Key macro trends driving today’s eHealth market include aging populations, rising health care costs, and the demand for remote access to medical diagnosis and treatment. On the technology front, recent innovations in wireless technologies, storage and databases, security protocols, USB connectivity, and intuitive interfaces are changing the way health care is provided. Similarly, exciting innovations in telehealth and telemedicine – particularly in device technology – are enabling body area networks (BAN) and making highly connected health care a reality.

As a result, medical-device manufacturers are concentrating their efforts in the areas of portability, wireless connectivity, compelling user experiences, safety, data security, quality, and reliability.

Why customers choose QNX

QNX Software Systems enables medical-device manufacturers to build reliable, secure, and highly-available products with rich interactive HMIs. We offer a unique field-proven medical portfolio to build reliable, secure, and highly-available products with rich, interactive HMIs. This portfolio contains an innovative and comprehensive family of technologies, solutions, ecosystem, and services:

• Technology — QNX Neutrino RTOS, awarding winning development tools, deployment technologies, and innovative middleware solutions
• Certifications — IEC61508 SIL 3, ISO/IEC15408 EAL4+, ISO, and devices with FDA certifications
• Ecosystem — FDA certification consulting, customized support, HMI-graphics services, and design consultations, etc
• Services — FDA certification consulting, customized support, HMI-graphics services, and more

Here’s how you’ll benefit

• Ensure in-field reliability with a microkernel-based OS that encourages clean modular software
• Reduce BOM costs with a small technology footprint
• Guarantee high availability with self-healing systems thanks to enhanced OS features like adaptive partitioning and high availability monitoring (HAM)
• Shorten debug times with comprehensive, Eclipse-based development tools for static code analysis and traceability
• Reduce regulatory burden with SIL3 and EAL4 certification and proven FDA validation history
• Cut your time to market with pre-integrated and optimized HMI technology for selected hardware
• Reduce time to market with pre-integrated protocols for connectivity (USB, Bluetooth), wireless (802.11 a/b/g), and security (WEP/WPA/WP2)

From the bedside to the operating room, QNX technology allows medical-device manufacturers to bring unparalleled reliability to life-critical equipment.

QNX technology is found in virtually every type of medical and life-science application including surgical, diagnostic, patient monitoring, and homecare devices. Its microkernel design offers unprecedented reliability by encouraging clean modular software and architecturally-enforced process isolation. A full range of rich HMI technologies offer medical staff and patients alike the rich graphical interfaces they have come to expect. With many field-proven medical devices, the QNX Software architecture is the platform that you can depend on for your next design.

QNX medical software stack

Tools

Integrated development environment

Writing reliable software for high-risk devices requires high-quality tools and adherence to good design practices. The QNX Momentics Tool Suite is an Eclipse-based IDE that is tightly integrated with many sophisticated tools for debugging and optimizing code during all phases of the software development life cycle. In particular, innovative profiling tools provide maximum insight into system and application behavior. Medical device developers can use these tools for code coverage testing, performance profiling, debugging, and source-level verification, resulting in early detection of problems.

See also: QNX Momentics Tool Suite

Graphics / HMI

Advanced HMI

Having an intuitive human-machine interface with high-resolution graphical displays is becoming increasingly common in modern medical devices. QNX Software Systems offers a cost-effective way to include state-of-the art HMIs in sophisticated instruments, equipment, monitors, and the like. Our comprehensive solution – a universal application platform – supports today’s best HMI technologies (Adobe Flash, HTML5, OpenGL ES, and Open VG), hardware acceleration, and a wide range of platforms. We also offer a set of tools and runtime components for creating sophisticated displays that feature accelerated 2D and 3D graphics rendering.

See also: QNX Aviage HMI Suite

Middleware

Media rendering

Media capabilities are becoming increasingly important in modern medical devices, especially in systems that provide a rich and compelling user experience. The middleware services layer of the QNX software architecture allows developers to separate application logic from the HMI layer. This facilitates the rapid integration of multimedia codecs from a wide range of sources, including hardware-accelerated codecs for playback and recording of audio/visual media.

See also: QNX Aviage Multimedia Suite

Browsers

For patient-monitoring applications in portable medical devices that require a browser, QNX Software Systems supports Webkit.

Web servers

For tele-health and tele-remote monitoring of portable medical devices, QNX Software Systems supports a tiny embedded HTTP 1.1 web server that supports CGI 1.1, authentication, and dynamic HTML.

OS Services

File systems

A fault-tolerant file system is considered a critical entity for many medical devices. QNX Software Systems supports a wide range of block and flash file system formats along with a power-safe disk file system for guaranteed data integrity and reliable storage. Our flash file system (FFS3), designed primarily for NOR flash, supports wear-leveling, error-handling, background reclaim, and fault recovery; our NAND flash file system (ETFS) offers wear-levelling and resists power failure corruption.

