• 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
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    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
    Accelmed Partners II, Lauxera Capital Partners Invest in Veranex

    Agnes Lee Named SVP of Investor Relations, Strategic Planning at Inogen

    Dr. Brandee Pappalardo Joins Fresenius Kabi as Chief Medical Officer

    XACT ACE Robotic System Wins Expanded FDA Clearance

    MPO's Most Read Stories This Week—June 25
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Theranos Fraud Trial, Part II: The Blame Game Continues

    An Update on Surgical Robotics

    Letting the Light In: How Failure Analysis is the Cornerstone of Success

    Three Talent Strategies to Attract High-Demand Skills

    The Advantages of Bioburden Screening for Sterilization Validation
    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
    Trademark Plastics Inc.

    Concise Engineering

    Cirtec Medical

    JBC Technologies

    Arthur G. Russell Co. Inc., The
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    The Power of Leveraging Customer Relationships

    Cost Effective & Efficient Wire EDM Techniques

    How MedTech Professionals Can Help Combat Physician Burnout

    How to Optimize Manufacturing Lines and Choose Which Machines to Buy

    How Are Hypodermic Needles Made?
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Trademark Plastics Inc.

    Concise Engineering

    Cirtec Medical

    JBC Technologies

    Arthur G. Russell Co. Inc., The
    • 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

    Three Crucial Elements of Conducting International Usability Research

    It is important to conduct usability research throughout the product development cycle.

    Three Crucial Elements of Conducting International Usability Research
    Related CONTENT
    • Strategic Prototyping for Human-Factors Engineering
    • FDA Advises Transition to Disposable Duodenoscopes
    • What Is Human Factors Engineering and Why Is It Important?
    • Beyond 510(k)/PMA: De Novo 101—Mike on Medtech
    • ClearDATA Joins the Healthcare and Public Health Sector Coordinating Council
    Joe Pratt, CHFP, Lead Human Factors Engineer, BlackHägen Design09.06.19
    It is important to conduct usability research throughout the product development cycle. In the United States, this process is advocated and regulated by the U.S. Food and Drug Administration (FDA). Internationally, regulations vary but typically follow U.S. guidance and those found in IEC 62366-1 and -2. (The scope of this article focuses on evaluative user research and does not include generative methods such as contextual inquiry.) Early in the process, there is a need to confirm confidence in the design and inform system architecture decisions via user preference testing. Once the design is defined, formative studies focusing on user interface details may be conducted. These studies allow for the discovery of new risks while ensuring the design employs proper risk mitigations.

    For a U.S.-based device, this process is straightforward. However, what if you are designing a device seeking initial clearance in the U.S., but will eventually transition to international markets? What if the device will be released in OUS (outside U.S.) markets then be adapted back to the U.S., or be an OUS offering exclusively? It is usually necessary to conduct usability studies overseas to receive regulatory approval for your device. Language barriers, cultural subtleties, long-distance logistics, and various unknowns can easily result in disastrous outcomes. The following best practices are wisdom from the field and should ensure valuable data is collected for your project.

    1. Logistics
    The first challenge—possibly one of the greatest a project team must overcome for usability research—is logistics. Moving prototypes around the globe, arranging study facilities, recruiting, and ensuring competent partners are prepared can be daunting.

    One of the critical issues R&D teams should be concerned with is packaging and shipping prototypes. International shipping is entirely different than domestic logistics and success is paramount to ensure prototypes arrive in time for research activities. When shipping prototypes, ensure nothing is labeled as a “medical” or “clinical” device and everything is clearly labeled “Not for Human Use.” Regardless of where prototypes are shipped, customs will identify a medical device as a high-risk item and investigate to ensure proper taxes and tariffs have been satisfied before releasing the shipment. This will likely result in significant delays and days, if not weeks, of communication to release prototypes. Check local regulations or work with a local expediter to ensure the shipment is able to clear customs without delays. Take the same precautions when returning prototypes to the U.S., as imports can be just as challenging.

