IAA is well versed in the FDA's Human Factors process, having conducted many formative assessment studies and summative validation studies for a wide range of medical products and drug delivery systems. Our testing process satisfies the FDA's requirements, from study design to execution to reporting; we make an effort to stay up-to-date on the FDA’s usability testing requirements. We have developed a unique approach that couches the study findings in the context of known use-based risks and observed errors. Our high-tech laboratory is configurable to accommodate a home setup or another test environment with cameras that can zoom in and capture the smallest of screens so observers know what part of the device the user is interacting with throughout the session.

Our Role

IAA can help your team develop a user experience that is safe, comfortable, easy to learn, simple to use and satisfying. We address both cognitive-usability and physical ergonomics issues to help ensure that your device has beneficial usability and ergonomics properties from the start. Identifying potential HF/E issues early in the development process is key to designing a successful product.

IAA has designed, evaluated and usability tested numerous medical device and drug delivery products over the past 20 years. These include:

• Needle Safety Syringes (manual/active & automatic/passive)
• Autopens (fixed dose & variable dose)
• Autoinjectors (single-use & reusable, pre-assembled & self-assembled)
• MicroInfusers
• Insulin Pumps (standard & pod/patch)
• Continuous Glucose Monitors (sensor and remote control/monitor)
• Blood Glucose Meters
• Infusion Pumps (single, multi, ambulatory)
• Drug Reconstitution Kits
• Electronic Patient Record Applications
• Patient Imaging Applications
• Heart Pump Systems (LVAD)
• Cardiac Monitors / Medical Telemetry Systems
• Bar Code Medication Systems
• Vascular Closure Devices
• Laparoscopic Surgical Devices
• Automated External Defibrillators (AED)
• Ultrasound Machines
• Blood Cooling Systems
• Ophthalmic Equipment (WaveFront imaging, LASIK excimer laser)
• Instructions, labeling and illustrations for a variety of products (IFU, Quick Guides, Checklists, labels, etc.)

In Addition, We Have Conducted Research On A Variety Of Medical Topics And Products:

• Effects of syringe forces (drug viscosity) on injection performance, posture and acceptance among patients and health care providers
• Drug labeling (vial labels, vial caps, syringe labels, carton labeling)
• Computer skills of medical providers
• Mobile computing (tablet PC) needs in hospital settings
• Ergonomic Issues with Diagnostic Medical Sonographers
• Effects of different packaging approaches on patients’ ability to open and assemble products/kits
• Factors that influence instructional comprehension, education and adoption