My contributions to ultrasound metrology

Abstract

My work in ultrasound metrology has centered around developing pre-clinical testing methods for therapeutic ultrasound devices. These test methods include radiation force balance systems and methods specifically for high-intensity therapeutic ultrasound, time-delay spectrometry methods for measuring hydrophone sensitivity, acoustic characterization of tissue-mimicking material that has been approved as a medical device development tool and a comparison protocol of computational and experimental acoustic characterization for therapeutic ultrasound devices. The purpose of this work at the FDA is to develop bench testing methods to ensure proper review of medical ultrasound devices to evaluate device safety and performance. The test instruments and methods developed have helped promote the development and recognition of voluntary consensus standards, as well as FDA industry guidance, that can provide the basis for least-burdensome data collection requirements by manufacturers and allow the FDA to assess device safety and effectiveness in a more consistent, methodical and scientifically rigorous manner.