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TY - THES AU - Theisgen, Lukas TI - Process model for the systematic design of modular surgical robots VL - 77 PB - RWTH Aachen University VL - Dissertation CY - Düren M1 - RWTH-2024-07730 SN - 978-3-8440-9595-1 T2 - Aachener Beiträge zur Medizintechnik SP - 1 Online-Ressource : Illustrationen PY - 2024 N1 - Druckausgabe: 2024. - Auch veröffentlicht auf dem Publikationsserver der RWTH Aachen University N1 - Dissertation, RWTH Aachen University, 2024 AB - The potential of robot-assisted surgery is huge in terms of surgical outcome, safety, ergonomics, and cost efficiency. Most commercial robots and research projects focus on optimizing a few aspects while unwittingly worsening the others. Appropriate design methods are missing. The manufacturing industry faces similar problems and uses systematic modularization to harmonize conflicting goals during product development. A prerequisite for the adaptation to surgical robotics is the adequate consideration of intraoperative hazards, deficits of current robots, and the safety and usability of emerging intraoperative interfaces. Here, a process model was developed for the systematic modularization of surgical robots with integrated risk estimation (MORE) and recommendations for the subsequent design of intraoperative interfaces. Main requirements were being traceable, use case independent, value-based, risk-preventive, usability-enhancing, and suitable for digitalization and integration into Product Lifecycle Management (PLM) systems. First, the state of the art of surgical robots, modularization methods, and development practices for medical devices were examined. A modularization method for surgical robots was created as the first part of the process model. For the second part, hazard and risk analysis were added. A reference architecture model (RAM) approach was developed to allow computer assistance. Lastly, appropriate Design-for-X (DfX) guidelines and a representative functional mock-up were analyzed to develop a Design-for-Intraoperative-Assembly (DfIA) checklist. The MORE process model, the approach for computer assistance, and the checklist were formatively evaluated, separately. The resulting modularization method uses 11 reference functions to suit various use case scenarios and 59 module drivers as quality criteria based on the analysis of 15 surgical robots and the feedback from 51 experts. The Point-of-View (PoV) framework expands the search area for hazards suggesting seven predefined perspectives while the Catalogue of Hazards (CoH) provides a database to store them and complement future risk analyses. PoV and CoH were initially tested on the example of robotically assisted laminectomy, which led to the identification of 133 hazards and 108 hazardous situations. The RAM approach provides structural and procedural rules between functional and physical system elements based on SysML. The DfIA checklist contains 44 control questions of which 18 refer to hygiene and 26 to the assembly process. The formative evaluations confirmed the usefulness of the approaches and revealed opportunities for improvement. Most promising seems the integration of surgical workflow modeling, the formation of system scores, and the improvement of the user experience. Overall, the methodological approach proved to be crucial for the effective modularization of surgical robots. LB - PUB:(DE-HGF)11 ; PUB:(DE-HGF)3 DO - DOI:10.2370/9783844095951 UR - https://publications.rwth-aachen.de/record/991197 ER -