• Our Work
    • Case Studies
    • Our Clients
  • Services
    • Medical Product Design
    • Design Research & Strategy
    • Industrial Design
    • Medical User Interface Design
    • Engineering
    • Human Factors Engineering & Usability Testing
  • Insights
    • Articles
    • Downloads
    • Whitepapers
    • Webinars
  • About Us
    • Leadership
    • Testimonials
    • Our Facility
    • Careers
  • Contact Us
  • The Living Lab
Leader in Medical Product Design and Development Leader in Medical Product Design and Development Leader in Medical Product Design and Development Leader in Medical Product Design and Development
  • Our Work
    • Case Studies
    • Our Clients
  • Services
    • Medical Product Design
    • Design Research & Strategy
    • Industrial Design
    • Medical User Interface Design
    • Engineering
    • Human Factors Engineering & Usability Testing
  • Insights
    • Articles
    • Downloads
    • Whitepapers
    • Webinars
  • About Us
    • Leadership
    • Testimonials
    • Our Facility
    • Careers
  • Contact Us
  • The Living Lab

Archives

Author Archive for: "Elyse Hallett"
Home » Archives for Elyse Hallett
 Your Medical Device Is Not Ready for a Human Factors Validation Study Until You Complete These 4 Steps
By Elyse Hallett
In Human Factors & Usability Testing, Medical Product Design
Posted February 20, 2023

Your Medical Device Is Not Ready for a Human Factors Validation Study Until You Complete These 4 Steps

If your human factors validation study is inadequate, the FDA can bounce your entire submission back. Consequently forcing you to revise your submission file — or worse, your actual design — and [...]

0
Read More
 3 Steps to an FDA-Worthy Human Factors Validation Study
By Elyse Hallett
In Human Factors & Usability Testing, Medical Product Design
Posted November 1, 2022

3 Steps to an FDA-Worthy Human Factors Validation Study

Human factors validation testing shows you’ve done your due diligence to mitigate identified hazards and the resulting harms your device might cause users and patients. For the majority of [...]

0
Read More
 Whitepaper: Medical Device Leaders’ Comprehensive Guide to Human Factors Engineering
By Elyse Hallett
In Human Factors & Usability Testing, Medical Product Design
Posted July 29, 2022

Whitepaper: Medical Device Leaders’ Comprehensive Guide to Human Factors Engineering

Developing a medical device is already a long, involved, and often expensive process. Adding time and personnel to conduct human factors engineering (HFE) seems like a high cost addition, and for [...]

0
Read More
 Why User Needs Matter During Medical Device Development
By Elyse Hallett
In User Insights & Design Research
Posted April 18, 2022

Why User Needs Matter During Medical Device Development

To market any type of product successfully, it’s important to identify how people will use it and what difference it will make in their lives. Put simply: You must understand your end users’ [...]

0
Read More
Mindflow Design
An MPE Company

ISO 13485:2016-Certified
iso logo
MindFlow Design is a leading medical product development firm for Medical, Life Sciences, and Consumer Health Companies and is based in Carlsbad, CA. We aspire to introduce powerful, intuitive healthcare technologies to the world.
INSIGHTS
  • Essentials of a Medical Device Manufacturing Plan
    Essentials of a Medical Device Manufacturing Plan
    March 22, 2023
  • The Only Human Factors Planning Guide You Need
    The Only Human Factors Planning Guide You Need
    March 22, 2023
  • Your Guide to FDA Device Classification
    Your Guide to FDA Device Classification
    March 22, 2023
  • Your Medical Device Is Not Ready for a Human Factors Validation Study Until You Complete These 4 Steps
    Your Medical Device Is Not Ready for a Human Factors Validation Study Until You Complete These 4 Steps
    February 20, 2023
  • Medical Device Developers: Give IFUs and Information Design Details Their Proper Due
    Medical Device Developers: Give IFUs and Information Design Details Their Proper Due
    February 15, 2023
CONTACT US
Mindflow Design
2036 Corte Del Nogal Carlsbad, CA 92011
(760) 930-9285
mindflowdesign.com
CONTACT US TODAY
Mindflow Design Copyright © All Rights Reserved.
MindFlow Design is a business unit of MPE
  • Our Work
  • Services
  • Insights
  • About Us
  • Contact Us
Close
Close
Scroll to the bottom to agree