Mender Resources

Business best practice dictates that organizations focus resources on areas that create market differentiation. Areas that are not a direct source of competitive advantage — such as enabling unique customer experiences or creating new revenue streams — are likely to be infrastructure or operational rather than strategic.

At their essence, software updates are simple – transfer data from one place to another. But, just as a tent, a bicycle, or a recreational player differ from a house, a car, or an Olympic athlete, production-grade software updates fit for enterprise commercial products are different. The qualifying process surrounding software updates is the difference. Baseline best practices for production-grade software updates focus on the minimum standards required for most commercial environments and enterprise products.

Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the Medical Device Regulation (MDR), ensure the safety, effectiveness, and quality of medical devices. For software-driven devices, compliance is an ongoing process; each update or modification can present regulatory challenges for manufacturers. The rapid pace of software innovation makes navigating regulations more complex. Proactively addressing these challenges enhances quality, improves reliability and safety, and adds value for both patients and healthcare providers.

Expanded health access with telemedicine and digital health solutions; personalized healthcare and advanced detection and monitoring for improved patient outcomes. Operational efficiencies through automation, digitalization, and entirely new workflows. Promising cutting-edge Internet of Medical Things (IoMT) and AI-powered solutions tackling today's most challenging issues. For the medical and healthcare industry, technology holds massive untapped potential. Yet, it also comes with novel challenges.

To realize the massive potential of new technology, medical and healthcare device OEMs must embrace modern, purpose-fit infrastructure. Advancing patient outcomes requires innovation, and innovation in a software-centered world requires robust and secure over-the-air (OTA) updates. Without it, innovation and, thereby, progress fail.

The rapid growth of IoMT and escalating cybersecurity threats make it necessary for healthcare and medical OEMs to adopt a medical-grade OTA update strategy. Solutions must both address immediate security concerns while simultaneously accommodating regulations like FDA 501(k) and the NIS2 directive.

As devices become increasingly software-defined, managing them in the field requires more than delivering updates. In this Embedded World North America 2026 session, Luis Ramirez, Senior Customer Engineer at Northern.tech, explores the challenges of managing complex, distributed device fleets and the strategies organizations can use to securely maintain and update them throughout their operational lives.

Mender Customer Engineer Jana Perić shares lessons from real-world deployments on building secure and robust OTA software update infrastructure that holds up in the field.

In this panel webinar, STMicroelectronics' Mena Roumbakis and Northern.tech's Eystein Måløy Stenberg discuss the practical implications of EU Cyber Resilience Act (CRA) compliance.