How We Can Assist You With Medical Device Design...
Interface Analysis / Usernomics provide guidance throughout the medical device development process, to include design, evaluation, usability testing, instructional design, FDA approval and regulatory issues.
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 specialized patient and health care provider populations.
Our Role & Expertise
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 is well versed in the FDA's Human Factors process, having conducted many formative assessment studies and summative validation studies 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. 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.
Dr. Andre, Founding Principal of Interface Analysis Associates, shown with patient safety pioneer, Dr. Lucian Leape. This photo was taken at the 2011 HFES Symposium on Human Factors and Ergonomics in Healthcare, organized and chaired by Dr. Andre.
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 spoke as an invited panelist on "FDA Human Factors Compliance" at the American Society for Quality Usability Event on March 21, 2013.
View: Human Factors and the FDA presentation.
- Dr. Andre presented a plenary session address at the PDA's 2012 "Universe of Pre filled Syringes and Injection Devices" Conference in Las Vegas, NV on October 16, 2012. Dr. Andre shared the stage with Kathy Lee, of the FDA. His address, entitled "The Human Factors Top 10 List", discussed the top 10 most critical mistakes made by drug delivery device and biopharma companies when attempting to obtain FDA Human Factors approval for a combination product.
View: The Human Factors Top 10 List
- 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, 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