Your medical device's journey to market can live or die in the microscopic details captured by a pathologist's trained eye. Yet most innovators treat histopathology as a checkbox commodity service rather than the regulatory make-or-break moment it truly is. Picture this: after months of preclinical testing and significant investment, your submission lands on an FDA reviewer's desk. What separates a smooth approval from a cascade of questions, delays, or outright rejection? Often, it's the quality of your histopathology report that translates raw tissue data into evidence of safety.
Contributors: Laurence Fiette (DVM, DESV-APV, PhD, HDR), Kate San Souci (HT, ASCP), Butch Stanley (DVM, MS, DACVP) & Gauthier Terrade (DVM, MSc, DESV-APV)
Whether you're a startup bravely guiding a new device through the commercialization pathway or an established company launching your next innovation, understanding what elevates a histopathology report from adequate to outstanding can be a strong competitive edge in a world where regulatory excellence determines who reaches patients first.
The following are five hallmarks of outstanding histopathology reports reviewers will appreciate, with high likelihood of accelerating commercialization timelines.
Unlike diagnostic pathology reports that focus on individual animals, outstanding histopathology reports for medical device studies analyze findings at the group level. This group-focused approach to preclinical reporting including histopathology provides regulatory reviewers with the comparative data they need to assess overall device tolerance and safety trends, not merely diagnosis of an individual. Individual animal descriptions are of lower value compared to comprehensive group interpretations that highlight patterns, calculate average scores, and explain the biological significance of findings across treatment cohorts.
Exceptional histology reports include carefully selected, annotated photomicrographs with histopathological documentation that tell the visual story of device-tissue interactions. Overall clarity in histopathology reporting is paramount. Effective visual storytelling is a crucial component of clarity and ease in understanding for reviewers.
“Since many regulatory reviewers aren't pathologists, annotated images with clear legends serve as crucial evidence that studies were properly conducted and help non-specialists understand complex findings,” says Veranex Senior Director of Research Pathology Laurence Fiette. “High-quality illustrations help demonstrate transparency, support written interpretations, and make regulatory submissions more compelling and easier to review.”
Another hallmark of excellence for medical device histopathology reports is moving beyond mere observation to meaningful interpretation. Outstanding tissue analysis reports don't just document what pathologists see, they explain what it means for device safety and biocompatibility. This includes contextualizing findings within the study design, comparing data to historical controls, and providing expert opinions on the clinical relevance of observations; ultimately helping sponsors answer potential FDA questions before they're even asked.
“Innovators should demand high levels of experience, accountability and demonstrated evidence in preclinical pathologists’ and histopathologists’ expertise, especially regarding interpretation of observations in data and imagery,” Fiette says. “These interpretations can have enormous implications in both directions, for innovators. Demand nothing less than highly credentialed, highly experienced, proven professionals for this work.”
Top-tier histopathology reports explicitly detail how pathology scores are assigned, calculated, and interpreted. Rather than presenting unexplained global scores, high quality histology reports break down the components (inflammation, fibrosis, etc.), explain the grading criteria, and show how group averages were derived.
According to Fiette, this transparency allows regulatory reviewers to understand the basis for conclusions and builds confidence in the data's reliability and reproducibility.
Excellence requires early and continuous pathologist engagement, not just at the slide-reading phase. Board-certified veterinary pathologists should contribute to protocol development, anticipate regulatory questions, and remain available for discussions throughout the study. The very best can also develop preclinical models for which there is no predicate.
According to Butch Stanley, DVM, Vice President of Histology for Veranex, “I would agree that the best histopathology reports, the ones reviewers appreciate the most, reflect this deep involvement, with pathologists who can join pre-submission FDA meetings and help defend findings—adding value for sponsors navigating complex regulatory pathways.
"Most sponsors understand that as medical device pathologists, our assessment of the tissue responses to their product and the writing of concise and relevant histopathology reports for the regulatory submission thereof is a critical part of our support for their GLP study," Stanley explains. “However, many sponsors are unaware that partnering with a medical device pathologist during the early R&D and pilot-work phase of their new or generational medical device or material is also ultimately critical for a successful GLP submission.”
"Medical device pathologists with a comprehensive, end-to-end understanding of medical device innovation combine not only an expertise in histopathology assessments but also in model development, hands-on necropsy techniques, and the histology processes necessary for the development of truly novel preclinical models for breakthrough devices, for which there is no device or model predicate.
“This soup-to-nuts capability can dramatically improve the odds of success for medical device innovators and is where the Veranex pathology team distinguishes itself from standard preclinical testing providers."
The Veranex pathology team are specialist experts in pathology and histopathology to assess the safety, performance and efficacy of new biomaterials and medical devices. Unlike most other pathology labs that support medical innovation, 100% of our work involves new or generational medical devices associated with new medical devices or biomaterials every single day. You will find at Veranex one of the most qualified, most capable medical device pathology teams in preclinical research anywhere, dedicated to your project.
If you are evaluating your readiness for preclinical work, preclinical service providers or pathology services providers, contact us today to discover how our cutting-edge labs and expert team can elevate your projects supported by the world’s first “innovation CRO.” Veranex is the only CRO capable of integrating design, preclinical, clinical, regulatory, and commercialization expertise under one roof, applying that expertise precisely where and when it’s needed, delivering life-changing treatments to patients faster, safer, smarter.