Does a Structured Development Process Help or Stifle Innovation?
In some R&D environments there is a strong belief that procedures and a structured development process hampers the creative process. In a well-designed product development process, there are phases or stages that allow for innovation, such as concept and feasibility.
Requirements & Regulations Enables Creativity
As there are definite design control criteria that must be met, per the U.S. FDA Quality System Regulation (QSR) and ISO 13485:2016, a rigorous framework actually enhances the creative process as well as maintaining design control. Once it can be shown that critical product characteristics can be met, typically at the conclusion of the feasibility stage, they need to be controlled as the product moves through development.
Connecting the Dots
Starting with measurable and clear design inputs, verification and validation plans can be developed to test them in order to create design output documents and design transfer requirements. Think of each design input as a “dot” that must be connected, traced, tracked and controlled throughout the entire development and commercialization process. Ultimately you need to make sure that you made the right product and that you made it per expected and planned requirements.