Real-World Evidence-Based Regulatory Decision-Making Requires Collaboration

Advancing remote patient monitoring depends on the use of connected medical devices that generate large amounts of real-world data (RWD). To leverage these resources to generate usable real-world evidence (RWE), manufactures must work with firms specializing in digital health infrastructure, according to a new MedCityNews article. The RWE gleaned from these devices can be used to validate or expand their approved uses.

According to Stephany Baum, “Another reason why medical device manufacturers value RWE is it’s crucial to patient engagement. The insights from patient-generated data that it enables help patients track their progress and gain a window into their condition, compelling patients and their clinicians to value the device even more. RWE is also a critical component to supporting personalized medicine.”

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(Source: MedCityNews, October 27^th, 2022)