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  • 1.  training program human factors medical devices

    This message was posted by a user wishing to remain anonymous
    Posted 17-Sep-2020 10:25
    This message was posted by a user wishing to remain anonymous

    Hi all,
    Does anybody have a good training program on human factors for medical devices to recommend? Something that covers 62366-1, the FDA guidance, and possibly even HE75?
    I have already noticed the three-days training proposed by AAMI. It is a little bit expensive though compared to the budget that I have available.
    Any other proposal to start building an expertise in usability?
    Thanks in advance for any suggestion that you can provide.
    Best


  • 2.  RE: training program human factors medical devices

    Posted 17-Sep-2020 12:27
    Hi - I attended a RAPs session with UL. I thought it was a great presentation. I do not know what it would cost to formally train with them or if they have scheduled training programs. 

    There is an event coming up, it may be worth looking into: https://www.raps.org/events/integrating-human-factors-into-your-next-regulatory-submission-lemons-or-lemonade

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    Allyson Swartz
    Quality Engineer II
    Coralville IA
    United States
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    Original Message


  • 3.  RE: training program human factors medical devices

    Posted 18-Sep-2020 08:14
    You could look into Axeon's training programs.  They have a lot of good stuff, though  training is better in person,  many organizations are not offering that now.   

    Axeon has a lot of training that provides Exemplar Global certification (like auditor training) and is frequently offered half- price ...I like taking those  deals when they come in...

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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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    Original Message


  • 4.  RE: training program human factors medical devices

    Posted 18-Sep-2020 10:12
    Edited by Adam Atherton 18-Sep-2020 12:40

    There is SO much stuff available without taking a course. Consider just the FDA website;


    * CDRHLearn - https://www.fda.gov/training-and-continuing-education/cdrh-learn
    * Presentations - https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/applying-human-factors-and-usability-engineering-medical-devices-february-19-2016 
    * FDA pages dedicated to HF - https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/human-factors-and-medical-devices
    * FDA Guidance on HF - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices

    Of course, reading the FDA recognized standard is helpful too https://www.iso.org/standard/63179.html

    Read anything you can find written or presented by Molly Story. She spearheaded FDA HF for years. She is with Sanofi now. - https://www.fda.gov/media/84709/download

    I would encourage spending time reading the free stuff online from reputable sources before spending money on a course. Once you are ready to pick a course, don't pick one just because the person claims to be an HF expert. You want to make sure they know development too. HF is not a standalone function, but one of many.

    Hope it helps.



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    Adam Atherton
    Farragut TN
    United States
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    Original Message


  • 5.  RE: training program human factors medical devices

    This message was posted by a user wishing to remain anonymous
    Posted 18-Sep-2020 17:01
    This message was posted by a user wishing to remain anonymous

    Thank you all for your kind responses.
    Adam, I have actually already read all the documentation that you mentioned and listened to several webinars (CDRH learn, greenlight guru and others). I believe I got the usability basics, at least from a regulatory point of view (i.e., my domain of expertise).
    However, I have just been assigned (in addition to RA) the new responsibility of leading all the usability activities, some of which are very linked to D&D. My company offered to pay a 2-3 days training to help me build expertise in this area.
    While I understand the general concepts, I think I still lack expertise in the practical aspects of this discipline, including how to analyze/optimize interfaces, build test protocols, questionnaires, how to choose acceptance criteria, specific methodologies to analyse use-errors, etc.
    I hope this clarifies what I am looking for.
    Thanks

    Original Message


  • 6.  RE: training program human factors medical devices

    This message was posted by a user wishing to remain anonymous
    Posted 18-Sep-2020 17:01
    This message was posted by a user wishing to remain anonymous

    I also agree that there is so much available without spending any money.

    As already listed, FDA's CDRH learn has a lot of resources, including free webinars about the guidance.

    Green Light Guru has also done a number of free webinars and podcasts. Here are the best ones that I share with others:

    • https://www.greenlight.guru/webinar/human-factors-fda-success
    • https://www.greenlight.guru/blog/integrating-human-factors-into-design-controls-to-improve-patient-outcomes
    • https://www.greenlight.guru/blog/design-validation-vs-human-factors-validation
    • https://www.greenlight.guru/blog/intersection-of-medical-device-usability-and-risk-management
    • https://www.greenlight.guru/blog/how-human-factors-impact-your-medical-device
    • https://www.greenlight.guru/blog/intersection-of-medical-device-usability-and-risk-management 
    • https://blog.greenlight.guru/when-design-inputs-go-wrong-design-your-label-like-your-design-your-device 

    Other articles I share for those learning:

    Original Message


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