J. J. Scutti, NMT Medical, Inc., Boston, MA; R. A. Mayville, R. A. Mayville & Associates, Inc., Newton, MA
An optimized product development process is critical to the development of medical devices that meet customer durability and performance criteria. Such a process involves identifying needs, developing requirements, defining concepts, creating a detailed design (including modeling, and selection of materials, manufacturing approach, and processes), validation, followed by production. Often, the durability and performance requirements are met during the design phase, through trade-off analyses that balance durability and performance criteria with such factors as ease of implanting, variabilities in patients, manufacturability, production costs, volume and supply chain issues. This paper discusses these typically competitive factors, and provides insight into detailed design features, materials, and processes that can either maximize or degrade durability and performance in medical devices. Included are representative examples involving a stent, intramedullary nail, and surgical instruments.