All implantable BCI systems are currently in the early feasibility stage. Historically, most of these studies were investigator sponsor studies that were academically based and fell within the category of Early Feasibility Studies (EFS). In the last few years, medical device manufacturers have emerged with the goal of bringing implantable BCI systems to the market. There is now an added focus on how to transition these device studies from EFS to pivotal and how to design the pivotal study to address not only FDA’s concerns, but patient advocate and payer concerns.
In this webinar, MCRA experts Devjani Saha, Alex Cadotte, John Schmitt, as well as patient advocate Ian Burkhart, discuss patient adoption considerations, payer perspectives on product adoption, as well as regulatory and reimbursement implications associated with designing a pivotal study. The webinar took place on Wednesday, May 1st from 12-1pm EST. Webinar hosted by MCRA.