Linking Real-World Clinical Data with Medical Device Data to Demonstrate Device Value

Apr 2, 2024

Real-World Data in the Medical Device Market

Many life sciences organizations are focused on harnessing real-world data (RWD) capabilities to inform every part of the drug development product life cycle. The same types of RWD can, and should, be applied to innovation around the development and measurement of the effects of medical devices. RWD derived from healthcare sources, such as electronic health records, provides insights into the burden of disease, and after a device market launch, provides insights into competitive stance, safety, efficacy, and outcomes. Traditionally, these types of analyses have been difficult to perform for medical devices because the specific details surrounding the medical device make, model, and manufacturer used in procedures are often buried in the electronic health record or other IT systems, and historically have not been collected uniformly. 

Medical Devices in the Real World

Medical Devices have become a critical part of a patient’s daily life, and how patients interact with these devices can tell us a lot about their effectiveness. From joint replacements to life-saving arterial stents and pacemakers, device manufacturers are interested in the benefit-risk profiles to inform future device modifications and technological advancements, Providers can glean important evidence for the clinical effectiveness of these devices, helping to inform what devices to use in their procedures. 

Medical device manufacturers are motivated to invest in new strategies to support success. According to McKinsey, despite a period of growth from 2012 through 2019, S&P medical device investments slowed during the pandemic. Recently, however, signs have been promising; in 2023, the U.S. approved more novel medical technologies than in any single year before, and revenue growth rates are starting to stabilize to pre-pandemic levels. 

Aggregation of RWD to Inform Device Safety and Evidence for Effectiveness

Using relevant and reliable RWD is important for generating RWE to understand and regulate medical device usage and safety. To get a complete picture of the patient’s use and interaction with a medical device, RWD from clinically relevant sources is required to give a holistic view of the clinical experience both before device implant/initiation and after usage has been initiated. The ability to combine disparate data from multiple sources and care settings is where OMNY Health excels. 

The OMNY Health Medical Device Data Advantage

OMNY Health’s Medical Device product offering is a best-in-class view into the healthcare industry’s use of medical devices in patients. Our Medical Device offering is constructed directly from our health provider data sets, with precision down to the patient encounter level. Utilizing the Unique Device Identifier (UDI) and the device version, we have partnered with the FDA’s AccessGUDID database to ensure the highest quality and completeness of data, with unrivaled recency. 

OMNY Health’s Medical Device product offering linked with OMNY Health’s EHR data, can help device manufacturers and provider networks better understand and assist the patients they are servicing by examining: 

  • Medical Device use and trends 
  • Patient journeys and continuity of care
  • Impact of medical devices on clinical, functional, cost, and utilization outcomes
  • Safety/adverse event reporting
  • Providers who are interested in value-based contracting and making procurement decisions

Check out the Total Knee Replacement study utilizing the OMNY Health Medical Device product offering. 

Contact OMNY to learn more about how our Medical Device product offering will boost your real-world evidence generation.