Medical device testing

Solutions for testing medical devices

The healthcare sector has integrated a multitude of established and cutting-edge medical devices for a wide range of applications. Performance degradation or malfunction of these devices can have serious, potentially life-threatening consequences.

As a frontrunner in the field of test and measurement, Rohde & Schwarz is well-equipped with the best solutions for medical device testing. We work closely with our customers at every stage of development and deployment - from defining testing needs to bringing products to market.

Medical device testing and development

There are several aspects to consider when testing medical devices:

• Powering the device under test (DUT)
• Battery life and power consumption
• Power integrity
• Signal integrity
• Precompliance EMI debugging
• Measuring small sensor signals

Battery life is crucial for many medical applications, including:

• Pacemakers
• Prosthetics
• Neurostimulation
• Respiratory assistance
• Defibrillators

A battery simulator is necessary to evaluate how long a device can be powered and functionality guaranteed. There are two main testing aspects, and it is possible to optimize for both:

1. Functionality based on battery stages: A new battery has zero resistance, but this increases with age and affects the circuitry. A battery’s behavior also changes with its discharge status.

2. Power consumption: The expected power consumption of a device must be established to determine battery lifetime.

Power supplies and source measure units (SMU) are often used for battery simulation. These instruments can emulate the real output behavior of a battery over time. However, unlike a battery, a power supply draws significantly more current when it becomes active, leading to a voltage drop. Fast voltage regulation is crucial to reduce the effect of this phenomenon and more accurately simulate real battery behavior.

As medical devices grow more compact and streamlined, supplying clean and stable supply voltages becomes an increasing problem. Testing electronic designs for power integrity necessitates extremely sensitive, accurate measurements. Ripple, noise and load step response measurements on integrated circuits, such as ASICs, DDR memories and FPGAs, require:

• Probes that can measure in the single-digit millivolt range
• Measurements of very small disturbances at relatively high DC offset levels

Wireless medical device development

Over the last few years, there has been a significant increase in the demand for wireless medical applications such as:

• Remote patient monitoring
• Real-time diagnostics
• Smart surgical systems
• Wireless implantable medical devices

Many medical devices use wireless machine-to-machine communication technologies to interact with one another as well as with IoT applications in the cloud.

Important testing considerations for medical wireless communications are:

• Signal generation: Medical applications use many different wireless communications standards, and it is useful to generate signals that meet these standards during the development process.
• Signal and spectrum analysis: Medical applications also need to analyze signals for compliance with wireless communications standards.
• Over-the-air (OTA) testing: Many modern medical devices have antennas integrated directly into their design or even etched onto the RF chipset, making it impossible to connect an RF cable.
• Wireless coexistence testing: The proliferation of wireless medical devices necessitates wireless coexistence testing in line with existing standards.
• EMC compliance testing: EMC certification is critical in the development of electronic products, as it ensures their compatibility with electromagnetic environments.

EMC testing for medical devices

Rohde & Schwarz is the global market leader in EMC compliance testing, with over 80 years of business experience. Our instrument designs meet - and even exceed - the latest EMC standards and customer requirements.

With the increase of electronic devices, such as smartphones, wearables and even IoT smart products, there is a growing concern that electromagnetic emitters will interact with wireless implantable medical devices. As such, ensuring active implant electromagnetic resilience is very important. The International Organization of Standardization (ISO) has determined standards ISO 14708-2, 14708-3, 14708-6 and 14117 for the proper operation of wireless implantable medical devices, such as cardiac pacemakers, cardioverter defibrillators, neurostimulators and cardiac resynchronization devices.

Medical device security solutions

Rohde & Schwarz offers more than cutting-edge test and measurement equipment: we also provide cybersecurity solutions. Medical facilities have access to highly sensitive personal information, and they need to take adequate measures to protect patient data.

Many healthcare facilities are vulnerable due to aging equipment acting as a gateway for more IT system failures, leaving data less protected than in other industries. And although they realize the important of adequate cybersecurity, their security updates are often lagging due to budget shortages and lack of qualified staff.

Rohde & Schwarz Cybersecurity provides solutions to secure applications and protect medical data. These solutions ensure compliance with international regulations and are not subject to the Patriot Act or the CLOUD Act.

Master your medical device testing challenges

Wireless medical devices offer a variety of end user benefits, but they are challenging for designers.

Key test challenges include:

• Reducing the battery charge frequency to a minimum for implanted medical devices
• Measuring the power consumption of low-power devices
• Simulating real-life use cases with wireless networks
• Ensuring extremely stable and clean supply voltages
• Determining interference locations
• Complying with regulatory standards

Explore our range of medical testing equipment

We support the entire medical device development cycle - from development all the way to production. Our comprehensive product portfolio has the right test and measurement solutions for every application and budget.

Browse our selection and discover:

• A broad range of power supplies that address the complex power issues of medical devices
• Multi-channel probes for measuring power consumption in different device modes
• Wideband radio communication tester for simulating real-life use cases and synchronizing signaling activities with power measurements
• Advanced oscilloscopes that are perfect for analyzing small signals
• Compact far-field OTA test chambers that provide an ideal environment for uninterrupted measurements
• Affordable, customized security solutions to protect sensitive patient data