ARTICLES BY NATALIE ABTS
Selecting The Best Human Factors Method For Your Medical Or Drug Delivery Device Evaluation7/21/2021
A robust human factors process is critical to product optimization and market competitiveness for medical devices and drug delivery devices, but not all companies have the resources, funding, or time to conduct such user studies. Genentech's head of human factors engineering examines the three major categories of evaluation that you should consider, the pros and cons of each, and how to select study participants.
Your Drug Or Mine? Managing Drug Delivery Device Differentiation Hazards5/13/2020
To ensure that patients receive the correct product and medication dosage and to minimize the potential for medication error, drug delivery devices must be designed both to be differentiable from similar products and also to facilitate distinguishability between varying doses of the same medication.
Examining FDA’s New Patient Labeling Draft Guidance9/9/2019
The FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format. Instructions for use (IFU) are a critical element of the device user interface, and special considerations must be accounted for in their design.
Developing A Set Of Usability Guidelines For Mobile Health Applications5/29/2019
Most mHealth does not have to meet the FDA requirements for application of human factors and usability engineering. Thus – to date -- the processes used to design and assess mHealth have been widely variable and developer dependent.
Maximizing Clinician Involvement For Improved Device Design3/7/2018
When considering human factors for medical devices and combination products, running a validation test with the device’s target end users (often clinicians) is universally understood as the primary requirement to meet FDA expectations. However, these activities too often are the extent of clinician involvement in the device lifecycle.
Incorporating Accessibility Into Medical Device Design12/28/2017
When incorporating human factors into medical device development, conducting user testing and gathering feedback from the device’s target end users is critical. To do this properly, the end user groups must be appropriately defined.
Navigating The Ethics Of Product Validation6/14/2017
Competing priorities can potentially lead to ethical conflict between consultants and device manufacturers, especially when development is near-complete. The keys to avoiding such conflict are a mutual understanding of shared safety and usability goals, and honest communication.
Beyond Validation: How Meeting Only Minimum Usability Requirements Can Affect Devices After FDA Approval2/23/2017
Because FDA requirements focus heavily on usability issues related to safety, device developers can fall into the trap of assigning less meaning to usability problems that won’t cause harm. But, it is not always possible to catch all unanticipated use errors during validation, and usability problems not directly related to safety risks can still affect purchasing decisions and device acceptance.
The Case For Formative Human Factors Testing10/4/2016
Because the validation test is required human factors testing, it can be tempting to skip over preliminary human factors activities during the development process. However, this approach is problematic from both a device usability and a safety standpoint.
How To Effectively Evaluate Instructional Materials and Labeling Before Development Is Complete6/30/2016
How do we ensure that the instructional materials are going to facilitate safe and correct product use, and not introduce the potential for error? Ideally, we want to take the same approach that should be taken for device design: Incorporate human factors evaluations early and often. However, understanding the best way to do this is not always simple.