Why compliance is not good enough

Although reducing risks for medical devices is an element of product liability risk management, reducing risks for medical device manufacturers is the ultimate objective. With so much riding on the product development pipeline, what can manufacturers do to ensure a successful launch and healthy return on their investment? We argue in this editorial that the operating environment for the medical device industry is so dynamic that compliance is not enough. Instead, we suggest that risk abatement must become a part of a medical device manufacturer's operating strategy. We outline a robust risk abatement strategy involving corporate cultural changes, scenario modeling tools, and implementation systems.