• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    Japanese Universities Start Joint Trials for Fall Detection Tech

    FDA Clears H2o Therapeutics' Parkinson's Disease Monitoring App

    MICRO's Costa Rica Facility Achieves ISO 13485:2016 Certification

    FDA Clears SafeSource Direct's Nitrile Exam Gloves

    Baxter, Miromatrix Team Up for Bioengineered Liver
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Reflections on 2022 and What’s Ahead for Medtech: MPO Sounding Board

    3 Ways to Prepare for ISO 13485/Part 820 Harmonization

    A New Home for Theranos' Elizabeth Holmes?

    Health Cost Drivers for Large Employers

    Braving Change: Facing Fears in the Midst of Major Transitions
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Medbio LLC

    Paragon Medical

    Fusion Biotec Inc.

    Arthur G. Russell Co. Inc., The

    Providence Enterprise USA Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Artificial Intelligence Can Combat Key Issues Impacting Healthcare

    Why Advanced Sensors Are Crucial Within Medical Pumps

    How Artificial Intelligence Could Help Prevent 80% of Chronic Diseases

    4 Ways to Use Injection Molding in Medical Device Manufacturing

    Telemedicine and Connectivity to Drive Material Innovation in the Near Future
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Medbio LLC

    Paragon Medical

    Fusion Biotec Inc.

    Arthur G. Russell Co. Inc., The

    Providence Enterprise USA Inc.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Columns

    What Is Human Factors Engineering and Why Is It Important?

    ...

    What Is Human Factors Engineering and Why Is It Important?
    Related CONTENT
    • 2. Johnson & Johnson
    • Shockproof Power Supplies for Today’s Medical Devices
    • Verb Surgical Appoints New CEO
    • FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting
    • Prosthetic Heart Valves Global Market Expected to Reach $1.4 Billion by 2028
    Rich Newman, Usability Engineering Manager, BlackHägen Design07.30.19
    It is becoming common knowledge Human Factors Engineering (HFE), also known as Usability Engineering (UE), is required as part of most medical device development. But what exactly does that entail and how does it affect product development?

    A recent Johns Hopkins study suggested medical errors are responsible for over 250,000 deaths each year.1 It has been suggested 15 percent, or almost 40,000, of those errors were related to the device user interface (UI).2 Over the years, the medical device industry has developed methods for ensuring the hardware and software are safe if used as intended. Applying HFE during product development is one method to verify the UI is safe and effective.

    The 2016 U.S. Food and Drug Administration (FDA) Human Factors Guidance defines Human Factors Engineering as: “The application of knowledge about human behavior, abilities, limitations, and other characteristics of medical device users to the design of medical devices including mechanical and software driven user interfaces, systems, tasks, user documentation, and user training to enhance and demonstrate safe and effective use.”

    A fundamental aspect of HFE is changing how use-related errors are treated. In the past, when a user made a mistake while interacting with a medical device it was called a “User Error” and was considered the user’s fault. However, the mistake likely occurred because the device UI allowed the user to make that mistake, now referred to as a “Use Error.” The FDA HFE guidance defines Use Error as: “User action or lack of action that was different from that expected by the manufacturer and caused a result that (1) was different from the result expected by the user and (2) was not caused solely by device failure and (3) did or could result in harm.”

    Common use errors include setting an alarm limit incorrectly, entering an improper dose, misconnecting two components, or the inability to start or stop therapy. A use error that occurs during device use must be treated as a defect like a component failure or software anomaly. While a medical device’s ease of use is still important from a regulatory (validation) perspective, the focus is on Use-Safety, where Use-Safety is defined as freedom from unacceptable use-related risk.

    Do I Have to Do HFE?
    While HFE has always been encouraged, recent standards and guidance documents drive the requirement to apply HFE. In 2007, an International Standard, IEC 62366, “Application of usability engineering to medical devices,” was released. It was amended in 2012 and revised in 2015. In 2016, the FDA released a guidance document, “Applying Human Factors and Usability Engineering to Medical Devices.”

    In the 3rd edition of IEC 60601, part 1-6, the collateral standard for Usability, was revised to reference IEC 62366-1. Manufacturers must show their product meets IEC 62366 to receive CE mark. When submitting to the U.S. FDA, manufacturers must follow the FDA guidance, which is closely aligned with IEC 62366. Both IEC 62366 and the FDA guidance outline a process for developing a safe UI, then validating the final UI is free from unacceptable use-related risk. The process applies to all points of user(s)-product interaction including displays, controls, packaging, product labels, instructions for use (IFU), etc.

