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“Because” is not an answer

“Because” is not an answer

By Naomi Cherne In a courageous parenting move, my parents not only encouraged the question “why?” but also taught that an unaccompanied “because” (as in “Because I said so!”) was not an acceptable answer. We children embraced this cognitive tool, much to the chagrin...

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The Rationale of Representativeness

The Rationale of Representativeness

By Sam Sye A key step in designing any human factors study is to define the intended user groups. User groups are determined by unique demographic characteristics that may impact how a particular user interacts with a given medical device. These characteristics may...

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CORE does Paint Nite

CORE does Paint Nite

By Arathi Sethumadhavan The employees at Core Human Factors unleashed their inner Picasso, engaging in creative thinking and socializing at Paint Nite. Results were some spectacular masterpieces!

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Role of Paper Prototyping in Product Development

Role of Paper Prototyping in Product Development

By Patricia Anderson Paper prototyping is a simple way to get complex and valuable insight into your user interface. It is a user-centric design technique that can be an effective means of early usability testing. The typical application is software of some sort, be...

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Instructions for (you to please) Use

By Arathi Sethumadhavan and Patricia Anderson  Instructions for Use (IFU) is a frequently discussed and debated topic in the Health Care Human Factors world. How to test them? What do they mitigate? What should be in them? Often, companies despair when it comes to...

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Usability metrics: Knowing what to assess

Usability metrics: Knowing what to assess

By Arathi Sethumadhavan In my last blog post, I wrote about the common usability misconceptions that Philip Kortum identified in his latest book. In this blog, I will discuss the usability metrics that the author has identified and provide my impressions on the...

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Usability myths

By Arathi Sethumadhavan I just finished reading Philip Kortum’s latest book on Usability assessment: How to measure the usability of products, services, and systems. This is a very comprehensive book for beginners to understand what usability assessment is, why it is...

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When should you care about literacy?

When should you care about literacy?

By Naomi Cherne If you are reading this blog, you are probably pretty comfortable with reading. You can engage with the text in your world to understand and evaluate your options, guide your actions, and pursue your goals. However, literacy is a struggle or even a...

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CORE celebrates Annual Holiday Party!

By Arathi Sethumadhavan The employees at Core Human Factors celebrated their Annual Holiday Party at a Philadelphia local restaurant with a New Orleans flavor called Bourbon Blue. Great food and festive spirits abound, the fun culminated with a raffle...

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Summary of FDA Guidance on Patient Preference Information

Written by Arathi Sethumadhavan   This guidance was issued by the FDA last month and provides answers to the following: What is Patient Preference Information (PPI)? Refers to patients’ experiences with a disease or condition and its management Can also include...

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Everything bold, red, and underlined

Everything bold, red, and underlined

Written by Naomi Cherne When participants in our studies use a product and skip a step or do something that the product’s designer did not intend, we ask them about it. In the discussion that follows they often tell us, very confidently, that they would have known...

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Thanks, Human Factors

Thanks, Human Factors

Sitting in the Philadelphia airport waiting for a flight through London to Berlin. I checked a manikin. A “m-a-n-i-k-i-n” is a humanoid medical simulation, a “m-a-n-n-e-q-u-i-n” is a dress form. Core was hired to study a medical device in development for marketing in the U.S. and E.U., and the best way to make sure real-life users in the E.U. will understand and be able to use the device is to test it there with study participants carefully selected to be representative of real-life users. The best way to conduct such a test is with the careful attention of an experimenter – in this case, yours truly – who has been developing the study protocols and testing the device in similar ways in the U.S. I don’t speak German, so we have hired a local “moderator” to conduct study sessions and also a live translator. Study sessions will consist of study participants being asked to approach this new medical device and use it, as if for real – but instead of “actually” using it to deliver an injection to someone who needs it, instead deliver it to Bert, our manikin.

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Medication dosing errors: Are you giving your child the right dose?

Unlike adult medications, pediatric medications rely heavily on liquid formulations and parents have to use appropriate dosing tools with standard markings such as syringes and dosing cups to accurately administer the medication to their child. This article published in the Official Journal of the American Academy of Pediatrics discusses how dosing errors are influenced by the design of such dosing tools.

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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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CORE does Escape The Room! Zombie Edition

The employees at Core Human Factors decided to go a different route for their Holiday Party. What better way to build our team work than participating in an Escape the Room, Zombie Edition? This activity required lots of skills and abilities and most importantly, TEAMWORK!

We escaped in record-setting time. Way to go team!

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Announcing our new IRB

Core Human Factors, Inc., is proud to announce the formation of a new IRB, Institutional Review Board. The new Core Human Factors is registered with the U.S. Department of Health and Human Services, and is comprised of approximately 6 ethically interested scientists and non-scientists, men and women from a variety of backgrounds. We aim to provide fast, high-quality, and inexpensive IRB review as a for-profit service for low-risk behavioral (non-drug) research.

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Using “use events”

Before a medical device can be sold in the U.S., the manufacturer needs to demonstrate that it can be used safely and effectively. Do people hurt themselves by mistake when they try to use it for the first time? Can people pick it up and hold it so that it doesn’t slip and fall? Core Human Factors, Inc. specializes in testing new medical devices for just these sorts of issues, by having representative users come in and use new devices in a variety of scenarios designed to represent real life.

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Integrating Human Factors Engineering into Design Controls for Combination Products

Correctly defining, integrating and documenting the scope and timing of HFE activities are fundamental to risk management, regulatory compliance, customer satisfaction and liability control. This presentation will illustrate the human factors engineering implications and opportunities of the recently published FDA final rule (21 CFR Part 4) on current good manufacturing practice (CGMP) requirements applicable to combination products. In particular, it will provide a roadmap for how best to define, integrate and document HFE methodologies throughout the required Design Controls (21 CFR 820.30) activities.

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Creating the future with Human Factors

The future will arrive, including new technology. Do we want whatever future just happens to happen, or do we want to guide the process? If the latter, here is an explanation of how how it is that the field of human factors (HF) is responsible for planning and building a sustainable future human civilization.

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Disclaimer

The views expressed in this blog are those of the author(s) and do not necessarily represent the views of, and should not be attributed to,
Core Human Factors, Inc.

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