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Digital Transformation: Building Smarter, More Resilient Products and Operations
As complexity accelerates across orthopedic product development and supply chains, leading organizations are shifting from fragmented, static approaches to data-driven frameworks that improve visibility, reduce risk, and enable proactive decision-making. Through commercialized products and internal processes, orthopedic companies seek to leverage the speed and flexibility of digital ecosystems that can scale efficiently, respond faster, and operate with greater confidence. But how should companies adopt these cutting-edge technologies, and what risk mitigation measures need to be put into place?
Attendees of this session will hear presentations from companies with expertise in AI, connected medical devices, and cybersecurity.
Beyond the eQMS: The Rise of Audit Intelligence
Monica Burt & Associates
Security You Can Prove: Reducing Risk in Medical Device Innovation
DornerWorks
Medical devices are more connected, software-driven, and exposed than ever, with risks of failure, breaches, and unintended behavior rising. As attack surfaces grow, traditional “patch-and-protect” approaches to safety and cybersecurity are falling short. A new generation of provably correct system architectures embeds safety and security into the foundation of device operation, ensuring systems behave as intended under fault or attack. By leveraging formally verified components and memory-safe software practices, organizations can achieve guarantees of correct behavior, including robust process isolation and elimination of entire classes of software defects. Beyond stronger security, these approaches reduce maintenance burden by minimizing latent bugs and simplifying updates over the device lifecycle. This session explores how provable security reduces development risk, accelerates time to market, lowers long-term cost, and increases confidence in next-generation medical systems.
Understanding a Medical Device Cyber Attack: An Inside Look
Plante Moran
Manufacturing companies face a unique cybersecurity threat landscape due to the convergence of modern enterprise networks and connected OT (Operational Technology) and IoT (Internet of Things) devices, such as medical devices. This convergence expands the attack surface and allows cyber incidents to move from network systems into production environments and devices, potentially causing downtime or safety risks.
Attackers rarely focus on a medical device alone. Instead, they take advantage of weaknesses in the surrounding hospital or manufacturing environment — such as poor network segmentation, legacy systems, weak credentials, or insecure remote access. Once inside the environment, they may monitor activity, disrupt operations, or compromise device behavior and data. This presentation illustrates a typical attack path and highlights the types of vulnerabilities that can be exploited to demonstrate the associated risks, as well as, best practices to mitigate these risks.