How can manufacturers help consumers to distinguish real from fake? Swiss start-up Morphotonix provides a safe and reliable way forward to protect brands and lives.
Whether a simple prefilled syringe, an auto-injector, or high-tech equipment for an examining room, plastic components within the medical industry must maintain strict standards to ensure patient safety, product reliability, and regulatory compliance. Unfortunately, it is far too easy to produce counterfeit products that cannot be distinguished from the genuine article by the naked eye alone.
With the global medical device market estimated at over $450 billion in 2021 and the World Health Organization stating that 8% of devices on the market in 2010 were fake, the size of the problem and the resulting risk to patient safety cannot be underestimated.1,2
Mould nano-engraving technology
To ensure the authenticity of rigid plastic materials against counterfeiting, Morphotonix has designed,
Overt Morphotonix security used on three different substrates: polymer, rubber, and pharmaceutical pills.
developed, and patented a unique advance in lithography-based nano-engraving. The technology is integrated without any extra steps in the manufacturing process and does not affect product integrity. Security features, which can be anything from complex diffractive designs to forensic signatures, are engraved directly into steel production molds. These custom markings are then replicated on the surface of each plastic part without using labels, ink, or additional post-processing (Figure 1). The technology is so safe manufacturers can apply it to medical plastics and even directly onto pharmaceuticals such as medicine pills — the company, in fact, launched with proof-of-concept holographic designs on gourmet Swiss chocolate.
The technology has already found many uses in a variety of industries, from auto parts to nutraceutical packaging to high-tech components.3 Overt, covert, and machine-readable features are nano-engraved with a precision of 130,000 dpi.
New legislation introduced into US and Europe, and measures such as serialisation and unique device identification is insufficient to prevent counterfeiting.4,5 Traditional security measures involve labels, direct printing or taggants. In most products, these usual approaches add complexity and can have high investment costs to adapt manufacturing lines. In the medical industry, these approaches may have additional failure points under standard usage conditions, such as sterilisation or exposure to UV or chemical interactions. Furthermore, the anticounterfeit measures may be on outer packaging, leaving the device itself unprotected. By comparison, the Morphotonix solution appears directly on the device component, dramatically increasing the level of protection.
The Morphotonix solution is intrinsically embedded within the products themselves. The process does not involve any additives or post-processing that increase the production cost, face concerns about health interactions, or require additional detection machinery. There is no change to the material or its processing, and therefore no need to perform expensive and time-consuming process and material revalidation. With a lifecycle of more than a million units per engraving, the process is extremely cost-effective at industrial scale.6
Features are designed according to the custom needs of each client, including functional and branding considerations — from instant authentication by consumers and in-field investigations to differentiated authentication channels for multiple stakeholders. The logistics to securely send out the mold inserts to Morphotonix is as simple as sending a shoe box-size package. The inserts are engraved in a nanotechnology cleanroom in Switzerland. Once they are marked with the custom design, they are returned to the customer’s production line. This entire process usually takes 6–8 weeks.
Future development
Morphotonix is developing its technology so that it can be applied to other substrates.3 Each substrate has characteristics that present unique industrial manufacturing requirements. The company is currently looking at rubber so that vial septums for vaccines can be authenticated to prevent counterfeiting.
Case study
A Swiss market leader in the global breastfeeding products industry integrated the Morphotonix security solution for a device selling millions of units, where authenticity is crucial to consumer confidence. Given the babies’ extreme sensitivity, being able to authenticate the high-quality, regulatory-compliant products, the customer decided to pre-emptively include Morphotonix highly secure technology which does not use any extra additives. To secure a smooth manufacturing process for a delicate product, Morphotonix merged its nano-engraving with Wild & Kupfer’s expertise in complex and high-precision molding.7
This successful collaboration led Wild & Küpfer to further recommend Morphotonix technology to their clients, contributing an effective advance to their product portfolio.