Human Factors Engineering Integration

⏳ Late Human Factors = months/years lost + millions spent 💵 Over the next few weeks, I’ll be sharing personal, real-world examples of why integrating #HumanFactors earlier leads to: - more intuitive, safe, and effective devices - meaningful time and cost savings - successful regulatory submissions Over the last decade, I’ve seen many companies only consider HF at the V&V stage 💔 1️⃣ A pre-summative study reveal the need for an entirely new training programme 2️⃣ A validation fail because the user interface didn’t adequately consider colour-blind users 3️⃣ A validation study uncover a mechanical failure that should have been caught during verification 4️⃣ An FDA pre-sub meeting confirm that simulated use alone wasn’t sufficient. Actual-use testing was required 5️⃣ Two rapid formative studies + ongoing expert HF reviews (over five months) cut six months off the development timeline (earlier validation confidence, faster submission, investor timelines met) 6️⃣A device that was intuitive by design become less usable once the IFU was used All examples will be shared in an anonymised way, with full respect for client and device confidentiality. Stay tuned! My hope is this encourages more teams to integrate Human Factors earlier and throughout development, when it can have the greatest impact ❤️

The FDA recently finalized its guidance on the use of human factors engineering (HFE) in the development of combination medical devices with a drug or biological product. The guidance document, titled "Application of Human Factors Engineering Principles for Combination Products," replaces a draft guidance issued in February 2016. This guidance is intended for combination products submitted to the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, or the Center for Drug Evaluation and Research. The guidance emphasizes that intended user population characteristics must be considered in the design of combination products. For example, if a combination product is intended for use by geriatric patients, factors such as decreased vision and hearing, varying literacy levels, and cognitive decline should be taken into account. The design should also consider the use environment, including any limitations such as limited internet or cellular phone service. The document introduces two unique definitions related to HFE in combination products: 1) Final Finished Combination Product: This refers to the final form of a product intended for the market and to be submitted in regulatory applications. It includes the user interface for the product, packaging, labels, labeling, and training materials if applicable. 2) Combination Product Critical Task: This is a user task that, if performed incorrectly or not at all, could cause harm to the user or the patient. Harm includes compromised medical care, and the definition differs from that used for standalone devices because it considers risks associated with both the drug and device components used together. The guidance emphasizes the importance of conducting a comprehensive use-related risk analysis (URRA) to identify combination product critical tasks. This analysis should systematically evaluate all the tasks involved in using the combination product, including intended use, use environment, user interface, and the users themselves. Tasks that directly impact dosing, administration of the product, and potential harm should be carefully assessed. The FDA provided specific examples of what would and wouldn't be considered critical tasks. Tasks that could result in harm or compromised medical care are more likely to be considered critical tasks. In summary, the FDA's finalized guidance on the use of human factors engineering in combination products highlights the importance of considering human factors in the design of these products. It provides definitions for key terms and emphasizes the need for a comprehensive use-related risk analysis to identify and address critical tasks that could impact safety and efficacy. #humanfactorsengineering #HFE #CombinationProducts #drugdelivery Andrew Bryan Colleen Murphy Rebecca Walters Elliott Fegelman

The Most Underrated Advantage in MedTech Design “Human Factors" When I studied MedTech Device teams... I found ONE clear pattern — ⇒ The earlier they involved Human Factors (HF) in design, the faster and safer their path to approval. Here’s what the data showed: → The Needs Finding stage cut usability issues by 40% later in testing. → Waiting until validation cost 2x more time fixing design errors. → Early HF collaboration improved clinician adoption rates by 33%. In MedTech, Human Factors isn’t just about ergonomics or interface design — it’s about aligning how people think, decide and act with how devices actually work. When engineers build with empathy, devices perform with clarity. ↳ Start HF early ↳ Test with real users ↳ Treat usability as safety Because in MedTech, every click, button and feedback loop can SAVE or COST → A LIFE. ------ Follow Mitra Soltani for more insights on how MedTech can grow smarter, not just bigger.

Human Factors Engineering Design in AI Deployment In industrial engineering, Human Factors means designing systems that fit people and not forcing people to fit machines. But with AI the “machine” now “thinks.” We no longer just design for physical ergonomics, we design for cognitive compatibility. The real challenge? Humans reason causally; AI reasons statistically, a cognitive mismatch waiting to happen. The solution isn’t more dashboards or data. It’s situation-specific Human Factor Engineering: - Study the context: who, where and why. - Balance autonomy vs. oversight. - Match AI transparency to human expertise. - Design for trust calibration, not blind reliance. - Adapt in real time: cognitive ergonomics that learn. Human factors used to make systems safe and efficient. Now, it must make AI systems understandable, trustworthy and aligned. Because this time, the greatest design flaw is not a broken algorithm, it’s a broken relationship between human and machine intelligence. Human factors must be in the system design, not only algorithms and software.

