The Role and Regulation of Medical Devices
Medical device manufacturing includes all aspects of the fabrication of a medical device, from designing a manufacturing process to scale-up to ongoing process improvements. It also includes the sterilization and packaging of a device for shipment. Many medical device manufacturers excel in the concept, and prototyping phases of product growth and outsource the production of components or entire devices to contract manufacturers. Contact manufacturers vary in size and expertise as well- some comprise small, precise operations specializing in particular materials or components. Throughout the manufacturing process, medical device makers strive to be faster and more efficient, but they also wish to be responsible corporate citizens. Thus, manufacturing demands constant insight into renewable resources, sustainable materials, equipment that is more energy efficient, and methods to reduce waste creation. Solutions to these issues can come in the form of improved processes, technol...