• Selecting The Best Human Factors Method For Your Medical Or Drug Delivery Device Evaluation

    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 Hazards

    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  • Examining FDA's New Patient Labeling Draft Guidance

    The FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products –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.

Natlie Abts Author Page Photo

Natalie Abts

Natalie Abts is the head of human factors engineering at Genentech, where she manages a team of engineers conducting human factors assessments for drug delivery devices. Before joining Genentech, Abts worked as a consultant providing advisement on human factors considerations for medical products. She has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Abts holds a master’s degree in industrial engineering, with a focus on human factors and ergonomics, from the University of Wisconsin, where she was mentored by Ben-Tzion Karsh.