Lifecycle of a Medical Device: From Idea to Market Medical devices play a critical role in modern healthcare, from simple thermometers to advanced imaging systems and life-support equipment. But before any medical device reaches a hospital, clinic, or patient, it goes through a long and carefully regulated journey known as the medical device lifecycle. This lifecycle ensures that every device is safe, effective, reliable, and capable of delivering the intended medical benefit. Understanding this lifecycle helps us appreciate the complexity, responsibility, and innovation involved in bringing a medical device from a simple idea to the global healthcare market. Identifying the Need: Where Every Medical Device Begins Every medical device starts with a problem that needs a solution. This problem may be identified by doctors, biomedical engineers, researchers, or healthcare organizations. For example, a physician may notice that current devices are slow, uncomfortable, or inaccurate...
THE BIOMEDICAL ENGINEER