Process

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.

1

Target Product Profile

2

Phase 2 Clinical Trial

3

Phase 3 Clinical Trial

4

Market Submission

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.

1

Pre-Design Control

2

Design

3

Development

4

Validation

Scroll to Top