track and trace their products, gain visibility into their supply chain, and prove each item’s authenticity.
When it comes down to verifying the authenticity of medical implants, emerging technologies such as NFT and blockchain can help.
Blockchain infrastructures are decentralized digital ledgers created to safely store all the information regarding a product’s location, ownership, and transactions. Manufacturers can then track each medical item or supply by creating a digital twin – or NFT – of the item. These NFTs exist in the metaverse and can be used to safely track and provide proof of ownership of the underlying physical item.
Over the past years, the healthcare industry has had to step up and grow to meet the rapidly growing global demand for accessible, high-quality, and affordable healthcare. But while the global supply chain has already undergone a significant transformation, it is not yet entirely bulletproof. In turn, this provides opportunities for bad actors to divert, refill, and clone products, which are then sold through unregulated markets.
In this digital age, it is crucial for manufacturers to adopt high-tech solutions that allow them to automate labor-intensive and risk-prone aspects of their businesses. What’s more, technologies such as blockchain can play a vital role in recording transactions safely and immutably.
The product authentication specialists at Authena have developed an end-to-end solution that allows manufacturers and patients to operate with confidence and safety. Get in touch with our team to access a customized authentication and traceability solution for your medical device or healthcare organization.