Emergo by UL insights

Mar 16, 2023

How Can We Define Successful Task Completion Within a Usability Test?

Suggestions for defining task completion and measuring completion rates in medical device usability testing

Mar 10, 2023

Wiklund's Perspective: Applying Human Factors to the Wide Spectrum of Life Science Products

How human factors engineering and usability practices can impact life sciences beyond medical devices

Feb 24, 2023

US FDA Annual Report: Nearly 6,000 Medical Device Authorizations in 2022

FDA annual report shows depth and breadth of Center for Devices and Radiological Health (CDRH) medical device activities through 2022

Feb 22, 2023

Expectations for Post-Market Surveillance (PMS) in the European MDR

What’s the status of your EU MDR Article 86 Periodic Safety Update Report (PSUR)? Class IIa legacy devices are approaching the deadline of their first PSUR, whereas Class III and IIb legacy devices should already have their first PSUR issued.

Feb 13, 2023

The HFR&D Process for Conducting Root Cause Analysis

Our Human Factors Research & Design (HFR&D) team's seven-step process for analysis of root causes of medical device use-related issues

Feb 8, 2023

Wiklund's Perspective: Patient Deaths Due to Medical Error

The central role human factors engineers play in efforts to mitigate and reduce medical errors

Feb 3, 2023

The Age-Old Question: HFE, Usability, ID, UX or UI?

Distinctions between human factors engineering, usability and user experience

Usability lab clinical product observation room HFRD

Dec 14, 2022

Creating a Realistic Simulated Medical Environment

Recommendations for creating realistic medical device and healthcare product test environments

Important considerations for conducting in-home research

Dec 14, 2022

Reflecting on 2022

Our Human Factors Research & Design leader looks back on the year that was

Dec 14, 2022

The Future of Healthcare in the Metaverse

A look at how the metaverse may affect healthcare delivery and medical product development

Dec 14, 2022

Wiklund's Perspective: New Technology Creates New Barriers

Innovative technologies and the need for inclusivity

Nov 21, 2022

Wiklund's Perspective: Electronic IFUs are Gaining Popularity

Electronic indications for use (IFUs) becoming more common for medical products and devices

New guidelines published on integrating UDI into quality management systems under MDR, IVDR in Europe

Oct 21, 2022

Quick Reference Guides: When Products are Better With – and Without Them

For medical devices and drug-delivery combination products, the Instructions for Use (IFU) or equivalent manual is usually the primary source of guidance.

US FDA rolls out notification requirements to protect medical device supply chains

Oct 18, 2022

Wiklund’s Perspective: Applying Human Factors to Standard Operating Procedures (SOPs)

People write SOPs for many important reasons, such as ensuring that company workers manufacture a vaccine properly.

Sep 21, 2022

Wiklund’s Perspective: Automation is (Mostly) a Good Thing

From an HFE standpoint, the main benefit of automation is that it largely eliminates the opportunity for a use error.

US FDA medical device user fees see modest increase for 2022

Sep 16, 2022

Self-selection Study Tips, Part 1: Recruiting for a Successful Study

The US Federal Drug Administration (FDA) defines a self-selection study as an evaluation that “assesses the ability of consumers to apply drug labeling information to their personal health situation to make correct decisions."

Aug 25, 2022

Don’t Let Software Bugs Stand in Your Way

How to approach software bug issues in the context of human factors validation and usability studies.

Aug 17, 2022

Are US Residents Representative Usability Test Participants for the Entire World?

There are some major differences that might influence the way users interact with products between the US and Europe. Here are a few that should be considered.

Jun 20, 2022

Wiklund's Perspective: IFU Designers Helping Us Get Through the Pandemic

A look at how high-quality instructions for use drive positive user experiences with at-home COVID-19 and related testing. Learn more at Emergo by UL's Human Factors Research & Design.

Person looking at themselves with a tablet.

May 31, 2022

Considerations for Post-HF Validation Design Changes

Emergo by UL's Human Factors Research & Design team provides recommendations for when manufacturers make changes to the designs of their medical devices.

Insights

Get the latest global medical device insights from our experts, and more.

How Can We Define Successful Task Completion Within a Usability Test?

Wiklund's Perspective: Applying Human Factors to the Wide Spectrum of Life Science Products

US FDA Annual Report: Nearly 6,000 Medical Device Authorizations in 2022

Expectations for Post-Market Surveillance (PMS) in the European MDR

The HFR&D Process for Conducting Root Cause Analysis

Wiklund's Perspective: Patient Deaths Due to Medical Error

The Age-Old Question: HFE, Usability, ID, UX or UI?

Creating a Realistic Simulated Medical Environment

Reflecting on 2022

The Future of Healthcare in the Metaverse

Wiklund's Perspective: New Technology Creates New Barriers

Wiklund's Perspective: Electronic IFUs are Gaining Popularity

Quick Reference Guides: When Products are Better With – and Without Them

Wiklund’s Perspective: Applying Human Factors to Standard Operating Procedures (SOPs)

Wiklund’s Perspective: Automation is (Mostly) a Good Thing

Self-selection Study Tips, Part 1: Recruiting for a Successful Study

Don’t Let Software Bugs Stand in Your Way

Are US Residents Representative Usability Test Participants for the Entire World?

Wiklund's Perspective: IFU Designers Helping Us Get Through the Pandemic

Considerations for Post-HF Validation Design Changes