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Physical criteria and challenges in the design of an intraoperative handheld probe for margin assessment in breast conserving surgery

SessionHC10: Women's Health and HF/E

DescriptionAchieving negative surgical margins is critical for oncologic safety and cosmetic outcomes in breast-conserving surgery (BCS). However, current intraoperative margin assessment techniques remain limited, contributing to re-excision rates of 3–40%. This study explores physical design criteria and challenges in developing an intraoperative handheld probe for margin assessment during BCS. Using a multidisciplinary approach, we conducted nine surgical observations, 11 semi-structured interviews with breast surgeons, and interdisciplinary meetings involving surgeons, pathologists, and engineers. Inductive thematic analysis revealed four key areas: (1) breast and surgical anatomy considerations, highlighting variability in cavity shape, tissue density, and the impact of tunneling techniques; (2) probe design and functionality, emphasizing the need for ergonomic, compact, and flexible devices with consistent tissue contact; (3) surgical applications, stressing seamless workflow integration and timely scanning; and (4) outcome preferences, favoring binary margin assessments complemented by optional imaging outputs. Surgeons emphasized high sensitivity, specificity, and cost-effectiveness as critical for adoption. These findings offer early-stage design insights essential for guiding the iterative development of an effective intraoperative imaging probe. Ongoing studies are further refining workflow requirements and decision-support needs. Ultimately, this work aims to inform the creation of clinically viable tools to reduce re-excision rates and improve patient outcomes in BCS.

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