Services

Our Human Factors and Research Services

Maximize your regulatory and clinical success through our human factors and usability research services. We employ various methods to help you collect and incorporate meaningful patient-engagement data that supports innovation, benefit-risk decisions, and project timelines.  We proactively identify usability risks that would cause project delays or costly mitigations. 

User Characteristic Research

Understand your user population like never before. Gain cutting-edge insights into your product’s usability needs through our information analytics and user characteristic attribute assessments.

User Characteristic Research Services

Information Sciences / Analytics

Physical, Behavioral, and Psychometric Attribute Measurement

Patient Experience Research

Support your patient-focused product development process through our comprehensive HF-focused patient experience research options. Whether you are looking to gain deeper insights into the patient’s journey, identify treatment burdens and areas of improvement for a clinical study through simulation, or evaluate potential drug delivery devices, we have a human factors focused solution for you.

Patient Experience Research Services​

Patient Therapeutic Assessment

Exploratory Key Stakeholder Interviews

Drug Delivery Device(s) Assessment

Clinical Study Design Assessment

Technical / Regulatory Analysis & Documentation​

Ensure your medical product documentation needs are met with our HF assessments and usability documentation offerings. Our expert usability analyses provide documented evidence on the safety and efficacy of your product, while our quality system management and data security practices support compliance with your design history file needs.

Technical / Regulatory Services​

Known Use Problems

Functional / Task Analysis

URRA: Use Related Risk Assessment

User Specification Development

Summary of Usability

Human Factors / Usability Research

Identify use-related risks, refine design, and enhance usability through iterative formative testing in preparation for your HF validation study. Ensure your product’s user interface meet the needs of your users, confirm design inputs, and evaluate the effectiveness of risk control methods prior to validating the clinical or commercial design.

HF/Usability Research Services​

Simulated and/or Actual Use

Patient Therapeutic Assessment

Validation Testing

Human Factors Support Service Offerings

Promote safety, compliance, and success at every stage through our comprehensive HF support services. We offer a variety of services to help support HF program and/or HF study needs.

HF Support Services

Material Development

Research Documentation Support​

HF Consulting

Research Study Ancillary Services

Scroll to Top