Human Factors Engineering
Human Factors Engineering (HFE) is essential to product design and user interface development (including labeling) in order to improve use-related safety, effectiveness, and overall usability of a product. Our proprietary HFE strategies seek to cost-effectively optimize device design in a way that aligns with regulatory requirements. Agilis offers early-stage design evaluation and product concept consultation.
Our human factors services can be applied at various phases within your product development lifecycle. We work closely with our clients to help them achieve their goals.
- Shorter product development time
- A broader market and the ability to reach emerging markets
- Enhanced global usability
- Greater product differentiation
- Improved usability, accessibility, and user satisfaction
- Access to industry experts
- Formative evaluation/Pre-Summative
- Validation study/Summative
- Actual use studies
- Self selection studies
- Threshold analysis
- Comparative use studies
- Non-inferiority studies
- Human usability studies (for pre-EUA/ EUA diagnostics)
Additional HFE Services:
Instructional Labeling & Training
Agilis uses evidence-based methods to analyze user skill and performance requirements and provide an array of services for Instructions for Use and product training.
Regulatory Guidance
Agilis can offer regulatory guidance at any stage within your product lifecycle. Our team of consultants actively work to monitor the evolving regulatory landscape so that we can align our HF strategy for our clients with regulatory expectations. Staying abreast of the latest requirements of regulatory bodies has allowed Agilis to help our clients successfully navigate regulatory submission.
Post Market Surveillance
Post-market use related issues could have a dramatic impact to product life-cycle issues including longevity and profitability. Our usability-centered post-market methods help clients to identify trends now that should be avoided in the future.