Quick Tip: When developing new medical devices, optimize both benefits and risks
Consider the available state of the art, stakeholder expectations and unmet needs of patients when developing new medical devices that can be considered both safe and effective.
Risk practitioners in the medical device industry focus mostly on identifying and controlling risks associated with their devices. There is good reason for that, because we want to make sure our devices are safe and do not cause avoidable harm to patients.
But safety is not an absolute measure. It depends on the balance between benefits and risk. A single-minded focus on risk tends to undermine the benefit side of the safety equation.
To be considered safe, benefits from the intended use of a medical device must outweigh the residual risk. But by how much? How do we know when we have optimized the benefit-risk balance for our intended patient population?
New product development is not easy. It involves a considerable amount of decision making and trade-offs to optimize the cost and time of development. We don’t want to build features in our medical device that are not clinically meaningful to patients and physicians. At the same time, we don’t want to overdesign our devices to minimize risk far below the tolerable level.
It is helpful to review the available state of the art, stakeholder expectations and unmet needs to target an optimal benefit-risk balance.
