Katherine brings more than 30 years of medical device experience to her role as a Science Lead at 3D Communications. Her background in research and development, clinical research, and regulatory affairs gives clients an experienced perspective on developing their scientific story and preparing for critical regulatory interactions.

Approach

Katherine draws on her experience designing clinical trials, leading FDA interactions, and preparing for Advisory Committee meetings to help clients explain their data and address challenging questions. Having worked across the full development pathway—from early research through pivotal trials and approval—she understands how individual study findings fit into the broader evidence supporting a product.

Background

Katherine held research positions at W. L. Gore & Associates and St. Jude Medical, and executive leadership positions at HeartStent, EnteroMedics, and Senseonics. Her experience spans cardiovascular disease, obesity, tissue regeneration, and implantable continuous glucose monitoring.

At EnteroMedics, she directed two large randomized controlled trials of an implantable neuromodulation device for obesity and led FDA interactions through premarket approval. At Senseonics, she directed clinical studies supporting U.S. and European approvals of the Eversense implantable continuous glucose monitoring systems. Across both companies, she led 12 clinical trials and played key roles in FDA Advisory Committee preparation and presentations.

Katherine has published 38 articles and holds 113 patents. She earned her bachelor’s degree in chemistry from Gustavus Adolphus College and her master’s degree and PhD in biomedical engineering from Iowa State University. She completed postdoctoral training in oral biology and surface chemistry at the State University of New York at Buffalo.

Special Interests

Outside of work, Katherine is passionate about the re-establishment of native tall grass prairies for the health of pollinators, birds, and mammals.  She recently became a Master Naturalist from the University of Minnesota Extension and works with her husband to convert the land surrounding their home to prairie. She also loves to be outdoors biking, hiking, and camping—and to end the day reading.