HealthCore’s Flora Siami in a recent tHEORetically Speaking blog post highlights some of the challenges and benefits of using real-world evidence (RWE) in the medical device landscape.
Siami writes that RWE has the potential to give regulators a huge evidence base to assess a device’s safety, and can expedite time to market for manufacturers.
“The use of RWD to generate RWE in devices is expanding and now more widely accepted by our industry,” Siami writes. “This is seen through FDA’s continued commitment through public meetings and funding initiatives, as well as industry’s demonstrated use of RWE in regulatory decision making.”
To read the full write up on tHEORetically Speaking, HealthEconomics.Com’s official blog, click here.