Does Medical Device Usability Study = Clinical Trial?

Mark Meer

Trusted Information Resource
#1
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....
 
Elsmar Forum Sponsor

mihzago

Trusted Information Resource
#2
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

Staff member
Super Moderator
#3
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

Inactive Registered Visitor
#4
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

Trusted Information Resource
#5
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

Inactive Registered Visitor
#6
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

Trusted Information Resource
#7
"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

Inactive Registered Visitor
#8
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

Trusted Information Resource
#9
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

Inactive Registered Visitor
#10
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.
 
Thread starter Similar threads Forum Replies Date
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
R When does the FDA consider a component a medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5
S Does the cable assembly supporting a medical device gets classified accordingly? US Food and Drug Administration (FDA) 1
A UDI on medical device: Does it make other markings obsolete? EU Medical Device Regulations 2
N Does FDA allow comparing with the competitors Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Investigational Testing - Does the Medical Device have to be "sold"? Canada Medical Device Regulations 7
B Does an ?Rx Only? medical device require an actual medical license from the buyer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
R Does oral irrigator fall within the scope of Medical Device Directive 93/42/EEC? EU Medical Device Regulations 11
L Medical Device New Product Design & Development- How long does this process take you? Other Medical Device and Orthopedic Related Topics 1
R Does long-term body worn medical monitoring device need to meet IEC 60601-1-11? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
E Does R&D Equipment in Medical Device Industry require IQ/OQ Qualification and Validation (including 21 CFR Part 11) 9
L When does Medical Device New Product R&D stop and Design start? Design and Development of Products and Processes 6
B Does Saudi Arabia mandate that a CE Mark for a Medical Device is Required? Other Medical Device Regulations World-Wide 10
C Medical Device Malfunction during misuse - Does this need to be reported to the FDA? Other US Medical Device Regulations 5
C At what stage does Design Control play a role in Medical Device Development ISO 13485:2016 - Medical Device Quality Management Systems 2
R First MDR (Medical Device Report) - Does the FDA give feedback? US Food and Drug Administration (FDA) 4
Y Does FDA have regulations about Braille use for Medical Device Other US Medical Device Regulations 2
B Does a Medical Device Battery need CE Mark CE Marking (Conformité Européene) / CB Scheme 20
B Does this count as a 510(k) Medical Device Modification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
E Does MDD (Medical Device Directive) Require a CAPA Procedure? Document Control Systems, Procedures, Forms and Templates 3
K Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
supadrai How does the FDA count violations of, for example, misbranding? (Medical Devices) Other US Medical Device Regulations 1
S What does SOR and DORS stand for in the Medical Devices Regulations? Canada Medical Device Regulations 2
Fatima444-4 Medical devices that does require reg in MoH Other Medical Device Regulations World-Wide 1
M How does Australia handle products that are EU PPE, but Australia Medical Devices? Other Medical Device Regulations World-Wide 7
J How does your organization store documents for Class I and Class II Medical Devices? Benchmarking 4
R RoHS for Medical Devices - Does the directive apply to non-EEE accessories? RoHS, REACH, ELV, IMDS and Restricted Substances 1
A Does EN 60601-1 apply to stand alone software medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
AnaMariaVR2 St. Jude Medical does the unthinkable: Warns of FDA warning letter before FDA issues US Food and Drug Administration (FDA) 5
S Does the power supply need to be medical grade like the EU requires? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
A Does anyone know of a WHO fast-track program for Medical Devices? Other Medical Device Regulations World-Wide 3
C Does a "Significant Change" apply to Class II Medical Devices? Canada Medical Device Regulations 8
R Where does the definition of ME (Medical Electrical) Equipment originate? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
A How does Japan PMDA classify Medical Devices - Classification Guidelines Japan Medical Device Regulations 6
R What does the Programmable Electrical Medical System really mean? IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
P Does the the EU ban BPA and/or Bis-GMA in Medical (Dental) Devices EU Medical Device Regulations 2
K Does Australia require any annual registration or license renewal for Medical Devices Other Medical Device Regulations World-Wide 1
A How does the USFDA treat compilers? (software use in medical devices) Software Quality Assurance 2
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2

Similar threads

Top Bottom