When a Principal Investigator received a significant NIH grant to evaluate a wearable diagnostic device in a large multi-center clinical study, the path forward was far from certain. Industry partners were hesitant, and FDA approval was critical to moving ahead. That’s when the PI turned to us for strategic guidance.
Our team stepped in to manage the delicate relationship with the industry partner, crafting a product validation plan to address their concerns and build confidence in the study. Simultaneously, we took the lead on FDA communications, preparing and submitting a successful IDE application.
With our support, the study secured FDA approval and the industry partner’s buy-in, allowing the project to proceed as planned. This collaborative effort positioned the wearable device for a rigorous evaluation and future impact in diagnostic care.
