Medical device human factors and usability consulting
We help medical device companies develop safe, effective, and regulatory-compliant products through human factors engineering and usability testing.
End-to-end human factors and usability testing services
We support medical device companies at every stage of development, from early concept phase through to human factors validation testing and regulatory submission.
Medical device usability testing
Conduct an expert review, formative usability test, or human factors validation usability test of your medical device in compliance with FDA, MDR, MHRA, and NMPA.
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Use-related risk analysis
Develop a task analysis and use-related risk analysis (URRA) in alignment with ISO 14971 and ISO / IEC 62366 to timely identify and mitigate use-related risks.
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Usability strategy
Plan and execute an end-to-end human factors and usability engineering process to develop a safe, user-friendly, and regulatory compliant medical device.
Learn moreAbout us
Human Factors Insight is an independent human factors and usability engineering consultancy specializing in medical devices. We help medical device and pharmaceutical companies develop safer, more intuitive medical devices and navigate regulatory requirements with confidence.
Our mission is to make high-quality human factors engineering accessible to medical device companies of all sizes, from early-stage startups to global manufacturers.
We ensure full regulatory compliance with IEC 62366 and FDA’s final guidance on Human Factors and Usability Engineering. In addition, we help clients with both MHRA, Europe MDR, and United States FDA regulatory pathways such as 510(k), De Novo and PMA submissions.
Exclusive focus on medical devices
Senior-level human factors expertise
Global participant recruitment
FDA, MHRA, EU MDR & international expertise
15+
Years of experience
Specialized in medical human factors and usability
1000+
Formative and human factors validation
Usability test sessions conducted
25+
Medical devices supported
Successfully cleared FDA and MDR
Testimonials
“Human Factors Insight organized, managed, and conducted our human factors validation usability test in the United States. In addition, they provided clear human factors engineering guidance to ensure we met FDA’s regulatory expectations.”
Project Manager at Medical Device Startup
“Human Factors Insight conducted a formative usability test of our wearable medical device with a high level of professionalism and expertise. Thanks to their input, we timely enhanced the design of the wearable and labelling.”
Regulatory Lead at Large Medical Company
“We contracted Human Factors Insight to support the full usability engineering process of our medical device and it’s associated companion application. They delivered high-quality work and were significantly more accessible compared to other vendors.“
Marketing Director at Medical Device Company
Case study
Applying usability and human factors engineering to design a safe, intuitive, and user-friendly medical wearable device.
Learn how we applied human factors engineering principles to the design of a medical wearable device to reduce use errors by 85% and achieve FDA clearance within 6 months.
85%
Use error reduction
6 months
To FDA clearance
Global
Launch succes
Global usability and human factors support
At Human Factors Insight we support medical device innovation worldwide. Our human factors and usability work spans the United States, Europe, Asia, and beyond.
Expertise
Human Factors Insight has experience in a wide range of medical devices and complex systems, including but not limited to:
- Auto-injectors (AI)
- Pre-filled syringes (PFS)
- Blood glucose monitors (BGM)
- Drug delivery inhalation devices
- Insulin patch pumps
- Software as a medical device (SaMD)
- Diagnostic imaging systems
- Hemodialysis systems
- Wearable medical devices
- Hemodynamic systems
- Implant devices
- Airway clearance systems
- Endoscopic systems
- Incontinence systems
- Preventive stroke treatment kits
- Laboratory immunosupressants kits
- Ostomy pouching systems
- Surgical instruments
- Operating room (OR) systems
- Medical mobile applications
- Negative pressure wound therapy systems
- Dental systems
Insights
Read our most recent insights and knowledge sharing on human factors and usability engineering.
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How to Prepare for an FDA Human Validation Test
Read more: How to Prepare for an FDA Human Validation Test -
FDA Updates Its Final Guidance on Human Factors and Usability Engineering to Medical Devices
Read more: FDA Updates Its Final Guidance on Human Factors and Usability Engineering to Medical Devices -
Human Factors Engineering in Medical Device Development
Read more: Human Factors Engineering in Medical Device Development
How can we help?
Schedule a free consultation or fill out the form to discuss your human factors and usability engineering needs.
Schedule a free consultation