During the past few years, one topic that has really stuck out in the industry is medical device complaints.
Complaints are often controversial and definitely misunderstood.
Complaints are viewed as negative.
Medical device companies seem to want to avoid complaints because of the negative stigma.
Yet I think “avoid” is the wrong verb in this case. I think companies actually want to ignore them.
You know as well as I that ignoring something does not mean it will go away.
And ignoring medical device complaints is not a good idea.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Instead, you need to figure out two things:
- What can you do to reduce the number of complaints?
- What can you do to manage and embrace complaints?
Reduce Complaints
Based on FDA 483 observations for FY 2014, over 10% issued relate to medical device companies.
And this has been a common statistic for the past few years.
Complaints consistently represent one of the top three areas medical device companies receive 483 observations.
The number one source and contributing factor to medical device complaints is your company’s product development and Design Controls practices.
Design Controls are intended to be a framework and foundation for your medical device product.
By spending time going through and documenting Design Controls in a thorough and methodical way, you will improve your product design and you will reduce the number of complaints.
The Design Control Mad Dash
You see, here’s the problem:
There is always a mad dash to get your product to production and to the market. A dash that only seems to accelerate once you get FDA clearance.
Those last few steps are often rushed and haphazard.
However, had you done more homework up front, your product would be better ready for the market.
It’s the common mad dash that I’ve experienced many times.
Sometimes you get away with it. Often times it will come back to bite you later.
Manage and Embrace Complaints
When you receive a complaint, embrace this as an opportunity to get better.
This is a chance to learn about an issue with your product and figure out what you need to do to improve.
Listen to what the user is telling you. Work to identify the root cause.
And fix it!
Medical device complaints are a reflection of your product and your company.
No one asks for product complaints. Yet every medical device company is going to receive a complaint or two about their products. It’s inevitable.
So learn to manage and embrace them productively.
No Band-Aid Fixes
It’s pretty easy to just slap a band-aid on a complaint. Or worse, sweep it under the rug.
I have heard the explanation “. . . aw, the end-user made a mistake . . .” or some variation of this so many times before.
Newsflash: When a user has an issue with your product, it usually is not a user error.
And if it is, then you need to spend a little bit of time understanding how a user can make such an error with your product.
What if you could design the product in such a way so the user error isn’t possible?
Use this as an opportunity for you and your medical device company to get better.
Photo: Flickr user Sybren Stüvel
