R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.


Medical Device Development: Avoiding Pitfalls in Human Factors / Usability and Design


This article was originally published in Summer of 2016's Made in PA issue, a publication of the Pittsburgh Technology Council.

The competitive landscape of medical devices combined with the advantages of being first to market often tempt manufacturers to move through the product development process at a rapid pace. Deficiencies in the production and process controls subsystem of the Quality System Regulation (QSR) accounted for 32% of the 483 observations cited in 2015.¹

Inadequate Design Controls accounted for 15% of the 483 observations in the same time period. It's no surprise that Warning Letters related to Quality System problems in 2015 often focused on those two areas, along with the Corrective and Preventative Actions (CAPA) subsystem. 

A robust Quality System is certainly the first line of defense that device manufacturers must have in place not only to be compliant with Food and Drug Administration (FDA) regulations, but also to avoid costly mistakes during product development and beyond. Here are a couple of items to consider.

FDA Approved: A Human Factors and Usability Case Study

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FDA Approved: Creating and Implementing a Compliant Usability Engineering Process


PMA supplement for usability updates not approved.

A medical device manufacturer made an update to the design of their Class III device to improve usability and promote proper care and maintenance, and they submitted a PMA supplement to the FDA for the changes. The PMA supplement included a human factors test report from a usability study intended to demonstrate the effectiveness of the changes. The company received a letter from the FDA expressing concern with the level of evidence provided by their human factors testing. The FDA noted that the recent usability study had focused on ease of handling rather than comprehensive safe and effective use, engaged company employees as study participants rather than unaffiliated representative users, and failed to demonstrate that risks related to the most critical aspects of device use had been appropriately addressed in the design and evaluated in testing. The FDA requested that the client conduct another human factors study that addressed these concerns, validating safe and effective use of the device by intended users.

AdvaMed Workshop: Integrating Human Factors into Med Device Design Control and Beyond

Attention any and all regulatory affairs specialists, engineering managers, quality & production engineers, QA/Q directors and managers and compliance officers: AdvaMed is presenting a Design Control-focused workshop in Golden Valley, Minnesota, June 7-8. The workshop has been pre-approved by RAPS as eligible for up to 9 credits towards a participant’s RAC recertification upon full completion. R&Q's Bob Marshall (pictured) and Ryan Kasun will be on hand to present. Read on for more details and to register!

Human Factors

Recently I had to get my annual mammogram. They were running behind like doctor’s offices sometimes do - there were seven women in dressing gowns in the waiting room with me. After a few awkward moments, we all started to talk to each other. Every single one of the ladies talked about how they hate to come and get their annual mammograms. They talked about the pain of it, joked about the embarrassment of it - there was even a suggestion that they should serve wine in the waiting room instead of coffee. But each also showed a deep appreciation for the necessity of breast cancer screening - telling stories of aunts and mothers who were saved by it. Finally one woman told us that she was 39 when a mammogram detected her breast cancer for the first time. She was able to get minor surgery and was put on a regimen of annual mammograms. Six years after, she got breast cancer again. Again the mammogram was able to catch it early. She said she was now 57 years old and she felt like she owed 18 years of life to her doctor who suggested she get a mammogram at 39. There is no doubt about it; mammograms save people’s lives.

An Alarming Trend

If you’ve ever spent any appreciable amount of time in a hospital or other medical care facility, you may have been driven temporarily insane by the never-ending chorus of medical device alarms. I was recently reminded of a few nights I spent in the hospital with my dad a year or so ago. Just when I thought I was drifting off to sleep, one of the infusion pumps delivering his pain medication would go off and wake both of us up. This got me thinking about alarm fatigue, and the drain that so many medical device alarms must have on medical staff, not to mention patients and family.

Set Phasers on Stun

Several years ago a good friend who knows my interest in human factors and engineering psychology gave me a book called Set Phasers on Stun and Other True Tales of Design, Technology, and Human Error, by Steven Casey. I started to read it again recently and wanted to share it with you because the book demonstrates, according to the message on the jacket, “how technological failures result from the incompatibilities between the way things are designed and the way people actually perceive, think, and act. New technologies will succeed or fail based on our ability to minimize these incompatibilities between the characteristics of people and the characteristics of the things we think and use.” In the book Casey relates quite a few real-life stories about the interactions of people with modern technology and discusses the what caused the resulting human error. So if you need some new reading material, I encourage you to pick up a copy – I think you’ll find it fascinating!

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