    The FDA guidance includes criteria for determining when formal UE activities are required. HFE should be applied if the risk analysis result indicates use errors could result in serious harm. HFE processes should also be applied if changes are being made to address a use-related CAPA.

    IEC 62366 allows for tailoring, or scaling, the HFE effort based on specific criteria including the UI’s complexity, severity of harm, and the extent of HFE processes applied to an existing medical device. These criteria help determine the amount of generative research and number of UI design iterations and formative evaluations to conduct. Risk analysis and summative validation are not subject to tailoring.

    The HFE Process: The HFE process is risk-based, similar to those used in other aspects of development. The process involves identifying potential use-related hazards, mitigating those risks, and validating the risk mitigations are effective.

    Pre-Design Controls HFE Activities: To develop a safe and effective UI, first understand how the device is used, who uses it, which use environment aspects could impact its use, etc. This information is obtained by conducting generative research such as Contextual Inquiry (observing device use in context), mining complaint databases, and conducting expert reviews of existing devices. Output of these activities is documented in the Use Specification.

    Use-Related Risk Assessment: Perform the Use-Related Risk Assessment (URRA) to identify known or foreseeable hazards and identify hazard-related use scenarios. A URRA can use methods derived from analysis tools such as FMEA as well as HFE-specific methods and is part of the system risk analysis. Because probability is very difficult to determine for use errors and many use errors cannot be anticipated until device use is simulated and observed, URRA focuses on potential harm severity rather than probability.3 Probability of occurrence is generally not included in a URRA. The URRA is used to inform the UI design and determine what tasks and use scenarios to include in formative evaluations and the Summative Usability Validation.

    UI Design and Evaluation: UI design is an iterative process. Each iteration consists of UI design, prototyping or implementation, and evaluation. Each iteration builds on the learnings from previous cycles. Early iterations might employ sketches, static prototypes, or GUI simulations running on a laptop or tablet. Later iterations typically use working prototypes, software, and eventually pre-production devices. The fidelity of the prototypes (and the usability evaluation) and amount of functionality evaluated continue to increase as the product is developed. The number of iterations varies.

    Usability Testing Overview: Usability testing is one of the most common and effective methods of evaluating a device UI. Usability tests are typically conducted as simulated use studies, where representative users interact with prototypes or actual devices and perform “hands on” tasks that simulate the actual tasks performed during use. Testing is conducted in an environment that simulates aspects of environment that might impact the ability to safely use the device, such as noise, lighting, or stress. UI aspects not easily or safely simulated are evaluated as knowledge-based tasks, where users are asked questions to assess their understanding of that UI aspect.

    Testing is generally performed in a usability suite with an attached observation room that allows observers to view testing through a two-way mirror without influencing the test. If a higher fidelity environment is required, testing can be conducted in a medical simulation center or similar facility.

    Formative Evaluations: Evaluations conducted during UI design are referred to as formative evaluations. The purpose of Formative Evaluations is to inform the UI design. The focus is on finding the root cause of potential use errors with the intent of understanding how to prevent them and mitigate the risk. They may also identify unanticipated use errors or hazards and inform the design of training, labeling, and the summative test. While not the primary focus, formative evaluations may also yield insights on usability issues that can be used to improve ease-of-use for the product. Formative evaluation methods include expert reviews, user preference tests, cognitive walkthroughs (guided interviews), and formative usability tests.

    Summative Validation Testing: A Summative Validation test is a more formal usability test intended to validate the device’s use-safety. Devices used for summative testing must be production equivalent. If labeling, IFU, and/or training are mitigations for use-related risk, they must also be validated. On the other hand, training should not be included if the user might not be expected to receive formal training prior to using the device. If summative participants are trained, there should be an appropriate break between training and testing to simulate the “falling-off of knowledge” that would occur in the time between training and when the user would use the device for the first time. Data is gathered during summative testing to identify the root cause of use errors and difficulties with the intent of informing a residual risk analysis.

    Residual Risk Analysis: The final step is to perform a residual risk analysis. It is expected there will be use errors and difficulties observed during the summative test. The results of the summative test should be analyzed to show the UI is safe and effective and the use-related risk has been reduced as much as is reasonably practicable.

