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Optimizing Root Cause Analysis In Medtech Manufacturing


In December 2021, a manufacturer of insulin infusion pumps received a warning letter from the U.S. Food and Drug Administration (FDA) following an inspection of its facility. Among the list of infractions included a damaged component on the device. The warning letter cited that the company “failed to adequately analyze all sources of quality data, failed to identify actions needed to correct nonconforming product, and you did not appropriately verify or validate the change to your device to ensure corrective and preventive actions taken were effective and did not adversely affect the finished device.”1

When a medical device fails to function as intended, the stakes can be high — potentially affecting patient safety and brand reputation and even lead to a recall. FDA and International Organization for Standardization (ISO) mandates apply to identifying problems discovered before distribution occurs, not just after. The intent behind these regulations and standards is to encourage organizations to detect, resolve, and prevent problems. In other words, companies need an effective root cause analysis process (RCA) in medical device manufacturing.

The FDA's Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.2

An established, integrated RCA methodology helps bring essential structure to the problem-solving process. This helps medical device manufacturers produce accurate reports for satisfying the regulatory requirements.

What Is Root Cause Analysis?

A root cause investigation is performed to determine the underlying cause of a nonconformance. The nonconformance can be the discovery of a product defect by quality assurance or from a customer complaint after the product is on the market.

In medical device manufacturing, malfunctions can be difficult to resolve. Often the approach is to quickly implement a solution based on an assumption of the cause. If the core issue of the malfunction is not clearly understood and addressed, the problem will likely recur. It's important to thoroughly investigate and identify the underlying cause of the issue. This process involves completing a problem statement to identify the following:

  • What happened?
  • When did it happen?
  • Where did it take place?
  • Who was involved?
  • Why did it happen?
  • How did it happen?

To find the answers to these questions, complete the following steps:

  • Examine the device design, manufacture, and instructions for use.
  • Identify potential causes of the failure.
  • Analyze the potential causes until the root cause is discovered.

Organizing your process in a checklist fashion helps keep you organized and on task. Still, identifying the actual root cause of an issue in medical device manufacturing is challenging. There is often a sense of urgency in finding and resolving the problem. With more intricate systems, one troublesome aspect is that the root cause can actually set off a combination of events. Moving at a faster pace to resolve the issue often leads to taking shortcuts and potentially misinterpreting the causes. This can result in faulty conclusions and resolving the wrong issue.

Your medical device root cause investigation must adequately probe the sequence and interaction of events that led to the malfunction. Even when you think you've identified the root cause, consider further evaluation to ensure you have identified the specific root cause.

While the primary goal of a root cause investigation is to understand exactly why an issue occurred, it can also provide an excellent opportunity for improvement. You may be able to discover ways to apply root cause analysis examples from one point along the life cycle of a product, say in its design, that can be useful in identifying other root causes at another point, perhaps in a manufacturing process.

Mastering Root Cause Analysis In MedTech Manufacturing

To be more confident with your decisions with root cause investigation, gather compelling data before ruling out a potential cause or declaring that the root cause was discovered. Conduct controlled experiments and use statistical analysis when needed. Avoid over-interpretation of data and conclude only what the data supports. Conclusions can rarely be made with absolute certainty. Seek strong evidence to make sound decisions.



David Jensen is a content marketing specialist at MasterControl, where he is responsible for researching and writing content for web pages, white papers, brochures, emails, blog posts, presentation materials and social media. He has over 25 years of experience producing instructional, marketing and public relations content for various technology-related industries and audiences. Jensen writes extensively about cybersecurity, data integrity, cloud computing and medical device manufacturing. He has published articles in various industry publications such as Medical Product Outsourcing (MPO) and Bio Utah. Jensen holds a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.

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