Downstream Effects of Inadequate Complaint Handling

July 24, 2022

Downstream Effects of Inadequate Complaint Handling

Getting a product to market is the number one goal of any MedTech startup. But the job isn’t over once that product is on the market—it’s just the beginning.

Post-market surveillance is a critical component of your product lifecycle, and how you handle those responsibilities will have downstream effects on both your business and the patients your devices serve.

As you receive feedback and complaints begin to trickle in, you have a choice. Do you focus on building out a streamlined, cross-functional process for handling those complaints and acting on them? Or do you put one person in charge of your entire process and hope that complaints reach the right people?

I hate to say it, but too many companies take the latter path. So, let’s take a look at what can happen when your complaint handling isn’t up to par.

BONUS RESOURCES: Click here to download 3 Free Templates for Managing Complaints, Nonconformances & CAPAs.

Why do medical device companies fail at handling complaints?

A lot of companies that fail at complaint handling just don’t have a good process in place to classify and evaluate complaints.

For example, some device companies will use a flowchart to classify different types of complaints depending on severity. There’s nothing wrong with that per se, but if you use a flowchart thoughtlessly, you can miss the less-obvious implications of a complaint. 

Let’s say you receive a complaint that the color on your device faded quickly—making it look different than a provider expected. You look at the flowchart and see that this feedback is  low-impact or no-impact. It’s just a little change in color—no big deal.

But if you stop there, without closely examining the consequences (or potential consequences) of a complaint, you may be missing the big picture. Because in this case, the faded color delayed a surgery, which cost the hospital $5,000. 

A delayed surgery isn’t great, but in this case, the patient who was supposed to get the surgery got an infection while they were waiting. And a “minor” complaint has now led to patient harm. 

However, if the complaint is still going into the lowest-impact bucket—because that’s what the flowchart says—then you aren’t accurately capturing the effects of the problem. If there’s no process for thoroughly analyzing and upgrading a complaint based on the results of that analysis, then you could find yourself in a situation where you think you’re dealing with some low-impact complaints that are actually having much more serious effects.

That failure to look past the flowchart is a failure in your complaint handling process, and it will have downstream effects. 

What are the consequences of a poor complaint process?

First and foremost, people can get hurt. Seemingly small problems with a device can have cascading effects when they’re ignored. 

You never want to be in a position where you’ve been accumulating “low-impact” complaints that you don’t act on with urgency, only to find out that the issue you ignored led to a debilitating illness or death. The ethical implications of that should be obvious. 

But this type of inadequate complaint handling process also puts you in the crosshairs of regulatory bodies. I’ve been in situations where FDA came knocking to examine our complaint process, and I can assure you it was not a fun experience. 

Depending on the complaints you’ve failed to act on, you could easily be looking at multiple 483s and even a recall. A warning letter from FDA is not off the table if you can’t provide adequate resolution to those 483s—and neither is the dreaded consent decree.

And when the dust clears, what can you trace your problems back to? The process you had in place to manage and act on complaints. 

How do you improve your complaint handling?

Fortunately, there are a number of ways you can make sure you’re evaluating and acting on complaints in a responsible manner. 

The most important step you can take is to create a cross-functional process for your complaint handling. Siloing your complaints personnel in their own department is a recipe for disaster.

Your complaints process should have a feedback loop that alerts quality and product development of any complaints so they can be properly evaluated. Sometimes, a complaint indicates that your device needs a change in design or materials, and that needs to be conveyed to product development as soon as possible. 

If an investigation shows the problem is systemic, that should initiate your CAPA process, which will involve everyone—product development, quality, manufacturing, and even marketing.

Finally, make sure that your engineers are encouraged to analyze complaints thoroughly and determine the root cause of what’s happening. If you’re just relying on a flow chart to tell you whether you have a problem, you may be in for a rude awakening down the road. 

BONUS RESOURCES: Click here to download 3 Free Templates for Managing Complaints, Nonconformances & CAPAs.

Greenlight Guru gives you the tools to upgrade your complaint handling

Every complaint is valuable feedback about your product, and that means all complaints should be given careful attention. 

And the best way to ensure they get that attention is by using dedicated complaint management software from Greenlight Guru. Part of our suite of post-market tools, our complaint management software streamlines your complaint processes by eliminating excess documentation and automating your quality event processes. You’ll also be able to assign complaint-related tasks to your team and track their progress toward due dates—making sure nothing slips through the cracks. 

If you’re ready to finally handle complaints in a compliant and safe manner, then get your free demo of Greenlight Guru today.


Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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