Which of the following is NOT a stage in the product development lifecycle for medical devices?

The product development lifecycle for medical devices typically includes several key stages that are critical for bringing a device from initial idea to market and beyond. Among these stages, concept initiation, regulatory approval, and post-market surveillance are established steps in this lifecycle.

Concept initiation refers to the initial phase where ideas for new medical devices are generated, researched, and assessed for feasibility and market potential. This is a crucial starting point for any medical device, allowing teams to define the problem they aim to solve and the needs of the target market.

Regulatory approval is an essential stage wherein the device must undergo rigorous scrutiny by regulatory bodies to ensure that it meets necessary safety and efficacy standards before it can be marketed. This process is vital for compliance and is a legal requirement for medical devices.

Post-market surveillance involves the continuous monitoring of the device's performance and safety once it enters the market. This stage is important for identifying any issues that may arise after the device is used by patients, ensuring ongoing safety and the device’s long-term effectiveness.

Supply chain formulation, while important in the overall management and logistics of producing and distributing medical devices, is not formally recognized as a distinct stage in the product development lifecycle. Instead, it is typically a part of the operational aspects that accompany the development and