North America Diagnostic and Monitoring Devices Market Size and Forecast by Offering, Technology, Clinical Application, Distribution Channel, and End User: 2019-2033

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Industry Assessment Overview

Industry Findings: Cross-border regulatory alignment is becoming one of the biggest structural forces shaping device development cycles and procurement priorities. The coordinated IMDRF workstream between US and Canadian regulators on cybersecurity and SBOM transparency (Mar-2023) is pushing OEMs to redesign architectures for resilience. This shift elevates vendors with traceable supply chains and lifecycle-security capabilities, directly influencing hospital purchasing criteria and long-term platform standardization.

Industry Progression: The region is now moving into a phase where cybersecurity compliance is no longer optional. The release of the FDA’s final premarket cybersecurity guidance (Jun-2025) forces vendors to support SBOM disclosures, vulnerability management, and secure-by-design documentation. This adds engineering burden but also accelerates market separation, as compliant players gain smoother regulatory navigation and earlier customer adoption within health systems seeking procurement-ready solutions.

Industry Player Insights: Leading vendors influencing the North American market include Roche Diagnostics, Siemens Healthineers, Abbott Laboratories, and Becton Dickinson etc. Competitive momentum is rising as major vendors expand capacity and secure differentiated regulatory positions. Siemens’ ELF Test gaining Breakthrough designation (Jul-2023) boosted its advanced liver-disease testing profile, while Roche’s acquisition of LumiraDx (Jul-2024) and US manufacturing investment (May-2025) strengthened rapid diagnostics and domestic supply. These moves tilt buyer preference toward integrated platform ecosystems.