Sound advice—Sound design

Abstract

Ultrasound energy offers unique capabilities to treat a wide range of medical conditions, through numerous distinct physical interactions with tissue. Unlike diagnostic ultrasound, where safety and efficacy are easily demonstrated and the underlying technology has been available for decades, therapeutic ultrasound applications have explored new regimes and therefore required novel technologies and approaches. This presentation will describe the journey from discovery to clinic, based on examples from the author’s personal experience as a consultant and entrepreneur. Developing therapeutic ultrasound products involves several specific and sometimes unique steps. It generally starts with the observation of a therapeutic effect, or a realization that an existing approach could be applied to a different clinical situation. Moving from “N = 1” to a repeatable treatment paradigm can be both exciting and discouraging. The next key steps, which are the hardest, involve translating the initial idea/data/concept into a commercial design, or at least a plan for one. The regulatory, financial, commercial, and clinical environments can be as challenging as the purely technical hurdles, and all factor into the development process. While creating new clinical ultrasound treatments and devices can be difficult and time consuming, it can also be immensely rewarding and satisfying.