A Critical Analysis of FDA Guidance for User Percentile Device Design Criteria Versus Currently Available Human Factors Engineering Data Sources and Industry Best Practices

2019 ◽  
Author(s):  
Charles Mauro ◽  
Peter Pirolli ◽  
Chris Morley
Keyword(s):  
Best Practices ◽  
Human Factors ◽  
Critical Analysis ◽  
Data Sources ◽  
Design Criteria ◽  
Human Factors Engineering ◽  
Device Design ◽  
Fda Guidance ◽  
Engineering Data

Iterative Implementation of a Remote Cardiac Patient Monitoring Device using Qualitative Analysis and Human Factors Engineering

2017 ◽  
Vol 61 (1) ◽  
pp. 1081-1085 ◽  
Author(s):  
Bethany R Lowndes ◽  
Dawn Finnie ◽  
Julie Hathaway ◽  
Jennifer L. Ridgeway ◽  
Kristin Vickers-Douglas ◽  
...  
Keyword(s):  
Human Factors ◽  
Qualitative Analysis ◽  
Improve Patient Care ◽  
Cost Of Care ◽  
Cardiac Monitoring ◽  
Monitoring Device ◽  
Human Factors Engineering ◽  
Device Design ◽  
Or Education ◽  
Education Material

Remote monitoring has the potential to improve patient care and satisfaction while reducing the cost of care and burden on the healthcare system for Congestive Heart Failure (CHF) and Atrial Fibrillation (AF) patients. However, the device must be convenient and easy for the population to use correctly. In this study, human factors and qualitative researchers evaluated the use of a remote cardiac monitoring device during a clinical trial with 74 CHF and AF patients. Human factors usability concerns centered on device use and the information presented in the manual. The key themes identified during the qualitative analysis were related to patient education. These findings were incorporated into device design, user manual, or education material updates. This study illustrates how these methods can infuse patient experience into device design to inform continued quality improvement and usability refinement specifically in devices to aid CHF and AF patients without added burden.

Best Practices: Human Factors for Combination Products

2017 ◽  
Vol 6 (1) ◽  
pp. 139-142
Author(s):  
Molly Story ◽  
Sherri Biondi ◽  
Valerie Fenster ◽  
Kevin Cluff
Keyword(s):  
Best Practices ◽  
Human Factors ◽  
Product Differentiation ◽  
Expert Panel ◽  
Regulatory Agencies ◽  
Human Factors Engineering ◽  
Medical Products

The paper presents industry perspectives on best practices for several topics related to human factors engineering for combination (medical) products. The four primary topics discussed were training decay periods, product differentiation testing, construction of questions for knowledge tasks, and the most appropriate and productive ways to engage regulatory agencies when their human factors feedback is unexpected. The expert panel shared their own experiences and invited the session attendees to share their own perspectives and experiences.

Effective human factors engineering

1983 ◽  
Author(s):  
S. L. Ehrenreich ◽  
M. J. Cosky
Keyword(s):  
Human Factors ◽  
Human Factors Engineering
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