Katrina’s Blog™
Insightful News and Commentary
On leadership, product innovation, talent cultivation, and ecosystem development across drugs, devices, diagnostics, and digital health tools.
Join us as we explore the latest trends and share expert insights to help you navigate the ever-evolving landscape of healthcare innovation.
Let’s embark on this journey of transformation together!
Evergreen Bioscience Innivation Cluster Presentation to WSU ETM575 Class
I always love talking with students. A few weeks ago, I had the opportunity to share the Evergreen Bioscience Innovation Cluster with students in the Washington State University EM575 class. https://youtu.be/wDgmCPSiw_g
What are the FDA’s Orange, Purple, and Green Books?
Among the many resources made available by the FDA, the Orange, Purple, and Green Books stand out for their names and content. These books address public demand for lower-cost drug products, which prompted laws and regulations requiring lists of alternatives.
Turnaround Time and Success Rate for Medical Device Decisions
All medical device companies need to include a success rate and time to decision for their submissions in their go-to-market plan. It turns out that helpful information on both subjects is readily available from the FDA.
The Operational Challenges Inherent to RWD/RWE
In the introduction to my June article, “FDA Guidance for Real-World Data and Evidence,” I said, “This increased activity raises questions about practical approaches to collecting and using RWD in generating RWE and concerns about patient data privacy, ownership, and informed consent.”
Customer and Product Discovery Through Data
Photo by Tool., Inc on Unsplash Over the past few years, I’ve been a mentor for startups launching from Washington State University (Go, Cougs!). Most of the co-founders I work with struggle to understand their product-market fit. They aren’t alone –...