    Packaging should also be a strong concern for prototypes while shipping internationally. Obviously, package the prototypes in a robust manner to prevent damage in transit; however, many people fail to remember numerous international shipments are opened and inspected prior to delivery. When packaging prototypes, make sure the customs paperwork and packing list is easily accessible if the package is opened. Enable the package to be easily re-packed and be conscientious of how you describe the contents on the manifest. It is always best practice to carry the most critical components with you in your luggage for the best chance of success. If possible, create a virtual prototype of the user interface so the research activity can still be salvaged—even if the study stimuli don’t arrive on time. Check with the shipping provider and discuss the logistics early in the planning for research activities to ensure an appropriate amount of time has been estimated for project planning. Plan for setting up and testing everything with a day of buffer to act as a contingency if possible.

    While conducting usability research activities internationally, it is also important to maximize the return on investment and collect as much data as possible. So much time and resources will have been invested that you cannot redo any portion of the study, so too much data is better than missing data. There will be multiple actors for lab-based studies, each creating their own data. When possible, always record the participant’s actions via multiple video cameras and the audio feeds from the room, the native-speaking moderator, and the simultaneous interpreter. Each of these audio and video feeds are recorded individually, then later mixed together. This allows the analysis team to hone in on each individual audio track. Additionally, a native language video can be provided back to the moderator or client for further analysis. All these individual data feeds produce a significant amount of insights. Plan ahead and bring appropriate technology to back up the data before traveling back to the states. Do not underestimate the amount of data that will be created; one of our recent one-week studies produced over 1.5 TB of video and audio data. Additionally, check local privacy and confidentiality laws. The EU is currently stricter than the United States and this requires different strategies for collecting and managing data.

    2. Language Barrier
    Selecting an appropriate recruitment partner is one of the most crucial elements of a successful international usability study. The recruitment partner should have experience conducting usability studies and medical device research. It can be beneficial to locate a recruitment partner who also has experience conducting pharmaceutical research, as they may be privy to local laws and regulations pertaining to clinician compensation. Having a base level of medical knowledge is important to ensure the recruitment partner can access local clinicians for your study. The recruitment partner should have the ability to arrange on-site logistics and have a shipping address for incoming prototypes. At the end of the day, the recruitment partner will be the best resource for local knowledge. They will have the ability to temper expectations and inform you of local culture and practices. Feel comfortable interviewing multiple recruitment partners to ensure they are a good fit for your company and project.

    The recruitment partner should have the ability to recommend staffing resources for your study. At a minimum, you will need a simultaneous interpreter and a native-speaking moderator. Even if the participants speak English, it is best to bring on a local moderator because they are familiar with local cultural norms and non-verbal cues. For example, in certain cultures it is best to run through a study as fast as possible with the least formalities. However, in some Asian countries, it is recommended to allow time for a break in the middle of a study to create a formal environment for the participants.

    While it may seem inconsequential, it is best to find a moderator and interpreter that have collaborated before. The moderator will be the lead to your study and the direct interface to your participants. The simultaneous interpreter will be the bridge between yourself and the study’s activities. If the interpreter and moderator have worked together before, they will be cognizant of each other’s pace and cadence throughout the study’s activities. Much like the recruitment agency, it is important to review this pair’s experience to ensure they have sufficient knowledge of the medical ecosystem. Once the study staff that will partner with your company has been identified, plan on having multiple collaboration meetings to review the study protocol during its development. After arriving in the study locale, meet with the study staff to review the final protocol and run through a rehearsal to make sure everyone’s expectations have been met.

    Typically, study stimuli will require input from the study facilitators to offer the most immersive experience for the participants. An engineer may need to operate prototype features that may not be entirely functional at the time of the study. Study facilitators must create a system of communication between the moderator and themselves to operate the prototype or study stimuli in sync with the study; language barriers may make this difficult. Radios and hands-free ear pieces can be used for the simultaneous interpreter to communicate with the study facilitators discreetly and efficiently.

    3. Stakeholders
    It requires multiple individuals to pull off a successful international study. Planning, logistics, study execution, and data analysis all require their own set of expertise.

