Why Data Chain of Custody is Essential to Reducing Product Liability Risks

When a market grows as quickly as implantable medical devices, set to top a staggering $153.8 billion by 2026, the potential risk to patients can rise as well. As implantable medical devices proliferate, so do the number of costly, life-threatening, and reputation-tarnishing recalls. A single large recall can account for millions of device units. A 2017 McKinsey Report estimates manufacturers typically experience as much as a 10% decrease in share prices after a major recall, and some never recover. 

With a growing number of recalls, now considered one of the most serious risks to public health, the healthcare industry is at a critical juncture for staying ahead of a largely avoidable problem before it snowballs. Neglecting the issue is a game of Russian Roulette that too many manufacturers are unprepared and unequipped to play, due to the complexity and interconnectedness of their products. For instance, a leading medical device manufacturer identifies a potentially life-threatening malfunction in a device due to electrical failures. A Class 1 recall, which means exposure to the device will cause serious adverse health consequences or death, is then issued. Even if the company works swiftly to address the problem and is in full compliance with the FDA, a potentially larger-than-necessary recall campaign will be required if its unable to precisely differentiate defective devices from non-defective ones. Without a means of pinpointing where, when, and how the problem originated in each device’s life cycle– there’s no way to accurately track and trace to then correct and contain. 

Detect, Correct and Contain via Track and Trace:

Three critical capabilities are essential to drastically reduce the severity and size of medical device recalls. First, product-related issues must be detected in the field as quickly as possible. Next, corrective actions must be undertaken in a timely manner, limiting the proliferation of additional defective devices into the field. Third, and equally importantly, is the need to contain the scope of impact by limiting recalls to only those devices with defective designs or manufactured using non-conforming production processes. Achieving all of this, however, requires maintaining a strong product Data Chain of Custody; in short, the ability to definitively “track and trace” the lineage of each individual device in the field. Companies mastering their products’ Data Chain of Custody can significantly reduce their product liability risks by limiting the scope of recalls to only those devices negatively impacted by defective designs, manufacturing processes, or adverse operating conditions in the field. 

A New Data Management Paradigm

What’s required is a modern data management platform capable of ingesting, storing, and analyzing data across the device life cycle. The whole gamut of interconnected data must be tracked: from detailed design data on the device to how the device was manufactured, down to how the device is performing in the field. Achieving this requires collecting and blending data from diverse sources, such as product lifecycle management (PLM) and design systems, manufacturing ERP systems and manufacturing sensors and connected device IoT data streams.

Once data is collected, modern analytics capabilities provide the ability to “connect the dots” between failures of individual devices in the field to the specific manufacturing and design characteristics unique to that individual device. The specific root cause of the device failures can now be investigated, discovered and isolated. Finding and removing only those other devices designed or manufactured under the same conditions becomes easier and faster– and the recall’s expense and potential to create further harm considerably smaller. 

The Cloudera Data Platform provides all these track and trace capabilities within an integrated data platform that is easy to deploy, manage, and use. Simplified operations allow designated users to easily collect  all device-relevant data across diverse systems within a centralized data lake deployed either on-premise or in the Cloud. Cloudera DataFlow provides an end-to-end streaming data platform to collect and analyze IOT data at scale. Together, Cloudera Data Platform and Data Flow create a robust product Data Chain of Custody, providing accurate product traceability across the device lifecycle – all within a common framework offering unified security, governance, and management. With data collection, ingestion, transformation, curation and enrichment all happening within a unified platform, Cloudera is the clear choice for medical device manufacturers looking to gain actionable insights from all the disparate sources of data across the device lifecycle, from the edge, across the enterprise and out in the field. Taking full command of the product data chain of custody can reduce the scope of recalls today– and save countless resources and lives tomorrow. 

Click here to learn more about Cloudera’s Enterprise Data Cloud and how it can help you achieve Data Chain of Custody. 

Michael Ger
Michael Ger

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