FDA Human Factors Engineering Guidance Is Now Serious Business Pharmaceutical companies can now have their new drugs rejected by the FDA based on how usable and understandable the delivery device and labeling is for the intended patient population. This new factor has for the first time placed professional usability testing and human factors engineering at the core of successful drug development and market acceptance. MAURO Usability Science (founded 1975) has completed a four-year development effort focused on providing leading drug device development groups with a robust new suite of highly focused and powerful new testing methods designed to meet FDA human factors guidance. These new techniques provide multi-dimensional and scientifically valid data on patient interactions with the entire drug delivery patient experience.
New Data Capture Methods From MAURO Usability Science
3D spatial tracking
Newtonian force measurement
High Definition Electromyography
High-resolution eye tracking
Micro-facial expression analysis
Automated task analysis and data capture
Cognitive workload analysis
Information foraging theory
New Data Capture Methods Demand Advanced Data Analysis These new methods produce vast amounts of new data that would be useless without advanced data aggregation and data analysis methods. To ensure the highest level of FDA compliance, MUS has developed proprietary and certified hardware/software systems that combine these new advanced testing methods into a unified data collection steam that provides unprecedented hard data on the human factors engineering performance of drug delivery devices, instructions for use, package design and dosing information.
Addressing The FDA Guidance on Bio-Similar HFE Performance The new MUS methods are effective in resolving the complex problem facing companies planning to release bio-similar drugs that are required to meet the new FDA Threshold Guidance. With in the field of professional human factors engineering science this new FDA Guidance is well understood to be a potentially serious and costly factor in securing FDA approval.
New System Utilized On All Major Device and Labeling Types Over 40 studies involving a wide range of FDA-driven device HFE performance enhancements utilized the MUS data capture and aggregation system.
Types of Device Tested Using New MUS System
Single action auto injectors
Complex action auto injectors
Advanced fully electronic auto injectors
On-body injectors involving complex data presentation
Multiple entirely new drug delivery configurations and methods
PFS devices for common and high viscosity drug delivery
Multi-use vials and related injection devices
Drug delivery monitoring Apps / software
Drug dosing (complex and simple)
Instructions for use (simple and highly complex data)
Drug device and drug package design
Pharmacist device interaction analysis
Threshold and learning transfer analysis
Who Is MAURO Usability Science? Founded in 1975 MUS is a leading provider of professional usability testing and human factors engineering expertise. We have executed over 4,000 major HFE research projects. The recipient of prominent awards for usability research MUS is known for the development of advanced science-based usability testing methodologies. MUS has been a primary provider of professional usability testing and human factors engineering expertise to leading pharmaceutical and medical device manufactures for more than 40 years. This extensive history provides a clear view of just how vital the new human factors engineering FDA guidance is for companies seeking FDA approval. For more information contact Charles L. Mauro CHFP or read on for additional system capabilities and benefits.
How The MUS System Reduces The Risk of FDA Rejection The new data capture methodologies combine into a unified data stream that produces for the first time a highly refined view into the actual human factors engineering performance of drug delivery devices and related labeling to be utilized by a wide range of patient populations. The combined data reduces the risk of FDA rejection by providing development teams and the FDA with scientifically valid human factors engineering performance data that verifies overall system HFE performance.
Understanding The Total Patient Experience Saves Costs The new MUS system can provide multi-dimensional and scientifically valid data on patient interactions with the entire drug delivery experience. This new capability allows development teams to resolve use errors by properly allocating enhancements between hardware design, labeling and HCP moderated training. Optimizing the entire patient experience is the cost effective approach to gaining FDA approval. This approach allows development executives to allocate HFE improvements to that portion of the total user experience that has the most significant impact on reducing risk and reducing development costs. The MUS system is used to determine the usability of the following key components of the total patient experience.
Patient Experience Data Capture and Optimization
Drug-device manipulation (cross all use-cases)
Instructions for use human factors analysis
Drug Device labeling human factors analysis
Drug dosing information sheets human factors analysis
Drug-device and drug package design human factors analysis
HCP training system design human factors analysis
Pharmacy interactions and drug device acquisition
Objectively Understanding Patient Limitations While FDA HFE guidance is an essential and critically important component for producing correctly human factored drug delivery mechanisms FDA guidance does not provide detailed human factors engineering specifications for most target patient populations that suffer from well understood physical and cognitive limitations when compared to healthy individuals.
Filling In Where FDA Guidance Leaves Off We know from over 40 years conducting professional usability testing and human factors research that detailed human factors specification for patient populations that have unique limitations is not available in the existing research data. Missing research data makes drug delivery device usability testing more complicated due to a lack of capabilities for target patient populations. This lack of objective data on patient limitations does not reduce a corporation's duty to create a usable product under FDA guidance. Such missing data includes but is not limited to the following key variables.
Missing patient physiological and biotechnical factors
BMI index and sub-cutaneous fat levels
Body, arm, hand and finger size ranges
Finger, hand and arm strength profiles
Missing patient cognitive factors
Reading comprehension levels
Color blindness profiles
Hearing and hearing loss profiles
General attitude toward self-injection and drug delivery devices
Automatic Collection of Missing Patient Data Missing patient performance data has a significant impact on whether or not patients will interact with a drug delivery device and labeling system in a manner that meets FDA guidance. The MUS data capture system provides development teams with robust data on the capabilities of their specific patient populations. The MUS system automatically includes data on patient baseline capabilities that reduce the risk of an FDA rejection based on a failure to design for the intended patient population.
For More Information: Contact Email Charles L. Mauro CHFP For more information on our FDA Guidance usability testing and human factors engineering system.