During which stage of product development is risk management most emphasized?

Risk management is most emphasized during the concept development stage of product development because this is when the foundational aspects of a medical device are defined, and potential risks are identified and assessed early on. At this stage, the design inputs, user needs, and intended use are established, allowing for a proactive approach to defining and mitigating risks that could arise later in the product lifecycle.

By focusing on risk management during concept development, teams can implement design controls, which include evaluating the risk associated with the device's design and functionality. This proactive identification of risks helps influence design decisions, ensures safety and efficacy in the early stages, and lays a critical groundwork for following stages, such as regulatory approval, clinical trials, and post-market surveillance.

While risk management continues to play a significant role in the later stages, such as during clinical trials and regulatory approval to address any new risks that may arise, the concept development stage is uniquely focused on establishing a thorough understanding of risks that can inform design and development moving forward.