Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi RAPS members,

For human factors validation testing it is advised in the FDA guidance document that some period of time should elapse between training and usability testing to factor in a training decay.  How do most manufacturer's determine the time needed for this elapsed time to account for training decay? 

Thanks!

Hi there,

It really depends on how the device is intended to be used, what the training format is as well at the training duration. Additionally, the complexity in terms of study design is taken into account often as a  "business decision."

I would be happy to chat about this more, I work at an HF consultancy where we advice all types of clients on this very common issue:

Tara 
Taraf@farmpd.com

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Tara
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Original Message:
Sent: 19-Jul-2017 09:00
From: Anonymous Member
Subject: Human Factors Engineering - Usability Testing

This message was posted by a user wishing to remain anonymous

Hi RAPS members,

For human factors validation testing it is advised in the FDA guidance document that some period of time should elapse between training and usability testing to factor in a training decay.  How do most manufacturer's determine the time needed for this elapsed time to account for training decay?

Thanks!

​Good morning

Besides being a regulatory affairs consultant for over a decade I co-founded a human factors consultancy a while ago (www.med-hf.com). Our experience is (based on numerous scientific advice meetings and protocols that we sent to FDA for review), that for devices that are used daily, a 1h break is acceptable to simulate training decay. For devices used less frequently (in most cases we were involved it was approx. weekly), this period should be >24h. The feedback we got for different products was very consistent.

Hope this helps!

Cheers, Beat

------------------------------
Beat U. Steffen
Founder, CEO
confinis ag
Duedingen
Switzerland
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Original Message:
Sent: 30-Oct-2017 07:19
From: Tara Feuerstein
Subject: Human Factors Engineering - Usability Testing

Hi there,

It really depends on how the device is intended to be used, what the training format is as well at the training duration. Additionally, the complexity in terms of study design is taken into account often as a  "business decision."

I would be happy to chat about this more, I work at an HF consultancy where we advice all types of clients on this very common issue:

Tara
Taraf@farmpd.com

------------------------------
Tara

Original Message:
Sent: 19-Jul-2017 09:00
From: Anonymous Member
Subject: Human Factors Engineering - Usability Testing

This message was posted by a user wishing to remain anonymous

Hi RAPS members,

For human factors validation testing it is advised in the FDA guidance document that some period of time should elapse between training and usability testing to factor in a training decay.  How do most manufacturer's determine the time needed for this elapsed time to account for training decay?

Thanks!