Fundamental to the effective development of a new medical device is having a clear definition of the clinical need it must meet. The clinical need may be related to improving patient outcomes, or reducing procedure times or costs. Once that need has been established, it’s the responsibility of the medical device development team to generate a product concept that will deliver the intended benefits. This is the objective of the first phase of the medical device development process: The Concept or Feasibility phase.

Designing devices that will be used to perform medical procedures on human patients involves inherent risks. To help developers minimize these risks, government and non-governmental organizations have established regulations and standards. And to ensure these regulations and standards are met consistently, we at Sage, and others throughout the industry, follow a relatively standardized medical device product development process.