Simon Bastarache, global head of strategy - medical devices for Optel Group, a global provider of vision inspection and traceability systems, explains why he believes the medical device industry is ready for serialisation.
In November 2018, the International Consortium of Investigative Journalists (ICIJ) released the Implant Files, the culmination of a year-long investigation into how governments around the world handled the approval and monitoring of medical devices.
The ICIJ report prompted governments to begin drafting new regulations, while industry players began contemplating better ways to detect defects, react quickly to recalls and protect their brands.
Serialisation provides a promising solution because it enables traceability - the ability to know exactly where along the supply chain an individual device or component is at any given time.
On average, one company per year sees a 10 percent drop in share price after a single, major quality event such as a recall, and the risk of long-term reputational damage is real. Serialisation can play an important role in mitigating these risks.
To date, mandatory unique device identifiers (UDIs) have been the focus of regulatory reform to address recalls and other issues. While UDIs are an excellent starting point, serialisation is the crucial next step that will allow the industry to better manage the flow of product through the supply chain, guard against counterfeiting, and reassure patients that the medical devices they use have been properly tracked, traced and monitored.
In order to achieve traceability, the industry needs to adopt systems that apply and manage serialised data and ensure connectivity with various databases. These systems need to collect and leverage granular data to gain visibility throughout the supply chain. This data could then be leveraged to facilitate inventory management. This would allow monitoring of product usage at the patient level, which could lead to improved product development strategies, and help the industry better manage recalls and inventories whilst complying with emerging government regulations. The entire supply chain becomes connected when all stakeholders become willing to share relevant data, from the manufacturers all the way up to the patient.
Serialisation could benefit the manufacturers of plastics in medical and drug delivery devices in many ways. For example, serialised drug-delivery devices can integrate end-user programs in order to provide information about what medication is used the most, what dosage works best for the patient and what types of usage affect the product’s life cycle. Importantly, serialisation can also enable the industry to respond promptly to defects and recalls.
Is the medical device industry ready for serialisation? Absolutely. Supply chain traceability technologies such as serialisation can and must play a key role in overseeing, improving and assuring the quality of medical devices, just as it does for pharmaceutical products. By tracking individual devices throughout their life cycle, traceability makes it possible for all stakeholders at every step along the supply chain - from the manufacturer to the healthcare provider to the patient, in order to know everything there is to know, about any given device, anywhere in the world.
Many manufacturers are expressing interest in ‘connecting’ their devices and taking advantage of artificial intelligence (AI) and other available technologies. That being said, both the medical device industry and its regulatory bodies have yet to fully embrace serialisation, perhaps because the conversation is still in the exploratory stage.
We’ve also learned from the pharmaceutical industry that adopting or reinforcing legislation to protect the patient and gain better control of the distribution channel is a long process that can take a decade or more. Therefore, what is clear today is that in this era of connectivity, data management and AI, the first adopters of serialisation will have a definite advantage over their competitors.