Medical Devices & Procedures

Protecting Innovations in Diagnostics, Treatment, and Patient Care

Medical device innovation bridges engineering and biology—translating ideas into solutions that monitor, diagnose, and treat human conditions. At Schmeiser Olsen, we help clients protect the full spectrum of device-based innovation, from implantable systems and diagnostic platforms to surgical instruments, wearable sensors, and software-driven procedures.

Our attorneys understand the challenges of patenting in a space that demands precision, regulatory compliance, and clear system-level functionality. We work with medical technology startups, R&D teams, and healthcare-focused companies to secure IP that supports clinical differentiation, investor confidence, and regulatory progression.

We protect the systems, materials, and methods that improve care—from bench to bedside.

Patent Strategy for Medical Devices and Procedures

Successful patent protection for medical devices and procedures requires careful articulation of mechanical, electrical, biological, and software interaction—often within highly regulated environments. Our attorneys focus on patent strategies that anticipate FDA review, enable market exclusivity, and align with both technical utility and human use. We draft claims that address form, function, method of use, and integration with diagnostic or therapeutic systems. We help clients secure patents for:

Diagnostic & Monitoring Devices

– Point-of-care devices for blood, saliva, or breath analysis

– Optical, ultrasonic, and electrical sensing platforms

– Implantable or ingestible sensors for continuous monitoring

– Noninvasive measurement systems for real-time physiological feedback

Therapeutic & Surgical Tools

– Minimally invasive surgical devices and instrument systems

– Robotic assistance platforms with feedback or force sensing

– Drug delivery devices with programmable or responsive actuation

– Biocompatible implants and prosthetics with structural or biochemical interface layers

Wearables & Digital Health

– Body-worn devices with motion, biometric, or EEG sensing

– Closed-loop systems integrating sensors and stimulation (e.g., neuromodulation)

– Remote diagnostics platforms and patient adherence systems

– Machine learning models embedded in device firmware for decision support

Methods & Procedures

– Image-guided interventions and technique-specific surgical workflows

– Noninvasive or transdermal delivery methods

– Positioning and alignment protocols for implanted systems

– Integration of medical imaging, real-time feedback, or augmented interfaces

practical insight

Navigating Challenges in Medical Device Patents

The medical device space requires attention to enablement, human factor claims, and compliance with FDA-regulated product classes. We help clients address:

– Multimodal systems: combining mechanical and software elements in a claim structure
– Method of treatment claim strategy: jurisdiction-specific constraints (e.g., Europe vs. U.S.)
– Clinical data integration: how to support device functionality without overclaiming future applications
– 510(k) vs. PMA strategy alignment: timing patent claims with regulatory approvals
– Joint development and IP ownership: managing rights across engineers, clinicians, and institutions

We work closely with inventors and regulatory counsel to build portfolios that are practical, enforceable, and aligned with the clinical realities of use.

Partner with Counsel Who Understand Medical Device Innovation

At Schmeiser Olsen, we support medical technology innovators with a combination of technical precision and real-world IP strategy. From Class II diagnostics to AI-driven therapeutics and next-generation surgical tools, we help position your inventions for protection and commercial success.

Protect the devices that improve lives—with patent counsel fluent in medical design, clinical workflow, and device regulation.

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