What is usability? Human factors? Are they one and the same or different in the medical device industry? When do each apply? Whatever you call it, both are very important in virtually all medical devices.

In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues from Vascular Sciences about human factors and usability—two terms used synonymously despite subtle differences—to help you better understand how each function and should be applied.

Some of the highlights of this episode include:

• Mike defines usability or human factors as the user’s ability to use the device in a way that it is intended to be used to get the result it’s intended to get.
• Jon understands how product development engineers forget that they designed a product based on how they think it should operate, function, and be used.
• Unfortunately, there are few opportunities for engineers to actually test, use, or implant a product that they developed and designed on actual end users, like cadavers or live animals.
• The user population has expanded beyond a trained healthcare professional. From a human factors perspective, it doesn’t always make sense or make it easier or complicated for some people to use medical devices.
• Current FDA guidances that focus on general usability/human factors for medical devices are inadequate. FDA does not differentiate devices that should be used by a trained healthcare professional versus a patient or lay person. 
• Usability is important in virtually all medical devices, but there are some exceptions. However, usability is even more important when medical devices are being used by non-trained medical professionals.
• FDA now requires usability testing for medical devices because of issues with infusion pumps. However, usability testing should be considered based on risk. Is usability testing needed to put on a BAND-AID® or spit into a tube?
• There are two types of usability testing: Formative is testing that happens prior to design freeze during the development process. Summative testing occurs after the point of design freeze to ensure that the product can be used as intended.

Memorable quotes from this episode:

“Usability or human factors is the user’s ability to use the device in a way that it’s intended to be used to get the result that it’s intended to get.” Mike Drues

“Those who are designing the product are stuck and convinced that they know the way the product should be used.” Jon Speer

“The user population has expanded beyond a trained healthcare professional.” Jon Speer

“Usability is important in virtually all medical devices across the board. Not all, there are some exceptions, but virtually all.” Mike Drues

Links:

FDA - Applying Human Factors and Usability Engineering to Medical Devices

FDA - List of Highest Priority Medical Devices for Human Factors Review

FDA - Premarket Notification 510(k)

FDA - In Vitro Diagnostics Regulation (IVDR)

The Global Medical Device Podcast, Episode 223: Understanding FDA's New Intended Use Rule and its Implications

Mike Drues on LinkedIn

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

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