The media investigation into the medical device industry has prompted governments to pledge stronger regulations to protect patients from the potentially harmful—or even lethal—consequences of receiving substandard medical implants.

Manufacturers and suppliers must now get ready to modify their ways of doing business, for their own sake as well as for the sake of patients. Public health and safety is and must always remain the top priority, but industry players also need to consider how to protect their brands from crumbling before an international crisis of confidence.


Medical device recalls cost the industry between $2.5 billion and $5 billion per year, and companies whose brand is associated with a recall can expect an average 10% drop in share price*. Lost revenue and increased spending on public relations and crisis communications are inevitable additions to the cost of doing business without a solid brand protection strategy. Companies whose products represent potential health and safety risks, such as medical implants, often face especially high costs, both financial and reputational.

Paradoxically, heightened regulatory scrutiny increases the number of recalls—giving medical device manufacturers and suppliers more reason to carefully consider their options as they plan and implement their brand protection strategy.

Companies would do well to consider harnessing the power of traceability by integrating digital brand protection tools into their supply chain initiatives, operational processes and marketing campaigns.

Traceability technologies help brands secure their supply chains by increasing visibility at every stage of a product’s life cycle to ensure product quality and integrity, as well as to detect and deter counterfeiting, diversion and tampering.

From materials and suppliers to manufacturing and distribution, all the way to the end user, OPTEL’s solutions collect granular data and generate real-time alerts and custom reports, which notify stakeholders about such events as duplicate code entries or invalid authentication activity in the supply chain.

As a result, healthcare professionals can authenticate their suppliers’ medical devices and confirm whether the unique identifier assigned to each product matches the item that was received and scheduled for implant.

The leveraged data can also provide valuable information to internal company investigators and contracted brand-protection agencies, helping each of them identify products as genuine or fake. These solutions also often lead to more successful litigations, helping brands recoup legal costs that can then be reinvested elsewhere.

Because of the nature and scope of the medical device industry and the complexity of the supply chain, the solution often needs to be deployed across many locations, supply chain partners and users in a cost-effective manner. Software solutions for serialization, authentication and traceability typically answer all those requirements, making them one of the most powerful toolsets for supporting brand protection activities and creating supply chain efficiencies.

When a recall is unavoidable, traceability technologies can greatly reduce the burdens of recall management, allowing companies to track product down to the most recent location and obtain real-time alerts and reporting analytics to minimize revenue losses, maximize efficiencies and ultimately preserve or win back consumer confidence.


*McKinsey & Company, The Business Case for Medical Device Quality, 2013



Combating Medical Device Counterfeiting with Product Authentication Technology

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