ABSTRACT
Many new firms have been founded with a particular focus on novel user interactions, device features, and manufacturing capabilities for autoinjectors and pen devices. Autoinjectors and pen devices are increasingly developed as a constituent of combination products to provide simplified administration of drugs and biologics. This combination product perspective has led to a more integrated approach for design and development of autoinjectors and pen devices. Issuance of combination product regulations represents a milestone in the application of autoinjectors and pen devices to drug and biologic therapies. Autoinjectors and pen devices offer unique benefits versus traditional delivery means. In addition to mechanistic enhancements of accuracy, preparation, and delivery, autoinjectors and pen devices can offer improvements in usability through ergonomics and information conveyance not present in traditional means. In order to comply with appropriate regulations, guidance, and improved practices, autoinjectors and pen devices employ a range of safety devices to protect users from accidental needle sticks.
