The application of additive manufacturing technologies for the development of invasive airway devices may enhance the quality of life of tracheostomy patients. The current research is intended to reduce clinical long-term complications that appear in the frequent use of classic tracheostomy tubes in airway management. The development of a bespoke tracheostomy device aims to improve functional ability, social anxiety and overall patient satisfaction. The study was conducted in four stages: preconception, patient specific design, additive manufacturing of the new endotracheal tube prototype and testing. Using patient specific data a new concept was designed with appropriate CAD software, while implementing the findings from deploying functional analysis. Starting with a cuffed tracheostomy tube for needs analysis, three new CAD models were generated. The initial functional prototypes were developed, with the main innovations brought to the tracheal fixing system, neck plate and obturator, and were enabled by the advantages of additive manufacturing technologies. Initial tests were undertaken on an explanted pigs’ trachea with the aim of identification of any surgical technique or concept shape related problems. The current research presents an integrated approach for developing a new tracheostomy device concept, fabricated using AM technologies. The advantages of AM were used to enable the design and manufacture of customised, unique features that target the reduction of late clinical complications of tracheostomy tube users.