Deciphering Fda Medical Device Design Guidance Documents

Deciphering FDA Medical Device Design Guidance Documents

What Can a New Medical Device Design Customer Learn From the New FDA Guidance for Human Factors?


A few weeks ago, we wrote about medical device design best practices as a consideration for anybody with a new medical device design seeking a company to help them move their innovating products “from concept to commercialization.” There are many ways processes by which a medical device design company develops their best practices—it can be through their own experiences and expertise, or it can be driven by design control practices (such as ISO 13485) and guidances (such as those published by the U.S. Food and Drug Administration).


Because getting FDA approval is a crucial step in commercializing a new medical device, it would be foolish to ignore any new guidances—if for any other reason, doing so can come at the peril of delaying a new medical product’s launch. Although guidance documents might be perceived merely as suggestions and recommendations, the reality is that they are highly qualified instructions that should inspire medical device development companies to more closely examine best practices that result in safer and more effective medical devices.


Recently, the FDA published a new guidance document, Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff. As the title suggests, it’s very technical reading and doesn’t offer much for somebody that is in the market for a medical device development company. Rather, its intended for companies like DeviceLab to evaluate and integrate into its policies, procedures and practices.


And rather than examining the document from the “insider” perspective of a medical device design company—which was very well done in the Med Device blog Final FDA Human Factors Guidance: 10 Updates That Affect Your Validationwe want to decipher some of its key features so that you can further prepare yourself to find the best medical device design company for your innovation.


What are Medical Device Human Factors?


This question is perhaps the best place to start. After all, what exactly are “human factors,” and why are they being discussed in a medical device guidance?


Most simply, medical device human factors are anything that relates to how somebody interacts with a medical device. They can include:

  • Controls
  • Displays
  • Packaging
  • Product Labels
  • Instructions for Use


In other words, human factors are anything that you need to see, touch, hear or understand in order for a medical device to perform its function(s).


Design Failure Hazards vs. Use-Related Hazards


Usability engineering (UE) is perhaps the primary reason why you would select one medical device company over another. After all, you want your device to actually do what it’s supposed to do, so you naturally want to find a company that can fulfill your vision.


However, at least in the spirit of the guidance, a good medical product is only as good as its ability to be properly and safely used. This is not to say that the FDA is advocating for better customer experiences—but instead, to reduce or eliminate problems (“errors”) that “could cause harm or degrade medical treatment.”


It’s an obvious and oversimplified notion to suggest that your new medical product should not only ideally do what it was designed to do, but it also shouldn’t explode or electrocute anybody when it is powered on. The FDA guidance defines these malfunctions as “device failure hazards,” and it includes categories such as:

  • Biological
  • Chemical
  • Electrical
  • Mechanical
  • Physical
  • Thermal
  • Radiation


However, by integrating best practices and quality controls into its design and manufacturing—which includes validating those processes—you can control the risk of device failure hazards.


But, what you can’t control is what happens when your medical device is put into the control of a human being that accidentally or willfully misuses it. Or can you?


Basically, the FDA’s guidance is an implied argument that says, yes, you can control what it calls use-related risks, and their risks can be minimized via human factors engineering (HFE).


User-related hazards can occur during the following:

  • Critical Tasks: These are actions that must be performed to properly use the medical device.
  • Abnormal Use: This is when a medical device is used in a manner in which is was not intended—which includes intentional not performing all critical tasks.


At first, it may seem odd to think that a healthcare professional would not follow instructions or misuse a medical device. However, this is not protect against him or her from using the device as a toy. Instead, the guidance is advocating deeper evaluation of users and the environments in which a medical device would be used.


For example, with users: How much training or experience does one need to use the medical device? How much do dexterity, coordination and willingness to learn how to use the device impact its proper use? Arguably, a medical device intended for a retail consumer should and would not require a skill set comparable to a surgeon.


Likewise, environment: Is the medical device intended for public use or in a hospital? Are distractions and interferences such as lighting levels, noise and other people in the vicinity where it’s being used matter?


The Takeaway for New Medical Device Design Customers


Your new medical device innovation’s commercial success begins with the ability to swiftly and economically get it to market—which often includes satisfying regulatory requirements. However, as human factors export Dr. Joely Gardner shared with us when discussing a draft of this blog, a product launch is only the beginning. For a product to truly enjoy long-term product life cycle success, the value-added rewards of HFE/UE for next-generation and future-generation devices cannot be understated.


She also pointed out that the sooner HFE/UE is integrated into the design and development process, the better. This is because one of HFE/UE’s hidden functions (and value-adds) is to enhance safety and decrease liability for problems. Doing so in the early stages ultimately saves both time and money.


So, in your quest to fulfill the vision that you have for what you medical device can do, what it looks like, etc., be sure to consider the concepts of HFE/UE and talk about them with the medical device design companies that you are interviewing. It not only will save you lots of time (and money) before and after launch, but it could very well be the “x” factor between why your product is superior to a competitor’s!