All workshops take place on Sunday, March 24, 2024
Full Day Workshops
8:00 AM – 5:00 PM
Show Me, Don’t Tell Me: Performing a Contextual Inquiry
- Jeffrey Morang, BlackHägen Design
- Keith Karn, Human Factors in Context LLC
Contextual inquiry includes observation and interviewing techniques originally developed by anthropologists. These techniques can help us gain insights about people, the products and systems that they use, the tasks they are trying to accomplish, and the environments (physical, social, & technical aspects) in which they live and work. This workshop is a concentrated course on how to conduct contextual inquiry to have the greatest positive impact on the development of medical devices and healthcare systems. Specifically, the course will cover how to plan and execute a study and how to analyze, synthesize, and translate findings from contextual inquiry in the healthcare domain. The FDA and IEC have recognized the inherent value of contextual inquiry as an integral part of developing medical devices and successful user experiences. Many products and systems have benefited greatly from applying contextual inquiry during the generative concept and feasibility phases of product and system development. This workshop will cover applying contextual inquiry in both clinical and home environments.
Introduction to Human Factors for Medical Products - Student Workshop
Complimentary to Student Registrants of the Symposium
- Denise Forkey, UserWise, LLC, a ClariMed Company
- Natalie Short, Harvey Medical, LLC, a ClariMed Company
This workshop is complimentary to STUDENT registrants. Prevailing rates apply to all others. This workshop will introduce students to the world of healthcare human factors and promote their entry into this exciting and growing field. The workshop will cover the following topics with the goal of enabling students to enter the healthcare HF industry. Current Opportunities for Human Factors Overview of FDA guidance and standards applicable to healthcare HF Typical phases of an HF program Application to drug delivery devices (combination drug products) Application to medical devices Risk-based approaches to HF Design of devices, instructions and labeling Case Studies of how the HF process was applied for a medical product Latest trends and future opportunities How to prepare for a career in healthcare HF Q&A.
Half Day Workshops – Morning
8:00 AM – 12:00 PM
Designing Simple Instructions for Medical Products
- Michael Wiklund, UL Solutions
- Katelynn Larson, UL Solutions
Until recently, IFUs (instructions for use) accompanying a medical product, such as a medical device, combination product, or in vitro diagnostic device, have been undervalued. IFUs were considered by many to be obligatory – required by regulators. However, they were not considered key to a product’s success, at least not by most manufacturers. The prevailing view among many manufacturers was that product users did not read the instructions, so why invest in making them great? Today, the need to conduct human factors validation testing of Class II and III products seems to have changed the mindset.
Product developers have come to appreciate that a well-designed IFU can help people interact safely and effectively with a product in real-world use and during a human factors validation test. In the latter case, an IFU may prevent use errors and other usability problems that can derail validation efforts. For example, an IFU that clearly delineates the steps for applying a heart monitoring patch to the chest and recording cardiac symptoms can be the key to error-free use, which in turn may streamline regulatory approval and help drive the product’s commercial success.
This workshop focuses on the practicalities of designing IFUs that help to ensure the safe and effective use of medical products. During the workshop, Wiklund and Larson will draw upon their collective hands-on experience and the content of their new, co-authored book, titled “Designing Simple Instructions for Medical Products,” which is pending publication (Routledge Press, 2024). They will cover the following topics of interest:
- The benefits and costs of an IFU Developmental steps
- Selecting and organizing content
- Choosing an optimal format
- Employing an optimal writing style
- Communicating effectively with graphics
- Differentiating and drawing attention to critical information
- Preventing use errors Creating visual appeal
- Evaluating an IFU’s performance
UX Metric Development: How do You Measure User Experience in Healthcare?
- Heena Dani, Biofourmis
- Danny Nou, Abbott
In an era marked by rapid technological advancements and an ever-evolving healthcare landscape, the need to prioritize user experience has never been more critical. This presentation, "UX Metric Development: How do you measure user experience in healthcare?" delves into the pivotal role of user experience in healthcare innovation and highlights the transformation of human factors engineering from a safety-focused discipline into a driver of enhanced user experiences.
This presentation explores how understanding and measuring UX in healthcare is not just a luxury but an imperative for both current and future product development. As healthcare solutions continue to innovate, it is essential to acknowledge that the success of these innovations depend more and more on a user’s experience of the product.
We will delve into the practical aspects of developing a UX metric, by equipping attendees with the tools to identify what truly matters to healthcare users, translating these insights into measurable parameters, and establishing a repeatable study framework to use as a tool in product development. By emphasizing the importance of UX metrics, attendees will gain a deeper understanding of how these measurements can be utilized to benchmark existing healthcare products and drive the evolution of upcoming solutions.
The presentation will offer valuable insights into the world of UX in healthcare, emphasizing its role in improving patient outcomes, enhancing practitioner experiences, and ultimately contributing to the advancement of healthcare as a whole. Join us as we navigate the exciting intersection of human factors engineering, user experience, and healthcare innovation, to ultimately foster a future where user experience is a driving force in healthcare product development & patient care.
Half Day Workshop – Afternoon
1:30 PM – 5:30 PM
Techniques for Invention: How Generative Research & Product Tensions Unlock Creativity & Improved Performance
- Ashley Nicodemus, UEGroup
In product land, we all dream of the day that we can create that completely new product: the one that is going to solve all those glaring issues and unmet user needs; however, those opportunities are few and far between. There are many obstacles that result in pushing out the same product with a few tweaks. As a designer, we do not have control over all these obstacles, but we can drastically improve a product by building on its current technology and regulatory state through the creation of well-balanced UX and inventive design practices.
In this workshop, Ashley will impart the skills to help you redefine your product experience within your current constraints using the Concept Tension Model—a tool to use during generative research and human-centered design to create uniquely fitting solutions that break past expected ideas and deliver on all competing goals. She will also discuss strategies for converting hesitant team members. Actual change is uncomfortable – there will be doubts and that is ok. We don’t want to ignore those doubts, but instead turn those doubts into questions answered with data. These objectives will be discussed in real project examples, like iRhythm’s Zio Patch, and practiced together in group activities.
What You Will Learn:
- How to push past current thinking with generative research using the Concept Tension Model ideation tool
- How to incorporate stakeholders to improve outcomes and increase buy-in
- How to safely leave tradition behind using Cognitive Based Design Principles
- Define a balanced approach to a product vision with or without user feedback