Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions - a podcast by Greenlight Gurus Jon Speer + Medical Device Quality Regulatory Leaders, Entrepreneurs, Consultants, R&D Engineers
from 2019-11-07T15:07:18
The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draft guidance was issued last summer and the final guidance was issued in August. So what does Real-world Evidence mean for you and from a regulatory perspective?
Today we speak with Mike Drues, President of Vascular Sciences, about how real-world evidence can help you develop products that will improve and save lives.
Some of the highlights of the show include:
● Why medical device companies should care about real-world evidence and why it’s as important and more realistic than the “gold standard” of randomized clinical trials.
● Reasons that a clinical trial can be less informative than real-world evidence and how the FDA is beginning to change its thoughts on accepting real-world evidence.
● Thoughts on why the quality of the real-world data is important when it comes to getting FDA to accept it.
● The mechanism of going down the path of using real-world evidence in regulatory matters.
● How real-world evidence might be used even after a device or product is already on the market, either in lieu of a clinical trial or as a reason to use a smaller clinical trial.
● Thoughts on the future of credible real-world evidence.
● Examples of how real-world evidence can be used.
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