Medical device human factors and usability consulting
We help medical device and pharmaceutical companies design medical products that are safe, user-friendly, and regulatory-compliant.
How we help
Medical device usability testing
We have over a decade of experience conducting formative and human factors validation usability testing of medical devices.
Participant recruitment
Thanks to our global network, we can recruit patients, caregivers, and healthcare professionals on a global level.
Regulatory excellence
We have an in-depth understanding of the human factors and usability expectations required for an MDR, FDA, or NMPA submission.
Our services
We provide end-to-end human factors and usability services, from early concept development through to regulatory submission.
Medical device usability testing
Conduct an expert review, formative usability test, or human factors (HF) validation / summative usability test of your medical device in compliance with MDR, FDA, and NMPA.
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Use-related risk analysis
Develop a medical device task analysis and use-related risk analysis (URRA) in alignment with ISO 14971 and IEC 62366 to timely identify and mitigate use-related risks.
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Human factors strategy
Plan, execute, and document an end-to-end human factors strategy to design a safe, effective, and intuitive medical device.
Learn moreAbout us
Human Factors Insight is a global medical device human factors and usability engineering consultancy. We believe that human factors and usability engineering should be accessible to medical companies of any size, ranging from early-stage medical device startups to global pharmaceutical companies.
We make human factors and usability engineering accessible to companies of any size, ranging from early-stage medical device startups to global pharmaceutical companies.
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 Europe MDR and United States (U.S.) FDA pathways such as 510(k), De Novo and PMA submissions.
Exclusive focus on medical devices
Experience in MDR, FDA, and NMPA regulations
Dedicated senior human factors expertise
Global participant recruiting network
Extensive medical device experience
Transparent and accessible HFE services
15+
Years experience
Specialized in medical human factors and usability
1000+
Formative and summative
Usability test sessions conducted
50+
Medical devices approved
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
Supporting 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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FDA Human Factors Validation Testing: How to Prepare Your Medical Device
Read more: FDA Human Factors Validation Testing: How to Prepare Your Medical Device -
FDA Updates Its Final Guidance on Human Factors Engineering for Medical Devices: What Manufacturers Need to Know
Read more: FDA Updates Its Final Guidance on Human Factors Engineering for Medical Devices: What Manufacturers Need to Know -
FDA Finalizes Human Factors Submission Guidance: Key Takeaways
Read more: FDA Finalizes Human Factors Submission Guidance: Key Takeaways
How can we help?
Schedule a free consultation or request a quote for your human factors and usability engineering needs.
Contact Us
info@hf-insight.com