    A protocol author is an obvious requirement, and no different than what’s required for a domestic study. However, the author must have the ability to communicate and collaborate with the international resources. During the early planning stages, the protocol author should lead the charge in developing and planning the study activities. Whoever is filling this role will be the most familiar with the study tasks and should be very intimate with the study stimuli. Multiple collaboration meetings between the author and R&D team are necessary to ensure the author is familiar with the prototypes or study stimuli. The author will also be the main point of contact between the simultaneous interpreter, moderator, and study site. They should have a flexible schedule to ensure collaboration can occur over multiple time zones.

    As previously discussed, a successful study requires a simultaneous interpreter and native-speaking moderator. The day of activities will be handled by a set of study facilitators. It is best to have a usability testing specialist and an R&D engineer to staff the study. This combination is important, as the usability specialist will have the skills and knowledge to alter the study protocol or handle any issues that may occur with the study tasks. The R&D engineer is particularly important if the prototypes require emergency fixes. Understandably, it is important both have extensive knowledge of the study tasks and the study stimuli.

    While international usability research may seem daunting—especially in comparison to domestic research—it is the best way to ensure that you gather the correct data for the intended users and use environment. With the proper planning, scheduling, partner selection, and logistics, a successful international usability evaluation study can be achieved that optimizes ease of use, use safety, and effectiveness. 


    Joe Pratt is a Certified Human Factors professional and the Lead Human Factors engineer at BlackHägen Design, an R&D and HFE consultancy. Experienced with devices ranging from respiratory care to interventional cardiology, Joe has contributed to the design of over 150 medical devices through usability research and usability consulting.
    Related Searches
    • pharmaceutical
    • human
    • cadence
    • data
    Related Knowledge Center
    • R&D & Design
    Suggested For You
    Strategic Prototyping for Human-Factors Engineering Strategic Prototyping for Human-Factors Engineering
    FDA Advises Transition to Disposable Duodenoscopes FDA Advises Transition to Disposable Duodenoscopes
    What Is Human Factors Engineering and Why Is It Important? What Is Human Factors Engineering and Why Is It Important?
    Beyond 510(k)/PMA: De Novo 101—Mike on Medtech Beyond 510(k)/PMA: De Novo 101—Mike on Medtech
    ClearDATA Joins the Healthcare and Public Health Sector Coordinating Council ClearDATA Joins the Healthcare and Public Health Sector Coordinating Council
    FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting
    Connected Quality Systems Reduce Risks Connected Quality Systems Reduce Risks
    Developing Market Access Strategies Developing Market Access Strategies
    FDA Approves Device to Help Increase Access to More Lungs for Transplant FDA Approves Device to Help Increase Access to More Lungs for Transplant
    Varian Forms Global Clinical Consortium to Advance Adaptive Radiotherapy Varian Forms Global Clinical Consortium to Advance Adaptive Radiotherapy
    FDA OKs Coag-Sense Second-Generation PT/INR Monitoring System FDA OKs Coag-Sense Second-Generation PT/INR Monitoring System
    A New, Tailored Review Framework for Artificial Intelligence-Based Devices A New, Tailored Review Framework for Artificial Intelligence-Based Devices
    Five Questions to Improve Your Requirements Management Five Questions to Improve Your Requirements Management
    Hand-in-Hand with Quality and (Regulatory) Changes Hand-in-Hand with Quality and (Regulatory) Changes
    Philips Releases Results of 3-Year Telehealth Study Affecting Over 100,000 European Patients Philips Releases Results of 3-Year Telehealth Study Affecting Over 100,000 European Patients

    Related Online Exclusives

    • R&D & Design
      Strategic Prototyping for Human-Factors Engineering

      Strategic Prototyping for Human-Factors Engineering

      Collecting formative feedback.
      Andrew DiMeo, Innovation & Design Coach at Trig 09.06.19

    • Surgical
      FDA Advises Transition to Disposable Duodenoscopes

      FDA Advises Transition to Disposable Duodenoscopes

      FDA recommends moving away from using duodenoscopes with fixed endcaps due to challenges cleaning them for reuse and persistent high contamination levels.
      U.S. Food and Drug Administration 08.30.19

    • R&D & Design
      What Is Human Factors Engineering and Why Is It Important?

