Risk management is one of the most important, if not the most important, aspects of working in the medical device industry. The industry’s main goal, after all, is to create safe products. How can risk management help achieve this? We turn to ISO 14971, a standard you will often see in the medical device industry. It defines safety as the “freedom from unacceptable risk.”
Risk management is present in all aspects of making a product, from start to finish. It has to be considered even when developing software. Imagine a self-driving car for which no one bothered to think about risks. You probably wouldn’t want to be in the same street as that car.
This article will discuss risk management for medical devices and what other industries can learn from the medical device industry. But first, let’s clarify some of the terms related to this industry.
What Is ISO 14971?
Talking about risk management within the medical device industry translates to talking about ISO 14971. In essence, the standard provides the requirements that manufacturers need to satisfy to launch a safe product. These requirements are mostly related to risk management.
ISO 14971 versus FMEA
Failure Mode and Effects Analysis (FMEA) is another term frequently used when discussing risk management in the medical device industry. It is a method that requires you to analyze how components and processes can fail and what such failures will lead to on the system level.
There are quite a few differences between risk management according to ISO 14971 and FMEA, but the two most important would be:
- Risk management is an ongoing process over the whole life cycle of the device. That means that you will continue to track and reevaluate risk management execution even after development is done and take the necessary actions accordingly. So, what is the difference between risk management according to ISO 14971 and FMEA in the medical device industry? ISO 14971 covers both the risks from regular use and those from fault conditions, whereas FMEA calculates only fault condition risks.
- FMEA looks at component and process step failures, which means you cannot start until reasonably late in the product development process. But ISO 14971 starts by looking at hazards or potential sources of harm. That means you can come up with the significant risks already before starting the detailed design of a product. And controlling risk early, as opposed to late, usually saves both time and money.
What Can Other Industries Learn from the Medical Device Industry?
Other industries, such as gadget manufacturing, can learn quite a lot from the medical device industry risk management. That includes thorough risk analysis and possible case scenarios to safety measures that minimize the damage, among others.
Some of the more essential things here include ensuring that people are trained in risk management and are not overlooking risk management, not even in software. Read on to learn what medical device developers pay attention to.
Know Your Stuff
Since risk management is required for all medical devices in all major markets in the world, the industry needs, by default, to be good at it. Because when it comes to medical devices, people’s lives are directly affected, and sometimes, it can even be a matter of life and death. Therefore, people who develop these devices must know their products inside and out. They have to calculate the risks and know how to manage and reduce them.
The word “must” is used purposefully here because being trained in risk management is not an option in the medical device industry. When regulatory bodies audit medical device manufacturers, the auditors will ask for records of risk management training.
This approach applies to other industries as well, even if they are not developing products that can directly put human lives in danger. Possible risks must always be calculated and reevaluated, and knowing your product inside out could help.
When There Is a Risk, People Can Die
Even if you’re not from the medical device industry, that does not mean that whatever you’re making does not put people at risk. And any risk means an effect on someone’s life. A child could choke on a small part of a device or eat a battery. A user could get electrocuted. Or, someone could run off a cliff with the car when the GPS wrongly tells them there is a road.
It is sometimes easy to hope for the best and go with the flow. Other industries might follow this thought, but the people in the medical device industry simply do not have that kind of luxury—they must always be on top of everything.
So, another essential thing other industries can learn is that no risk can or should be disregarded or overlooked. That way, you will know you did all you could, and you also have the documents to support that.
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To sum it all up, other industries can learn quite a lot from medical device industry risk management. Some of the more essential things here include ensuring people are trained in risk management and are not overlooking the crucial practice. That is true even for those developing software.
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