Design of the medical device Sangair SangAsept : A usability, conceptualization and design centered analysis of a blood treatment device

Abstract: This thesis report presents a collaborative project carried out by Industrial Design Engineering students, Björn Carlshamre and Kristoffer Regard, together with KTH, Svensk Konstruktionstjänst AB ("Svekon") and Sangair AB. The project mainly explores research and implementation of human centered design of an extracorporeal ozone therapy medical device for sepsis treatment, Sangair's recent successful study on swine and human blood demonstrated the effectiveness of their ozone treatment method for eliminating bacteria and potentially revolutionizing sepsis treatment. However, Sangair needed assistance regarding product design. The project focuses on three key aspects: Documentation, Simplification, and Product Usability. Documentation aims to meet medical industry standards and facilitate future upgrades. Simplification involves optimizing the complex single-use tubing system to expedite experiments and research. Product Usability considers ease of use, aesthetics, and compliance with medical regulatory standards. The research showed multiple design-oriented areas of improvement regarding medical devices inm general, and helped inspire several solutions to the issues that Sangair had been facing early on in their development. The main issue being that their disposable tubing kit, in which the treatment occurs, is too complicated and not ready to be put into use in a hospital as it would require too much of the users. The research carried out can be seen as a result itself, however the project group also took the insights further and developed a concept for a future medical device. In this concept, the disposable tubing kit has been simplified and integrated into a cassette system, which would ease the installation process for the users. The concept also offers solutions to many other issues found along the way.