How We Can Assist You With Medical Device Testing...
Usernomics / IAA brings our large testing experience and vast domain knowledge that will ensure you walk away from any medical device usability test understanding the user experience and a clear set of actionable design improvements.
Our Role
Dr. Andre and his staff are well versed in the FDA's process having conducted numerous studies for a range of medical products. Our process is congruent and accepted by the FDA and we make an effort to stay up-to-date on the FDA's usability testing requirements.
Usernomics / IAA's medical usability testing process satisfies the FDA's requirements from study design to reporting. We understand the difference between conducting an assessment study from a validation study and have developed a unique approach to medical device usability testing that couches the usability findings in the context of known use-based risks and errors.
Testing Procedure
Our full-service usability test includes a complete turn-key process from test development to reporting:
- Development of the test design
- Writing of participant protocol/s (test scripts)
- Provision of test materials (data logs, pre- and post-test surveys)
- Participant recruitment, screening, scheduling and payment
- Test administration (conducting participants through the protocol/s)
- Data recording and behaviors-logging
- Analysis of objective, observational, and subjective data
- Creation of a video highlights montage
- Report generation, including (re)design recommendations
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. Andre presented an invited talk on incorporating human factors inputs into early device design and selection activities at the 2012 Symposium on Human Factors and Ergonomics in Health Care.
View: It May Be Over Before It Started: Why You Should Have Incorporated Human Factors Science Before Designing Your Device
- 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. 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 Usability Testing Clients
Medical Device Testing