      What Is Human Factors Engineering and Why Is It Important?

      ...
      Rich Newman, Usability Engineering Manager, BlackHägen Design 07.30.19


    • Beyond 510(k)/PMA: De Novo 101—Mike on Medtech

      Beyond 510(k)/PMA: De Novo 101—Mike on Medtech

      Sean Fenske and Mike Drues discuss the third most common regulatory pathway—the De Novo—clearing up details about its advantages and when it's used.
      Sean Fenske, Editor-in-Chief 07.02.19

    • ClearDATA Joins the Healthcare and Public Health Sector Coordinating Council

      ClearDATA Joins the Healthcare and Public Health Sector Coordinating Council

      ClearDATA executives serving on HSCC task forces to address security in medical devices and cybersecurity best practices.
      Business Wire 06.25.19

    Loading, Please Wait..

    Trending
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • 7 Steps To Create Your Own Medical Device Marketing Plan
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • World’s First Non-Invasive, Saliva Glucose Biosensor
    Breaking News
    • Cepheid, BioGX Partner to Create GeneXpert Monkeypox Test
    • Siemens' Varian Gains FDA IDE Nod for FAST-02 Trial
    • Acutus Medical Launches AcQCross Line Extension
    • Accelmed Partners II, Lauxera Capital Partners Invest in Veranex
    • Agnes Lee Named SVP of Investor Relations, Strategic Planning at Inogen
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • OEMs Seek Molders Offering Timely Techniques
    • Robotic Surgery: Cutting Through to the Latest
    • Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    • 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

    Japanese Mushroom Extract Appears Helpful in HPV Infections
    Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected
    United Plant Savers Launches First Film Festival
    Coatings World

    Latest Breaking News From Coatings World

    H.M. Royal Becomes Exclusive OCSiAl Distributor
    American Colors to Expand Sandusky, Ohio Facility
    Vaughn O’Dea Named Director of Epoxytec
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Accelmed Partners II, Lauxera Capital Partners Invest in Veranex
    Agnes Lee Named SVP of Investor Relations, Strategic Planning at Inogen
    Dr. Brandee Pappalardo Joins Fresenius Kabi as Chief Medical Officer
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Ixaka & Minaris Sign Tech Transfer & GMP Manufacturing Agreement for Cell Therapy Candidate
    Pfizer, BioNTech Adapt COVID Vax Against Omicron
    CoreRx Expands Capabilities
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Top 5 Beauty Tech Trends at Perfect Corp.'s Global Forum
    John Frieda Supports the LGBTQIA+ Community
    Athena Club Launches in Canada
    Happi

    Latest Breaking News From Happi

    Past Henkel Exec Christian Chopra Named President of Scotch Porter
    Color Street Celebrates Foster, Adoption Awareness with Limited-Edition Print
    CIR Panel Conducts 161st Meeting Regarding Safety Assessments for Cosmetic Ingredients
    Ink World

    Latest Breaking News From Ink World

    Dr. Tammo Boinowitz to Join Management Board of ALTANA AG
    Flint Offset Packaging Solutions Announces Price Increases for Sheetfed Inks
    Weekly Recap: INX’s VC Fund, Screen Industry and Ball Top This Week’s News
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Harveer Sahni recognized with Global Achievement Award
    Color-Logic partners with Taktiful 
    ALTANA announces Management Board change
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Fibertex Personal Care Awarded EcoVadis Awards for Sustainability
    Yanpai Orders Batt Forming Equipment for Needlepunch Line
    Weekly Recap: SWM and Neenah Introduce Mativ Inc., Avgol honored for Biotransformation Technology & More
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Researchers Discover Novel Patching Material for Bone Defects
    Boston Centerless Opens Second Manufacturing Plant in Indiana
    Researchers Develop Patient-Specific 3D-Printed Smart Metamaterial Implants
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Identiv-Powered CVS Spoken Rx Wins NFC Forum 2022 Innovation Award
    LG Display Announces Winners of This Year’s OLEDs GO! Competition
    Weekly Recap: eMagin, Applied Materials, and Schott Top This Week’s Stories

    Copyright © 2022 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