Human Factors Engineering for Safer, More Intuitive Products

Helping medical device teams design products that are safer to use and ready for FDA and CE regulatory review.

How We Help

Our services support the entire medical device development process — from early concept through usability validation and regulatory submission.

Evaluate how real users interact with medical devices to identify usability issues
and potential risks.

Usability Testing

Support teams in preparing usability studies and documentation for FDA and international regulatory submissions.

Regulatory Advice

Conduct research to better understand users, tasks, and environments throughout product development.

Design Research

Support product teams with interface design, ergonomics, and user-centered product development.

Design

Perform task analyses, risk analyses, and use-related risk assessments to improve product safety and usability.

Human Factors Analyses

Provide training and workshops to help teams understand and apply human factors engineering principles.

Training & Workshops

Learn About Services

What Our Clients Say

“We know we are working with the best."

"I have heard a lot of great things about LHF, and that means a lot because our team is very passionate and expects a lot from their partners. I usually hear some good things, but literally hearing all good things from multiple team members is very uncommon. So we know we are working with the best."

~ Anand Krishnamurthy, Becton Dickinson

Trusted By

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Products We've Worked On

Loring Human Factors has supported the development and evaluation of a wide range of healthcare and medical technologies.

Due to client confidentiality, the images represent similar types of products our team has worked on.

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Why Human Factors Is Critical for Medical Devices

89% of first-time 510(k) submissions to the FDA are deemed inadequate due to deficiencies in their Human Factors sections.

LHF helps medical device teams avoid costly delays and regulatory setbacks.

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Meet Our Leadership

Our team combines expertise in human factors engineering, usability research,and regulatory strategy.

Beth Loring

Founder and Principal Consultant

Laurie Reed

Senior Director of Human Factors

James Railey

Director of Human Factors

Meet the Whole Team

Join the Team

Loring Human Factors is expanding! We are looking for a full-time Human Factors Engineer/Usability Specialist with at least 4 years of work experience to join our team. Experience in healthcare and/or medical devices is strongly preferred. This position is hybrid with 1-2 days per week expected in our office in Lowell, MA (on average). Travel is also required to conduct research studies.