How to do Medical Device Design Validation

Aphel

Involved In Discussions
#1
Hello everybody,

Medical Device Design Validation is a nice topic...

Everyone in here knows the following defintion:

"Design Validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions."

What does this mean in the daily business - at my site I often have problems to explain people the legal ways and possibilities for performing a design validation to be conform to §820.30g

So I come to my question: what are legally correct ways for performing a design validation (concerning medical devices class 1 and 2)?

Is it allowed to do a kind of "field testing" (user gets the verified product for e.g. 3 months to use it allone at home)??? - of course I am not talking about a clinical study (IDE,...) when I use the term field test.

In my opinion this way is not allowed - am I right?

Thank you very much for your support. :)

Best regards,
Aphel
 
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yodon

Staff member
Super Moderator
#2
Go back to the definition. How would you defend yourself if asked if sending it out for 3 months confirmed user needs and intended uses were met? What documented evidence could you show?

Certainly field testing is a valid means to gather data to support your claims that user needs and intended user were met; but you'd want to have some way to collect the data and some way to show the scope of use is addressed.
 

Aphel

Involved In Discussions
#3
Hello,

Thank you very much.

But I am still not clear with one point regarding "field testing" for the purpose of design validation....

Field Testing is only allowed in combination with a clinical trial, am I right with that?

Thanks a lot for your support.

Have a nice day, Aphel.
 

somashekar

Staff member
Super Moderator
#4
Hello,

Thank you very much.

But I am still not clear with one point regarding "field testing" for the purpose of design validation....

Field Testing is only allowed in combination with a clinical trial, am I right with that?

Thanks a lot for your support.

Have a nice day, Aphel.
Clinical trials is a planned design validation.
It is the legal way as it is done under controlled conditions through authorized personnel and in recognized organizations.
In what context do you use the word "field testing" as a part of validation ?
 

Aphel

Involved In Discussions
#5
Exactly.

I am faced with the problem that "field testing" (= end user uses the medical device alone - no clinical trail) should be part of the Design Validation...


I just wanted to hear from professionals - if this kind of getting information from the user is a legally alowed way. In my opinion it is not. The regulation says that desing validation has to be finished before commercial distribution...

Am I right?

Best regards,
Aphel
 

JeantheBigone

Quite Involved in Discussions
#6
I think the key here is "simulated use conditions." If you are not conducting clinical trials but can find a way to adequately "simulate" the use of your device and carry out tests under these conditions, you are allowed to use the results to validate your design.
 

Aphel

Involved In Discussions
#7
Hello,

I know about the possibility to perform design validation via simulation...
Thanks for the hint but this adressed not my question :-(

Perhaps I try again to formulate my question:

Is it legally allowed to perfom design validation under real (not simulated) conditions with real users (patients use the product alone at home for days or weeks) but without the background of a clinical trial?

Nice regards,
Aphel.
 

somashekar

Staff member
Super Moderator
#8
Hello,

I know about the possibility to perform design validation via simulation...
Thanks for the hint but this adressed not my question :-(

Perhaps I try again to formulate my question:

Is it legally allowed to perfom design validation under real (not simulated) conditions with real users (patients use the product alone at home for days or weeks) but without the background of a clinical trial?

Nice regards,
Aphel.
Risk Risk Risk ....
What is the risk to the real patient with regard to the device you are talking about ?
Is the real patient population informed and aware that they are a part of this, and have given the consent in writing?
Legal comes into place with the authorities are approached with a complaint... ?
You might have done some other form of validation and now are looking for some early feedback perhaps ?
 

JeantheBigone

Quite Involved in Discussions
#9
Hello,

I know about the possibility to perform design validation via simulation...
Thanks for the hint but this adressed not my question :-(

Perhaps I try again to formulate my question:

Is it legally allowed to perfom design validation under real (not simulated) conditions with real users (patients use the product alone at home for days or weeks) but without the background of a clinical trial?

Nice regards,
Aphel.
I'll say that owing to semantics, the answer is "no." This simply has to do with the definition of a "clinical trial."
http://www.nichd.nih.gov/health/clinicalresearch/aboutclinicaltrials.cfm

As soon as you test your device on a group of human beings, it fits a definition of a clinical trial.

This testing may or may not involve assessing the efficacy of your device.

The big question I think what it comes down to is whether your device is considered to be "significant risk" or "non-significant risk" for determining whether you need and IDE and have to get the FDA involved or whether your device is insignifcant risk and you *only* need approval from an IRB.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Hello everybody,

Medical Device Design Validation is a nice topic...

Everyone in here knows the following defintion:

"Design Validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions."

What does this mean in the daily business - at my site I often have problems to explain people the legal ways and possibilities for performing a design validation to be conform to §820.30g

So I come to my question: what are legally correct ways for performing a design validation (concerning medical devices class 1 and 2)?

Is it allowed to do a kind of "field testing" (user gets the verified product for e.g. 3 months to use it allone at home)??? - of course I am not talking about a clinical study (IDE,...) when I use the term field test.

In my opinion this way is not allowed - am I right?

Thank you very much for your support. :)

Best regards,
Aphel
Mind you, most class I devices are exempt from 820.30 (design controls) altogether. :2cents:
 
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