Medical Devices & Digital Health
Medical devices are becoming more connected, intelligent and complex, expanding what they can do and the risks organizations need to manage. A product failure may no longer be purely a product liability issue. Software, cybersecurity, patient data, manufacturing and regulatory requirements can intersect, creating exposures that cross traditional lines of risk.
HUB’s Life Sciences specialists understand how these risks connect. We help medical device and digital health organizations build integrated protection around their products, technologies and operations, from established device portfolios to emerging connected and AI-enabled technologies.
Stay Ahead of Industry Challenges
As devices become more connected, risk becomes more interconnected
Medical device and digital health organizations manage exposures spanning product performance, manufacturing, technology, patient data and regulatory requirements. Understanding how those risks interact is critical to building protection around both established products and emerging technologies.
A medical device can create product liability exposure through alleged design, manufacturing, labelling or performance failures. The nature of that exposure varies considerably across device types, intended uses, regulatory classifications and commercial markets.
HUB evaluates product liability against the device portfolio, intended use, manufacturing model and distribution footprint to help structure coverage around the organization’s actual products and operations.
The insurance program should start with what the device does, how it is used and where it is sold.
Product liability protection aligned with the device portfolio and commercial footprint.
Connected devices bring cyber risk directly into the product environment. A software vulnerability or security failure can compromise patient data, disrupt device performance or affect clinical outputs, creating interconnected cyber, technology and product liability exposures.
HUB considers cybersecurity and technology exposures alongside product liability, helping organizations evaluate where software, connectivity, data and physical product risks intersect.
For a connected device, cybersecurity is part of the product risk conversation.
A more coordinated view of product, technology and data exposures.
Medical device organizations must manage manufacturing quality, regulatory requirements, suppliers and distribution alongside evolving technologies. Established manufacturers may also introduce new software, connected functionality or digital products into existing portfolios.
HUB assesses operational and commercial exposures across manufacturing, property, supply chain, regulatory requirements and distribution, with coverage designed around the organization's current operating footprint.
Risk changes as the product portfolio and technology change, not only when the organization reaches a new stage.
Protection that reflects the organization's products, operations and technology as they evolve.
Tailored Risk Solutions for Your Industry
Bring product, technology and operational risk into one view
Medical device and digital health organizations carry different risks depending on what they develop, manufacture and deliver. HUB considers the products, technologies, manufacturing model, data environment and commercial footprint together to help build an integrated program around how the organization actually operates.
Product liability is assessed against the device portfolio, intended use, manufacturing model and commercial footprint. Recall expense and intellectual property protection can also be considered alongside contractual and distribution exposures to help address risk surrounding the product itself.
Connected devices, embedded software and digital health technologies can create exposures across traditional product and cyber lines. HUB considers technology errors and omissions, cybersecurity and data privacy alongside product liability to help address how software, connectivity and sensitive information affect the broader risk profile.
Property, equipment, supply chain and other commercial exposures are assessed against the organization’s manufacturing and operating footprint. Employee benefits and workforce solutions can also support organizations competing for specialized scientific, engineering, technical and operational talent.
Industry Insights
Insights for medical device and digital health organizations
