This interactive 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 Human Factors industry with some baseline knowledge: What is human factors; What is the user interface; Overview of FDA regulations, guidance and international standards applicable to healthcare Human Factors; Typical phases of a Human Factors program; Application to drug delivery devices (combination drug products); Application to medical devices; Risk-based approaches to Human Factors; and Case Studies of how the Human Factors process was applied for medical products. Throughout the workshop both small and large group activities will help attendees apply their newfound knowledge.  In addition, we will cover: Careers in Healthcare Human Factors, Latest trends and future opportunities; and How to prepare for a career in healthcare HF.

At the end of the workshop, we will have a Human Factors Career Panel where seasoned Human Factors experts with experience in Combination Products, Medical Devices, Hospital Systems, and/or Government/Notified Bodies share their knowledge about what it's like to work in the industry, and tips for entering the workforce, and keys for success. [This panel was introduced last year and was a huge success, where Jake Johnston, Kaitlin Erdman, Alexandra Benbadis, and the workshop presenters shared their knowledge with attendees and answered questions.]

Human Factors in healthcare is unique due to FDA’s influence on the process and requirements for human factors engineering for medical devices and combination products. During the workshop, the instructors will share information and resources to acclimate and prepare students and Human Factors Engineers who are new to medical products for careers in healthcare human factors, a growing and rewarding field.

Healthcare is a complex, high-stakes environment where the design of systems, devices, and processes directly impacts patient safety and quality of care. Human factors and ergonomics professionals are increasingly called upon to contribute to safer, more effective healthcare solutions. Yet one of the greatest challenges remains authentically understanding and involving the people who use those systems every day: frontline clinicians, patients, and caregivers. Many HF professionals and designers do not have regular access to hospital environments, making it difficult to learn directly from their end users. Even when access is possible, the pressure and pace of healthcare can limit opportunities for robust ethnographic observation, interviews, or prototyping. Without thoughtful approaches to discovery and co-design, solutions risk being misaligned, underused, or unsustainable.

This workshop responds to these challenges by providing participants with practical, hands-on tools and methods to support two critical phases of human-centered design in healthcare: discovery (learning from users and understanding lived experiences) and co-design (collaboratively developing solutions with users). Participants in this workshop will be introduced to and practice methods that can be easily adapted to many diverse healthcare contexts, particularly when access is difficult and or seriously limited.. Through interactive group activities, role-play, and rapid prototyping, attendees will learn how to uncover insights, frame opportunities, and co-create safer systems. The workshop will be designed as a highly interactive and collaborative session. Participants will be led through a cumulative process of learning and practice as they are introduced to both real world case studies and fictional project assets. Participants will walk away from this session with a comprehensive toolkit of techniques and a renewed sense of confidence to apply them to their own projects and work.

What Participants Will Learn: In this interactive session, participants will break into smaller groups to have collaborative conversations, unpacking the challenges and actively practicing new skills and exploring innovative approaches to designing solutions for hospital settings. The benefits of a more proactive approach to change, challenges and solutions in healthcare The value of engaging end users—including clinicians, patients, and those with lived experience—throughout the design process to create more impactful solutions. Practical skills, such as photovoice, cultural probes, and flexible research methodologies to gain an understanding of clinician’s experiences when you aren’t able to be present in the physical environment.

This workshop is designed for a broad audience, including: Human Factors Engineers working in or entering the healthcare sector. Healthcare Leaders and Administrators involved in patient safety, quality improvement, or innovation initiatives. Medical Device Designers and Developers seeking to involve users meaningfully in product development. Policy Makers and Regulators interested in integrating user perspectives into system design. Students and Emerging Professionals in HF/E, healthcare, or design disciplines who want hands-on experience with co-design methods. While rooted in healthcare, the methods and insights are transferable to any context where user access is constrained and collaborative design is valuable. Participants don’t need to have any design or frontline experience to join. This workshop is great for anyone who is wanting to expand the scope of what they do and the lens in which they approach problems. Participants don't need to bring anything except themselves and a willingness to participate and have fun!

