Which stage comes first in the product development lifecycle of medical devices?

In the product development lifecycle of medical devices, the first stage is concept development. This stage involves identifying a need in the medical field and generating ideas to meet that need. It encompasses research, brainstorming, and the initial formulation of a product concept. During this phase, factors such as the target market, competitive landscape, and preliminary assessments of technical feasibility are considered.

Following concept development, the process typically advances to stages such as testing and validation, where prototypes are developed and assessed through rigorous trials. Commercialization and regulatory submission are further stages that ensure the product can be successfully launched and adheres to applicable regulations, but these occur after establishing a solid product concept. The emphasis on concept development in the early stages is crucial, as it lays the groundwork for the entire product lifecycle, informing the design and development processes that follow.