The US Food and Drug Administration (FDA) Medical Device Development Tools (MDDT) program aims to expedite innovation and streamline the approval process for medical devices by eliminating risk and uncertainty in the product development process. The program does this by qualifying tools, meaning they evaluate the tools and determine if they are appropriate for use with specific types of measurements. Medical device companies can then use these qualified tools in the development and evaluation of their devices.
In a recent article about the MDDT program, the advancement of focused ultrasound technology was cited as an example of the program’s utility.
Specifically, a new tool for High Intensity Therapeutic Ultrasound (HITU) devices – a tissue-mimicking phantom – was recently qualified and can be used by device developers to test the safety of their device early in the development process – before beginning clinical trials – when it’s easier to make changes to improve the safety profile if necessary. This also streamlines the FDA process for device developers as it provides one standard method for the entire field to use.