    Integrating UE into the PDP
    Including HFE activities in a product development plan (PDP) can help reduce the impact of those activities on the project schedule and cost. Points to consider include:
    • Align UI iterations with major development milestones. Availability of prototypes drives the usability testing schedule, not vice-versa.
    • Plan for the effort to create the stimuli needed for usability testing, whether dedicated prototypes, “hardened” software versions, etc.
    • Include time in the schedule to make UI changes in response to formative test findings. Although one doesn’t know what will be found, expect to find at least one issue requiring significant changes, especially during early formatives.
    • Be conservative about schedule estimates. Rescheduling usability tests because prototypes were late can be very costly, especially after participant recruiting starts.
    • If training or accompanying documentation (IFU) is used to mitigate risk, they should be evaluated in formatives prior to validation.
    This article presents a high-level overview of the HFE process. The process should be conducted by a trained Usability Engineer with experience applying HFE to medical devices. There are many HFE consultancies that offer these services. Even manufacturers with dedicated HFEs or teams often outsource parts of the HFE process due the amount of overhead and effort required to conduct usability testing. HFE consultancies bring efficiency to the process by having dedicated tools and resources. 

    References
    1. http://bit.ly/mpo190761
    2. Estimate by former FDA Human Factors Chief Peter Carstensen in mid 1990s
    3. FDA Human Factors Guidance, 2016, pg 6

    Rich Newman is the Usability Engineering Manager at BlackHägen Design, an R&D and HFE consultancy. Rich has over 25 years of experience in the medical device industry, starting as a software engineer before transitioning to Human Factors. His prior experience includes ZOLL Medical, Philips Healthcare, and DEKA Research.
    Related Searches
    • u.s. food and drug administration
    • safety
    • standard
    • packaging
    Related Knowledge Center
    • R&D & Design
    Suggested For You
    2. Johnson & Johnson 2. Johnson & Johnson
    Shockproof Power Supplies for Today’s Medical Devices Shockproof Power Supplies for Today’s Medical Devices
    Verb Surgical Appoints New CEO Verb Surgical Appoints New CEO
    FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting
    Prosthetic Heart Valves Global Market Expected to Reach $1.4 Billion by 2028 Prosthetic Heart Valves Global Market Expected to Reach $1.4 Billion by 2028
    Implanted Drug ‘Reservoir’ Safely Reduces Injections for Macular Degeneration Patients Implanted Drug ‘Reservoir’ Safely Reduces Injections for Macular Degeneration Patients
    New Blood Test Uses DNA ‘Packaging’ Patterns to Detect Multiple Cancer Types New Blood Test Uses DNA ‘Packaging’ Patterns to Detect Multiple Cancer Types
    RIMSYS Regulatory Management Software Forms Advisory Board RIMSYS Regulatory Management Software Forms Advisory Board
    Reed Tech Introduces Reed Tech SingleSource for Medical Devices Supporting Global UDI Requirements Reed Tech Introduces Reed Tech SingleSource for Medical Devices Supporting Global UDI Requirements
    FDA Approves Device to Help Increase Access to More Lungs for Transplant FDA Approves Device to Help Increase Access to More Lungs for Transplant
    Early Detection, Home Monitoring Tests for Lupus Nephritis Under Development Early Detection, Home Monitoring Tests for Lupus Nephritis Under Development
    A New, Tailored Review Framework for Artificial Intelligence-Based Devices A New, Tailored Review Framework for Artificial Intelligence-Based Devices
    FDA to Modernize Mammography Services and Improve Their Quality FDA to Modernize Mammography Services and Improve Their Quality
    FDA Warns J&J and Sientra for Breast Implant Compliance Failure FDA Warns J&J and Sientra for Breast Implant Compliance Failure
    FDA to Closely Examine Surgical Stapler Risks FDA to Closely Examine Surgical Stapler Risks

    Related Top30

    • 2. Johnson & Johnson

      2. Johnson & Johnson

      ...
      07.30.19

    • Electronics
      Shockproof Power Supplies for Today’s Medical Devices

      Shockproof Power Supplies for Today’s Medical Devices

      Advancing energy to minimize leakage current and maximize patient safety.
      Shane Callanan, Director of Engineering Technology, Advanced Energy Industries Inc. 07.29.19

    • Surgical
      Verb Surgical Appoints New CEO

      Verb Surgical Appoints New CEO

      Kurt Azarbarzin most recently served as chief technology officer of ConMed.
      PR Newswire 07.25.19


    • FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting

      FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting

      Among other changes, the agency formally ended the Alternative Summary Reporting (ASR) Program.
      U.S. Food and Drug Administration 06.24.19

    • Prosthetic Heart Valves Global Market Expected to Reach $1.4 Billion by 2028

      Prosthetic Heart Valves Global Market Expected to Reach $1.4 Billion by 2028

      Asia Pacific and Middle East will be one of the fastest growing regions, according to GlobalData report.
      GlobalData 06.17.19

    Loading, Please Wait..

