Preclinical Testing: Generating Safety and Effectiveness Data for Medical Devices

Preclinical testing is a critical stage in the development of a medical technology that is necessary to advance it from concept to clinical use. Preclinical data, particularly animal study findings to support a product’s safety and effectiveness, are often a key requirement from stakeholders including regulators, investors, government partners, and clinicians. This presentation will introduce key concepts and considerations in preclinical evidence generation to meet strategic and regulatory goals and discuss the challenges of translating medical device performance between animal models and human patients. The talk will also highlight strategies to minimize animal use while maximizing data as told from a veterinarian surgeon-scientist perspective.

Date & Time

August 27, 2025