Merriam Webster defines cadence as “a rhythmic sequence or flow of sounds in language.” The word carries nuanced meanings in poetry, in military processions, and in music. This may seem like an odd reference in the strict world of medical device regulations and rules. Yet once one understands not only the regulations by which we are governed but the history and reasoning behind those rules, their logic and predictability become more apparent.

Cadence Regulatory does not view US laws as arbitrary or unnecessary. We may disagree with the FDA on the applicability or interpretation of a certain rule, but their fundamental mission aligns with ours: to bring safe new medical technologies to market in order to help patients. While relations with regulators can be adversarial at times, the ability to see regulators not as obstructions, but as they see themselves—protectors of the public health—pays dividends in designing and negotiating a path to market.

This is my approach. We will find creative solutions.