FDA has accepted every human factors research submission built on our protocol.
PhD-led medical device human factors consulting — usability research, validation testing, and regulatory documentation. Senior scientists on every engagement, from first prototype to final submission.
HFE experience
Human factors consulting across the full medical device lifecycle
From early-stage usability research through summative validation and regulatory documentation. Every human factors research engagement is led by a PhD scientist.
Regulatory HFE consulting
Build an FDA-ready human factors program from day one. IEC 62366 compliance, submission strategy, and HFE/UE report development.
Formative usability testing
Find usability problems before they become redesign costs. Iterative studies from early prototypes through design lock.
Summative validation testing
Prove your device is safe to use with data FDA accepts. Simulated-use studies, knowledge tasks, and validation documentation.
Use-related risk analysis
Connect your risk management to real user behavior. uFMEA methodology integrated with ISO 14971 design controls.
Voice of customer research
Know what your users actually need before you build it. Strategic VoC research for market viability and unmet needs.
Expert review & gap analysis
Get a clear picture of where your HFE program stands. Low-commitment entry point to identify gaps and build a plan.
The senior team you work with
is the senior team that does the work
At large HFE firms, you meet the PhDs at the pitch meeting. Then they hand you off to junior staff. At Human Factors Research, our senior scientists lead every study, write every report, and present every finding. No handoffs. No surprises.
PhD-led engagement
Two PhD scientists with complementary backgrounds in human factors research and the physical sciences. Every project gets both perspectives.
A perfect FDA record
Every client who followed our protocol received clearance. Across 510(k), PMA, and De Novo pathways. Zero rejections.
Cross-industry perspective
Consumer tech rigor from Google, Sony, and Intuit meets FDA regulatory expertise. Your users deserve both.
Right-sized capacity
3 to 4 concurrent programs without enterprise overhead or 6-month contract minimums. Faster turnaround, competitive pricing.
Senior human factors research specialists. No junior handoffs.
Every member of our team brings deep domain expertise in medical device human factors consulting. You'll work directly with the people listed here.
Dr. Joely Gardner
Marina Zielinski
Wendy Eichenbaum
Dr. Stephie Althouse
Request a discussion
Tell us about your medical device project and Dr. Gardner will reach out to discuss how our human factors research team can help.