Companies should be holistically thinking about risk management and not just “checking the box.”
Good risk management protects patients and users / caregivers.
Improve Patients Lives
Obviously, we’re all in this to improve patients’ lives so the thought of avoiding harming patients should be paramount in our processes.
From a business perspective, a device that causes harm can be extremely costly: financially through litigation and a company’s reputation (and small companies may be utterly devastated by either).
A solid Risk Management process will result in a product that is more reliable and easier to use.
One thing to keep in mind:
Can’t Eliminate Risk
We can’t completely eliminate risk; we need to strive to control it.
And we must decide how much risk is acceptable.
Never forget that we’re dealing with humans so we want to endeavor to control pain and suffering.
Life and Death
We also can’t forget that people using the devices are doing so for a reason.
Many times, they have a serious condition that needs treating, sometimes use of the device is a matter of life and death.
We’re going to take a longer look at scope but it’s a good idea at this time to make sure we have a common understanding of the terms used herein.