Reporting data and supporting evidence in a compelling yet concise fashion comprises one side of the regulatory approval equation. Another component of the job requires an ability to read and interpret regulations from agencies around the world and anticipate questions those regulators might have.
Comprehensive Review Process
When Abbott released a new app feature that updated its neuromodulation platform, every aspect of regulatory affairs came into play. With remote programming and video chat capabilities, the app provides options for patients to have virtual clinical visits with their doctors. While this digital innovation maintains the patient's existing medical treatment, other considerations, like its additional capabilities, cybersecurity controls and required software updates, must be validated by supporting evidence before U.S. Food and Drug Administration approval.
"When developing a regulatory strategy for medical devices, we need to understand what new questions of safety and performance might be introduced and what scientific evidence is required to demonstrate safety and effectiveness," Parana said. "In partnership with our cross-functional teams, we demonstrated that the updated app did not introduce any new risks to clinical performance. We then focused on how our software, cybersecurity and usability data validated the change introduced. We spent a significant amount of time explaining our thought process and received approval with minimal questions from the FDA."
This cross-functional role requires the ability to interact with technical and non-technical teams, collaborate to define the most creative ways to glean evidence throughout the process, and communicate results to different stakeholders. Regulatory affairs specialists need to adjust their communication styles accordingly and technical expertise helps them quickly distill complex information.
"The regulatory approval process depends on the nature of change of the product," Director of Regulatory Affairs Manasi Khare said. "These agencies may not be as familiar with the change as we are. Our work involves extensive communication and negotiation to identify the best way to address potential questions in the least burdensome manner.