Medical Robotic Devices Insurance
Insurance advice for businesses that design, manufacture, import, distribute, integrate or support robotic and computer-assisted medical devices.
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Tell us what the robotic device does, who uses it, where it is sold and the services your business provides.
Why specialist cover matters
A robotic device combines product, software and clinical risk
A conventional product-liability policy may not fully reflect the exposures created by robotic medical technology. A single incident can involve hardware performance, software logic, sensors, control systems, user training, maintenance, connectivity and clinical decision-making.
We review both the physical injury exposure and the potential financial loss where the system fails to perform as promised but no bodily injury occurs.
Product injury
Alleged malfunction, unintended movement, loss of control or component failure can lead to serious bodily injury claims.
Software & control logic
Programming, updates, interfaces, sensor inputs and algorithmic functions can affect how the device behaves or the information it provides.
Training & services
Installation, commissioning, user training, maintenance and technical support can create professional-services exposures separate from the physical product.
Regulatory risk profile
Classification depends on intended purpose and potential harm
In Australia, programmable and software-driven medical devices are treated as active medical devices. Classification is risk-based and depends on factors including intended purpose, how the device is used and the potential consequence of failure. More than one classification rule can apply to complex multifunction devices, with the highest applicable classification governing the device.
Insurance programme
Cover areas we consider
| Cover | Why it can matter |
|---|---|
| Products liability | Bodily injury or property damage allegedly caused by the robotic system, hardware, components or accessories. |
| Product & services E&O | Pure financial loss from failure of the device or related services to perform as intended, where expressly insured. |
| Professional indemnity | Design, integration, installation, training, maintenance, calibration or other professional services. |
| Product recall | Specified costs associated with locating, withdrawing, transporting, testing or replacing affected devices, subject to the policy trigger. |
| Cyber | Connected devices, remote support, software updates, network compromise, ransomware, privacy and security incidents. |
| Clinical trials liability | Participant injury exposures where the company sponsors or undertakes insured clinical investigations of the device. |
| Property & business interruption | Prototype equipment, test rigs, stock, demonstration units and interruption following insured physical loss. |
| Marine transit | High-value robotic equipment moving between manufacturers, hospitals, demonstrations and service locations. |
| Management liability | Directors, employment and corporate-management exposures relevant to growing medical technology businesses. |
Software and cyber
The software cannot be separated from the machine
Robotic systems may depend on embedded software, external applications, hospital networks, imaging systems, cloud services or remote diagnostics. A software error can therefore become a product-liability, E&O or cyber event depending on what happens.
- Embedded and externally hosted software.
- Remote connectivity and vendor access.
- Software updates and patching responsibilities.
- Sensor and imaging-system interfaces.
- Data integrity and patient information.
- Cybersecurity controls and incident response.
- Responsibility for third-party software and components.
Human factors
Operator error does not automatically remove product exposure
Robotic medical devices are often used by trained clinicians, but claims can still involve allegations about interface design, warnings, instructions, training, ergonomics or the way the system responded to user input. Insurance should therefore examine the boundary between product defect, user error and the manufacturer’s or distributor’s services.
Where the business trains clinicians or provides onsite technical support, those services should be specifically considered rather than assumed to be incidental to the product.
Claims scenarios
How losses can arise
Unexpected robotic movement
During a procedure, a system allegedly moves outside the commanded range and a patient is injured. The claim may involve hardware, software, calibration and operator training.
Software update error
An update creates an intermittent fault that forces hospitals to suspend use of the system while devices are inspected and corrected.
Integration failure
A hospital alleges that an interface between the robotic system and its imaging platform fails to operate as specified, causing delay and financial loss without bodily injury.
Medical-device trials
Clinical investigations need separate review
Where a robotic device is undergoing a clinical investigation, the risk depends on the device, procedure, patient population and the company’s role. Clinical-trial liability should not be assumed to be included simply because the business already holds products liability.
We consider whether the company is manufacturer, sponsor, Australian sponsor, investigator-support provider or another contractor, and how participant injury and contractual responsibilities are allocated.
What insurers will ask
Preparing a robotic-device insurance submission
- Device description, intended purpose and Australian classification.
- Whether the device is diagnostic, therapeutic, surgical, rehabilitation, assistive or another robotic system.
- Level of autonomy and the role of the clinician or operator.
- Hardware, software and third-party component responsibilities.
- Whether the business is manufacturer, importer, distributor, sponsor or service provider.
- Countries of sale, with US and Canadian exposure identified separately.
- Annual sales, installed base and maximum value per unit.
- Installation, maintenance, calibration and training services.
- Cybersecurity architecture, remote connectivity and software update controls.
- Clinical investigation history, adverse events, recalls and previous claims.
- Key customer contracts, warranties, indemnities and requested insurance limits.
Common questions
Frequently asked questions
Is robotic medical equipment automatically Class III?
No. Classification depends on intended purpose and the applicable TGA rules. Some high-risk functions may fall into Class IIb or Class III, while other active devices can be lower classes.
Does product liability cover a software error?
It may respond where a covered product defect causes bodily injury or property damage, but pure financial loss and technology-service failures can require E&O or professional indemnity cover. Cyber events may engage a separate cyber policy.
What if the hospital misuses the system?
That does not necessarily end the manufacturer’s exposure. Allegations can still concern warnings, instructions, training, interface design or whether misuse was reasonably foreseeable.
Do servicing and maintenance need to be disclosed?
Yes. These activities can create their own liability and should be included in the business description and insurance review.
Specialist medical technology insurance
Insurance for the product, software and services behind the robot
Mercantile Insurance Brokers can review your robotic device, contractual responsibilities, markets and services and structure cover around the complete exposure.
Request a robotic-device insurance review
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