Medical Device Innovation

Medical device innovation is the process of moving from understanding a clinical need to creating a solution and then moving beyond to commercialize the solution as a new medical device. Value-based healthcare means that to be successful, a new medical device must lead to better clinical outcomes at lower costs, demonstrated through evidence. Developing new medical devices is different from developing ordinary consumer products as medical devices have long development cycles, are highly regulated, and must meet third-party payers’ requirements for reimbursement. To determine if an idea has value many innovators use a variation of a 10-question screen that includes everything from examining the unmet need to determining if there is a regulatory path. Extensive user research to fully understand the unmet need is needed as is testing the solution on the bench, in an animal model, or a clinical trial. In the United States, regulation of medical devices is covered by the Food and Drug Administration (FDA) with devices falling into one of three classes depending on their risk. A case for reimbursement must be made to the third-party payers who require data to support the claims that the device is effective. Patents are essential for protecting the ability of innovators to develop their invention because competition is fierce, and medical device development requires a considerable investment in time and money. Funding is needed throughout the entire process with multiple funding sources available for the innovator although competition for those sources is often fierce. Despite these hurdles, medical device innovation is motivating because the ultimate goal is to improve the lives of patients. Successful innovators not only must have a deep understanding of the disease state but also an understanding of regulatory, reimbursement, and business considerations. Innovators understand they cannot go at this alone and surround themselves with a team that together has the necessary expertise.