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Tips for Effective Risk Analysis in the Medical Device Industry

by Nicolle Cannon

In the medical device industry, managing and mitigating risk can be a challenge, but it is essential because the consequences of doing a sub-par job comes at great cost: time that’s better spent on developing a high quality product, money you didn’t plan on spending, and a reputation that takes years to build can be irreparably damaged within minutes.

To be effective, risk analysis must be conducted from start to finish; you need to take a holistic, connected approach; and it’s important to adopt the right tools.

Conduct risk analysis from beginning to end.

You have to begin risk analysis at the very start of the product design phase, and manage it through the manufacturing and distribution phases. Anything less than managing risk throughout the entire product lifecycle is to knowingly risk the health of your end users.

If you start risk analysis in the middle of product development, you are taking an approach that goes against the very definition of the term. Generally speaking, within the medical device, risk analysis consists of recognizing and addressing any factor that might hinder the ability to get your product to market. If you are in the midst of developing a medical device without doing an appropriate risk analysis, chances are high the product has a flaw. Even if you’re able to address it early on, it will still take longer than if you had conducted risk analysis from the very start.

To be effective, risk analysis must start at the beginning of product design and continue throughout the full product lifecycle.

Take a holistic, connected approach to risk analysis.

Connected risk analysis gives you a holistic view of risks and their potential impact. In the medical device industry, having this level of visibility isn’t optional.

There are four specific actions required for connected risk analysis: identify possible threats, estimate the likely impacts and the likelihood these threats will happen, and consider risk management options.

Identify possible threats: Compile data from throughout the organization, and use this information to develop a list of possible threats. Assess each item on the list, and determine whether or not they apply to your device.

Estimate the likelihood and impact: Calculate the likelihood and impact of each possible threat. It’s important to consider their impact to your organization, the device, the environment, and end users.

Consider risk management options: You can choose to manage risk in four separate ways: avoiding the risk, sharing the risk, accepting the risk and controlling the risk. Ideally, you want to avoid the risk, and with connected risk analysis you can put risk and compliance measures in place early in the product lifecycle.

Adopt a Digital Quality Management System

A digital quality management system (QMS) is essential to connected risk analysis because it provides you with a methodical approach to determining and managing risk. You also have the ability to track and analyze the recurrence of issues, which enables you to recognize and mitigate long-term, systemic risks. In addition, a digital, connected solution unifies risk-related activities and documentation.

Additional advantages of a digital QMS include the following:

  • When you start risk analysis, and need to gather data, it’s all electronically stored in a central location, and everything can be accessed quickly.
  • You don’t need to compromise quality and the risk-management process in favor of speed-to-market. By having an end-to-end solution, quality is built into every phase of the device’s life cycle. A higher degree of quality combined with effective risk management results in getting to market more quickly.
  • The tools you need to mitigate risk (e.g., CAPA management, design controls, audit management, supplier management, analytics and reporting etc.) are all in one place.

Conclusion

You need to use a consistent method to estimate and mitigate risk. Connected risk analysis helps ensure you use consistent processes to get a compliant, life-changing product to market on time or ahead of schedule. To learn more about connected risk analysis and how to carry out the steps mentioned above by using a digital quality management system, download the whitepaper.

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Cannon Quality Group (CQG) was founded in 2010 as a full-service outsourced quality management company serving the medical device, Medtech, pharma, IVDR, SaMD, and general life science community with right-sized quality management system solutions.

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