AI IP Year in Review – Key Takeaways—AI-Equipped Medical Devices Require Speculative Patent Approach

Traditional hardware-driven patent strategies long used by the medical device industry should be updated for the AI era. Because AI and software evolve much faster than physical hardware or regulatory (FDA) timelines, companies should adopt a patent approach that is more speculative—one that looks past current product versions to anticipate future software capabilities and technical milestones.

Takeaways

• Move Beyond Hardware: Historically, medical device patents focused on physical designs and circuitry. In the AI era, value has shifted to the “code-based” innovations, such as how a device makes decisions, adapts to patient data, or transforms clinical workflows.
• Adapt to AI Roadmaps: Companies should use their internal product roadmaps to identify and “extrapolate” future features early in the lifecycle. This allows them to file initial applications that contain a range of anticipated technical variations before they are even built.
• Adopt a Nimble Mindset for Dynamic Timelines: AI features are often only a few coding sessions away from reality and move much faster than the slow iterations of regulated hardware. Patents must be filed early to capture these rapid software milestones before competitors do.
• Focus on Technical Novelty: Teams should prioritize features that improve clinical performance in a technically novel way that would be difficult for a competitor to replicate or work around and ensure that those features are properly claimed.
  • Weak: Claiming functional features that merely use AI, such as to “detect arrhythmias faster.”
  • Stronger: Claiming a specific implementation or architecture, such as a trained neural network, that performs the functions, such as classifying waveforms by dynamically adjusting feature extraction parameters based on historical patient-specific data.

Read the full article, AI-Equipped Medical Devices Require Speculative Patent Approach, which first appeared in Bloomberg Law.

This article appeared in the 2025 AI Intellectual Property: Analysis & Trends Year in Review report.