Design validation testing and human factors Validation Human factors (HF) validation and user interface (UI) design validation are both performed at the end of a product’s development to ensure that the product is suitable for its intended use, users, and use environments, but each with a slightly different scope. Whereas HF validation testing is conducted to generate data related to whether users can interact with the product safely and effectively, UI design validation is conducted to yield evidence that the product meets users’ needs.   Noting the similarities between HF validation and user interface design validation, manufacturers might wonder how they can combine these activities. Incorporating design validation activities into human factors validation testing can be an excellent use of time and resources. This is especially true when the combined human factors and design validation test sessions are short enough that participants are not fatigued by the session’s end, enabling them to participate fully and generate robust data. Furthermore, combining these activities is useful from a recruiting perspective, noting you can recruit one set of participants for the combined session rather than recruiting one set of participants for each activity.  Consider the following best practices to ensure you are integrating user interface design validation elements into HF validation testing is a smooth and productive endeavor:  Understand the scope of HF validation and UI design validation activities. For the HF validation test, you will have participants complete use scenarios and knowledge tasks encompassing all critical tasks, and many of these activities will likely be important for user interface design validation as well. Ensure you have a clear understanding of what activities must be performed for the HF validation as well as the UI design validation such that you can determine what additional activities should be added for UI design validation. Furthermore, consider if you need to collect additional data from the HF validation test activities beyond what is traditionally planned (e.g., dominant hand used, glove size, task time).   Complete HF validation test activities before user interface design validation questions. Noting the necessary rigor in an HF validation test to avoid bias and represent a realistic interaction, you should not ask any UI design validation questions until you have completed all HF validation test activities. Completing the HF validation test activities would include completing any debrief on use scenarios and knowledge task performance, as well as any further subjective feedback questions. Furthermore, if there are additional hands-on activities required to validate the UI design elements that were not already encompassed within the HF validation test, you should also wait until completing the HF validation test activities to proceed with these UI design validation activities.  

Human factor engineering (HFE) in medical equipment is crucial to ensuring that devices are designed with the end-user in mind, promoting safety, efficiency, and effectiveness. By considering how humans interact with technology, HFE aims to reduce errors, improve user experience, and enhance overall patient outcomes. Let's consider Ventilators in Critical Care as an example. Ventilators are essential in critical care settings for patients who cannot breathe on their own. Key Considerations in Human Factor Engineering for an ICU Ventilator. 👉 User Interface Design 🔸️ Clear and Intuitive Controls: The interface should be easy to navigate, with clear labels and logical grouping of controls. 🔸️ Feedback Mechanisms: The machine should provide immediate and understandable feedback on settings and alarms. 👉👉 Training and Usability 🔸️ Simplified Training Requirements: Medical staff should be able to learn how to operate the ventilator quickly and efficiently. 🔸️ Consistency Across Models: Standardization of controls and displays across different ventilator models can reduce training time and errors. 👉👉👉 Alarm Systems: 🔸️ Effective Alarm Management: Alarms should be distinguishable and convey the urgency and nature of the problem clearly. 🔸️ Minimizing Alarm Fatigue: Strategies to reduce the number of non-essential alarms to prevent desensitization. 👉👉👉👉 Challenges if Human Factors are Not Addressed: 🔸️ User Interface Issues: If the ventilator's controls are not intuitive, it can lead to incorrect settings, potentially harming the patient. 🔸️ Ambiguous Feedback: Poor feedback mechanisms can make it difficult for healthcare professionals to understand the machine's status and respond appropriately. 👉 👉👉👉👉Training Deficiencies: 🔸️ Long Learning Curve: If the ventilator is difficult to learn, it can delay critical interventions, especially in emergency situations. 🔸️ Inconsistent Operation: Differences in design across models can confuse staff, leading to misuse. 👉 👉👉👉👉👉Alarm Mismanagement: 🔸️ Alarm Overload: Excessive, non-urgent alarms can cause staff to miss or ignore critical alerts. 🔸️ Inadequate Alarm Signals: Alarms that are not clear or distinct can lead to delayed or incorrect responses, endangering patient safety. 👉👉👉👉👉👉👉 Real-world Implication: During the COVID-19 pandemic, the rapid increase in ventilator usage highlighted the importance of HFE. In some instances, poorly designed interfaces and overwhelming alarm systems led to increased stress for healthcare workers, delayed responses, and even critical errors. Conversely, ventilators with well-designed user interfaces and effective alarm management systems contributed significantly to better patient outcomes and reduced staff workload. #biomedical #engineering 💕

