Unfortunately, participation often drops off once the physical product specifications have been established. In the past, prototypes were all too often created by design engineers in what was essentially a vacuum. Drawings and specifications were developed from the prototype, and the design was simply passed on to the production department with little concern for the product's manufacturability. Often, when this occurred, the device could not be manufactured consistently and reliably. 1 One of the primary reasons FDA initiated design control in the new rule was to diffuse design responsibility throughout the organization and ensure shared decision making.
Design control requires input up front and continuing involvement from the project team.
They must then receive the project team's feedback on their initial design. The entire team must work together to identify any problems early in the design phase to avoid delays later in development and to ensure a reliable, high-quality medical device. In most cases, the primary reason is that team members lack the time required to understand the design. Yet without a thorough understanding of how the designer plans to assemble, test, and service the product, they cannot provide constructive feedback. Thus, design engineers are still often faced with presenting output from these sophisticated, interactive tools in the form of static, two-dimensional printouts.