Physical Criteria and Challenges in the Design of an Intraoperative Handheld Probe for Margin Assessment in Breast Conserving Surgery

Abstract

Breast-conserving surgery (BCS) is a standard treatment for breast cancer, but achieving clear negative margins to avoid re-excision remains a challenge. Current intraoperative margin assessment techniques, such as frozen section analysis and imprint cytology, are limited by resource demands and workflow integration challenges. This study explores the physical design considerations for a handheld intraoperative imaging probe to assess tumor cavity margins during BCS. Data were collected through 9 surgical observations, 11 semi-structured interviews with breast surgeons, and interdisciplinary team meetings. Inductive thematic analysis identified key design priorities, including ergonomic handling, flexible probe tips, consistent tissue contact, and compatibility with both direct and tunneled access. Surgeons emphasized the need for quick scanning times and binary margin outputs, with interest in supplementary real-time imaging. These findings offer foundational insights for the iterative development of a clinically viable margin assessment tool aimed at reducing re-excisions and improving surgical outcomes in breast cancer care.