Our objective was to design, develop and validate better clinical breast examination (CBE) models addressing the deficiencies of previous models. Detailed research and a methodological design approach led to the development of a new technique for creating lifelike models for teaching CBE. Six multi-layered breast models representing a range of normal human variation for durity (hardness/softness), nodularity (fibro-glandular tissue) and adiposity (fatty tissue) were developed and validated. Various construction materials, MRI scans, traditional casting and three-dimensional (3D) printing were used to build models with lifelike look and feel (biofidelic). The models realistic in anthropometry (size and shape), feel (durity and nodularity) and appearance (skin feel and colouring) – visual biofidelity enhances perception of feel – incorporate anatomically correct layering of ribs, soft adipose tissue, nodularity and additional signs of breast disease, both benign and pathological. These were validated by four breast surgeons who compared their feel alongside a sample of breast patients (N = 78). Models were rated as ‘undecided’, ‘similar’ or ‘very similar’ to 81% of patients for nodularity and 82% for durity. These are the first models to incorporate normal human variability and be validated with real patients. These novel biofidelic models provide a standardized way of teaching health professionals normal from abnormal.@en