Digitalization and automation are just as important as ever in nearly every sector of today’s economy. The Industry 4.0 vision has consolidated into a mature model which unites technology adoption and newly gained capabilities with levers and value drivers at organizations. Due to a lack of comprehensive implementation, however, the resultant possibilities have yet to be fully exploited in many sectors, not least in healthcare.
With its digital automation and IT solutions for IVD companies and the clinical lab markets, STRATEC is addressing key value drivers. Here, STRATEC is helping to modernize the healthcare sector by ushering in benefits such as reliability, higher throughput, repeatability, fast results, advanced process control, and the rapid dissemination of new test protocols and technologies. All these factors serve to benefit patient outcomes worldwide.
STRATEC’s Internet of Things (IoT) platform
Vigilant online
Vigilant Online, STRATEC’s cloud-based Internet of Things platform, is designed to provide valuable insights into the instrument performance and assay data of your fleet. It provides important instrument information for the purpose of analysis, control and business process integration.
At the same time, it upholds the highest standards in terms of data protection and cybersecurity. The platform enables you to share data with your team and remotely access log-files for troubleshooting. This will make your customer support as efficient as possible.
Main benefits for customers
INCREASE EFFICIENCY
by gaining insights into the performance of instruments and reagents
IMPROVE SERVICE
by optimizing fleet management
REDUCE COSTS
by optimizing customer support
- USE CASE FOR VIGILANT ONLINE
Vigilant Online is designed to readily support all typical use cases for connected instruments. To connect and integrate existing customer IT solutions, Vigilant Online offers B2B interfaces which can be tailored exactly to your needs. To meet individual customer requirements we additionally offer customized modules.
- KEY FEATURES
- REDUCTION OF SERVICE COSTS
Analyze instrument usage history
Visualize event statistics and telemetry data
Remote log-file requests for troubleshooting
Assignment of service technicians to specific instrument groups
Constant monitoring of instrument status
- SECURITY
User account management with role-based access
Enforced password policy with expiration settings
Complete audit trail for instrument and user activities
Encrypted data in transit and at rest
- SCALABLE
Scalable to support several thousand simultaneously connected instruments emitting large data volumes
- DATA PRIVACY
All data including operator data are handled in a GDPR-compliant manner (EU General Data Protection Regulation)
- PERFORMANCE MONITORING
Usage statistics (cycle counter, assay usage, rate of invalids)
Instrument configuration (software & firmware version with history)
Error event statistics per category and assay
- COLLECTION OF INSTRUMENT DATA
Telemetry data of sensors & actuators
Monitoring of hard drive capacity
Events data including severity, source, and context
Assay-related data
- REMOTE CONFIGURATION MANAGEMENT
Remote distribution of settings, assays files, user manuals
Upload software and firmware updates
- FLEET MANAGEMENT
Organize instruments in groups and regions
Manage user assignments
Visualize instrument locations on map
- REDUCTION OF SERVICE COSTS
- CUSTOMIZATION OPTIONS
Vigilant Online is designed to support all typical use cases for connected instruments. To match our partners’ corporate style and branding, the product appearance can be customized by changing the user interface. Vigilant Online offers B2B interfaces that allow for the integration and connection of existing customer IT solutions. STRATEC additionally offers its partners a customization of modules to meet individual needs.
cybersecurity services
specifically designed to protect medical devices
In today's interconnected healthcare environment, safeguarding medical devices against cyber threats is paramount. STRATEC stands at the forefront of this critical domain, offering a comprehensive suite of cybersecurity services designed specifically to protect our customer’s medical devices. Our solutions are meticulously aligned with the stringent guidelines laid down in federal regulations such as those issued by the U.S. Food and Drug Administration (FDA). This ensures that our clients not only comply with regulatory requirements but also achieve the highest standards of security and patient safety.
STRATEC’s cybersecurity services encompass a holistic approach, addressing every phase of the medical device lifecycle. From the initial design and development stages to post-market surveillance, our expert team provides robust risk assessments, threat modeling, and continuous monitoring solutions. We implement advanced encryption and operating system hardening, offer dynamic authentication, and provide operating system security update mechanisms. These ensure that devices remain secure against evolving cyber threats in the post-market launch phase and enable our customers to react swiftly to avert cybersecurity threats.
- SBOM (SOFTWARE BILL OF MATERIALS)
Our SBOM service provides a detailed inventory of all software components within a medical device, ensuring transparency and traceability. This allows for the identification and management of vulnerabilities in third-party and open-source software, facilitating timely and effective remediation efforts. We provide our customers with quarterly reports that list and rate cybersecurity risks. By maintaining an up-to-date SBOM, we help our clients achieve compliance and enhance their cybersecurity posture.
- SECURE TOKEN AUTHENTIFICATION
To fortify access control, STRATEC offers a dynamic authentication solution that excludes the use of static passwords. These layers of security significantly reduce the risk of unauthorized access, ensuring that only verified personnel can interact with medical devices. Our flexible and robust authentication methods adapt to varying security needs, providing an additional safeguard against potential breaches. The dynamic authentication is also a mandatory cybersecurity measure that is requested by the FDA’s regulatory guidelines.
- OPERATING SYSTEM SECURITY UPDATES
Keeping medical devices secure requires regular and reliable operating system updates. STRATEC provides a seamless update management service, ensuring that all devices run the latest software with the most recent security patches. In this, STRATEC not only provides the updates but also ensures the testing and verification of our customers’ medical devices. This proactive approach mitigates vulnerabilities and protects against emerging threats, maintaining the integrity and functionality of medical devices in compliance with FDA regulations. Furthermore, STRATEC helps its customers to save valuable time and money by remotely deploying security updates within a short time for an entire fleet.
Note: STRATEC offers further cybersecurity services on request. For security reasons, not all cyber security measures and services are mentioned on the public website.
Frequently Asked Questions
- How does Vigilant Online help with customer support?
It supports remote access to log files, troubleshooting, service technician assignment, and efficient fleet management.
- Can Vigilant Online be integrated with existing IT systems?
Yes. The platform offers B2B interfaces that can be tailored to connect and integrate existing customer IT solutions.
- Does STATEC provide cybersecurity services?
Yes, STRATEC offers workshops for threat modelling and cybersecurity risk analysis and provides cybersecurity support like system hardening for instrument PCs, SBOM including vulnerability monitoring, Windows security updates process or secure token authentication.
- How does STRATEC address cybersecurity for medical devices?
STRATEC offers cybersecurity services across the medical device lifecycle, including risk assessments, threat modeling, monitoring, encryption, and OS hardening.
- What is STRATEC’s SBOM service?
STRATEC’s SBOM service provides a detailed inventory of software components to improve transparency, traceability, and vulnerability management.
- How does STRATEC support operating system security updates?
STRATEC provides update management, testing, verification, and remote deployment of security patches across device fleets.
