Quick Tip: Safety is important but not the only objective for risk management
Risk management in the business context is more than medical device safety.
In the medical device and pharma industries, risk is generally associated with harm to patients. Regulatory agencies expect the benefits of a medical product to outweigh the risks associated with its use before it can be considered as safe and effective. As a result, the dominant view of risk in the medical device world is that risk needs to be controlled and minimized for patient safety and regulatory compliance.
But risk also means opportunity. “No risk, no reward”, is a often invoked as a mantra to encourage achievement, especially in business. Sometimes the highest risk maybe the one you did not take when it was worth taking! Risk, therefore, can be perceived both as a negative force to be avoided, or as a positive force to be leveraged.
Risk practitioners should broaden their perspective to help achieve business success.