How We Can Assist You With Medical Device Design...

Usernomics / Interface Analysis provides guidance throughout the medical device development process, to include design, evaluation, usability testing, instructional design, FDA approval and regulatory issues.

Our Role

Dr. Andre and his staff have designed, evaluated and usability tested numerous medical device and drug delivery products over the past 18 years, to include syringes, autoinjectors, insulin pumps, glucose meters, drug reconstitution kits, Automated External Defibrillators (AED), patient record applications and more. We have performed research and testing for a variety of patient populations and health care provider populations.

Usernomics / 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.

Usernomics / IAA is well versed in the FDA's Human Factors process, having conducted many sutdies for a range of medical products and drug delivery systems. Our testing process satisfies the FDA's requirements, from study design to execution to reporting. We have developed a unique approach that couches the study findings in the context of known use-based risks and observed errors.

Usability Testing Lab

IAA owns and operates a high-technology laboratory with a configurable participant test environment, separated by one-way mirror from an adjacent control room, along with two observation areas for use by analysts and/or clients. State-of-the-art video and audio recording capabilities are employed, along with scan conversion for recording 'on-screen' inputs.

Project Assistance

Please contact us if you would like further information or wish to discuss our consulting services.

IAA Medical Human Factors Resources

• To learn more about our medical and drug delivery device services and experience, view our brochure: Healthcare, Drug and Medical Devices
  
  
• Dr. Anthony Andre, IAA Principal, recently presented a webinar entitled, "What Makes a Pre-Filled Syringe Usable and Ergonomic? Critical Human Factors Design Attributes and Interacting Factors", sponsored by the Parental Drug Association (PDA), July 14, 2011.
  
  View: What Makes a Pre-Filled Syringe Usable and Ergonomic? Critical Human Factors Design Attributes and Interacting Factors
  
  
• Dr. Anthony Andre, IAA Principal, recently presented a keynote session presentation at the PDA "Universe of pre-filled syringes and injection devices" conference in Las Vegas on October 18, 2010. The presentation focused on the human factors process necessary for both FDA approval and effective and safe user experiences.
  
  View: How to Obtain FDA Approval for Human Factors/Usability: What every Drug and Injection Device Company Should Know
  
  
• Dr. Anthony Andre, IAA Principal, recently presented a poster presentation at the PDA "Universe of pre-filled syringes and injection devices" conference in Las Vegas on October 18. The presentation focused on the consideration of human factors in syringe design.
  View: What Makes a Pre-Filled Syringe Usable and Ergonomic?
  
  

For information about these resources, contact Dr. Anthony Andre at: andre[at]interface-analysis.com

Selected Medical Device Usability Studies

• Numerous usability studies to assess the ease of use and instructions associated with a range of safety syringes and autoinjectors. Our studies have been conducted with both healthcare providers and a range of patient populations (Multiple Sclerosis, Rheumatoid Arthritis, Diabetes, Psoriasis, and Lupus to name a few).
• Multiple usability studies to assess the acceptable maximum force required to express a drug through a syringe for healthcare providers and a range of patient populations.
• Numerous usability studies for Diabetes-related products. Our studies ranged from discussion of future concepts of insulin delivery devices to assessment and validation tests of handheld devices and related desktop software. Some of the products tested include glucose meters, insulin pumps, glucose monitoring systems, insulin pens, and the product packaging.
• An assessment study of dentists' computer and technology skills in combination with collection of feedback on practice technology, and a software system used by dentists.
• Multiple assessment and validation usability tests for heart-related products to include heart pump systems, blood oxygen monitor, and a cardiac outpatient telemetry device.
• A number of usability tests involving of drug kits to include reconstitution kits and highly viscous antiemetic drug kits.
• Empirical human factors study of healthcare providers to identify if the presence or absence of information on the drug vial cap affects performance.
• Multiple assessment and comparative usability tests of automatic external defibrillators (AED) involving lay persons.
• Multiple studies assessing instructions and guides for medical devices.

Selected IAA Medical Device/Healthcare Clients