While a working prototype is necessary to prove out a concept, it may not be the best version of that concept. And while there is rarely a “golden ticket” design that perfectly solves every problem in the project, the goal of the Design and Development Phase is to tune that concept so that it optimally balances functionality, cost, and risk. Those three aspects are often at odds with each other, and it’s up to the team of engineers to decide what balance represents the optimal design.

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.