Orthogonal and Matter are hosting a discussion on patient preference information for medical devices. RTI Health Solutions researcher Christine Poulos is part of the discussion along with Cynthis Grossman, Director of the FDA's Division of Patient-Centered Development at the Center for Devices and Radiological Health.
Medical Devices & Patient Preference Information:
How Understanding Your Medical Device's Users Can Support Your Regulatory Submission
Live virtual event
November 20, 2024, 3 - 4:30pm EST
From the organizers
"[T]he U.S. Food and Drug Administration (FDA) is actively encouraging medical device manufacturers to gather Patient Preference Information (PPI) for use in their regulatory submissions. PPI studies scientifically quantify the value patients place on a medical device’s specific features and the risks they’re willing to take to use those features to address their medical conditions. The FDA has made it clear that this information, while voluntary, can influence regulatory decisions, such as a medical device’s labeled indications for use. Additionally, PPI provides manufacturers with valuable data on the desires and limitations of their target patient audience, enabling them to build a potentially more clinically and commercially successful device."
"You’ll leave this webinar with:
- A high-level understanding of PPI as a unique type of scientific data and how to acquire it
- Knowledge of how PPI has been used successfully in regulatory submissions to inform the ultimate shape of the medical device
- Strategies to conceptualize how PPI might be leveraged within your company as part of your future devices' lifecycles."