October 29, 2026
AgencyHow FDA Clearance Changes Your Insurance Needs
FDA clearance proves your device can be sold, but your insurance determines whether buyers will let you sell it. This guide covers how liability exposure shifts from clinical use to commercial distribution, what GPOs and hospital procurement teams require, three policy updates to make before your first sale, and an insurance readiness checklist.
October 9, 2026
AgencyClinical Trial Insurance: What Medtech Startups Need Before IRB Approval
Your first human subjects study changes your risk profile, and your insurance has to keep pace. This guide explains how clinical trial liability coverage differs from general and product liability, what reviewers and sites look for in insurance and consent documentation, how investigator coverage interacts with sponsor liability, and five questions to answer before enrollment begins.
September 23, 2026
AgencyHIPAA Compliance vs. Cyber Liability Insurance: Understanding the Difference
Being HIPAA compliant and being financially protected from a breach are two different things — and most health tech founders discover the gap between them only after an incident occurs. This guide breaks down what HIPAA compliance actually requires, five financial exposures your compliance program cannot cover, what cyber liability insurance is built to handle instead, and how to tell if your current policy is actually sized to your company's real data footprint.
September 10, 2026
AgencyWhat Happens When a Medical Device Gets Recalled — And How Insurance Factors In
Nearly all medical device recalls are technically voluntary — but that label is doing more work than it should. This guide breaks down the real difference between voluntary and mandatory recalls, why standard product liability policies almost never cover recall expenses, the true operational cost of pulling a device from the field, and how to build recall preparedness into your risk framework before the FDA calls.
August 3, 2026
AgencySecuring the Future: The Crucial Role of Insurance in the MedTech Revolution
The pace of medical technology innovation has never been faster. From artificial intelligence that reads diagnostic scans to wearable devices […]
July 29, 2026
AgencyProduct Liability 101 for Medical Device Companies
For medical device startups, product liability insurance isn't an administrative checkbox — it's the financial structure that determines whether your company survives its first serious adverse event. This guide covers what product liability insurance actually covers for device makers, how FDA Class I, II, and III classifications affect your coverage requirements, the four most common gaps in medtech policies, and what a real claim looks like for a monitoring device manufacturer.