What Is “Preclinical Device Pathology”: An Introduction of the Unfamiliar

Abstract

Medical device pathologists are involved in the preclinical evaluation of medical devices that will be temporarily inserted or permanently and often irreversibly implanted in the human body. The medical device industry is technology based, allowing for rapid device iterations; innovations occur at an accelerated rate compared to the innovations in the pharmaceutical industry. The device pathologist provides the pathology results and is, by training and experience, in an ideal position to help the medical engineer and innovator tackle biomedical problems and to comment on the possible and actual outcomes of preclinical studies. Device pathology expertise is typically a necessity in the prelude for regulatory submission. However, there is a lack of detailed guidelines for a comprehensive preclinical pathology evaluation of the final product after implantation in a test animal. What specifically unites device pathologists is the reliance on gross pathology as the basis for spatial context needed for appropriate histopathologic analyses, the knowledge of detailed protocol instructions, a good understanding of wound healing including the “implant trauma,” and interaction with ambitious device innovators. In this article, it is my aim to amalgamate the following articles in this issue with pertinent background information intended to be informative, critical, and stimulating.