Does Medical Device Usability Study = Clinical Trial?

[Mark Meer]

Hi Everyone,

Just seeking people's opinions as to whether conducting a usability study for a medical device necessarily equates to a clinical trial (and all the regulatory headaches this entails).

Basically, the intent is NOT to demonstrate efficacy (with respect to its indications for use), but just to see if subjects in the patient population can follow the instructions, setup, and use the device.

On the one hand, I see the following arguments for clinical trial:
- It involves patients in target population
- It involves using a non-commercial (prototype) device

...but on the otherhand, the device has no adverse reactions identified that could occur in the period of the usability study (10-20 minutes), so it seems extreme to enter the realm of "clinical trial"...

Input much appreciated....

 

[mihzago]

using a term clinical trial is probably an overkill, but it is still a clinical study or a study on human subjects and as such all requirements related to studies on human subjects (e.g. IRB) may apply.
Is the device NSR (non-significant risk)?

Although you state the data my not be used for safety or efficacy, it is still used as part of design validation, which in turn indirectly provides information related to safety (use risk) and effectiveness (usability, can user use the device properly).

It seems that you have satisfied a good part of the requirements e.g. risk assessment, safety testing, and other evaluations prior to administering the device. If the data from the study is not used for any treatment or diagnosis and you have proper consent forms, you may be covered.

If you really want to cya, have a private IRB review and approve your study protocol.

 

[yodon]

Agree with Mihzago that a usability study is not necessarily a clinical trial. If you look at BS EN 62366, in fact, there's the following statement:

This International Standard does not apply to clinical decision-making relating to the use of a MEDICAL DEVICE.


(This was from the :2008 version - there's a :2015 version but I wouldn't expect any change in this perspecitve).

The intent is not to establish efficacy, just that it's usable to the target population. As you indicated, you may not even be using actual devices (which is perfectly acceptable in a usability study).

 

[Marcelo]

Usability studies are not clinical trials, nor clinical studies at all. The objective is to test the user interface, not any clinical aspect.

And it is used for safety, to verify the safety of the user interface design.

 

[mihzago]

Marcelo, I have to disagree.
It is clinical because it's used in an actual or simulated clinical environment and is done on actual or representative sample of population, but human subjects nevertheless.

Moreover it's not just user interface e.g. can I plug in that cable, see numbers, hear alarm, or properly select a menu. It is a study to determine if the device can be used properly, both from the patient and/or clinical user perspective, which in turn has pretty significant input into the safety and effectiveness of the device.

It is not a study to determine the "clinical utility", which is what I think you are referring to.

Many people belittle the importance and extent of usability, many think of preference study. And if it is in fact just a preference study e.g. does it look pretty, what does a user think about my device, then yeah, that's not a clinical study.

 

[Marcelo]

It is clinical because it's used in an actual or simulated clinical environment and is done on actual or representative sample of population, but human subjects nevertheless.

Depends on what you understand as "clinical". Clinical trial is related to clinical functions, not clinical environment.

Moreover it's not just user interface e.g. can I plug in that cable, see numbers, hear alarm, or properly select a menu. It is a study to determine if the device can be used properly, both from the patient and/or clinical user perspective, which in turn has pretty significant input into the safety and effectiveness of the device.

Again, it depends on what you understand as usability.
The most current definition on IEC 62366-1 is:

characteristic of the USER INTERFACE that facilitates use and thereby establishes EFFECTIVENESS, EFFICIENCY and USER satisfaction in the intended USE ENVIRONMENT

So, if we use this definition, a usability study is about verifying the user interface.

We have even a new definition for usability testing:

USABILITY TEST
method for exploring or evaluating a USER INTERFACE with intended USERS within a specified intended USE ENVIRONMENT

 

[mihzago]

"Clinical trial" is a term typically used by pharma or in high risk device trials in support of PMA. That's why I use study, which indicates an activity at a smaller scope and scale.
But it is still clinical, in that it is in an actual environment performed on patients. Here's a definition of "Clinical"
of or relating to the observation and treatment of actual patients rather than theoretical or laboratory studies.

The definition of usability you provided is what I understand. what I was trying to get at is that it applies to all interactions of the user with the device including the understanding what information does the device relay or provide.
Note the terms in your definition: effectiveness (performance), efficiency, USER (patient, clinician, etc., which refers to clinical environment) ... in a specified USE environment (again refers to clinical)

 

[Marcelo]

We also have a definition of clinical trial, from ISO 14155:

clinical investigation
systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a medical device
NOTE ?Clinical trial? or ?clinical study? are synonymous with ?clinical investigation?.

And, as I mentioned it?s related to the device clinical functions, not the clinical environment.

 

[mihzago]

did you read the definition you've quoted?
it says "systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a medical device" , which is exactly what the usability study does.

Also, you can't separate the clinical function from the clinical environment.

Maybe try to separate the word clinical from the word study and look at each separately.

 

[Marcelo]

did you read the definition you've quoted?
it says "systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a medical device" , which is exactly what the usability study does.

Where does it say that a usability study does that????

As mentioned in my other, the usability definition is related to the user interface, and usability testing is testing the user interface. It includes interaction with the user.

Clinical study/trial/whatever is the clinical interaction of the device with the patient. Not the user.