Human Factors Engineering
Identify and address safety and usability risks early.
Design safer products, strengthen FDA submissions
Develop safer, more effective medical devices, medication-related devices, and pharmaceuticals that meet Food and Drug Administration requirements for faster approvals. Med Safety Board, an Institute for Safe Medication Practices (ISMP) company powered by ECRI, helps teams identify and mitigate use-related safety risks, navigate human factors engineering (HFE) requirements, improve product usability, and gain FDA approval with fewer delays, rework, or redesigns to reduce patient harm, and deliver safer products from concept to market.
Prevent harm, avoid rework, reach faster approvals
Use-related safety issues can lead to adverse events, recalls, FDA delays, and costly setbacks. We support product teams with expert guidance throughout the product lifecycle:
Identify safety risks early to reduce patient harm
Ensure FDA readiness with human factors validation and regulatory documentation
Strengthen usability through early-stage concept, design, URRA and/or uFMEA, heuristic evaluations, formative studies, and validation studies
Avoid costly redesigns by streamlining HFE and avoiding common usability pitfalls for faster approvals
Protect your brand with safer, intuitive products backed by rigorous, real-world testing
Solving the HFE resource gap for manufacturers
Human factors validation is required for new Class II and III devices, as well as many updated ones. The FDA also encourages HFE consideration for Class I devices—but many teams lack:
- Internal HFE expertise and clinical insight
- Access to known use-error databases and research
- Access to end-user clinicians and clinically informed human factors engineers for formative and validation testing
- A clear understanding of evolving FDA requirements and submission process
- Experience minimizing HFE costs without compromising design quality
Addressing these challenges effectively can mean the difference between market approval and starting over.
Bring safer products to market—with confidence
Med Safety Board taps into over 50 years of combined expertise from ECRI and ISMP to provide unmatched safety solutions.
In-house team
Licensed clinicians (PharmDs, RNs) and human factors engineers
Exclusive access
ISMP and ECRI national error reporting databases
Real-world usability testing
A partner network of clinicians and simulation labs
Participant Recruitment
A network of real-world clinical users across specialties to ensure representative end-user feedback
Trusted
Insight into FDA regulatory requirements
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Let's start zeroing in on exactly how we can help.
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