Explore how early integration of toxicologic pathology can improve medical device safety, reduce miscommunication, and strengthen regulatory outcomes in device development.In medical device development, a critical gap exists between the engineers who design devices and the pathologists who evaluate device interactions with living tissue as part of safety assessment. Misaligned scientific languages and fragmented study design approaches create costly miscommunications and ultimately, weaker data.

StageBio pathologist Dr. Jaime Paulin, ACVP, and consulting pathologist Dr. Abraham Nyska joined a team of distinguished pathologists to tackle this problem head-on. Their 2025 paper, "Pathology as a Core Discipline in the Biological Evaluation of Medical Devices," published in the International Journal of Toxicology, makes the case for early pathologist involvement in the design of non-clinical studies for medical device development, as well as safety studies for regulatory submissions.

Key topics covered include the limitations of rigid ISO scoring rubrics, the risks of applying informative standards as required endpoints, and the value of pathologist-designed scoring systems that better reflect real tissue response.

From checkbox to core discipline: Why early pathology integration matters

Current biocompatibility frameworks are largely shaped by engineers and materials scientists, with limited input from toxicologic pathologists experienced in medical device pathology assessment.

The result: biological evaluation reduced to a formulaic exercise rather than a nuanced investigation of tissue response. Early integration of pathologists, from animal model selection through endpoint design, produces more accurate, credible, and regulatory-ready data while reducing wasted resources.

For device developers navigating complex regulatory pathways, involving experienced pathologists at the study design stage is one of the highest-impact steps you can take toward safer, smoother submissions.

Access the full review published in the International Journal of Toxicology

Download the review paper here.

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