What if you could build a working prototype for a healthcare solution in just minutes, without writing a single line of code? This workshop will introduce participants to two emerging approaches in artificial intelligence that make this possible. The first, known as vibe coding, allows anyone, not just developers, to describe a project’s goals and desired outcomes in natural language while an AI system generates the underlying code. The second, agentic AI, represents a new class of AI systems that can reason, act, and collaborate across tasks rather than simply answering prompts. These approaches are already transforming industries: for example, Amazon has implemented vibe coding as the backbone for prompting its machine interfaces, while Apple reports automating nearly half of its internal processes with AI agents. Together, they open up exciting possibilities for healthcare innovation as well as for everyday professional workflows.

Participants will gain hands-on experience with both methods, including building a simple AI prototype through vibe coding, designing how an AI agent could automate or support parts of a workflow (such as scheduling, analysis, or documentation), and experimenting with ways these tools can address real healthcare challenges. Alongside healthcare case studies, we will also explore how these tools can save time and reduce cognitive load in the daily work of human factors professionals.

By the end of the session, participants will understand the concepts of vibe coding and agentic AI, learn practical prototyping skills, and leave with strategies to apply these techniques in both healthcare projects and their own professional workflows. No prior coding or AI expertise is required. This workshop is designed for human factors/ergonomics professionals, clinicians, designers, researchers, innovators, and anyone curious about how AI will reshape healthcare work. Computers or tablets are recommended; all other materials will be provided.

Contextual Inquiry is a field-based, “show me, don’t tell me” research approach that reveals how people truly use products and systems to accomplish tasks and achieve goals in the real-world. This workshop equips participants to plan and conduct contextual inquiry, capture authentic data, and translate them into insights that provide a springboard for innovation, sharpen design requirements, de-risk development, and align teams early. Recognized by the FDA and IEC as a cornerstone of usability engineering and risk management, contextual inquiry accelerates device development, strengthens risk controls, and builds regulatory confidence for safer, more successful products in both clinical and home environments. The workshop will cover the following topics • Introduction to Contextual Inquiry – purpose, benefits, and process overview • Planning the Study – study plan, team roles, checklists, and administrative documentation • Recruitment & Access – recruiting/screening participants and gaining access to environments of use • Data Collection – tools, techniques, passive vs. active observation • Analysis & Synthesis – coding data, extracting insights, and translating findings into user needs and product/system requirements • Reporting & Communication – creating deliverables and communicating results

Learning outcomes: At the conclusion of the workshop, participants should feel equipped to apply these techniques in their own work to fuel future system and product innovation and design. Specifically, the participants will • Develop a deep understanding of contextual inquiry—its meaning, scope, and place among other research methods in the product development cycle. • Identify and frame research problems by developing targeted research questions, crafting interview and observation probes, and creating structured research guides. • Plan and execute effective studies by securing stakeholder buy-in, selecting and recruiting the right participants, forming the right research team, and managing scheduling and logistics. • Refine interviewing and observation skills—eliciting natural responses, avoiding bias in questions and observations, and taking clear, usable notes. • Handle challenges and difficult situations confidently while maintaining the integrity of the research process. • Analyze and synthesize data effectively by extracting themes from interviews and observations and understanding how planning decisions shape analysis outcomes. • Integrate and advocate for contextual research within one’s own work and organization by championing its value and demonstrating how it informs product development.

This interactive workshop confronts a persistent but often overlooked problem: most medical devices are still designed around a “one-size-fits-male” paradigm, even though women comprise the majority of the global healthcare workforce. Instruments for surgery, diagnostics, patient monitoring, and even large-scale equipment often default to male physical and cognitive models, creating barriers to healthy, safe and effective use by women, and may also hinder equal participation by women in certain medical fields.

