Key Pathology Considerations for Successful Preclinical Medical Device Studies, from Protocol to Report

This webinar will provide a comprehensive overview of the protocol development process with emphasis on tasks crucial to successful pathology evaluations in preclinical medical device studies.

In this webinar, the speaker will review the study-critical pathology operations at each phase of the process, including selection of endpoints and acceptance criteria, macroscopic tissue examination and collection strategies, histology processing and stain selection and histopathology scoring.

Attendees will also learn how ancillary imaging procedures, such as radiographic fracture analysis, micro computed tomography (microCT) and scanning electron microscopy (SEM), affect sample selection, tissue preservation and relate to histopathology evaluation.

The expert speaker will share recommended best practices for protocol development and pathology-driven tasks appropriate for medical device studies run under good laboratory practices (GLP), in accordance with ISO 10993-6 and in non-GLP environments.

Examples will be provided from a range of study types to illustrate strategies for selecting suitable controls, collecting appropriate tissues and designing applicable histopathology scoring. In addition, attendees will receive practical tips on avoiding common pitfalls that might compromise pathology success.

Register for this webinar today to learn how preclinical medical device studies can be optimized and how successful outcomes can be ensured for medical device research.

Speaker

Dr. Lynette Phillips, Senior Pathologist, StageBio

Dr. Lynette Phillips is a board-certified veterinary anatomic pathologist with over 20 years of industrial pre-clinical medical device pathology experience covering a broad range of implantable devices and interventional treatments. Since joining the StageBio team in 2021, she has been involved with all stages of the study process, including protocol development, necropsy oversight, histopathology evaluations, and report writing tailored for both non-GLP investigational work and GLP submissions. Dr. Phillips has a particular interest in implants and treatments for cardiovascular, bone, and skin applications.

Prior to joining StageBio, Dr. Phillips worked at medical device company Medtronic, Inc. and CRO American Preclinical Services (now part of NAMSA, LLC) and was a faculty member at the University of Wisconsin-Madison School of Veterinary Medicine. She earned her DVM from the University of Wisconsin and completed her Anatomic Pathology residency training at the University of Florida. Dr. Phillips holds undergraduate and PhD degrees in chemical engineering and worked as an engineer prior to entering veterinary school.

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