To decrease the possibility of failure, medical device companies must employ critical thinking, risk process point analysis, and control measures.

Walt Murray

In the medical device industry, the life cycle for risk assessment as it relates to product development is a subject that is commonly misunderstood. A proper risk management process focuses on the analysis and treatment of risks and increases the likelihood of success and decreases the possibility of failure for medical device companies, which makes it one of the most important processes in the product life cycle.

To be successful, companies must consider three different levels of risk assessment.

The first level that is most often looked over by highly regulated companies is critical thinking. This type of thinking is very important and should be applied throughout the entire life cycle, especially in the development component of the product life cycle.

The second level is risk process point analysis. This is an understanding of how to move in and out of the risk management process at the appropriate points where certain processes are met. For example, an immediate action that must be done at the beginning of the product development life cycle is to conduct a products hazards analysis. In doing so, a person or group will lay the foundation for understanding the intended use of a product and how it can create risks or pitfalls at the endpoint of its application.

The third level is the outcome in the form of control measures and triggers related to when and how to address risks.

While there are three different levels of risk assessment companies must consider, it is equally important to understand processes that do not necessarily work well. There are certain things which, by virtue of their application, create risk in the product development life cycle. Two common mistakes companies make is groupthink and using risk assessment tools without a set process. The latter will result in discovering data and not having a process by which that information can be used for assessment, understanding of data and application.

Walt Murray, CLA, CSSMBB, is CEO of ARC Experts and a member of MasterControl's quality and compliance consulting  services team. 

[image courtesy of JSCREATIONZS]