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Publications

Publications from the Core team.

Core’s team has a wide range of basic and applied publications and scholarly presentations under its belt. Some of these including national and international forums in human factors, psychology, medical devices, and biology. Below are representative publications from the team. Feel free to contact us for reprints.

Remote Assessment Of Daily Fluctuations Of Patient-Reported Disease Symptoms And Activity In Rheumatoid Arthritis: Feasibility, Compliance And Acceptability

I. Gourley1, C. Calderon1, M. Beyer1, L. Hamade1, R. Margolies2, K. Gilmer1, T. Messina1, O. Fields1, D. Tisdale1, M. Curran1, A. Rowe1. 1Janssen R & D, LLC, Spring House; 2Core Human Factors, Bala Cynwyd, United States (2016) Remote Assessment Of Daily Fluctuations Of Patient-Reported Disease Symptoms And Activity In Rheumatoid Arthritis: Feasibility, Compliance And Acceptability. In this publication, Existing clinical measures for Rheumatoid Arthritis (RA) patients, eg: Disease Activity Score (DAS)28 are labor-intensive and typically compiled once every three months by a physician. In contrast, wearable fitness activity trackers allow for continual measurement of activity and lifestyle events. If correlated to disease activity, use of data from “wearable” will provide an understanding of impact on activity on a more frequent basis than the physician-applied tests.

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Injecting Human Factors Engineering/Usability Engineering Into Injectable Device Design

Egeth, M., Johnstone, S., McGahern, P. (2016) Injecting Human Factors Engineering/Usability Engineering Into Injectable Device Design. In this article, the fourth in a series of articles covering quality system requirements for medical devices used to deliver drugs and biologics and combination/borderline products, Marc Egeth, PhD, Director of Research; Patricia McGahern, Associate; and Sarah Johnstone, Research Associate, all of Core Human Factors, discuss use errors associated with marketed and in-development injection systems.

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Quality & Systems Usability Requirements For Drug Delivery Devices & Systems

Gross, M., Shames, A. (2016). Quality & Systems Usability Requirements For Drug Delivery Devices & Systems. In this article, Michael Gross, PhD, RAC, Principal Consultant, Chimera Consulting, and Adam Shames, MBA, Chief Executive Officer, Core Human Factors, discuss US FDA quality system requirements for combination products, especially Design Controls, which includes the requirement to validate the design of the medical device constituent part of a combination/borderline product.

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US FDA Issues Guidance On Human Factors Studies For Combination Products

Gross, M., Shames, A. (2016). US FDA Issues Guidance On Human Factors Studies For Combination Products. This is the second in a series of articles covering quality system requirements for combination products and borderline products in the US and EU. In February 2016, the US FDA issued three guidance documents which focus on identifying, assessing and mitigating hazards related to how people use medical products that include a medical device.

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How is prospective memory used to complete instrumental activities of daily living? Examining the topic through focus groups with older adults: Pilot results.

Fink, N., Goodwin, M., Jewell, N. Kohn, S., Price, M. & Pak, R. (2012). How is prospective memory used to complete instrumental activities of daily living? Examining the topic through focus groups with older adults: Pilot results. Proceedings of the Human Factors and Ergonomics Society 56th Annual Meeting. 56(1), 2137-2141. Boston, MA: Human Factors and Ergonomics Society.

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