Development of a Non-Invasive Blood Pressure Measurement Device for Cardiopulmonary Exercise Testing

Abstract

In this thesis the conceptual development and prototyping of a non-invasive blood pressure (NIBP) measurement device intended for use during cardiopulmonary exercise testing (CPET) at Sahlgrenska University Hospital (SU) is presented. Reliable blood pressure (BP) monitoring during exercise is essential for both patient safety and clinical decision making, but existing methods are challenged by limited usability and reliance on outdated equipment. The aim of the project was to identify clinical and regulatory requirements, develop a conceptual design and prototype solution. This while simultaneously initiating technical documentation in accordance with the Medical Device Regulation (MDR). The project included literature studies, interviews with healthcare professionals, regulatory analysis and iterative prototyping. User and product requirements were established based on clinical needs and relevant standards. Four prototype iterations were developed and evaluated with respect to controllability, inflation and deflation performance, leakage and usability. The results demonstrated that a mechanically controlled system using hospital compressed air can provide rapid and controllable cuff inflation and deflation suitable for CPET environments. Clinical feedback highlighted the importance of usability and compatibility with existing workflows. The project also identified key regulatory considerations related to in-house manufacturing under the MDR. In conclusion, the study demonstrates the feasibility of developing an in-house NIBP device adapted for CPET and provides a foundation for further technical development and future clinical evaluation.