Systech Delivers Layered Approach for Medical Product Supply Chain Transparency and Safety

Systech’s solutions create and capture product identification on the packaging line and deliver value from that data throughout the med product supply chain

Princeton, N.J., June 6, 2023 – Systech, part of Markem-Imaje and Dover, and a leading provider of digital identification and traceability software solutions, is supporting medical device manufacturers to stem product counterfeiting and ensure safety while providing manufacturers with essential business insights.

A pioneer of productized item serialization with decades of experience in pharmaceutical packaging execution, Systech leads in providing digital identification and traceability solutions. These offerings establish essential product data, ensure digital connectivity, and enable real-time insights starting on the packaging line and moving throughout the supply chain to help ensure products land safely with medical providers and their patients.  

Over the past three years, bad actors searched for ways to profit from the pandemic. Unfortunately, the medical device industry was not immune to these threats. While the Personal Protective Equipment (PPE) medical device category experienced unprecedented demand, counterfeiters seized the opportunity. Systech worked with major manufacturers of PPE to detect counterfeits and ensure authentic PPE was in the marketplace and available for practitioners and patients.

“The COVID-19 pandemic highlighted the fragility of the global supply chains and spawned widespread counterfeiting. Everything from test kits and personal protective equipment to surgical equipment is in jeopardy,” observes Girish Juneja, Senior Vice President and Chief Digital Officer at Dover Corporation. “In an environment of unyielding global demand, unprecedented lack of supply, and emerging e-marketplaces, protection from counterfeiting is essential to keeping medical devices safe for patients and healthcare providers.”

Systech is the only company to offer a complete set of solutions capable of creating product identification data at the line level for popular packaging form factors and delivering meaningful value from that data throughout the supply chain. It begins with easily configured, integrated vision inspection, device management, line control and workflow management backed by decades of experience, reliable implementation, and expert support.

Systech’s® solution can leverage existing product barcodes, like the Unique Device Identification (UDI) required for all medical devices, to create a unique e-Fingerprint, individually identifying each singular product digitally. For example, one thousand of the same UDI barcodes assigned to a type of medical device would be captured as one thousand different and unique e-Fingerprints. The e-Fingerprint allows for proper item identification and provides authenticity confirmation anywhere in the world a device may go.

Systech also offers comprehensive serialization and traceability solutions for the medical device industry and its supply chain. Individual items, bundles, or cases are serialized depending on customer needs. Aggregating serial numbers into cases and potentially onto pallets allows one scan to add current location data for all the items as they move through the supply chain. This approach provides better supply chain visibility and facilitates recalls.

“Systech’s proven capacity to secure the supply chain, protect products and meet regulatory requirements in the rigorous pharmaceutical space makes us the partner medical device manufacturers can rely upon to support their anti-counterfeiting, anti-diversion, and brand protection objectives,” continues Girish. “Job one is to protect medical devices, patients and medical teams that need them. Systech solutions do that and more.”

The threat of illicit trade, specifically counterfeit, diversion and tampering, is growing globally. The global value of counterfeiting and diversion is over $1.7 trillion annually. Counterfeiting of medical devices is on the rise and impacts everyone. While the World Health Organization (WHO) estimates 1 in 10 medical products in developing countries is substandard or falsified, counterfeit healthcare products are one of the most frequently seized commodities by U.S. Customs and Border Protection (CBP, 2019).

Better traceability and product authentication support patient safety initiatives that also drive regulatory requirements. These include the EU Medical Device Regulation (EU MDR) and In-Vitro Medical Devices Regulation (IVDR) program requirements, as well as US Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID). As these regulations continuously evolve, regulatory agencies recommend that medical device manufacturers continue to improve their processes to ensure they are protected. 

EN SAVOIR PLUS about how Systech leveraged the humble printed barcode on COVID-19 home test kits to protect the supply chain from counterfeiting and diversion.