The journey from bench to bedside: Converting the science of acoustics into medical technologies for the benefit of patients

The science of acoustics has extraordinary potential to enable the development of new therapies ranging from non-invasive surgery to oncological drug delivery, neuromodulation, transdermal immunization, and immune-modulation. However, these relatively complex medical devices or combination products often challenge established clinical pathways and face considerable regulatory, usability, adoption, and reimbursement challenges. Using case studies drawn from the clinical translation of novel ultrasound technologies for drug delivery and tissue fractionation, as well as other medical technologies, some of the generic choices and considerations that should be identified and mitigated early on in the technological and commercial development process will be highlighted. For example, products involving ultrasound-responsive injectables require an in-depth understanding of their stability and stimulus-responsiveness, accompanied by the ability to confirm these characteristics post scale-up and sterilization. For all ultrasound technologies, pre-clinical testing also needs to be expanded beyond animal models to address scale and other challenges unique to humans in order to ensure preparedness for a successful clinical trial. Last but not least, the design of early feasibility trials needs to enable confirmation of the mechanism of action of the proposed new therapy and quantification of its potential added benefit relative to the most appropriate current or emerging standard-of-care.