The medical technology industry faces various challenges, including increasing device complexity, strict regulatory requirements and high cost pressure. Hardware-in-the-loop (HiL) simulators offer a solution by enabling rapid prototyping, comprehensive safety testing and regulatory compliance. They allow developers to effectively secure medical devices and applications under realistic conditions. Supplemented by a CI/CD test process chain, they accelerate development processes, reduce costs and act as a driver of innovation.
Integrated early on in the product development process, HiL-based validation processes can support adherence to compliance requirements and industry-specific regulations during development. In addition, efficient creation, execution and management of test cases increases the safety of medical devices. Here, the EXAM test automation solution can serve as a central tool for validation and saves time and costs in the development process by automating repeatable tests and minimizing manual intervention.
In addition to the range of applications presented here, such as imaging devices, implants, dialysis machines or surgical robotics, XiL tests also offer decisive advantages in many other areas. Contact us and the experts at MicroNova will be happy to develop customized individual solutions for your requirements.
In the development of imaging devices such as ultrasound, CT scanners or MRI devices, quality assurance regarding high precision and image quality is of crucial importance.
Efficient XiL test methods offer a time-saving and cost-effective solution for various areas of application:
- Software validation: Checking complex control and image processing software to ensure proper function and interaction with the respective device.
- Safety testing: Simulation of safety-critical scenarios to test the scanner's correct response to unexpected situations.
- Sensor and actuator tests: Testing of ultrasound probes, magnetic field coils in MRI devices or X-ray tubes in CT scanners, among others.
- Fault simulation: Simulation of faults or errors to identify potential risks and check whether the imaging device reacts appropriately to them.
- Performance tests: Measuring the reliability of results under various conditions, for example in terms of image quality, accuracy or responsiveness.
Medical implants must meet the highest safety standards, as their functionality is crucial for the health of the wearer. These include pacemakers and implantable cardioverter defibrillators (ICD), neurostimulators, insulin pumps, cochlear implants, implantable drug pumps, blood pressure monitors with implants, brain stimulators, orthopaedic implants with sensors and actuators or retina implants.
Comprehensive testing with HiL simulators can help to ensure the required reliability and at the same time save development time and costs compared to conventional methods.
Test options for medical implants:
- Functional tests: Simulation of normal and critical operating scenarios with subsequent evaluation of the system's response.
- Interaction with external devices: Checking communication and interaction, including testing compatibility with external sensors, actuators or control systems.
- Performance monitoring: Testing the performance of the implant under various conditions, e.g. at different temperatures, humidity levels or electrical voltages, including evaluation of energy efficiency and battery life.
- Safety tests: Simulation of malfunctions or faults to check the system response with regard to safety mechanisms and emergency shutdowns.
- Data security and data protection: Checking the security of stored and transmitted data, including simulation of attack scenarios if necessary.
- Long-term tests: Simulation of long-term use to test the stability and reliability of the implant and to measure wear and aging effects.
The highest safety standards apply to medical devices used in surgery, as they have a direct impact on patient health. Extensive testing during the development phase is necessary in order to comply with these standards. HiL simulators not only offer reliable testing options but can also save development time and costs.
Test options of surgical robotics:
- Control and precision: Simulation of complex surgical procedures to test the accuracy of robotic control
- Collision avoidance and safety: Simulation of collisions with anatomical structures or other instruments in the operating room to test emergency stops
- Instrument control and end-effector testing: Checking the correct functioning, calibration and alignment of instruments
- Real-time processing and latency: Measuring and minimizing latency to ensure robotics respond immediately to inputs
- Communication with external systems: Simulating data transfers and interface protocols to measure communication between the robotic system and external devices, such as imaging systems
- Image processing and navigation: Simulation of different lighting conditions and image qualities to test the ability to process images and navigate
- Emergency scenarios: Simulation of critical situations, such as the failure of a robot arm or other component, to test the system response in emergencies
- Ergonomics and user-friendliness: Testing the control interfaces and working comfort for surgeons
Medical devices are subject to strict safety standards in order to minimize the risk to patients from any malfunctions. These requirements, combined with the complex design of dialysis machines, lead to a high level of testing during development. For this reason, software solutions for test automation are being deployed increasingly.
The efficient creation, execution and management of test cases improves the safety of medical devices. The EXAM test automation solution can serve as a central tool for the validation of dialysis machines. Integrating EXAM into the development process saves time and money by automating repeatable tests and minimizing manual intervention.
Advantages for medical technology providers:
- EXAM accelerates the market launch of dialysis machines as test cycles can be completed in less time.
- EXAM ensures higher product quality and safety, as extensive and complex tests are carried out automatically - even at night and at weekends.
- EXAM improves the traceability of test coverage and simplifies the management of test cases.
