Do medical device startups need clinical trial insurance?

A medical device company needs clinical trial liability once it runs human clinical studies - for example an investigational device exemption (IDE) study - because trial-subject injury is not covered by the general liability or products policies. Clinical trial liability is a distinct line that responds to bodily injury to study subjects arising from the investigational device or the study procedures, and it is frequently required by the IRB or ethics committee and the study agreement before enrollment.

The trigger is human studies. A device maker still in bench testing or animal studies does not yet need it, but once patients are enrolled in a clinical investigation, the coverage should be in place. Limits are driven by the device risk, the number of subjects, the indication, and the geography, with higher-risk and implantable devices carrying higher limits.

As the device moves toward market, the clinical trial liability coordinates with the products and completed operations coverage that will respond to the commercial product, so there is no gap at the transition from investigation to market.