Medical devices – what you are manufacturing can impact your insurance
May, 2011
If you’re a medical device manufacturer the type of product you manufacture can have a major bearing on the availability and cost of product liability insurance.
If your product is invasive then many insurers who ordinarily would be happy to offer a quotation would decline the opportunity. Insurers don’t like anything that enters the body and those that will offer a quotation will load the premium accordingly. They are many devices that are classed as invasive from those that merely pierce the outer tissue of the body or enter temporarily to deliver drug dosage to those that are permanently resident inside the body.
Drug eluting devices also present some difficulties. Typically these are stents and because this is new technology (within the last 10 years) Insurers are wary of the potential for claims. Also the type of drug administered and the circumstances in which the device is used will have a bearing.With growth of drug eluting devices many manufacturers have introduced coatings to improve the performance of their product. This can also have a impact on Insurers appetite to provide product liability insurance as their concerns relate to the biological response of the human body to the coating and again because this is new technology Insurers are wary of the potential for claims.
The type of material used to make your device can also have a bearing on the cost of insurance eg silicone. Insurers are paranoid about silicosis (especially in the US) and prolonged exposure to silicone. The development of new materials is crucial to the medical industry but with this comes the potential for claims which may take years to manifest.
So what can I do to mitigate the cost of insurance if my device falls into any of the above categories? It is crucial that you educate your insurance provider with all details relating to the history and development of your medical device. It is important that they understand all measures that are undertaken to prove both the safety and performance of your medical device.
If you are a medical device manufacturer and are having difficulty finding product liability insurance then please do not hesitate to contact me.
