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Innovative Advancement of a Blood Coagulation Device

Expertise

Embedded SW Development, Systems Engineering

Industry

Medical

Challenges

Optimization of a Blood Coagulation Measurement Device

The advancement of a complex medical device for blood coagulation measurement required analyzing and improving an undocumented hardware design while adhering to strict medical standards and process regulations to ensure a certified product.

Solution Implemented

Effective Implementation of Modern Hardware and Software Design

Effective Implementation of Modern Hardware and Software Design

Our solution focused on modernizing and cost-reducing the hardware of the blood coagulation measurement device. We analyzed and documented the existing undocumented hardware, created a new optimized design, and developed the associated firmware. We adhered to all relevant medical standards, simulated signal flows to ensure measurement reliability and accuracy, and conducted iterative prototyping and real-world testing to meet the high requirements of medical technology.

Analysis and Documentation of Existing Hardware

  • Examination and documentation of current hardware functions
  • Identification and mapping of interfaces
  • Creation of schematics and documentation of components
  • Simulation of signal flows

 

Concept Design & Prototype

  • Development of a new, optimized hardware concept
  • Creation of schematics and component list
  • Validation of the concept through detailed simulations
  • Prototype creation and testing with blood samples under realistic conditions

 

Development & Customer Support to Series Production

  • Requirements gathering and documentation according to medical standards (IEC 62304, VDI 5702)
  • Development and testing of device firmware
  • Hardware and software development with strict fault tolerance adhering to medical processes (IEC 62304)

Results

Successes and Benefits

Our collaboration enabled the client to solidify and expand their market position. By employing cutting-edge technologies and methods, we optimized signal integrity and measurement accuracy, significantly reduced production and material costs, and identified untapped potentials of the original system. This resulted in a more reliable and advanced medical device.

Our solution secured the client’s future market presence, optimized production costs, and significantly improved the signal integrity and measurement accuracy of the blood coagulation measurement device.

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1A CUE Consulting & Engineering GmbH specializes across industries in Functional Safety, Systems Engineering, Cybersecurity, and Embedded Software Development.