Medical human factors and usability consulting
We help medical device companies develop medical products that are safe, user-friendly, and regulatory-compliant.
How we help
Medical usability testing
We focus exclusively on medical devices and have over a decade of experience conducting formative and summative usability testing.
Regulatory experience
We have an in-depth understanding of the human factors and usability requirements for an MDR, FDA, or NMPA submission.
Accessible service
We understand developing a medical device is a rigorous and costly process. Therefore, we provide transparent and accessible usability consulting services.
Our services
Usability testing
Conduct an expert review, formative usability test, and a summative usability test to improve medical device design and meet FDA, MDR, and NMPA human factors requirements.
- Formative usability test
- Design expert review
- Summative usability test
Risk analysis
Conduct use-related risk management activities in compliance with ISO 14971 to identify, analyze, and mitigate use-related risks that could have a potential to cause harm.
- Task analysis
- Known problems analysis
- Use-related risk analysis (URRA)
Usability documentation
Develop usability documentation to ensure compliance with regulatory standards and develop safe, effective, and user-friendly products.
- Usability engineering plan
- Use specification
- User interface requirements
- Human Factors Engineering (HFE) / Usability Engineering (UE) Report
About us
Human Factors Insight specializes in global human factors and usability consulting services for the medical industry. Our mission is to make usability and human factors consulting more accessible for medical device companies of any size.
"Our mission is to make human factors and usability services accessible for medical device companies of any size"
Our consulting services include global formative and summative usability testing, use-related risk analysis, and the development of regulatory-compliant human factors engineering (HFE) documentation. Thanks to our network, we can recruit patients, caregivers, and healthcare professionals on a global level.
We ensure full regulatory compliance with global human factors and risk management standards such as ANSI / AAMI / IEC 62366, ISO 14971, FDA’s final guidance on Human Factors Engineering, MDR, and NMPA.
Testimonials
“Human Factors Insight organized, managed, and conducted our summative usability test in the United States. They provided clear human factors guidance to ensure we met FDA regulatory expectations.“
Project Manager at Medical Device Startup
“Human Factors Insight supported us through numerous formative usability tests with a high level of professionalism and expertise. They were a reliable partner every step of the way.“
Regulatory Lead at Large Medical Device Company
“We contracted Human Factors Insight to support the full usability engineering process for our medical device. They delivered high-quality work and were significantly more cost-effective than other HFE consultancies.“
Project Manager at Medical Device Startup
Expertise
Human Factors Insight has experience in a wide variety 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 monitoring device
- Airway clearance systems
- Endoscopic systems
- Incontinence systems
- Preventive stroke treatment kits
- Laboratory immunosupressants kits
- Ostomy pouching systems
- Surgical instruments
- Operating room (OR) systems
