Safety First, Bubbles Second: Integrating Regulatory Compliance with Innovation in Rapid Prototyped Focused Ultrasound Devices

Abstract

Focused ultrasound (FUS) devices are being developed for noninvasive treatment across a range of clinical applications. High-intensity methods, such as histotripsy, introduce safety and performance considerations that may arise during early stages of prototyping. This thesis presents an evaluation framework intended to support early-stage identification of factors related to clinical and regulatory requirements. The framework was developed using risk management principles to identify risks during prototyping and determine which may be addressed through design modifications for the specific application. For risks not fully mitigated through design, the research focused on three safety domains: biological compatibility (ISO 10993), electrical safety (IEC 60601-1), and acoustic characterization (IEC 62127-1). The framework was applied to a case study involving 3D-printed materials commonly used in rapid prototyping for FUS research, assessing performance according to established guidance documents and international standards. In this context, materials with favorable acoustic performance did not consistently meet biocompatibility criteria, and electrical safety issues were only identifiable through specific testing that might otherwise be overlooked in early development phases. These findings highlight the role of concurrent safety evaluation across multiple areas. Structured assessments during early development produced data aligned with regulatory expectations and identified factors that may influence later design stages. The framework may be applied to full-system prototypes and explored further across various FUS device types.