See also: QNX Neutrino RTOS File Systems (click on the Filesystems tab)

High availability

High availability is not an optional feature for life-critical medical devices. The QNX framework provides critical process monitoring and restarts without the need to reboot, ensuring 100% device uptime.

See also: QNX Neutrino RTOS High Availability (click on the High availability tab)

Adaptive Partitioning

CPU-intense third-party software is increasingly necessary in medical devices to keep up with technology trends and time-to-market needs. But, along with all the benefits, this software also adds some amount of uncertainty in terms of security and reliability. QNX adaptive partitioning technology offers a dynamic scheduling capability that enforces CPU guarantees for maximum system safety and guaranteed service availability while optimizing overall device performance.

See also: QNX Neutrino RTOS Adaptive Partitioning (click on the Partitioning tab)

Networking

To keep up with the body area networking (BAN) needs of remote health-care advancements, medical devices are becoming increasingly portable and connected. QNX Software Systems offers one of the most comprehensive networking solutions for an embeddable RTOS with capabilities typically reserved for desktops and servers. Our native distributed processing supports complex distributed systems in which multiple devices seamlessly share resources and communicate without custom protocols. Our networking ecosystem offers support for all forms of wireless networking from point-to-point connections such as Bluetooth and ZigBee to peer-to-peer networking like WiFi (801.11).

But networking – both wired and wireless – can't compromise the safety and security of patient data. Indeed, the Health Insurance Portability Accountability Act (HIPAA), requires patient data be broadcast in a way that maintains data privacy. This act is driving the need for various authentication and security protocols. Consequently, QNX Software Systems offers support for WEP, WPA/WPA2, Radius, 802.1x, SSL, IPSec, IPv6, NAT, etc.

See also: QNX Neutrino RTOS Networking (click on the Networking tab)

Core OS

Core operating system

The real-time operating system is the key component of any safety-critical medical device. The QNX Neutrino RTOS not only exceeds the most demanding reliability, safety, performance, and security needs of a medical device vendor, it also provides clear product differentiation. Its microkernel architecture incorporates core functionality into a tiny, well-tested kernel while leaving drivers, networking stacks, and other OS services outside in memory protected space – thus providing reliability, a higher degree of determinism, and fault-tolerance. The RTOS selection can simplify the FDA certification process and reduce cost. Indeed, our OS code is readily available, well-documented and of a small memory footprint provides a definite cost advantage for the overall FDA certification process.

See also: QNX Neutrino RTOS

Safety, security, reliability and quality are essential for any medical device. All these values lie at the very core of the QNX software architecture; they also form the foundation for certifications - FDA, etc - critical to all the medical devices. To demonstrate its commitment to medical devices market, QNX Software Systems has undertaken several strategic certification programs. These programs help customers to concentrate on their innovation, reduce costs, improve time to market, and quality of software assets.

	ISO 9001:2008 The QNX management system is certified to the internationally recognized ISO 9001:2008 standard. ISO is firmly established as the globally implemented standard for providing assurance about the ability to satisfy customer requirements and enhance satisfaction. Auditors have evaluated and then certified the processes and systems governing the design & development of QNX software, as well as the provision of related support services. ISO is the world's leading developer of voluntary, consensus-based international standards. There are more than 16,500 current ISO standards and related documents that specify the requirements for state-of-the-art products, services, processes, materials and systems, and for good conformity assessment, managerial and organizational practice.
	IEC 61508 Safety Integrity Level 3 (SIL 3) The QNX Neutrino RTOS Safe Kernel is certified to meet the requirements of International Electrotechnical Commission (IEC) standard 61508 Safety Integrity Level 3 (SIL3). IEC 61508 is an international standard for the functional safety of electronic systems, and offers a very high level of reliability and risk reduction when used in safety-critical systems for transportation, energy generation, process control, and other industries. Meeting the IEC 61508 requirements involves a systematic assessment by an independent certification body.
	Common Criteria ISO/IEC 15408 Evaluation Assurance Level (EAL) 4+ The QNX Neutrino RTOS Secure Kernel is certified to meet the stringent requirements of the Common Criteria ISO/IEC 15408 Evaluation Assurance Level (EAL) 4+. The Target of Evaluation (TOE) includes not only the mature QNX Neutrino OS kernel, but also its multi-core (symmetric and bound multiprocessing) and secure partitioning technology. Certification to EAL 4+ validates that the security parameters claimed have been methodically tested by an independent lab and the certification authority (the Canadian Security Establishment (CSE)), and means that the QNX Neutrino secure kernel will exceed the assurance requirements required for EAL4. The Common Criteria for Information Technology Security Evaluation is an international standard agreed to by the United States Government, Canada, and 23 other nations. It establishes standards for security functionality, security assurance, and security evaluation. View certification
	POSIX PSE52 Realtime Controller 1003.13-2003 The QNX® Neutrino® RTOS has been certified for conformance to  the POSIX PSE52 Realtime Controller 1003.13-2003 System product standard, under the “POSIX: Certified by the IEEE and The Open Group” program. As a result, commercial customers and government agencies can choose QNX Neutrino with the assurance that it provides both the code portability and the realtime determinism needed for an array of military, networking, medical, and automotive systems. In addition to the functions covered in the PSE52 standard, QNX Neutrino supports many hundreds of other POSIX 1003.1 commands, utilities, and programming interfaces. POSIX PSE52 certification also confirms QNX Software Systems’ commitment to the software defined radio (SDR) market, including the U.S. military’s Joint Tactical Radio System Software (JTRS) SDR program. PSE52 serves as a cornerstone of the Software Communications Architecture (SCA), the interoperability standard mandated by JTRS.
	OpenGL ES QNX Software Systems is certified conformant to the OpenGL ES standard. OpenGL® ES is a cross-platform API for full-function 2D and 3D graphics on embedded systems. QNX is also a contributing member of the Khronos Group, the industry consortium focused on the creation of open standard APIs to enable the authoring and playback of dynamic media on a wide variety of platforms and devices. QNX is active in the OpenGL® ES and OpenVG™ projects, which help bring accelerated 3D and 2D graphics to in-car computing devices, casino gaming applications, industrial control systems, and a variety of other embedded platforms.
	FDA With QNX, industrial customers have the assurance of using a software architecture proven in thousands of mission-critical and life-critical environments, including medical devices. In fact, QNX Software Systems has passed all audits by medical device companies seeking FDA approval for their QNX technology-based products.

