Improving the design and safety of drug-device combination products
Development of a Combination Product Taxonomy and Comparative Human Factors Testing Method for Drug-Device Combination Products Submitted in an ANDA
This study is looking at how to make the designs of certain drug-device products safer and more effective, especially for those trying to get approved by the FDA, so that patients can have better access to the medications they need.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Detroit Mercy NIH-funded |
| Lab location | 1 site (Detroit, United States) |
| Project ID | NIH-10698013 on NIH RePORTER |
What this research studies
This research focuses on enhancing the evaluation of user interface designs for drug-device combination products, particularly those seeking FDA approval through the ANDA pathway. By analyzing design differences that may affect the safety and effectiveness of these products, the research aims to develop a systematic approach to identify potential use errors. The project includes gathering insights from stakeholders, creating a visual taxonomy for design attributes, and establishing methods for comparative analysis between generic and reference products. Ultimately, this work seeks to improve patient access to safe and effective medications.
Who could benefit from this research
Good fit: Ideal candidates for this research are patients who use or may use drug-device combination products, particularly those that are generic.
Not a fit: Patients who do not use drug-device combination products or those who are not involved in the regulatory approval process may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to safer and more effective drug-device combination products, improving patient outcomes.
How similar studies have performed: While this approach is innovative, similar research has shown promise in improving user interface designs in medical devices, indicating potential for success.
Where this research is happening
Detroit, United States
- University of Detroit Mercy — Detroit, United States (Active)
Researchers
- Principal investigator: Conrad, Megan O'meara — University of Detroit Mercy
- Study coordinator: Conrad, Megan O'meara
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.