Integrating HF Activities throughout the Development Process
Integrating HF activities early on and throughout the entire development process can provide many benefits, including reduced project delays, increased user satisfaction, and minimization of risks. With nearly 30 years in the medical product industry, we bring our experience and expertise to help facilitate your HF needs for your project.
Target Product Profile
- Exploratory Key Stake Holder Research
- Patient Therapeutic Assessment Research
- User Characteristic Research
Phase 2 Clinical Trial
- Proposed Product(s) Assessment/Formative Studies
- Clinical Study Design Assessment
- Clinical Study User Material Development
- Known Use Problems Assessment
Phase 3 Clinical Trial
- Use Related Risk Analysis (URRA)
- Pre-Phase 3 Clinical HF Validation Study
- HF Documentation Development/Support
- Clinical Study Device Staff Training
Market Submission
- Commercial Product Use Evaluation
- Commercial Product Final Packaging Summative Testing
- Summary of Usability Report
Drug Development
Regulatory agencies are increasingly focused on incorporating the patient’s voice throughout the entire drug development process. This can be done through human factors activities, as well as collecting methodologically–sound patient experience data.
Whether you are developing your Target Product Profile, supporting your patient usage benefit-risk plan, preparing for your Phase 3 Clinical trial, or needing guidance on when or how to complete specific HF activities, we are here to support you.
User-Focused Device Development
Inform your formal device development process and planning with our quality system regulated research options in your pre-design control phase. Identify and prioritize use errors and control associated risks during the design phase by testing your user interface specifications. Gain confidence through formative testing that unanticipated and anticipated use errors associated with critical tasks have been identified and mitigated appropriately prior to finalizing your optimized design for validation testing. Explore our HF services below to see how we can help you create your robust HFE/UE documentation in support of your design history file.
Pre-Design Control
- Patient Experience Research
- Known Use Problems Assessment
- Information Sciences/Analytics
- User Characteristics Assessment
Design
- User Specification Development
- Risk Assessment Development/Review
- URRA
- Concept/Prototype Formative Studies
Development
- Packaging & Labeling Evaluations
- IFU Comprehension Testing
- Simulated and/or Actual Use Formative Studies
Validation
- Summative Testing
- Summary of Usability