Medical Devices

Bringing a medical device to market involves more than FDA approval—it requires intellectual property protection that aligns with innovation, clinical application, and business goals. At Brooks Kushman, we help companies protect and enforce the intellectual property that powers healthcare breakthroughs. 

Medical device innovation depends on precision, safety, and compliance. Yet the path from concept to commercialization is filled with challenges—from complex regulatory frameworks to evolving standards of patent eligibility. Devices that integrate digital software, AI algorithms, or wireless monitoring systems are subject to additional scrutiny regarding what can be claimed and how intellectual property rights are enforced.

For companies developing smart implants, diagnostic tools, or robotic surgical systems, securing strong and enforceable intellectual property requires navigating legal and technical barriers. Additionally, global competition and cross-border development raise questions of ownership, trade secret protection, and international filing coordination.

How We Can Help

Brooks Kushman provides comprehensive support across the lifecycle of medical device intellectual property—from early-stage innovation through commercialization and enforcement. Our attorneys work with inventors, engineers, clinical teams, and regulatory consultants to identify protectable innovations and build intellectual property portfolios that support growth and investment.

We assist clients with U.S. and international patent prosecution, intellectual property due diligence, trade secret strategies, licensing, and post-grant challenges. Whether you’re building a wearable diagnostic device or a next-generation surgical instrument, our legal guidance is tailored to your technology, compliance needs, and business objectives.

Why Partner With Brooks Kushman?

With more than 11,000 patent applications filed over the last five years and a deep bench of technical expertise, Brooks Kushman brings the strategic experience necessary for today’s complex device landscape. Our team includes professionals with backgrounds in biomedical engineering, computer systems, and materials science, allowing us to understand the intricacies behind Class I and III devices.

Partnering with a medical device intellectual property attorney from our firm means working with someone who understands how to align patent scope with clinical application and regulatory timing. We help clients anticipate patentability, enforceability, and competitive positioning challenges, ensuring their intellectual property supports business continuity and long-term innovation.

Key IP Considerations for Medical Devices

Cross-Disciplinary Innovation

Medical device technologies often combine engineering, materials science, electronics, software, and life sciences. Protecting these innovations requires attorneys who understand not only the device’s technical specifications but also how it interacts with the human body and complies with regulatory requirements. Our team has the technical and legal experience to protect devices across the full spectrum, from surgical instruments to AI-enabled diagnostic tools.

Patent Eligibility and Strategic Claiming

Medical device innovations may involve mechanical components, embedded software, diagnostic algorithms, or therapeutic delivery systems. We work with clients to develop claims that cover both structural and functional aspects, emphasizing technical improvements and real-world application. This approach supports patent eligibility in jurisdictions where software or diagnostic methods face heightened scrutiny.

Regulatory Coordination and Timing

Device development often runs parallel to regulatory review by agencies such as the FDA, EMA, or other national health authorities. We help clients coordinate their IP filings with regulatory submissions to ensure protection is secured before public disclosure and to align patent timelines with product approval and market launch plans.

Trade Secrets for Manufacturing and Design

Proprietary manufacturing processes, assembly techniques, material treatments, or calibration methods may provide a competitive edge that is better protected as trade secrets rather than through patenting. We assist clients in evaluating what should be kept confidential and in implementing confidentiality agreements, vendor controls, and internal protocols to maintain secrecy.

Freedom to Operate and Risk Management

The medical device industry is densely populated with patents, and infringement risks can delay product launch or lead to costly litigation. We conduct thorough freedom-to-operate (FTO) analyses to help clients identify potential risks early, evaluate licensing opportunities, and design around competitive patents where possible.

Global Protection Strategy

Medical devices are often commercialized in multiple jurisdictions, requiring coordinated global filing strategies. We develop protection plans that account for market priorities, regulatory differences, and jurisdiction-specific patentability standards, ensuring strong and enforceable rights across key regions such as the U.S., Europe, China, and Japan.

IP Strategy for Collaborations and Supply Chains

Many medical devices are developed in collaboration with component suppliers, research institutions, or technology partners. We help clients structure agreements that clearly define ownership of background IP, rights to jointly developed improvements, and licensing terms. This ensures proprietary technology is protected throughout the supply chain.

Design Patents for Product Appearance

In addition to utility patents, design patents can be an important tool for protecting the unique look of a medical device, especially in competitive consumer-facing categories like wearables and home health monitoring systems. We help clients secure design protection that complements functional IP rights.

Lifecycle Management and Product Iteration

Medical devices often evolve through incremental improvements, new features, or alternative configurations. We work with clients to maintain protection over the entire product lifecycle, including securing patents for enhancements, next-generation models, and related accessories.

Specialty Practice Areas

• Cardiac Pacing & Defibrillation Devices
• Catheters
• Cerebrospinal Fluid Shunt Valves
• Devices for Magnetic Resonance Imaging, Ultrasound, & X-Ray
• Diabetes & Blood Glucose Self Testing
• Digital System Processing
• Dialysis Systems
• Drug Delivery Devices
• Drug-Eluting Heart Stents
• Endoscopy & Urology/Gynecology Systems
• Imaging Devices & Methods
• Interventional Cardiology Devices
• Medical Supplies
• Monitoring Equipment
• Ophthalmic Devices
• Orthopedic Devices & Implants
• Prosthetic Organs, Joints, & Orthopedic Devices
• Surgical Instruments
• Therapeutic & Diagnostic Devices
• Tissue Engineering

Brooks Kushman protects the innovations shaping modern healthcare, from surgical tools to AI-driven diagnostics. Contact our team to learn how a medical device intellectual property attorney can help secure and enforce your inventions.