About the Conference
The 2019 International Symposium on Human Factors and Ergonomics in Health Care will take place March 24–27 at the Hilton Chicago in Chicago, Illinois.
The symposium offers cutting-edge presentations, posters, and workshops on emerging issues in health-care human factors and the challenges facing us in the near future. Expand your knowledge of human factors/ergonomics applied to health-care devices, environments, and end-users in a format that allows for interaction and exchange of knowledge among participants and presenters.
• Get insights on the latest science and best practices
• Understand innovations in the safety of health-care providers and patients
• Sharpen the focus of your HF/E initiatives
• Improve your regulatory approaches
Sean Hägen and Rich Newman’s Presentation
Challenges of Simulating Training Decay in Usability Studies
March 27, 2019, 10.30am – 12.00am
The presenters bring a wealth of knowledge and experience to help address both the practical aspects of simulating training decay. Participants will also have a chance to present their insights and hear from other members of the audience.
Medical and Drug-Delivery Devices Track Monday, March 25, 4.30pm – 6.00pm
Training Decay in Simulated-Use Studies: Research-Based Time Rationales by Nick Unger
A literature review was conducted on the topic of cognitive memory decay as it applies to training decay in simulated-use studies on medical devices for FDA submission. Today, it stands that training decay may be necessary for the testing of medical devices that may not be used immediately or frequently after training. The use of training decay is meant to more realistically test these devices. When a device might be used very rarely or potentially never, the use of only an hour of memory decay may not allow for the accurate measure of user performance. This poster will provide rationale for the justification of several different training decay periods based on research.
Contextual Inquiry: Experience-Based Best Practices by Ryan Hilgers
As the medical industry continues to evolve and become increasingly user-centric, research methodologies such as Contextual Inquiry (CI) have garnered interest from medical device professionals. However, many interested human factors (HF) practitioners and medical device manufacturers are inexperienced with CI and may benefit from experience-based guidance beyond that found in industry standards (e.g. FDA Guidance, AAMI, etc.). This poster shall summarize CI best practices drawn from BlackHägen’s unique experience with carrying out CI endeavors around the world.
Medical and Drug-Delivery Devices Track Tuesday, March 26, 4.30pm – 6.00pm
International Usability Studies – Best Practices for Overseas Usability Research by Joe Pratt
Throughout the product development cycle, it is important to conduct usability research. In the US this process is mandated and detailed by the FDA. Early in the process, you need to confirm confidence in your design via User Preference testing. Later on, you may conduct formative testing to ensure your design properly mitigates risk or to discover new risks. Finally, we conduct summative testing to ensure the device is safe for its intended users in their intended environment. For an FDA submission or US-based device, this process is straightforward. However, what if you are designing a device that will seek initial clearance in the US, then will transition to international markets? Language barriers, long-distance logistics, and various unknowns can result in disastrous outcomes. Best practices are presented for lab-based testing in addition to contextual inquiry field research.
When a User Interface is too Small; An Autoinjector Case Study by Sean Hägen
It is common with technology driven product design to continually iterate in an effort to make a device smaller, sometimes this spec driven strategy loses sight of the original objective for why small was important in the first place. Take cell phones for example, every year they got smaller, going from a brick to a credit card until they were nearly unusable, now they have grown back to something human hands can manipulate.
This case study follows the design and development of a new Epinephrine autoinjector device which utilizes micro liters instead of milliliters and therefore can be much smaller. What happens when a person entering anaphylaxis shock has to manipulate a hand-held user interface the size of a pen cap? Here is where the usability engineering process proves its value. HFE working alongside industrial design, following a rigorous UE Plan, guided the design of the device to actually become larger which ended up making the entire system better.
Tailoring the Usability Engineering Process by Richard Newman
An ongoing challenge that human factors professionals face is how to understand and plan the extent of the human factors engineering (HFE) activities that are required (or recommended) for a given product or project.
Both IEC 62366-1:2015 and the FDA Human Factors Guidance talk about scaling or tailoring the usability effort. The scope of the usability effort will vary based on factors including the complexity of the user interface, the severity of harm associated with the device or system, the extent of the modifications from current or predicate devices, if there are changes to the intended use, and if the changes are a result of a CAPA.
These criteria are very broad and, in some cases, subjective. It can be challenging for a trained HF professional to determine the scope of required activities, and even more challenging to communicate the rationale behind the proposed scope to clients or management.
This talk will present a more objective method to help HF practitioners determine the appropriate scope of HFE activities. It will describe a decision-tree based system to assist users in asking the right questions and considering all of the appropriate factors that impact the need for HFE activities at different points in the product development cycle when a HFE Plan may need reassessment. The method does not replace the subjective judgement of the HF professional but guides them in applying their expertise in a methodical and repeatable way.
This method was developed based on the presenter’s 12 years as a Human Factors Professional and 25 years of product development experience in the medical device industry.
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