Medical Devices Insurance - What you should know.

Medicine is innovating fast! Technologies, medical devices, medical products, and even AI is quickly changing the way care is administered to patients.

This is an exciting time in the advancement of new medical interventions, but with this comes a responsibility to ensure that manufacturers, researchers, and developers are taking every necessary precautions to ensure that these solutions are safe for use and serve its intended primary purpose.

Today, Servca explores important coverage aspects that should be considered when arranging a robust coverage for medical devices and products.

Please note that this article is intended to serve as value-adding information, and you should consult with a professional when taking steps in arranging cyber liability protections.

What is a Medical Device or Product?

A medical device refers to any instrument, apparatus, machine, appliance, implant, software, material, or any other similar product intended to be used (in isolation or combination) for medical purposes for humans.

While there is a vast and varying array of medical devices that have different purposes, the below examples demonstrate some of their typical uses:

•  For the diagnosis, prevention, observation, treatment, or improvement of the disease.
• For the diagnosis, observation, treatment, improvement of an injury.
• For the investigation, substitution, modification, or assistance of the body (and organs) or a physiological process.
• supporting or sustaining life.
• disinfection of medical devices
• aids for people with disabilities
• For analysis and examination of specimens that have been derived.

Importantly, medical devices do not accomplish its key intended actions by pharmacological, immunological, or metabolic means, but which may be supported in its function by the aforementioned means.

What Are Some Important Coverages to Consider When Arranging Insurance?

Since Medical Devices play an important part in patients' health, treatment, and diagnosis, many exposures need to be considered from an insurance policy perspective.

While the apparent exposure is the failure of the device or product (which can lead to patient harm), Servca explore other significant exposures to consider when arranging a suitable policy:

1. Products Liability Coverage.

As I have mentioned, a medical device can fail to perform its intended use. When this happens, there may be harm caused to a patient (medical malpractice).

For this reason, the products liability coverage section within a policy is essential to ensure that compensations are made available to claimant parties as a result of a defective product or device. A defective device or product can also include mislabelled or contaminated products.

2. Professional Indemnity Coverage.

Professional indemnity coverage will protect manufacturers and distributors from any negligent acts or errors, including the costs associated with the failure to fulfil contractual obligations.

Furthermore, there is a training process for the correct use of certain devices for many medical devices, and the PI is an essential coverage if training is not adequately delivered, which results in a claimable adverse outcome.

The PI portion of the policy will also cover any costs and expenses incurred in manufacturers and distributors' defence.

3. Recall costs Coverage.

When there is an identified defect, contamination, or error in labelling of a medical device or product, it may become necessary to recall all the devices that have been distributed. Recalling devices and products can be a costly and unanticipated expense.

4. Stock & Transit Coverage.

If stock or materials is transported (or distributed), this cover protects against the devices and products being lost, stolen, or damaged during the loading, unloading, or transportation. Importantly the Coverage should also apply at fixed locations and protect against both material damage and business interruption.

5. Property Damage & Business Interruption Coverage.

Suppose there is substantial property damage whereby a manufacturer of medical devices cannot be produced and cannot be effectively distributed. In that case, the property damage coverage can protect the costs of repairing the damage, and the business interruption can help in continuing to pay for staff if there is a loss in income.

6. Clinical Trials Coverage.

The clinical trial phase is when the research and development process is conducted to ensure the safe use of medical devices and products. Policies implemented need to provide protection against the costs and expenses in the event of injury to a research subject during a trial.

7.  Appropriate Jurisdictional & Territorial Cover.

If medical devices are being distributed and used internationally, it is essential to make sure that the policy triggers representing claims in the respective territories.

Summary

With most things within the medical sector, there's always a grey area to consider – is there a potential for subrogation claims through medical malpractice? Can a medical device cause harm to a patient with unknown underlying complications or illnesses?

While many medical device policies are generic (and specific) from insurers to insurers, it is vital to ensure that the representing broker you are working with has a firm understanding of medical devices and products and can challenge and supplement coverages.

As a specialist, Lloyd's broker in Healthcare, Servca, strives to challenge the norm of what excellent service should be. We feel it is our duty to advise and highlight critical concerns to our partner brokers and clients so that no stone is unturned or overlooked.

If you want to learn more about the specialist approach Servca take with Medical Device, Medical Products, Dietary products, Clinical Trials & Dietary Products insurance, give Dr. Edwin Rajadurai a call or get in touch today by clicking here. https://retail.servca.com/get-in-touch