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Software Development for EXCOR® Active 

EXCOR® Active is a mobile drive system for artificial hearts. It is predominantly used with children. The software developed by the CODIALISTS controls and monitors the system and enables its intuitive use.

EXCOR® Active is a mobile drive system for artificial hearts. It is predominantly used with children. The software developed by the CODIALISTS controls and monitors the system and enables its intuitive use.

Software Medizingerät MDR

The Task

Software development for EXCOR® Active

The task here was to develop a software system for a new type of mobile drive for EXCOR® blood pumps. The software was to provide the pump and alarm functions on a continuous basis, offer supplementary functions such as data logging and combine everything in one intuitive user interface.

Before the project began, there were already a number of ideas, expectations and requirements from users of the »legacy« system. As such, finding the right balance between the necessary and the possible - and thus not overburdening the product development process - was the overarching challenge. The biggest technical challenge was to find control algorithms that could generate the required pump power at all operating points.

Legacy-Software Medizingerät Dienstleister

»The greatest challenge consisted in finding the balance between what was necessary and what was possible.«

Heiko Atzpadin


Softwareentwicklung Medizinprodukt 62304

Our Approach

»We understand your ideas. Together, we make innovations a reality.«

The development of the control algorithms came with numerous technical challenges. To solve them, the CODIALISTS engaged in a close and iterative process of cooperation with design engineers, electronics engineers and clinicians. The goal was to develop a deep understanding of the clinical requirements and performance capacity of the hardware.

To implement some of the more sophisticated functional aspects of the software system, like the algorithms for ultrasonic flow measurement, the CODIALISTS brought specialized service providers onto the project. In addition, to ensure the proper integration of manufacturer documentation, the strategies for development, verification and documentation were coordinated early on with the notified body and the FDA. In order that the complexity of the project remained manageable, the team consistently drew on automated processes to perform the necessary verification. They chose a risk-based approach to facilitate optimal use of resources.

The Result

Accountable, efficient handling of the project at all times


EXCOR® Active achieved CE certification in November 2019 and is currently in clinical use. Solutions created by the developers at CODIALIST contributed to the product's overall success:

Innovative solutions:

  • High-performing, redundant pump control on the basis of a safety platform
  • Intuitive user interface

Efficient solutions:

  • Integration of appropriate off-the-shelf software (e.g. for operating system, file system)
  • Automated verification tests

Standard-compliant solutions:

  • Alarm system pursuant to IEC 60601-1-8
  • Single-fault-safe self-tests and monitoring
  • Energy management with multiple redundancy levels
Software medical products and services
Software Medical Device

Detailed Information

Expertise in control technology and signal processing


  • To design a high-performing pump control system


  • To facilitate the greatest possible performance capacity within the compact design of the EXCOR® Active, and thus to ensure that all patients could be cared for using a wide range of pumps and cannulas.
  • As part of this process, it was essential to consider thresholds in regard to pressure, power and speed. Particular demands placed on the control loop included fluctuating pressures before and after the pump and various mechanical tolerances.

Successful approaches

  • Close coordination with all project participants enabled the CODIALISTS to develop an in-depth understanding of what was necessary and possible in regard to the performance of the compact EXCOR® Active. Next, they used this understanding to select and implement optimal control algorithms.
  • The use of model-based tools guaranteed short development times, which in turn facilitated rapid development iterations during the optimization of the control loop.
Expertise in user interfaces


  • Development of an intuitive user interface (GUI)


  • It was planned that the EXCOR® Active would have a new, innovative pump control system. Since existing operating concepts were unsuitable, the complex technical dependencies within the control system had to be abstracted to such an extent that intuitive control of the control system was possible.

Successful approaches

  • The CODIALISTS involved the users of the GUI (physicians, cardio technicians, nursing staff) in the development process at an early stage.
  • The agile development process and the early provision of prototypes (»click dummies«) enabled the timely integration of change proposals and improvement requests into the development process.
Expertise in functional safety


Single-fault-safe monitoring of the system


  • As a life-sustaining system, the pump function of the EXCOR® Active drive must under no circumstances be allowed to fail. To ensure that this function was guaranteed, it was necessary to implement more than 120 internal monitoring mechanisms with the ability to reliably identify reduced performance or imminent failure.

Successful approaches

  • At an early stage, the CODIALISTS cooperated closely with electronics engineers and mechanics to create interface documents defining parameters for the required performance of components and modules. This meant that the threshold values for the monitoring of components and modules were made known to all relevant parties.
  • The CODIALISTS developed models to simulate potential faults and were thus able to verify that the software reacted correctly.
  • Stress test scenarios were carried out to trigger rare states.
Expertise in software documentation


  • CE and FDA approval of software documentation for a product in the highest risk class 


  • As part of an efficient development process, certain software modules for EXCOR® Active were also produced by service providers. The CODIALISTS were responsible for integrating all existing documentation into the approval documentation and thus for ensuring that the notified body was able to attain the necessary overview. The divergent documentation approaches and the service providers' desire for protection of their intellectual property represented particular challenges.

Successful approaches

  • Working in close cooperation with regulatory affairs managers the CODIALISTS presented the concept for the approval documentation early on in the process to the notified body and the FDA (e.g. via »Q submissions«).
  • To protect the service providers' intellectual property, the CODIALISTS carried out on-site design reviews with the service providers and recorded the results in the approval documentation.