Risk management is certainly a buzz topic in the medical device industry. And with good reason. Devices should be designed and manufactured to reduce risks to patients and end users. Risk management should be comprenhensive, cross-functional, and throughout a product’s lifecycle:
(figure above from ISO 14971:2000)
The above figure does not explicitly state that risk management should be addressed from the perspective of design and the manufacturing processes. However, a solid, robust risk management process must address risks from all perspectives of the medical device. And these activities must not be done in isolation.
Design, manufacturing, and use risk management activities are led by different functional groups. Often, these groups are adversarial and unwilling to cooperate and support one another. If these various functions do not work together and support one another through risk management activities, then the essence of risk management is lost and patient safety could be compromised.