In a multi-year program, MUS utilized advanced science-based design research methods to perform critical analysis of numerous forms of written and illustrated instructional materials and packaging for consumer-facing drug delivery devices. The methods employed included: high-definition eye-tracking (fixed and head mounted), facial micro-expression analysis, electroencephalography (EEG), galvanic skin response (GSR), and subjective ranking systems. This research focused on identification of critical confusions and use-errors for specific patient profiles recruited based on their related medical conditions. MUS has extensive experience in specialized testing and design research for patients with advanced medical conditions and advanced age. The findings from this research led to resolution of critical use-errors and secondary confusion based on the patient’s interaction with the graphic materials, package design, and actual drug delivery device. MUS has developed and makes use of specialized instructional material testing methods for near real-time error identification and correction mapped to AGILE-style design and engineering programs. The findings from MUS studies have been utilized in submissions to the FDA for drug-device approvals. MUS has given invited lectures to the FDA professional staff on best practices for testing instructions for use (IFUs) and package design for drug delivery devices.
Conducted Extensive Design Research and UX Optimization Studies on a Wide Range of Consumer-Facing Drug Delivery Devices Focused on Meeting FDA Drug Device Design Guidance
In a multi-year engagement, MUS conducted extensive formative and summative studies for submission to FDA, including 3D spatial tracking, Newtonian force measurement, and electromyography (EMG) testing for determining device manipulation and needle pain in the use of consumer drug delivery devices. Executed many complex formative studies across a wide range of medical devices covering hardware, software, drug delivery, surgical, and imaging modalities. MUS worked with large internal Amgen teams as a highly experienced HFE subject matter and usability testing resource. MUS created and oversaw complex SOWs, protocols, and related IRB approvals. MUS executed groundbreaking ergonomic research for complex handheld medical devices for consumer and commercial drug delivery systems. These programs included the development of ergonomic product performance measures, fully verified through rigorous user testing based on IRB approvals. Medical packaging is viewed by the FDA as a critical component of usability and must be considered in the HFE evaluation of drug delivery devices and products. MUS has worked with leading clients to ensure that FDA guidance human factors engineering performance criteria are documented and employed in the development of packaging for FDA approval. MUS provided subject matter expertise, HFE audits, information analysis, cognitive task analysis, and formal usability testing during development to confirm HFE performance is verified and documented before, during, and after approval by the FDA. MUS has executed many large sample formative studies utilizing live drugs and production devices in response to warning letters from the FDA based on drug delivery device ergonomic performance. MUS is the only design research firm formally invited by the FDA to deliver lectures on advanced design research methodologies, and related drug delivery device and IFU testing systems.