Product Liability Insurance for Medical Device Manufacturers

Product liability represents the single greatest financial threat facing medical device manufacturers today. Manufacturing defects, design flaws, and failure-to-warn claims can result in multimillion-dollar lawsuits that threaten your company's survival. Class I recalls—the most serious type involving reasonable probability of serious health problems or death—reached 114 in 2024, the highest recorded since at least 2012.

Your product liability insurance provides essential protection against claims alleging bodily injury or property damage caused by defective medical devices. This coverage extends beyond just the legal defense costs—it protects your business from settlements, judgments, and the devastating financial impact of a single product failure. Whether you manufacture diagnostic equipment, surgical instruments, or implantable devices, comprehensive product liability coverage ensures one defect doesn't destroy everything you've built.

The medical device industry faces unique challenges that demand specialized insurance solutions. Manufacturing errors during production, design defects identified post-market, and inadequate warnings about device risks all create liability exposure. With the FDA launching enhanced recall communications programs in 2024, manufacturers must maintain robust insurance coverage that addresses these evolving regulatory requirements while protecting against the financial consequences of product-related claims.

Regulatory Compliance and Risk Management Solutions

Medical devices increasingly connect to the Internet, hospital networks, and other medical devices, creating features that improve healthcare while simultaneously increasing potential cybersecurity risks. Regulatory compliance insurance protects medical device manufacturers against violations of FDA regulations, quality assurance failures, and mandatory recall costs. Your business operates in one of the most heavily regulated industries in America, where non-compliance carries severe consequences.

FDA regulations require medical device manufacturers to maintain comprehensive quality management systems, conduct rigorous testing, and ensure proper labeling throughout the product lifecycle. The FDA's 2025 cybersecurity guidance introduces significant new requirements, making cybersecurity a lifecycle obligation for medical device manufacturers who must demonstrate their devices meet security requirements. Regulatory compliance coverage helps manage these complex requirements while protecting your business from costly violations.

Risk management for medical device manufacturers extends beyond product liability to encompass supply chain disruptions, equipment breakdown, and intellectual property protection. Clinical trials insurance covers the unique exposures during product development and testing phases. Professional indemnity protects against errors in device design or manufacturing processes. Quality assurance procedures must align with ISO 13485 certification requirements and FDA approval processes, creating multiple layers of compliance obligations that proper insurance coverage helps you navigate successfully.

Comprehensive Coverage Options for Medical Device Companies

Medical device manufacturing demands a strategic approach to insurance protection. Beyond product liability and regulatory compliance, your business needs workers' compensation insurance for employees, property insurance protecting your facility and equipment, and business interruption coverage that replaces lost income during covered shutdowns. 

Cyber liability insurance has become essential protection for manufacturers of connected medical devices facing evolving security threats.

Equipment breakdown insurance covers costly machinery repairs and replacements that can halt production and cost hundreds of thousands in downtime. Supply chain coverage protects against disruptions from your vendors and suppliers. 

General liability insurance handles third-party injuries and property damage claims unrelated to your products. Professional liability insurance defends against claims of errors, omissions, or negligent advice provided during the manufacturing process.

The Allen Thomas Group understands that medical device manufacturers operate in a complex environment where regulatory requirements, product safety concerns, and business operations intersect. We build comprehensive insurance programs tailored specifically to your manufacturing operations, ensuring you maintain adequate protection as your business grows and regulations evolve. 

Our Smart & Easy process evaluates your unique exposures and delivers customized coverage that protects everything that matters to your business.