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  • 1.  Human Factors testing

    This message was posted by a user wishing to remain anonymous
    Posted 05-Mar-2018 14:25
    This message was posted by a user wishing to remain anonymous

    We are developing a drug/device combination product for approval in the US under a 505(b)(2) application.  ​​Part of the approval will depend on the results of a Human Factors study.  I am looking for a company or consultant that can help prepare a risk assessment, perform the studies, and write a final report, as required by FDA.  Who would you recommend?


  • 2.  RE: Human Factors testing

    Posted 06-Mar-2018 03:02
    Hi, a company i've had experience with in the past is Human factors MD.  they would definitely be able to help.  PM me if you need more info,
    seb



    Human Factors MD helps medical technology companies create more usable, safe, effective, and innovative products.
    Humanfactorsmd remove preview
    Human Factors MD helps medical technology companies create more usable, safe, effective, and innovative products.
    Human factors design firm specializing in medical devices. UI design, usability testing, user research, regulatory requirements.
    View this on Humanfactorsmd >


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    Sebastian Clerkin
    Consultant
    Cork
    Ireland
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  • 3.  RE: Human Factors testing

    Posted 06-Mar-2018 07:29
    Consider using a consulting firm like Regulatory and Quality Solutions. They have several consultants that have experience in both doing the initial work (user identification, use risk analysis and use specification) as well as conducting both the formative and summative evaluations working with drug companies as more of them enter the combination product space. Find them here: Regulatory and Quality Solutions (R&Q) | Medical Device Consultants
    Rqteam remove preview
    Regulatory and Quality Solutions (R&Q) | Medical Device Consultants
    Regulatory and Quality Solutions (R&Q) provides industry-leading regulatory and quality consulting and engineering services to medical device companies.
    View this on Rqteam >


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    Regards,
    Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
    Becker MN
    United States
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  • 4.  RE: Human Factors testing

    Posted 06-Mar-2018 07:44
    The best in this area is Lee Wood from Medical Human Factors (www.med-hf.com; lee.wood@med-hf.com). He has years of experience and a proven track record in the area of drug/device combination products. Furthermore he is highly respected at the Agency.

    Cheers, Beat

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    Beat U. Steffen
    confinis ag
    Founder & CEO
    Düdingen
    Switzerland
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  • 5.  RE: Human Factors testing

    Posted 06-Mar-2018 08:21
    I strongly recommend Agilis Consulting ( agilisconsulting.com).  They have been working in the human factors field since before it became known to most folks that it was important, and have navigated the testing and submission/approval process many times.  From personal experience, they are also great people to work with.  They will get it right the first time...

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    Christopher Jordan RAC
    Senior Director, Regulatory Affairs
    Zionsville IN
    United States
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  • 6.  RE: Human Factors testing

    This message was posted by a user wishing to remain anonymous
    Posted 06-Mar-2018 12:43
    This message was posted by a user wishing to remain anonymous

    You should call around and find the consulting firm that trains the FDA staff on Human Factors validation testing...that way they can tell you exactly what is required in your submission.


  • 7.  RE: Human Factors testing

    Posted 19-Nov-2018 16:47
    ​Use Interface Analysis Associates (IAA) for they were just training the FDA in HF!!! They have great combo experience. 
    Interface-analysis remove preview
    Interface Analysis Associates (IAA)
    "Welcome to Interface Analysis Associates (IAA),where the user experience comes first. Led by Dr. Anthony Andre, IAA is an award-winning, internationally renowned human factors, ergonomics, and user experience consulting firm. Located in the San Francisco Bay Area, we have served over 600 clients since 1993.
    View this on Interface-analysis >


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    David Dlugo BSc
    Director of Product Development, Quality Assurance and Regulatory Affairs
    Louisville KY
    United States
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  • 8.  RE: Human Factors testing

    Posted 21-Nov-2018 02:12
    Edited by Yogananth Rajendran 21-Nov-2018 02:15
    You can try cambridge consultants, they have very good experience, we used their service in one of our Drug-Device combination human factor studies. They can help you covering device useability study for EU as well. 

    https://www.cambridgeconsultants.com/expertise/human-factors

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    Yogananth Rajendran
     
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