The Ins and Outs of Risk Management for Medical Device Manufacturing

Risk management is one of the most important parts of the manufacturing process when it comes to developing safe, effective, and beneficial medical devices. Your company needs to implement risk management at all levels in order to create the kind of products consumers and regulators want, which shows just how necessary the process is.

The ins and outs of risk management for medical device manufacturing are detailed below and should be a concept you memorize from bottom to top in order to ensure the success of your company and its products.

Understanding Risk Management

Risk management is the careful and methodical implementation of every process and practice necessary in order to investigate, control, and monitor the possibility for risk in your products.

Risk Management is Necessary.

The reason risk management is so important is threefold:

  • Consumers want to know that products are safe and manufacturers have done everything possible in order to remove minimal to extreme risk factors from their production of the device.
  • Regulatory bodies like the FDA, the CEN, and the IMDRF all work to evaluate and eradicate risk as much as possible in medical devices, and these groups oversee your manufacturing processes in order to ensure that analysis of risk.
  • You want to be able to confidently state that your products are safe and beneficial as opposed to being uninformed or supplying false information.

Also you will want to take risk management into account at a high-functioning level because, without it, your products could be recalled, which will lead you to lose marketing opportunities and be forced to start over anyway to create a safer product. While recalls do occur with even the most carefully managed products, you can avoid possible issues from the beginning, making these setbacks less likely.

Risk Management Should Be a Constant Operation.

While some companies choose to evaluate risk only at the beginning or the end of their manufacturing process, the best way to create a powerful risk management system is to start from the beginning and continue analyzing and minimizing risk throughout the process.

  • Start with design. When your team is in the idea stage, make sure that any possible risk can be eradicated from the design as much as possible before the device is even approved for manufacturing.
  • During the manufacturing process, create a risk management plan so that each step of the manufacturing process is as safe as possible.
  • Every time something about the product is changed, whether it is a design modification or a manufacturing adjustment, run a risk analysis and try to minimize any issues as much as possible.
  • If a product is recalled, make sure to revisit all of your risk management processes to discover what you’ve missed.

There should never be a point where you are finished with risk management of your medical devices. Because these products are so meticulously regulated and have such a high possibility for risk, it is important that your risk management program be as thorough and robust as possible.

Risk Management Should Be Properly Planned.

When you choose an approach for your risk management program, it should be one that works best for your company specifically, is understood by all your employees, and can be explained to inspectors who will need to know the process. Some of the more popular examples of risk management processes are:

  • Failure modes and effects analysis (FMEA)
    • FMEA starts from the bottom and works up. It works by allowing the manufacturer to review every component of a product’s manufacturing process in order to evaluate risk.
  • Failure modes, effects, and criticality analysis (FMECA)
    • FMECA is an extension of the aforementioned process and implements charting of possible risk and the consequences of such.
  • Fault tree analysis (FTA)
    • This analysis starts from the top down and allows manufacturers to understand all the ways their systems might possibly fail.

Of course, you may always create your own risk management process, borrowing from the ones listed above. This can help in establishing a process that is specifically beneficial to your company, taking into account any interests therein.

Risk management is absolutely necessary for any manufacturing company, but understanding how, why, and when to do it is just as important. Knowing the details of this process will allow you to create quality devices and protect your company from possible setbacks as well as consumers from unsafe products.