Medical Devices

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Sterne Kessler helps medical device and diagnostic clients protect, defend, and enforce the technologies that are transforming healthcare. We advise innovators across the full intellectual property (IP) lifecycle, delivering patent and IP strategies designed to withstand challenges and support product development, competitive positioning, and long-term business value.

As medical devices and diagnostics become more connected, data-driven, and software-enabled, effective IP protection requires a firm with cross-functional technical insight and sophisticated IP legal strategy. Sterne Kessler’s multidisciplinary team brings deep experience in patent prosecution, portfolio strategy, post-grant proceedings, litigation, opinions, due diligence, licensing, and related IP counseling for medical technology companies. We work with executives, in-house counsel, and inventors to develop practical, business-aligned IP strategies in the United States and globally.

With more than 100 advanced degrees across our firm in science and engineering disciplines, including over 60 Ph.D.s across the firm, Sterne Kessler has deep experience across the disciplines that converge in modern medical technology, including: biomedical, mechanical, and materials science engineering; life sciences, including chemistry and biology; and computer science and electrical engineering.

Medical device technologies have evolved and often combine hardware, software, artificial intelligence, sensors, materials, biologics, chemistry, and data — creating complex patent and regulatory challenges. Our team advises medical device companies on the unique interplay between the patent process and the U.S. Food and Drug Administration (FDA) approval process. We help manage product development strategy, coordinating assertions made in FDA filings with claims made in patent applications. We also advise clients on freedom-to-operate, enforcement strategy, and portfolio development to preserve protection and support growth in a global market.

Our experience spans a broad range of medical device and diagnostics categories, including:

Implantable and interventional devices
Surgical devices and treatment systems
Drug delivery and combination products
Diagnostic platforms, instruments, assays, and reagents
Monitoring, testing, and patient care systems
Wearables, prosthetics, and assistive technologies
Materials, components, packaging, and manufacturing technologies for medical products

Comprehensive IP Services

IP Capabilities for Medical Devices & Diagnostics

Sterne Kessler advises medical device, diagnostics, digital health, and health technology companies across the full IP lifecycle, from early-stage research and product development through patent protection, commercialization, enforcement, and defense. Our services include:

Drafting and prosecuting patent applications, and managing global patent portfolios
Preparing and negotiating licenses and strategic transactions involving IP rights
Enforcing and defending patent rights in federal district and appellate courts and before the U.S. International Trade Commission (ITC)
Leading post-grant proceedings before the Patent Trial and Appeal Board (PTAB), including inter partes reviews, post-grant reviews, and ex parte reexaminations before the Central Reexamination Unit (CRU)
Providing freedom-to-operate, infringement, validity, and patentability opinions
Conducting IP audits and developing company IP guidelines for inventors, including this use of artificial intelligence in the product development lifecycle
Conducting IP due diligence for strategic transactions, including investments and mergers and acquisitions
Providing trademark prosecution, brand protection, and strategic counseling