The Importance of Risk Management in Medical Devices

My first day as a medical device engineer changed my life.

I started the day excited about a new job, but with no particular understanding of the gravity of that job. As I watched one of the training videos, it began to hit me. Like most who work in the medical device industry, I had a moment of clarity about the importance of my job.

The devices I designed and developed could one day be used by my mom, my sister, my kids…one day I might need to use one of these devices.

If you’re working in medical devices and haven’t had this moment yet, it might be time for a gut check.

Risk and Medical Devices

The dictionary definition of “risk” is the possibility of loss or injury. We do things every day that are extremely risky, like driving our cars. We don’t think about it, though, because the benefit of driving a car outweighs our belief that it will ever backfire on us.

The definition of risk in relation to medical devices, per ISO 14971 is the combination of the probability of occurrence of harm and the severity of that harm.

Nothing is foolproof. Everything–including medical devices–has risks. But one of the most important tasks of a medical device engineer is to identify, evaluate, analyze, assess, and mitigate potential product issues.

Another Perspective

Think of it from the patient’s point of view. Like most of us with our cars, patients have an inherent trust in the medical devices they use. They usually have full trust in the clinicians and don’t question the safety of their devices.

For this reason, it is our responsibility to think about safety and risk management for them. Risk Management isn’t just a step in the process; it’s a total life-cycle product process. From beginning to end, medical device engineers must keep risk in mind.


And check out the infographic below to see the risk management process from beginning to end as it directly corresponds with ISO 14971.

(Click infographic to enlarge.)iso-14971-risk-management-process

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