Medical Technology Insurance

This trade covers technologies that collect, store, display or transfer clinical and healthcare-related information or software that can be used to interpret data for the purpose of diagnosis, cure, mitigation, prevention or treatment of a disease or condition.

Please explain to us:

• What is the software designed to do and for whom?
• What is the intended function of the insured’s software/hardware and what would happen in the event it failed?
• Could a software failure have an impact upon patient safety/health/well-being?
• Is the software bespoke or off-the-shelf?
• What testing and sign-off procedures are in place?
• Who are the insured’s customers?
• How does the insured manage their contracts? What is their liability capped at, and do they exclude consequential losses in their terms and conditions?
• What cyber controls are in place to ensure the insured does not encounter a breach of security?
• What type and how many records of personally identifiable information (PII) information is kept?

Please provide details of the insured’s largest three contracts and a copy of the terms and conditions.

This trade sector is aimed at devices or products that aim to treat, diagnose, prevent or monitor illness and disease in humans or animals.

Please explain to us:

• What products are being supplied?
• What is the class of the products being supplied?
• What are the consequences of a product failure – worsening health/death?
• Who is the device or product sold to/used by; i.e., direct to patients or medical professionals?
• Are the products made/supplied to the insured’s own design or to a customer’s specification?
• What quality controls are in place?
• What quality standards are the products manufactured to?
• If the insured does not manufacture, who are they sourcing the products from, do they hold their own products’ liability insurance, and are all rights of recourse still intact?
• Does the insured have a product recall plan?
• Does the insured have details regarding traceability of the products?

This trade sector is aimed at the provision of services that aim to treat, diagnose, prevent or monitor illness and disease in humans or animals. An example would be contract research organisations.

Please explain to us:

• What work is the business doing and for whom?
• What are the financial implications if the insured services are not provided to the standard required?
• Could bodily injury arise as a result of the insured’s failure to deliver their service?
• How does the insured manage their contracts? Does the insured seek to cap their limit of liability and do they exclude consequential losses in their terms and conditions?
• What cyber controls are in place to ensure the insured does not encounter a breach of network security?

Please provide details of the insured’s largest three contracts.

This trade covers companies that are involved in research and development of biotherapeutics.

Please explain to us:

• What are the insured’s activities?
• What is their annual R&D spend?
• What revenue streams does the business rely upon to fund their research?
• Any R&D property stored in a controlled environment?
• Does the insured have any specialist facilities such as clean rooms? If so, what is the specification? Is the insured’s research dependent upon any one key item of laboratory equipment? What are the replacement lead times of such equipment?
• Does the insured have a tried and tested business continuity plan (BCP)? Is the insured able to supply a copy?
• What is the biohazard classification of the research being undertaken? What health and safety precautions are in place to protect laboratory staff?
• How does the insured manage their contracts? What is their liability capped at, and do they exclude consequential losses in their terms and conditions?
• What cyber controls are in place to ensure the insured does not encounter a breach of security?

Please provide details of the insured’s three largest contracts. Note we do not cover clinical trials.