Breast cancer is the most commonly diagnosed cancer in women worldwide. Although targeted screening programs using mammography have facilitated earlier detection and improved treatment has resulted in a significant reduction in mortality, some negative aspects related to cost, the availability of trained staff, the duration of the procedure, and its non-generalizability to all women must be taken into consideration. Breast palpation is a simple non-invasive procedure that can be performed by lay individuals for detecting possible malignant nodules in the breast. It is a simple test, based on the haptic perception of different stiffness between healthy and abnormal tissues. According to a survey we carried out, despite being safe and simple, breast self-examination is not carried by women because they are not confident of their ability to detect a lump. In this study, a non-invasive wearable device designed to mimic the process of breast self-examination using pressure sensing textiles and thus increase the confidence and self-awareness of women is proposed. Combined with other screening methods, the device can increase the odds of early detection for better prognosis. Here, we present the physical implementation of the device and a finite element analysis of the mechanics underlying its working principle. Characterization of the device using models of large and medium breast phantoms with rigid inclusions demonstrates that it can detect nodules in much the same way as does the human hand during breast self-examination.

Tissue Engineering and Regenerative medicine, empowered by Biofabrication technologies, hold the premises to provide solutions to unmet clinical needs, such as organ donor shortage or genetic diseases. These huge advancements are determining a changing scenario, with a quite confusing understanding about the steps toward the clinical translation of new researches and products, giving as result an overestimation or an underestimation of the required in vitro and in vivo tests for their validation. The proper definition and classification of the research products can be considered an action toward the refinement of animal experiments. An appropriate classification is crucial because the complications due to the combination of biological and non-biological materials need the application of specific rules. This paper aims at helping the academic and industrial community to clarify the identification and classification of their research products.