The FDA’s UDI label example: Product name, expiration date, reference and lot nos., manufacturer information, barcode, details and illustration.

By Rajeev Kapoor and Chris Paddison of A.T. Kearney Compliance

An FDA ruling is about to cross the threshold into the medical device industry, ushering in a new era in which Unique Device Identifiers (UDIs) must be placed on products and packaging.  This is a proven method for enabling companies to efficiently recall faulty products and thereby improve patient care.  The pharmaceutical industry has been held to this requirement for years and, as a result, has been much more efficient in recalling drugs. The new identifiers for medical devices will enable companies to track each product from warehouse to physician’s table and recall whole batches of devices immediately upon notification of a problem.  Whatever your take is on this new ruling, comply you must, or your products will be barred from market access. See infographic

Competitive Advantage
We see in this scenario a very compelling strategic opportunity for device manufacturers.  Aside from regulatory compliance, we’re quite sure that there is another big issue of the day that you’ve been thinking about:  Big Data.  Just think about what all of this new standardized UDI data can do for your efforts to win market access in the highly competitive, evidence-based and cost-driven environment in which you operate today. In the new UDI environment, you will have access to vast data on the journeys of your products through the marketplace, and access to competitive data as well.  Public device registries will enable you to compare products based on performance, and demonstrate quantitatively the success of your products in the marketplace.

And this is only the tip of the Big Data iceberg.  Within its mighty breadth and depth, Big Data encompasses the vast information now being digitized in electronic health records and the tidal wave of digitization that is occurring across the industry.  This is a transformation that will grow by geometric proportions in the years to come.  While data-driven product innovation will always be critical in the medical device industry, innovation in terms of how data is stored in the cloud, extracted from social media conversations, mashed up, analyzed and leveraged to demonstrate value and gain market access will be equally important. 

While UDI data will provide an all new source of information about product usage and performance, it is a mere spec in the sea of data sources and solutions emerging new, every day, in the healthcare arena. Predicting the exact path to the future is not possible.  But one thing is certain: the most innovative device manufacturers will create astounding innovations through the use of improved data. And composite profiles of UDI data will play a significant strategic role in enabling competitive advantage.

A brief look to consumer products sheds light on what is to come. When consumer packaged goods companies and retailers began putting RFID labels on products, a precise vision did not exist of how the data would be used to develop highly sophisticated predictive behavioral analytics and supply chain management systems that would transform the industry.  But that is what transpired, creating some big winners among the most innovative companies, and UDIs on medical devices will enable the same advantages.

Call to Action
With the long view in mind, we have a near-term recommendation, which is to ensure that you ‘get it right’ when you embark on the path to developing UDI-enhanced products.  If the foundation is not right, the long-term strategic value can never be optimized. 

Entering this new phase of business will require significant cross-functional alignment.  One of the common questions we get asked by clients is whether, at the heart of it all, this is an IT issue. The answer is that IT has a central, pivotal role to play in making sure that the right technical architecture is in place. But UDI implementation, and leveraging all of its benefits, is an initiative that spans all business functions, each having very specific and well-coordinated roles to play. More