UDI Implementation – The Key To Unlock Personalized Medicine?

In a new paper co-authored by myself along with Research Associate Ellyn McMullin, we look at UDI, or Unique Device Identification and its impact on the heathcare system.

The value of UDI goes well beyond the requirement to include a unique ID number; it is more than another Track & Trace metric; it is a plan calling for optimizing meaningful data collection and analysis.  UDI will allow a patient to be notified when a Medical Device issue needs to be addressed and the ability of healthcare providers to take appropriate and better focused corrective and preventive actions.

The implementation of Unique Device Identification (UDI) is having a profound effect on Med-Tech manufacturers, healthcare providers, regulators and ultimately the patient. The 7-year compliance timeline reached its second milestone on October 24, 2015.  As of that date the labels and packages of implantable, life-supporting and life-sustaining devices must bear a UDI and date.  Furthermore, software that is classified a life-supporting or life-sustaining device must include a UDI.

In addition, FDA’s new report: “Coordinated Registry Networks to Bridge Clinical Care and Research” calls for the adoption of UDI in patient identification across the entire device life cycle.

A primary objective of the Coordinated Registry Network is to promote operational elements supporting analytic methodologies.  This would include:

  • Implementation of UDI
  • Implement standardized, structured minimum core data sets and outcome definitions
  • Enhance data poolability across heterogeneous data sources

Once personal data has been stripped from electronic health records, data collected can be further associated with the UDI via data aggregation. As a result, modeling and statistical analysis can be used to identify and predict trends in medical data and optimize treatment.

Could UDI be a key that unlocks the potential of personalized medicine for the masses?

To request a copy of UDI IMPLEMENTATION – The Key To Unlock Personalized Medicine?  paper,  please click here.


Daniel Matlis

Founder and President at Axendia
Daniel R. Matlis is Founder and President of Axendia, An analyst firm providing trusted advice to Life-Science and Healthcare Executives on Business, Technology and Regulatory matters. Dan is the editor of Life-Science Panorama, a Publication covering the Business, Regulatory and Technology issues facing Industry Executives. He is a frequent lecturer at Industry events and has published numerous research reports and articles on key issues facing the Life-Sciences and Healthcare industries. Dan holds a BS in Electrical Engineering from Polytechnic University (now NYU Polytechnic School of Engineering) in NY and a MS in Management from the New Jersey Institute of Technology.