Pathology Assessment Of Medical Devices: Understanding the Basics
Pathology assessments provide crucial insights into how the body reacts to implanted materials, devices and substances by examining the tissue response and/or performance of a device or its materials. This information delivers critical data for evaluating patient safety of a device and in some cases, can be used to evaluate efficacy.
Understanding the basics of a pathology assessment, including how a sample is processed, which stains are most relevant for evaluating specified endpoints, and how a Pathologist scores samples are important components of any preclinical study. Just as important are the data derived from the pathological assessment and how this information is utilized to demonstrate device safety in regulatory body submissions and insight into how a device performs clinically.
Join us as our experts discuss:
- How pathology is used to assess medical devices
- Pathology techniques, including gross pathology, histology and microscopic pathology
- Potential pathology limitations such as data extrapolation, endpoint selection and study design
- How manufacturers can properly understand pathology results, which leads to a better recognition of how a device is evaluated for safety and/or performance