How To Reduce & Prevent Medical Device Complaints

November 13, 2014


Congratulations! You have successfully launched a new medical device after months and months of product development and extremely hard work.

Now get ready to receive medical device complaints.

Don't think that your device will have any complaints? Maybe.

But when was the last time you reviewed what a medical device complaint is?

As a reminder, here is the definition of "complaint" from FDA 21 CFR 820.30:

Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

That definition is VERY broad. Your company must establish complaint handling processes. I encourage you to define what is / is not a complaint for your company and document this in a procedure.

So what's the big deal about complaints?

In the event that your medical device company has a FDA inspection, I guarantee the inspector WILL review your complaint files.

In every FDA inspection I've been part, the FDA inspector spent a significant part of the visit just reviewing, evaluating, and analyzing complaint procedures, files, and records.

Depending on how well the company was documenting complaints determined how much time and scrutiny was devoted to the topic.

The best way to reduce FDA inspection time on complaint handling is to have a thorough and robust process with rock solid complaint files, documentation, and records.

Actually, getting a handle on complaints will make the rest of your FDA inspection go much, much more smoothly too.

But you just launched your product. Why in the world would there be any complaints about your new, exciting medical device?

In all my medical device product development experiences, there was nearly always a crazy rush to get through development and into the market. And the last few weeks of development are hectic.

Everyone within the company starts to become aware of how imminently close you are to a launch. You work hard to make sure everything is perfect before pushing into production and the marketplace.

Finally, you officially transfer your device out of development and into production. But you have these feelings that there might be some things you forgot.

Actually, you likely had these feelings throughout a significant part of product development.

You review your product development and Design Control checklists. You do one last overview of Risk Management records.

Your reviews are somewhat reassuring.

The product is as ready as it's ever going to be. Flip the switch. Pull the trigger. It's time to sell.

Months pass, and you keep tabs on the product's progress. You start to notice that there are some complaints coming in. Some of the complaints seem trivial.

You dismiss those things, believing that users will eventually learn the proper techniques and nuances of your product. But these trivial things are happening over and over.

Why? Is there something you could have done to prevent these complaints from happening?

Tough questions to answer.

And yes, I contend that there are things you can do before the launch of your medical device to reduce and prevent medical device complaints.

The major issue we have as medical device product developers is that we often times get tunnel vision.

We are aware of all the things we have to do during product development--Design Controls, 510(k)s, Risk Management. We are driven and focused on getting the product ready for launch.

We are NOT focused on post-product development. We do NOT consider what could happen once the product is in production and being sold and used.

But for us to develop better products and reduce (and hopefully prevent) post-development product issues, we have to look into the future. We have to bring this line of thinking into medical device product development.

corrective and preventive action CAPA for medical devices PDF download

Jon Speer is a medical device expert with over 20 years of industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to True Quality.

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