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Author:  Walt Ellenberger, Senior Director Business Development and Strategic Alliances, SAP

Join us for a can’t-miss webinar on November 15 and learn how data insights from Real-World Evidence are fulfilling healthcare’s mission and margins by analyzing product performance and patient outcomes. Register now for “How Mercy is Using Real-World Evidence to Improve Implantable Devices.”   

Some 70 million Americans have had a medical device implanted in them during the past 10 years. That number isn’t especially relevant until you know that in the first 4 months of 2018, implanted medical devices have been linked to the deaths of 2,368 patients. Both these stats were revealed in the thought-provoking Netflix documentary “Bleeding Edge” that takes a deep dive into the $400 billion medical device industry and makes a compelling call for more oversight and regulation for medical device approval.

The fascinating and sobering documentary is difficult to watch at times but even more difficult to ignore, as it raises lots of questions. Why are doctors implanting medical devices in patients that have not been rigorously tested across multiple demographics?

The controversy has moved Real-World Evidence (RWE) into the spotlight as an important solution that could improve drug and device effectiveness and prevent harm to you and me as healthcare consumers. As RWE gains momentum, advocates, including SAP and our customer Mercy, are at the forefront of a safer, better tested option for medical device implants.

The health industry needs more RWE that analyzes the performance and patient outcomes of implanted medical devices. Based on RWE findings, we could realize faster recalls of dangerous medical devices and prevent long-term patient health problems and loss of lives. Currently, medical device approvals are much less stringent than prescription drug approvals. Medicine must be tested in humans and manufacturers must compile data on the effects that is reviewed by a panel of FDA scientists. The same is not true for medical devices. If a manufacturer can demonstrate that a device is equivalent to a device on the market, it can be approved.

In the not-so-distant future, RWE has the potential to move the needle from medical testing on a small, homogeneous demographic to a much larger, diverse demographic. The increased scrutiny is much needed as medical devices, including IoT-connected devices, are expected to revolutionize the care of patients and the healthcare industry. In fact, as many as 8,000 medical devices enter the market each year.

The FDA is already evaluating the expanded use of RWE, and its biggest obstacle and need is accessing and analyzing detailed data at scale. In the very current here-and-now, Mercy, with an SAP-powered, orchestrated network, is using RWE to improve implantable devices and boost patient outcomes. Mercy is already studying the performance of its implantable cardiac devices.

We’re inviting healthcare providers, physicians, caregivers, medical devices suppliers, future patients, and all interested parties to join us in a must-see webinar that showcases the work Mercy is doing today with drug and device companies to provide curated data insights they never had access to before for a better understanding of their products effectiveness in the wild.

You’ll learn how:

  • Mercy mines its Epic electronic health record (EHR) system for data to track the failure rate of implantable cardiac devices with real-world evidence to improve the outcome of patients

  • Mercy uses real-world evidence data to track product performance across its enterprise

  • Device performance can inform risk-based contracting and inform regulatory decision-making

  • Mercy structures unstructured data through natural language processing

  • Mercy combines the power of SAP technology with its own data scientists to turn data into meaningful information

Learn more by registering for the upcoming SAP Webinar, “How Mercy is Using Real-World Evidence to Improve Implantable Devices,” on November 15, 2018, at 1:00 PM ET.