The Science of Human Factors Engineering

We examine all facets of how people will interact with a medical device or product including what they bring technically, physically, and emotionally. We incorporate our extensive experience with low literacy users to maximize first-time product success. Our proprietary human factors engineering methods seek to cost-effectively optimize device design while ensuring user satisfaction and regulatory requirements.

Agilis - Hand building puzzle globe
  • Our risk-based model evaluates safety and usability associated with users completing critical and essential device tasks.

  • Early formative evaluations ensure usability optimization, user satisfaction, mitigation of risks and use errors, and instructional labeling that effectively supports correct device use.

  • Data gathered during our processes provide evidence to regulatory bodies that the user interface has been optimized and potential device problems have been discovered and mitigated.

  • Complete turnkey services for IRB approval, subject recruitment and venue management.

  • 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.


We customize our services to accommodate each client’s needs and specific challenges

 
Agilis - Human Factors Engineering

human factors engineering

Agilis offers early-stage design evaluation and product concept consultation. Our proprietary, research-based methods delve deep to define your users’ specific needs for clinical and home healthcare settings.

 
Agilis - Evidence based Instructional Labeling and Training

Evidence based Instructional Labeling and Training

The Agilis proprietary, evidence-based instructional design process has proven to produce more effective labeling (IFU) and training in less time than other traditional methods. Our professional instructional designers are up to date on the latest innovations in information design and electronic delivery.

 
Agilis - Human Factors Regulatory Guidance

Human Factors Regulatory Guidance

FDA has never rejected the human factors regulatory strategy from an Agilis client. Industry is feeling the pressure from increasing regulatory scrutiny on a global basis. Agilis’ human factors regulatory guidance services offer more than conventional usability testing.

 
Agilis - Post Market Surveillance

Post Market Surveillance

Agilis applies a usability-centered post market data mining of complaint files and MDR reports to provide clients with a structured method of identifying trends in use problems.