Pathology as a Core Discipline in the Biological Evaluation of Medical Devices

Kathleen A. Funk, JoAnn C. L, Brad Bolon, Valerie Thomas, Jeffrey I. Everitt, Abraham Nyska, Jaime Paulin, Experimental Pathology Laboratories, Retired Consultant, Bainbridge Island, Retired Consultant, Department of Pathology, Duke University School of Medicine, Tel Aviv University and Consultant, Tel Aviv

International Journal of Toxicology

Published online on November 21, 2025

Abstract

International Journal of Toxicology, Volume 45, Issue 2, Page 157-170, March/April 2026.
The device development process encompasses an intersection of biological, physical, and engineering sciences principles culminating in translation of data from nonclinical animal studies to predict potential tissue responses in human patients. Evaluation ...