The Factor Podcast: Factors to Consider in Support of Clinical Readiness

The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. How do you know your combination product is ready for clinical trials? Will it pass the regulatory review for clinical approval to proceed? The complexities of harmonizing drug and device elements, managing risks, and understanding variability can be overwhelming. Join the discussion on The Factor, with Dr. Stefanie Johns, Director of Regulatory Affairs at Kymanox. Stefanie and Shannon Hoste dissect the nuances, discussing the importance of understanding the therapeutic index, managing risk, and incorporating the right data safety monitoring.

Watch Part 1 Here

Watch Part 2 Here