Life SciencesLiability

Question

How much does cyber insurance for a medical device company cost?

Short answer

Cyber insurance for a medical device company is priced on risk, not size, so the range is wide: a small manufacturer with strong security controls often sees a $1M-$2M cyber policy in the low-to-mid four figures annually, while a connected-device or software-as-a-medical-device company holding large volumes of patient data, or one carrying higher limits to satisfy hospital and GPO contracts, can run well into the five figures. The single biggest lever is the strength of the security controls the company can evidence at underwriting - multifactor authentication, endpoint detection, tested backups, and encryption move the price more than revenue does.

The short answer

There is no flat rate. Cyber pricing for a device company is built from the volume and sensitivity of the data held, revenue, whether the devices are connected or software-driven, the security controls in place, and prior claims. Because controls dominate the calculation, two device makers of the same size can see very different premiums.

As a rough orientation, a small manufacturer with clean controls and modest data volumes tends to see a $1M-$2M cyber policy in the low-to-mid four figures per year; a connected-device or SaMD company, a company holding large patient-data sets, or one required to carry higher limits by contract will see materially more. These are practitioner-typical ranges, not quotes.

What drives the premium

Data volume and sensitivity: how many patient, clinical, employee, and payment records the company holds, and whether that includes protected health information subject to HIPAA notification obligations.

Connected devices and software: a networked device or a SaMD product raises the exposure and usually pulls technology E&O into the program, which changes the pricing basis.

Security controls: multifactor authentication on all remote and privileged access, endpoint detection and response, encrypted and tested offline backups, email filtering, network segmentation, and a patch and vulnerability program. Underwriters price these directly, and missing controls can make coverage expensive or hard to place.

Revenue, contract-required limits, and claims history round out the calculation. Hospital and GPO contracts that specify a cyber limit often set the number the company must carry.

How to lower it

The fastest way to improve pricing is to close the control gaps underwriters ask about before going to market: turn on multifactor authentication everywhere, deploy endpoint detection, move backups offline and test a restore, encrypt data at rest and in transit, and document a written incident-response plan and a HIPAA risk assessment. A device maker that can evidence these at application time is treated as a better risk and prices accordingly.

The reverse is also true: applying without these controls is the most common reason a device company sees a high quote or a declination, so it is worth doing the security work before the submission goes out.

Cyber in the context of the whole program

Cyber is one line in a device manufacturer's program, alongside products liability, general liability, and, for connected or software products, technology E&O. Sizing cyber without confirming how it interacts with the products policy (specifically the bodily-injury and cyber-triggered-event exclusions) is where device makers leave a gap. The cost conversation and the coverage-architecture conversation belong together.

Primary sources

Sources and references

This answer draws on the following regulatory, statutory, and standards-body sources. Coverage availability and program structure also depend on carrier appetite and underwriter discretion not captured by these sources.

Related practice areas

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