In a complex perspective study, researchers explore the key role of human factors engineering (HFE) in medical device (MD) regulation within the European context. The piece analyzes the nuances of European regulations and the substantial impact these have on the design and use of medical devices. It emphasizes integrating human factors and ergonomics to enhance device safety and usability. 1️⃣ Regulatory Evolution. The shift from blaming user error to a more nuanced understanding of 'use error' has transformed regulatory approaches, focusing on design and context of use to improve safety. 2️⃣ Small Business Challenges. Over 95% of MD manufacturers in Europe are small- and medium-sized enterprises. Thus, compliance with stringent HFE regulations poses significant competitive challenges for them. 3️⃣ Varying Knowledge Levels. Across regulatory bodies, there is a diverse range of understanding about HFE, leading to inconsistent expectations and other issues regarding compliance assessment. 4️⃣ Post-Market Surveillance. The paper highlights the need for ongoing post-production evaluation of medical devices to capture emergent use issues not identifiable during initial design phases. 5️⃣ Future Directions. The research discusses the essential shift towards considering medical devices within their broader socio-technical systems. It suggests a more dynamic and responsive approach to HFE in health technology. 🔗 This detailed analysis outlines the current regulatory landscape and pushes for a broader, more integrated approach to HFE in medical device development and assessment. It shows that embracing the current challenges as opportunities leads to safer, more effective medical techs. 📄 Sylvia Pelayo, Romaric Marcilly, Tommaso Bellandi. Human factors engineering for medical devices: European regulation and current issues. International Journal for Quality in Health Care, Volume 33, Issue 1, 2021. https://lnkd.in/e599ZwPP ✅ Subscribe to my newsletter and dive deeper into the digital transformation of healthcare: https://lnkd.in/e6jujarm Are you considering implementing the latest techs in medical device software development? Write to me to discuss the details, and my expert team will gladly assist you with your project! #medicaldevices #medicaldevicedevelopment #HFE #healthtech #digitalhealth 

🔍 Designing for Safety: Human Factors & Usability Engineering in Medical Devices per EU MDR Ensuring medical devices are safe, effective, and user-friendly is crucial under the EU Medical Device Regulation (MDR). Human Factors and Usability Engineering (HFE/UE) help minimize use errors, enhance patient safety, and ensure regulatory compliance. This week’s infographic explores the process of usability engineering and human factors per #EUMDR. 🔄 Usability & Risk Management Process Flow 1️⃣ Identify the medical device’s purpose, target users, and use environment to ensure the design aligns with user needs and expectations. 2️⃣ Analyze potential use errors, foreseeable misuse, and hazardous situations that could arise from user interactions with the device. 3️⃣ Apply design modifications, user training, safety labeling, or instructions for use (IFU) to minimize usability-related risks. 4️⃣ Perform formative and summative usability evaluations with representative users to assess ease of use, safety, and effectiveness in real-world conditions. 5️⃣ Incorporate findings from usability tests into iterative design improvements to enhance user experience, minimize errors, and meet regulatory compliance requirements. 📌 Usability Testing Requirements per EU MDR Annex I 🔹 Ensuring Safe Use for Patients & Users 🔹 Risk-Based Usability Engineering 🔹 Minimizing Use Errors & Ergonomic Risks 🔹 Aligning Design with Training & Information Needs 📚 Mapping IEC 62366-1 & ISO 13485: Usability in QMS ✅ Resource Planning & Usability Effort 💠 ISO 13485: 6.1, 6.2 → Ensures necessary resources and skilled personnel are allocated for usability activities. 💠 IEC 62366-1: 4.1.1, 4.3 → Defines the usability engineering process and the level of effort required based on device complexity and risk. ✅ Risk-Based Usability Planning 💠 ISO 13485: 7.1, 7.3.2 → Covers product development planning, integrating usability considerations. 💠 IEC 62366-1: 5.5, 5.7 → Identifies hazard-related use scenarios and creates a usability evaluation plan. ✅ Defining Use-Related Hazards 💠  ISO 13485: 7.3.3 → Establishes design inputs, including safety, usability, and risk factors. 💠  IEC 62366-1: 5.1 – 5.6 → Defines usability specifications, user interface characteristics, known hazards, and use scenarios to guide safe design. ✅ Testing & Validation 💠  ISO 13485: 7.3.4 – 7.3.7 → Ensures final usability verification and validation meet safety and performance requirements. 💠 IEC 62366-1: 5.8 – 5.9 → Covers formative testing, summative usability evaluation, and iterative improvements. 🚀 Join the Discussion! 💬 How does your team incorporate usability engineering into medical device design? Share your thoughts below! #HumanFactors #UsabilityEngineering #MedicalDevices #EUMDR #IEC62366 #ISO13485 #MedicalDeviceRegulation #PatientSafety #HealthcareInnovation