Modular Design Approach for Mechanical Circulatory Support Architecture: A Novel Platform for Cross‐Technology Applications

Artificial Organs

Abstract

BACKGROUND: In a critical care setting, a plethora of life-saving devices, including mechanical circulatory support (MCS) systems, with their powering sources, wiring, and user interfaces, create significant challenges for operational efficiency and patient safety. We report a study of an integrated, user-friendly, modular life support platform (LSP) designed to be suitable for complex clinical and emergency use scenarios. METHODS: Surveys were conducted (21 centers of excellence), involving clinical and nursing staff (n = 39), focusing on functional requirements, environmental adaptability, alert systems, and user interfaces. In total, 77 user requirements specifications (URS), 272 product requirements specifications (PRS), and 30 KANO model parameters were analyzed by the cross-functional development team, complemented by industrial design analysis, usability engineering, and iterative validation of device features to produce a coherent modular architecture. We hypothesized that the integrated architecture would support task completion within predefined operational acceptance criteria and minimize potential use errors under simulated-use conditions. RESULTS: The LSP architecture incorporated three configurations: (1) an extracorporeal ventricular assist device (VAD) and adjustable support arm, (2) an extracorporeal membrane oxygenation (ECMO) system with a modular oxygenator and pump, and (3) an investigational percutaneous ventricular assist devices (pVADs) featuring a flushing pump system, a drive motor, and a catheter pump head. Usability testing confirmed its intended adaptability and effectiveness across ICU, ER, and cardiac intensive care units (CICU), operating rooms (OR), and cardiac catheterization laboratories. CONCLUSIONS: Demonstrated task completion within predefined operational acceptance criteria, whereas user failure modes and effects analysis (UFMEA) reassessment reduced the numbers of NAC and ALARP risk items.

Authors 8

1. Ifan Yen corresponding Aachen Cardiovascular Engineering Medical Faculty

   RWTH Aachen University

   Affiliation as printed

   Cardiovascular Engineering, Applied Medical Engineering, Medical Faculty RWTH Aachen University Aachen Germany

   magAssist Co. Ltd. Suzhou China

2. Kynan Taylor

   Climate Resource (Australia)

   Affiliation as printed

   Cobalt Design Pty Ltd. Melbourne Australia

3. Xusheng Qi
   Affiliation as printed

   magAssist Co. Ltd. Suzhou China

4. Steve Martinuzzo

   Climate Resource (Australia)

   Affiliation as printed

   Cobalt Design Pty Ltd. Melbourne Australia

5. Chiahao Hsu
   Affiliation as printed

   magAssist Co. Ltd. Suzhou China

6. Michael Neidlin Aachen Cardiovascular Engineering Medical Faculty

   RWTH Aachen University

   Affiliation as printed

   Cardiovascular Engineering, Applied Medical Engineering, Medical Faculty RWTH Aachen University Aachen Germany

7. Jamshid H. Karimov
   Affiliation as printed

   Medical Advisory Board Cleveland Ohio USA

8. Po‐Lin Hsu
   Affiliation as printed

   Artificial Organs Technology Lab, School of Mechanical and Electrical Engineering Suzhou China

   magAssist Co. Ltd. Suzhou China