IT Services & Solutions Blog

Could Customer Complaints be a Gift? MDM Complaint Management

By: Stephen Booze | Published on: November 16, 2018 | 2 minute read

We’ve all heard the customer service maxim that “complaints are a gift,” but that is a present that you want to receive as seldom as possible. It’s an unavoidable scenario in the best of circumstances, so you must have a planned management approach to handling it properly when it does arrive. When you’re talking about medical device manufacturer complaints, understanding and planning for the different types can have huge ramifications beyond a single incident.

If you’re a medical device manufacturer (MDM) customer support leader, it’s all about quickly recognizing the different types of complaints and applying the right management approach for risk mitigation. Here’s an important customer service primer that tackles three areas of managing complaints based on their type.


1. Understanding the Difference Between a “Big Gift” Complaint and a “Small Gift” Complaint.

While they’re both important, a “Small Gift” complaint” might seem to be something that is more easily handled such as standard billing discrepancies or insurance issues. Although these types of “Small Gift” complaints aren't necessarily considered complaints by the FDA, they can still require delicate and specific handling based on the customer’s attitude to de-escalate and resolve the situation. To do this requires a complaint management plan that takes into account the following ways in which it can be received:

  • Telephone
  • Email
  • Social media
  • Other channels


The Institute for Customer Service has a great approach to handling complaints and setting up a process for doing so that is all about ensuring positive resolution and improving the customer experience.


2. Defining and Dealing with “Big Gift” MDM Customer Complaints

Medical device management (MDM) complaints that are directly related to a device in terms of its performance and use is definitely a Big Gift” kind of complaint. We know that because of the FDA definition of complaint handling for CFR 820.198, CFR 803, and the more sweeping CFR 820. 

Here is where the rules about what information must be captured and how it is maintained per the regulations are very clear and must have an MDM management complaint approach that ensures it’s done correctly. But what tools do you provide your customer support personnel to ensure that process is done correctly and efficiently?


3. “Big Gift” and “Small Gift” Complaints Require the Proper Tools for Effective Management

Regardless of the type of complaint, your MDM customer service advocates must have the right tools that follow the management guidelines to ensure proper capture and resolution of the complaint for the best customer experience outcomes. That requires the following aspects of a computer system and software be put in place:

  • Well designed for intuitive and efficient use by customer service advocates to reduce customer friction
  • A system designed specifically for medical device complaints to ensure specific and detailed information capture


4. The Right Tools and Management Approach Must be Part of a Holistic Approach to MDM Customer Service Complaints

The FDA regulations for handling MDM complaint capture and reporting where a medical device has caused serious injury or malfunction are understandably strict. For your customer support team to meet those standards in what is likely a stressful and emotional customer encounter requires the computer system be capable of the following:

  • Easy creation of report execution
  • Clear data structure for easy input into BI and analysis tools for tracking and design modification considerations
  • An ability to meet all FDA regulations for data capture for the potential auditing that is clear efficient and complete.


While there are common complaint management processes that apply to areas of the MD sector, there are also highly specific needs that also must be met with very specific management processes and systems. It can certainly be true that customer complaints can be a gift to a company, but that is only true if they have the management processes and systems in place to properly handle and learn from each complaint. That’s the key to customer service excellence that results in receiving fewer of those gifts as time goes on.

Picture of Stephen Booze

About the Author - Stephen Booze

Stephen Booze is the VP of Digital Innovation for Solugenix where he supports the company’s mission of providing services, talent, expertise, and technology platforms that increase operational efficiency, performance, customer service and sales fulfillment.

 Tags: customer service, Customer Experience, customer support, medical device manufactures complaints, risk mitigation, CFR 820.198, CFR 803, MDM, complaints, FDA, CFR 820

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