Is My Class II Medical Device Covered Under a Standard BOP?

No. A standard business owners policy is not built to carry the products liability a cleared Class II device creates, and treating a BOP as your device program leaves the largest exposure on the table. A BOP is a sensible foundation for an ordinary small business. It is the wrong instrument to stand behind a regulated device in patient use. The same category error applies to a personal policy, since a homeowners policy does not cover a device startup.

What a BOP Actually Covers

A business owners policy bundles two things into one form: general liability and commercial property, often with a measure of business interruption. It is priced for conventional operations, an office, a clinic front desk, a small distributor. It responds well to a visitor who slips in your lobby, to damage to your space, and to the income you lose when that space is unusable. The underwriting assumes a routine risk. A company manufacturing and placing a 510(k) cleared device into the market does not fit that profile, and the policy was never rated for one. Before the coverage gap there is an eligibility gap, since a BOP usually excludes a device startup from eligibility in the first place.

Where the Gap Opens for a Class II Device

The exposure that defines a device company is products liability, a claim that the device caused bodily injury. Plaintiff counsel generally argues one of three theories: a design defect, a manufacturing defect, or a failure to warn. Any of the three can attach to a Class II device because these products act on or measure the body, and an adverse outcome tends to name the manufacturer first.

Most BOP forms treat products exposure as an afterthought. The products and completed operations grant is frequently sublimited, narrowed, or excluded outright, and where some coverage survives, the limit and the wording were set for a generic consumer product rather than a cleared medical device. When a real claim lands, three questions decide the outcome: does the policy respond at all, is the limit anywhere near the cost of device litigation, and does the carrier’s defense panel understand this kind of case. A generalist BOP tends to fail on all three. A purpose-built products liability program for device manufacturers is structured around exactly those questions.

The Coverage a Standard BOP Leaves Out

Products liability is the headline gap, but it is not the only one. A Class II manufacturer also carries exposures that sit entirely outside the general liability and property bundle. Recall costs if the device has to come off the market. Professional liability where a reading, calibration, or service is part of what you deliver. Clinical trial liability while studies are running. Cyber exposure if the device is connected or moves patient data. None of these live inside a BOP, and each can equal or exceed the cost of a property claim. The way these lines fit together shifts as the company moves from clearance into commercialization, and recall exposure in particular is one founders consistently underestimate.

What to Put in Place Before Commercialization

The working approach is a products liability program placed with a carrier whose underwriters actually price device risk, built around your device class, its indication, and where you distribute. That program is then layered with the general liability, property, and stage-appropriate coverage the business needs. If a BOP has any role, it covers the ordinary premises, not the device. The time to structure this is before the first unit ships, because the first claim is not the moment to learn that the products grant was never really there.

Before you commercialize, have your full exposure mapped against your actual device and stage rather than assuming a packaged policy carries it. A specialty review through Tower Street Insurance can show precisely where a BOP stops and where a real device program needs to begin.