Overview, Uniqueness, Format and Interactivity

Led by two complementary experts, the session merges physical ergonomics and cognitive ergonomics, while explicitly examining the gender gap in medical device design, inorder to provide a comprehensive, actionable framework for inclusive design in this field:

• Eran Franco, senior physiotherapist and certified professional ergonomist, focuses on physical factors in design - highlights how sex-related biomechanical and anthropometric differences lead to higher musculoskeletal risks among women, created when devices default to a “male average”.
• Dr. Ela Liberman-Pincu, industrial designer and cognitive design researcher, explores cognitive factors in design - how visual language, color, mental models and decision-making cues shape user interaction and how these factors can unconsciously favor male users.

The workshop alternates enriching presentations with immersive, hands-on activities. Participants will handle and critique a variety of medical and non-medical tools to sharpen observation of gender-related usability issues. In the final design challenge, teams will redesign a representative medical device -chosen to highlight both physical and cognitive demands - using the principles learned, for true gender inclusivity.

Main Learning Objectives

By the end of the workshop, participants will be able to:

1. Recognize how historical “one-size-fits-male” standards create physical barriers and even discourage women from certain specialties.
2. Apply anthropometric data and biomechanical analysis to accommodate the full range of female and male sizes, strengths, and postural needs.
3. Identify cognitive-ergonomic factors - labeling, visual hierarchy, interaction cues - that differentially affect male and female users.
4. Practice a step-by-step evaluation method to audit devices for gender inclusivity.
5. Co-create actionable design improvements that enhance health, efficiency, safety, and equity for all clinicians.

Target Audience

• Biomedical engineers and industrial designers developing medical technologies
• Human factors and usability professionals
• Clinicians, nurses, and surgical staff who use such equipment
• Regulators and quality managers seeking evidence-based standards for gender equity

Impact and Take-Home Value

Attendees leave with practical design guidelines to ensure sex-inclusive ergonomics, ergonomic checklists, and advocacy strategies that can be implemented immediately to:

• Reduce operator injury and fatigue
• Lower cognitive error rates
• Improve patient outcomes
• Foster a more diverse and inclusive clinical workforce

By uniting physical and cognitive perspectives and engaging participants in active problem-solving, this workshop provides the knowledge and tools necessary to move the healthcare technology industry beyond the male default—toward medical devices that truly fit every body.

Participants’ Background Knowledge and Expertise

No prior knowledge or expertise is required for participants attending the workshop. The interactive lectures are designed to introduce the subject matter and equip attendees with the necessary tools for effective participation.

Required Participant Materials

Participants are not required to bring any materials or equipment to the workshop. All materials needed for the integrated challenge exercise will be provided by the lecturers.

Every industry is seeking to understand the use and impact of artificial intelligence (AI). As human factors consultants in healthcare, we are increasingly finding that our clients and colleagues want to utilize AI in product development and usability testing but may not know where to start. Those of us “in the trenches” may be familiar with the concepts of AI but lack the resources (e.g., time, training, opportunities to explore) or space to develop skills in this area. This workshop will help you to position your team as thought leaders within your organization in responsibly integrating AI into your regular workflow, usability studies, and more.

Attendees will gain a practical understanding of how AI can enhance research (e.g., interview analysis, pattern detection, synthetic personas), recognize potential pitfalls (e.g., bias, regulatory concerns, over-reliance), and experience hands-on exercises comparing AI-generated and human-coded data. The session will empower participants to distinguish hype from practical value, enabling them to make informed decisions about AI adoption in their own organizations.

Learning outcomes include (1) Explain the current and emerging roles of AI in product development and usability testing for healthcare products, (2) Identify opportunities and limitations of AI in user research, including ethical implementation within organizations that deal with proprietary information, (3) Compare AI-generated and human-coded usability data through a hands-on mini-exercise, (4) Evaluate the value and risks of AI for clients and stakeholders in healthcare product development, and (5) Formulate recommendations for integrating AI responsibly into usability testing workflows.

Target audiences include: Seasoned human factors professionals who seek to develop effective ways to communicate the benefits of AI to their colleagues and other stakeholders, those with limited to moderate level of experience with usability testing who would like to develop a more detailed understanding of the nuances of using AI, and those with limited to moderate experience with AI who want to learn more about when and how to implement this technology into usability testing.

Attendees should plan to have access to ChatGPT on either their laptop or mobile phone for hands-on activities.