Each year brings advances in medical device and information technology, requiring increased vigilance in the protection of patients, their information, and medical practices. The daily work in hospitals and clinics is increasingly supported by intelligent medical devices to increase efficiency and optimize human resources in health care. Non-critical treatments such as the delivery of infusions can be done by Linux-based systems. Medical devices for critical treatments with highly effective drugs, diagnostic imaging procedures like MRIs or even to support surgeons in minimally invasive surgeries must meet safety regulations. A reliable software platform all of these diverse needs is vital and allows you to save costs and improve quality.
Safe & Secure Virtualization for Medical Devices
PikeOS is both an RTOS and a safe software platform designed to support and compartmentalize capabilities that are important to critical medical devices, such as real-time responsiveness, determinism, safety, security and diverse hardware and software support. The foundation of PikeOS is a small, certifiable micro-kernel, upon which a virtualization infrastructure provides the ability to house diverse resource and function needs into safe individual partitions. Medical applications can range from non-critical display devices to highly critical control functions during surgeries, and these needs are met by PikeOS personalities ranging from native to Posix and Linux. Separation technology allows concurrent operation of applications with differences in security levels, criticality levels, and real-time operations on a single standard hardware platform.
Medical architectures (single & multi-core):
ARM, MIPS, PowerPC, SPARC V8, x86
Certified POSIX®, Linux, Native, POSIX®
Certification success included
Safety-critical Medical applications must be certified to safety standards such as IEC 62304 and/or follow FDA Device Classification. PikeOS is the best certification solution for three reasons: small size, criticality partitioning, and unparalleled company support for the certification process. Because PikeOS is purpose-built to meet certification needs, its essential features comprise only about 10,000 lines of code. The PikeOS partitioning concept makes it possible for applications of various levels of criticality to be certified for their individual required safety levels while running securely in parallel on the same hardware platform. Even more important for certification is a competent and reliable partner who does not leave you in a tight spot when it comes to documentation, requirements and tests. For over 15 years SYSGO has been supporting our customers with our own resources, with engineers, with workshops and training, as well as with artifacts and provision of source code.
Why you should use PikeOS in Medical Devices
Medical devices for critical treatments must comply with safety as well as security regulations. Of prime importance, the life and health of patients may not be endangered. Furthermore, their personal data must be protected against unauthorized access. Its unique properties make PikeOS a uniquely reliable and efficient foundation for critical medical applications:
- Support for a broad variety of personalities allows consolidation: PikeOS can be used in complex mixed-critical applications where Linux based graphic or network functionalities run concurrently with POSIX® based safety-critical and time-critical medication applications in separate partitions on a single processor.
- Integrated safety and security reduces certification costs: applications of various levels of criticality and security are safely separated from one another in distinct partitions and certified separately.
- Extreme flexibility provides independence from suppliers in the choice of hardware and software: PikeOS supports a broad range of hardware and software. It is easy to add additional architectures and interfaces (including for legacy code).
PikeOS in action: B.Braun’s infusion system
The B. Braun Space infusion system represents the latest technology available to manage complex infusion therapies with up to 24 pumps integrated into the SpaceStation and linked to the SpaceServer or to the Clinical Information System. Linux based interfaces include Ethernet, RS 232, US B master/slave, Wi-Fi, and barcode scanner to be used with any standard Internet browser. The innovative design has resulted in a single pump platform that covers the entire spectrum of infusion therapy types (e.g. general infusions, PCA, TCI, etc.).
“We pay a lot of attention to the different hardware and software components used in our products. We are convinced that SYS GO offers not only the right technology but also the right team to support our business model.”
Dr. Clara Cavelier, Senior Product Manager Cell Biology, Hamilton
More customers in the Medical Devices industry:
B. Braun, Eckert & Ziegler, Fresenius, Hamilton, Roche
We take the lead by continuous research
In the fields of safety and security, national governments and the EU are supporting businesses and research institutions with considerable research funding that can be utilized in medical technology. SYS GO is a leading participant in major research projects, benefiting the industry while continually improving and expanding PikeOS, the sole European virtualization solution.
PikeOS software platform in many research projects focusing on safety and security:
ACROSS, ARAMiS, ESPOSA, RECOMP, SESAMO
Industry ecosystem and collaboration
Medical Device projects use a wide range of software and hardware products. Flawless interaction between the components used is vital to the success of complex projects. For this reason, we have been working in close collaboration with the leading global Medical Technology suppliers for many years now. We support a wide selection of hardware platforms with our software products and have developed interfaces for code generators and analysis tools which are constantly being expanded.
Our Medical Technology ecosystem:
aicas, ARM, Atego, Esterel, Freescale, Infineon, Intel, Kontron, Lauterbach, MEN, MIPS, Rapita, Renesas, Vector Software, Xilinx