Edited by Mary Beth Privitera, Academic Press, 2019, ISBN: 978-0-128-16163-0, xxv + 342 pages, $150
If you aspire to be involved in the proper design, development, testing, documentation, sales, or manufacture of (improved) medical devices, this text offers a comprehensive overview of the many standards and methodologies involved in the process of applying human factors analysis in the medical device design process. To a large extent, its many chapters offer guidelines and examples of various aspects specific to recommended U.S. and European design documentation standards and requirements.
To this reviewer, this text represents a significant expansion of the earlier work by the editor, which gave an overview of the use of contextual inquiry in medical device design . Here, the editor is joined by some 24 fellow design practitioners in the generation of 21 chapters covering specific subareas of human factors and usability analysis in medical device design. Each of the 24 chapters contains the following (as needed): outline, introduction, body of text, suggested additional reading(s), acknowledgments, and references. Each chapter is of reasonable length and can be readily be used as a basis for sections of related educational lectures, such as might be sponsored by the Association for the Advancement of Medical Instrumentation (AAMI).
Part 1 (Introduction, four chapters) serves to introduce the reader to the history of human factors work, introduces the reader to the alphabet of standards generators (AAMI, ISO, IEC, ANSI, etc.) and regulators (FDA, MHRA, European bodies), introduces the “Human Factors” toolbox and needs for same, followed by an overview of the remainder of the text. Part 2 (Discovery and input methods, two chapters) covers in detail the use of “contextual inquiry methods” wherein a design team attempts to broadly define new (or improved) product use and/or usability value, and a second chapter reviews the use of task (and subtask) analyses to improve device (or process) usability and generate initial user manual material.
Part 3 (Human factors in design, three chapters) covers applied human factors in design as detailed in ANSI/AAMI HE 75 (Human Factors Engineering—Design of Medical Devices) recommended practices document. Combination products are also covered, as are the application of the covered design principles to instructional materials. Overall, this section is an excellent overview of patient-centric use and usability design, with a very logical series of explanations for each step in a design. Part 4 (Formative design evaluation & reporting, two chapters) covers good practices regarding “walk-throughs” for device evaluations and simulated use scenarios, including FDA postmarket surveillance data (such as MAUDE and MEDWATCH information). Part 5 (Safety related risk, three chapters) overviews use-focused risk analyses, root cause analyses, and known and past use market surveillance [such as MAUDE and other database analyses as well as any documented corrective and preventive actions (CAPA)].
Part 6 (Usability validation & reporting, three chapters) gives an overview of human factors validation testing of products (including combination products) and the necessary documentation steps (and items) required to do an acceptable (FDA) human factors design report on the (proposed) device or device modification. A very prescriptive chapter 17 should assist one in developing an acceptable submission. The concluding part 7 (Special cases, four chapters) gives an overview of uses and problems with reusable equipment with special consideration of sterilization issues, a discussion of the need to consider users with limitations (the 15% or so with disabilities such as age, vision, size, and cognitive impairment) in the design and labeling of equipment and, lastly, a chapter on potential uses of augmented reality in medical device development.
This reviewer feels that the next revision of this text could use a few items to make it a bit more comprehensive. For example, the use of color in device and display design is alluded to, but there is absolutely no color used in the printing of the text, thus this item needs expansion. The potential use of artificial intelligence in device operation is not considered (did the patient take or get the proper dose, if not what can be done, etc.). A judicious use of and discussion of lawsuits in the discussion of device faults could assist in giving more motivation to the reader. An appendix should be added listing (in more or less order of importance) relevant standards (and their costs and place of purchase) such that readers can refer to this section when wondering (for the first several times) what, for example, is “ANSI/AAMI HE75:2019?”
Overall, this text is a very good contribution to the literature and is recommended for those persons entering medical device design. It gives a very good overview of the need for and use of human factors in medical device design, especially as experienced in the United States. All information is logically presented and is, as is necessary, very patient-centric.
—Review by Paul H. King, Ph.D., PE, Vanderbilt University
- P. H. King, “Analyzing how devices are used,” IEEE Pulse, vol. 7, no. 1, p. 62, Jan./Feb. 2016, doi: 10.1109/MPUL.2015.2498501.