    Trending
    • The Future Of Biomedical Engineering Advancements
    • Cirtec Medical Corporation Acquires Precision Components Business From QMD
    • Medtronic's Recall Of Mahurkar Catheters Is Class I
    • Coloplast Launches New Catheter In The U.S.
    • A New Approach To Post-Market Surveillance
    Breaking News
    • Japanese Universities Start Joint Trials for Fall Detection Tech
    • FDA Clears H2o Therapeutics' Parkinson's Disease Monitoring App
    • MICRO's Costa Rica Facility Achieves ISO 13485:2016 Certification
    • FDA Clears SafeSource Direct's Nitrile Exam Gloves
    • Baxter, Miromatrix Team Up for Bioengineered Liver
    View Breaking News >
    CURRENT ISSUE

    November 2022

    • MPO's 2022 Year in Review
    • Fine Print: A Discourse on Additive Manufacturing
    • Grab and Go: Examining the Thrombectomy Device Market
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Pycnogenol Supplementation Linked to Hair Density in Menopausal Women
    BAPP Paper Reviews Common Adulteration Practices Which Go Undetected
    CRN Announces Promotions and Welcomes New Staff Member
    Coatings World

    Latest Breaking News From Coatings World

    ROSS Offers Heavy-Duty Three Roll Mills for High Viscosity Dispersions
    PPG Achieves ISO 14001 Certification of Environmental Management System
    AmCoat’s Rhino Shield and Floor Shield Break Records in 2022
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Japanese Universities Start Joint Trials for Fall Detection Tech
    FDA Clears H2o Therapeutics' Parkinson's Disease Monitoring App
    MICRO's Costa Rica Facility Achieves ISO 13485:2016 Certification
    Contract Pharma

    Latest Breaking News From Contract Pharma

    HPNE Launches New Approach to Single-Use Assembly Production
    Andelyn Biosciences, Odylia Therapeutics Partner to Manufacture Gene Therapy for Vision Loss
    Lonza Breaks Ground on Commercial Drug Product Facility in Stein
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Paco Rabanne Launches FAME Fragrance in the U.S.
    Sally Beauty Expands Bondbar Lineup of Hair Care Products
    L’Oréal Group Recognized by Bloomberg Gender-Equality Index 2023
    Happi

    Latest Breaking News From Happi

    Ross Introduces Heavy-Duty Three Roll Mills for High-Viscosity Dispersions
    Perfect Corp Partners with Beekman 1802 for New My Skin Biome Tool
    OPI’s Nature Strong Introduces Botanical Base Coat and New Colors
    Ink World

    Latest Breaking News From Ink World

    C3Nano Offers New SuperGrid Flexible Low-Temperature Ink
    ROSS Develops Heavy-Duty Three Roll Mills for High Viscosity Dispersions
    Alexander's Adds Two New HP Indigo 100K Digital Presses to Fleet
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Baker Labels invests in Digicon 3000 for flexible packaging division
    PIM promotes Kristin Pilling-Davis to executive director
    Stratus Packaging embraces automation with Bobst
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    WPT Nonwovens to Add Thermobonding Line in Kentucky
    Superior Felt & Filtration Adds Domestic Injection Molding to its Medical Filtration Capabilities
    Ahlstrom Launches New Generation FluoroFree Technology
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Solid Growth Ahead for Orthopedic Power Tools Market
    Mobi-C Cervical Disc Replacement Procedures Top 200,000
    OPUM, Corflex Global Partner on Knee Assessment Technology
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Alexander Everke Hands Over ams OSRAM CEO Position to Aldo Kamper
    Angèle Reinders Named New Director of Solliance
    C3Nano Launches New SuperGrid Flexible Low-Temperature Ink

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login