Round Table Session: Closing a Medical Device Safety Gap: Can Medical Writers Improve Patient Outcomes by Harmonizing Stakeholder Perspectives?

Description

Panel Discussion

This panel discussion will present a hypothetical case about safety of medical devices based on a real incident and provide the necessary background information to discuss how medical writers can help reduce harm and improve patient outcomes. Topics of discussion will include (but will not be limited to) safety issue reporting, Summary of Safety and Clinical Performance, Instructions for Use, clinical practice guidelines and their patient-directed digests. The perspectives of the manufacturer, the device user (physician), patient organisations, and the patient will be explored to identify gaps and consider suggested approaches to fill those gaps.