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!
The eSTAR Program for 510(k) and De Novo Submissions
The FDA's electronic Submission Template and Resource (eSTAR) program currently supports medical device submissions for 510(k) clearance or De Novo evaluation. The program is voluntary, but these templates will be mandatory once the FDA publishes an adoption timeline....
Building the Next-Generation Life Science Workforce
The skills of reading and editing technical drawings are important in many life science facility and manufacturing roles. Continued development and expansion of the life science industry in Washington State and the entire Intermountain Northwest will depend on a...
Innovation Cluster Fundamentals
Many elements combine to form a successful innovation cluster.Innovation clusters are a hot topic globally. Many observers are looking keenly at the efforts of the Washington State Department of Commerce to jump-start innovation clusters in that state. However, many...
Kick Start Your Company With a Business Model
Business model creation and ideation can be done solo or with a team, as in this picture.When I started my business, many people advised me to create a business plan. I researched business plans and quickly found them tedious to develop and cumbersome to use. Instead,...
The What, How, and Why of Innovation Clusters
You may be wondering how your local companies could work with regional partners to grow, transform, or reinvent your industry to be more competitive nationally or even globally. Perhaps you’ve recently heard some the buzz about innovation clusters, or you have seen a...