Medical

Building blocks for life-critical medical devices

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The Evolution of Healthcare

Medical device manufacturers operate in a challenging environment filled with stringent regulatory requirements, connectivity and interoperability considerations, security threats and time to market pressures. In the face of these challenges medical device manufacturers must develop increasingly complex devices in timelines that are more typical of consumer-grade electronics, but difficult to meet in a regulated industry.

Central to alleviating these challenges, software plays a pivotal role in the operation of life-critical medical devices, so much so that software can be thought of as the lifeblood of a medical device. BlackBerry QNX offers a safety-compliant real-time operating system (RTOS) that works in perfect unison with security, connectivity, HMI and custom hardware considerations. 

Leading Medical Device Manufacturers Choose BlackBerry QNX

As a trusted industry leader for almost four decades, BlackBerry QNX is committed to providing operating systems and software solutions that meet the unique and constantly evolving challenges facing medical device manufacturers today. We provide the building blocks that make innovations come to life and get to market faster, while fully complying with the strict safety, security, and connectivity requirements of medical applications.

The world’s largest medical device manufacturers trust BlackBerry QNX to help run their blood diagnostics, ultrasound imaging, infusion delivery, heart monitoring and resuscitation, robotic surgery, and numerous other applications.

The BlackBerry QNX Safety and Security Story

Safety

Medical devices must adhere to the highest levels of safety-level compliance and regulatory approval.

BlackBerry QNX’s solutions are designed to reduce the regulatory approval effort, cost and time, and to facilitate software maintenance.

Security

Patient security and safety are critical concerns to medical device manufacturers, not only from the inception of innovation but through to post-market maintenance.

BlackBerry QNX offers solutions with built-in security measures, adherence to security standards and the ability to secure embedded software over the lifetime of the medical device.

Reliability

BlackBerry QNX has been trusted for nearly four decades to deliver software for life-critical medical devices.

The microkernel architecture of QNX OS for Medical is unique and perfectly suited for medical devices, where each component is protected, and each component can recover without a system interruption or reset.

Total cost of ownership

The total cost of ownership for a medical device project consists of many factors that may not be immediately apparent. A simple decision based on a shallow analysis of the cost of obtaining and licensing the source code is insufficient.  When evaluating an OS for a medical device it is critical to compare consider the cost of such big-ticket items as development cost, maintenance cost, support cost, and opportunity cost.

BlackBerry QNX compares favourably to competing open source software options.


  BlackBerry QNX vs. LINUX
Certification

Microkernel; only safety-critical components must be certified

Medical IEC 62304 compliant

 

Monolithic kernel; all OS components must be certified

Lack of traceabilitiy creates huge burden to 62304 compliance

Reliability Each and every component is protected and each component can recover without
a system reset
  If one component crashes, the entire kernel and OS itself will crash and require a reboot of the device
Cost Lower Total Cost of Ownership   "Free" software, no upfront license cost, higher development, maintenance, support and certification costs

Accelerate time-to-market with BlackBerry QNX

Forget about the need for finding, sourcing, configuring, and compiling open source software for your devices - accelerate your product development and minimize risk by leveraging QNX OS for Medical.

As a POSIX-compliant RTOS, QNX OS for Medical offers the capability for code porting, including porting Linux source code. Developers can ramp up quickly because QNX OS for Medical looks and feels like Unix and provides a familiar open standards-based development environment. This greatly simplifies the migration from a Linux-based prototype to a production system.

Further downstream, unlike with open-source operating systems, there is no need to worry about managing asynchronous patches affecting your source base. Save the time and resources it takes to manage that complexity!

QNX OS for Medical 2.0

QNX OS for Medical is a reliable, multi-core, POSIX-compliant real-time operating system (RTOS) for safety-critical embedded systems for the medical market, supported by field-proven development tools, feature-rich middleware, and expert professional services.

It derives its reliability from its unique microkernel architecture and carefully-designed separation mechanisms such as adaptive partitioning. Because the QNX OS for Medical is compliant to IEC 62304, overall certification of the final product is much faster and less complex than pursuing certification with a monolithic architecture such as Linux.

QNX OS for Medical is compliant for use in applications requiring up to Class C IEC 62304 compliance, a standard for “Medical device software – Software life cycle processes”. It has been assessed by a reputable auditing body, TÜV Rheinland, thereby helping medical device manufacturers avoid the problem of qualifying “SOUP” (Software of Unknown Provenance).

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QNX Hypervisor

QNX Hypervisor is a real-time Type 1 hypervisor that offers virtualization technology for complex embedded systems in industries such as medical, and facilitates safety certifications by separating safety-critical systems from non-critical systems in separate guest Operating Systems. Safety certifications can be achieved on components selectively, and different parts of the system can then be updated independently without impacting certifications. The Hypervisor for Safety is itself built from a safety-certified and security pedigree - it complies with IEC 62304 for medical device software and IEC 61508 SIL 3 for industrial safety.

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QNX SDK for Bluetooth Connectivity

The QNX® SDK for Bluetooth® Connectivity, is a reliable and flexible software offering that supports a broad set of profiles and services and includes an optional IEEE 11073 Personal Health Data (PHD) stack to enable easy interoperability with a variety of personal health devices, such as pulse oximeters and weight scales, for medical applications.

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Expert Resources

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