A Decade of Insights: Navigating the Ever-Changing Landscape of Diagnostics and Medical Devices

This June marks 10 years of independent consulting for me and Angie Purvis, LLC. As I reflect on those 10 years, I can see so much change in the diagnostics and medical device industries, and I see some sustained themes within the space as well.

In this blog series, I will provide a retrospective analysis of the changes I have seen, how those changes have led to the state of the industry present-day, and what I see for the future. I will speak from the perspective of each of my professional spheres—clinical Laboratory Director, CLIA lab builder, Quality Management System builder, regulatory expert (in vitro diagnostic and medical device), product developer, and advisor for investment.

This series is intended to be a resource for members of the professional community who are working on building systems to support product development efforts for diagnostics (IVD and clinical laboratory) and medical devices. I will provide my analysis and perspectives and will give some insights into how I approach challenges in developing and launching diagnostics and medical devices, based on 10 years of hands-on consulting and serving many organizations as they achieve their goals (and sometimes fail) in this space.

This series also is intended for the larger professional community who are curious about career development, career transitions, and how to find meaning and purpose in a career. I will emphasize the aspects of my work that are my passions, how I serve through my work, and how I found this path.