On January 10, 2020, Dr. Bruce Ramshaw, Managing Partner of CQInsights, joined one of CQInsights’ clients in a 510(k) meeting with the FDA. This client has been involved for multiple years, participating in Clinical Quality Improvement (CQI) initiatives with Dr. Bruce Ramshaw’s clinical team.
A CQI initiative, specifically one involving an industry partner, brings together a multi-disciplinary team representing patient care, the healthcare industry, and healthcare data and analytics. Through CQInsights, this client was able to generate value for its organization by seeking real-world clinical data to understand the value their product has in actual patient care, not just through a clinical trial.
A medical officer with the FDA, “commended Dr. Ramshaw on his efforts and noted that these efforts to provide real-world evidence through CQI process and publications are important to understanding patient care.”
All requested indications and contraindications included in the 510(k) submission were approved because of the real-world CQI data provided by CQInsights.