MAURO Usability Science
FDA-focused medical device human factors testing since 1975
About MAURO Usability Science
MAURO Usability Science is a human factors engineering and usability testing consultancy founded in 1975, with five decades of experience serving corporations, startups, government agencies, and NGOs. The firm has completed over 3,000 human factors and usability testing projects across medical devices, consumer products, industrial systems, and digital platforms.
The company specializes in FDA-compliant medical device human factors testing, employing advanced methodologies including 3D spatial tracking, Newtonian force measurement, electromyography (EMG), high-resolution eye-tracking, and micro-facial expression analysis. Their capabilities extend to drug delivery device optimization, instructions for use (IFU) testing, FDA warning letter response, and complex user profile recruitment spanning COPPA-age children to elderly patients with severe medical conditions.
MAURO Usability Science has worked with major pharmaceutical and medical device companies including Merck, Pfizer, Johnson & Johnson, Stryker, and West Pharma, as well as technology leaders like Apple, Google, Amazon, and Meta. The firm received the 2024 Titan of Industry For Human Factors Research Award and has earned citations from NASA, the Association for Computing Machinery, and the Human Factors and Ergonomics Society.
Best For
Medical device manufacturers and pharmaceutical companies requiring FDA-compliant human factors validation testing, particularly those facing complex regulatory submissions, warning letter responses, or high-stakes summative testing. Organizations developing drug delivery systems, pre-filled syringes, autoinjectors, or complex medical interfaces needing neuroscience-based validation methodologies and sophisticated biomechanical measurement capabilities.
Key Strengths
- 50 years of human factors engineering experience with over 3,000 completed projects across medical devices, pharmaceuticals, and consumer products
- Advanced neuroscience-based testing capabilities including 3D spatial tracking, EMG, force measurement, eye-tracking, and micro-facial expression analysis
- Deep FDA regulatory expertise with specialized experience in warning letter responses and time-sensitive submissions
- Extensive work with major pharmaceutical and medical device companies on business-critical validation studies
- Custom testing platform development including high-fidelity simulators and tri-axial force measurement systems
- Recognized industry leadership with 2024 Titan of Industry award and citations from NASA, ACM, and HFES
Why Choose MAURO Usability Science
Choose MAURO Usability Science when your medical device or pharmaceutical product requires sophisticated human factors validation that goes beyond standard usability testing. Their neuroscience-based methodologies and custom measurement platforms provide the robust quantitative data needed for high-stakes FDA submissions.
Expect a science-driven approach grounded in 50 years of experience across medical devices, drug delivery systems, and complex healthcare interfaces. The firm excels in time-sensitive FDA responses, complex user population recruitment, and IFU optimization where failure is not an option.
Healthcare Focus
MAURO Usability Science maintains a significant healthcare focus through medical device human factors testing, pharmaceutical product validation, and drug delivery system optimization. The firm specializes in FDA compliance, working with pharmaceutical companies on autoinjectors, pre-filled syringes, and intravitreal injection devices, as well as medical device manufacturers on complex healthcare provider and patient-facing systems.
Their healthcare expertise spans complex user populations including pediatric patients, elderly individuals with severe medical conditions, healthcare providers, and addiction clinic personnel. The firm has developed specialized testing platforms for healthcare applications including high-fidelity intravitreal injection simulators and custom force measurement systems for drug delivery devices.
Ideal Client Profile
Medical device manufacturers, pharmaceutical companies, and drug delivery system developers requiring FDA-compliant human factors validation with sophisticated biomechanical and neurophysiological measurement. Organizations facing complex regulatory challenges, warning letters, or summative testing where quantitative validation data is critical. Companies developing high-stakes medical products where usability failures could result in patient harm or regulatory rejection.
Specializations
Client Types
Why Choose MAURO Usability Science?
- 51+ years of industry experience
- 1-10 team members
- 1 certification verified
- Select Partner on Curatrix
- Verified on Curatrix
Quick Facts
- Category
- Healthcare UX Design Agencies
- Headquarters
- United States
- Founded
- 1975
- Company Size
- 1-10 employees
Certifications
Profile last updated: Jan 30, 2026
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