See also: Standards and Certifications

QNX® Software Systems recognizes the importance of delivering pre-integrated solutions to meet the growing challenges faced by medical-device customers – regulatory burdens and unrealistic schedules, for example. As a result, the QNX partner ecosystem includes a wide range of processors, protocols (connectivity, security and networking), tools, and package solutions for building almost any reliable and safety-critical medical device.

QNX Professional Services provides the end-to-end services medical-device manufacturers need to develop highly reliable embedded software and meet regulatory agency requirements. Our services range from architectural reviews through software debugging and optimization to support for building rich HMIs.

IEC 61508 Certification Assistance

IEC 61508 certification was initially used in the automation and process-control industry but is now becoming popular in safety-critical medical devices. QNX Professional Services can help pave the path to certification through our IEC 61508 certification support service. By leveraging existing confidence-in-use (CIU) data on various QNX-supported hardware platforms and QNX expertise in IEC 61508 certification, our team can identify the best solution to shorten your time to certification and considerably reduce your costs at the system level.

HMI/Graphics Consulting Services

The need for a rich and compelling user experience is not an optional feature for many medical devices; the challenge for device vendors is to train their development teams to produce cutting-edge human-machine interface (HMI) solutions. The QNX Professional Services team has many years of experience designing, developing, and optimizing HMIs for various target platforms from a mix of technologies – Flash, HTML5 and native apps (Open GL ES and Open VG). This experience includes training engineering teams and building prototypes.

QNX Secure Kernel Extension Service

As remote access and connectivity become increasingly popular in medical devices, the challenge for device manufacturers is to keep transient patient electronic data secure. This however is becoming increasingly complex due to HIPAA regulatory requirements and the Common Criteria ISO/IEC 15408 EAL4+ certification, which is proving to be the standard of choice for security requirements. The QNX Neutrino RTOS 6.4 is certified to the stringent security requirements of the ISO/IEC 15408 EAL4+, which includes two hardware platforms (x86 with SMP and ARMLE). Recognizing the diversity of our customer base, we offer a range of services to help obtain the same certification on other versions of the QNX Neutrino RTOS, expand the scope of certification to include modules that are critical to your success, and incorporate new hardware platforms in your medical device certification.

FDA Consulting Service

QNX Software Systems has a proven track record of successfully helping companies with FDA approvals for medical-devices running the QNX Neutrino RTOS, including deep experience with achieving FDA 510(k) clearance. Our professional services team can also provide product life-cycle management services — everything from process reviews to quality system audits. What’s more, service providers in the QNX ecosystem can help with the premarket notification process as well as the more complex premarket approval (PMA) process.

See also: QNX Professional Services

QNX Software Systems has significant presence in the healthcare industry with a platform that enables highly reliable, available, connected, and secure medical devices, including:

• Blood analyzers to test blood samples
• Pulse oximeters to measure the oxygen saturation of a patient's blood
• Handheld CTG monitoring units to monitor babies'' heart rate
• Angiography to visualize blood vessels
• Diagnostic equipment
• Patient monitoring units to monitor vital signs
• Anaesthesia monitoring devices
• CardioQ hemodynamic monitoring systems to evaluate heart performance
• Hemodynamic cardiac/pulse monitors
• Retinal scanning devices
• High-performance lasers for eye surgery
• Electrocardiograph stress test equipment