Customer:
Ably Medical
Selected Technology Partner for Cybersecurity and Hardware Development
Developing cyber-secure medical equipment entails significant demands regarding documentation, standards, and technical solutions. In the development of LYNG, Ably Medical collaborated with Prevas in selected technical areas, particularly focusing on hardware components, production testing, and cybersecurity.
A Smarter Way to Monitor Patients
LYNG is Ably Medical’s proprietary no-touch monitoring solution designed to assist healthcare professionals with real-time data, helping to prevent pressure ulcers and patient deterioration. The solution measures various vital signs, including heart rate, respiratory rate, and movement in bed, with a strong emphasis on data security and operational robustness.
LYNG provides accurate, continuous health monitoring that can be accessed via both mobile and stationary devices, thereby reducing administrative workloads for healthcare professionals.
LYNG measures vital functions such as heart rate, respiratory rate, and movement in bed. Additionally, the solution can be wirelessly integrated with third-party devices, providing insights into temperature, blood pressure, and blood oxygen levels.
Robust Hardware and Power Supply Development
The LYNG solution consists of two different sensor mats placed under the mattress in the hospital bed and a central unit that collects, processes, and forwards data from these mats. Prevas contributed to the development of hardware for the sensor system and its power supply, including a backup battery that ensures four hours of operation during patient transfers.
Data collection occurs on a Zephyr-based sensor board within the mats, and the data is relayed to a central unit. This unit is equipped with a powerful processor running a Prevas-developed Linux Board Support Package (BSP) that processes the data.
It also includes wireless communication capabilities utilizing WiFi-6 and 5G technology, allowing data to be transmitted directly to healthcare personnel’s platforms. This setup enables staff to receive immediate alerts and information, enhancing their reaction time in emergencies while significantly reducing their manual workload, allowing them to focus more on patient care.
Rigorous Testing for Demanding Environments
When developing medical equipment, compliance with numerous standards is crucial. These standards encompass a wide range of requirements, from patient safety and electromagnetic compatibility (EMC) to cable types and ingress protection (IP) ratings. Meeting these standards necessitates extensive documentation, especially concerning the cybersecurity of the product, which is a primary focus for Ably given that the system manages sensitive personal data.
In addition to enhancing Ably’s cybersecurity measures, Prevas developed the entire testing setup, which includes EMC pre-compliance tests, climate cabinet tests, 5G radio tests, and the necessary documentation.
Beyond environmental testing, Prevas also created test equipment for production, including test fixtures and racks for verifying printed circuit board assemblies (PCBAs) directly from the production line. This ensures high quality and minimizes the risk of incorrect assembly in the final product. Prevas supplied crucial components of the production test equipment and software, including installation and Factory Acceptance Testing (FAT) in the production hall.
Built for Compliance and Cybersecurity from Day One
For Ably, cybersecurity has been a vital consideration. To secure the product, Prevas adhered to IEC 81001-5-1, the standard for cybersecurity in medical devices. This process commenced with defining the requirements outlined in the standard, followed by threat modeling and risk assessment. Subsequently, procedures were established to ensure compliance with these requirements throughout the development, production, and disposal of LYNG.
When developing software for medical devices, compliance with the IEC 62304 standard is mandatory. Prevas created documentation packages to meet the standard’s requirements. IEC 62304 specifies lifecycle requirements for medical device software and is structurally aligned with the IEC 81001 standard, which details safety activities throughout the product life cycle.
Making Innovation Happen, Together
Prevas has made substantial contributions to Ably Medical’s development work, especially in hardware, testing solutions, and cybersecurity. The close collaboration and Prevas’ expertise in standards such as IEC 81001-5-1 and ISO 14971 have reinforced the solution and enhanced Ably’s overall development process.
Our expertise / Key contributions from Prevas include:
- Hardware development
- Development of Linux BSP
- Creation of Zephyr-based firmware
- Comprehensive environmental testing
- Development of complete production testing solutions
- Cybersecurity adherence to IEC 62304
- Risk management compliant with ISO 14971
Contact us
Henrik Møller, Prevas A/S, e-mail
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