The completion of process validation is a regulatory requirement that a manufacturer must adhere to. But in some cases as mentioned above the validation is not required .The main goal of human factors validation testing is to demonstrate that the device can be used by its intended users without serious use errors, or problems with the intended uses under the expected use conditions.
Personally, I think human factors validation should only be re-performed if the user interface has changed with whatever product update has been done. As said in your question, validation is often not required if it can be argued that the device has not changed significantly. I don't see why controls and human interaction with the product cannot be summarized under this as well. If human factor validation has not been performed, then I think it is necessary to do such since the success of a product is reliant on a persons ability to use it correctly.
If the device has gone through human factors validation and the user interface has not changed significantly, then I do not see why it should be retested.
An example I have encountered on when validation wouldn't be required is related to product packaging. At the company I work for we have a validated product A with packaging A. We are working on bringing to market product B which also uses packaging A. In this case we did not re-validate the packaging since it is identical and has already been validated. The impact of product B to the packaging such as weight was evaluated to be less worst case compared to product A as well. Therefore after evaluating risk and documenting the rationale, it was decided that a re-validation was not necessary.
In medical devices, validation is generally important to make ensure that the intended usages of a device are safe, if there is an update or change has been added to the device, and a clinical trial is required. So, I think it is unnecessary to have validation when there is no modification after verification and no clinical trial. If the device will be used to living people or cadavers the Validation is necessary, so I think human factors study is considered in most cases.
Verification is laying down the foundation of the validation. Verification makes sure the product works the product works the way it is supposed to. Validation test how well the product works and it is required to demonstrate tests on devices that are being used on humans. An example of these test would be human trials
According to the FDA, Human factors/usability engineering focuses on the interactions between people and devices. This includes understanding the user-device system, it's importance to understanding the ways people perceive information from the device, the way they interpret the information and make decisions about what to do, and how they manipulate the device, its components, and/or its controls. Human factors are important because they allow for input from the user, and then responses and provides important feedback to the user about the effects of their actions. Bottom line is that you want to validate or iron out the user-related hazards and risks, ensuring that the device is safe for mass consumption or usage in the population.
Even if we have passed the verification phase, I believe that if human subjects are involved there needs to be validations. They could change some of these requirements due to humans being involved. If everything is not validated then its a possibility that someone could face adverse effects.
As we all have learned this week, a validation may not be required if:
- There were no changes required to the product after verification.
- A clinical trial is not required
- Product changes did not affect the user interfaceFrom my experience, the human factors study is considered a part of the design validation. So if no changes were required after verification, does this mean that the human factors evaluation is not needed?
Human factors being evaluated are indeed still needed. Whether there were no changes required to the product after it was verified, data still needs to be collected on how the current product affects individuals. Although clinical trials may not have been required, it is not necessarily guaranteed that the design created for the product was perfect. Although the product may not have affected the user interface, this goes by the number of users involved. Although overall the product may go as intended, it may not always meet the proper requirements which is why human factors are necessary.
As we all have learned this week, a validation may not be required if:
- There were no changes required to the product after verification.
- A clinical trial is not required
- Product changes did not affect the user interfaceFrom my experience, the human factors study is considered a part of the design validation. So if no changes were required after verification, does this mean that the human factors evaluation is not needed?
Validation is checking to make sure of the products accuracy. Even if verification is the same and there are no changes I would still like to have the human factor evaluation. I believe that checking through the work and the design multiple times can assure that the product is still up to part. I believe that Verification and Validation both work hand in hand and work simultaneously of one another.
As we all have learned this week, a validation may not be required if:
- There were no changes required to the product after verification.
- A clinical trial is not required
- Product changes did not affect the user interfaceFrom my experience, the human factors study is considered a part of the design validation. So if no changes were required after verification, does this mean that the human factors evaluation is not needed?
Even though validation may not be required because all the aforementioned reasons are not triggered, a validation should still performed because of the human factors evaluation. It is good practice, and if the validation is done and there are problems that arise, the manufacturers would know and have a chance to fix it before the product is released.
Even if changes did not need to be made on the device after verification, it does not necessarily mean that users will particularly like using the device. It's always safe to run a human factors study to understand how one would interact with the device and maybe use participants' feedback to possibly improve on the device. This may lead to some scope creep, but it's better to put out a working device that users will want to use as opposed to one they won't.
Validation is necessary to verify whether the gadget satisfies the user's demands and is fit for its intended purpose; it also aids the corporation in determining whether they are building the proper item. The FDA places a strong emphasis on Validation, which is revisited throughout the whole design controls process of User Needs, Design Inputs, Design Process, Design Outputs, and the finished product to check if it achieves its primary goal. Validation is not necessary if no modifications were made after verification, according to what we learned from the lecture. It may not be technically required, but it would still be beneficial to run a validation report to check it continues to fulfill the user's expectations and that it did not deviate from the original design.
