Fady

Validation is powerful tool to achieve highly effective product. As we all have learned, Verification is to look any flaws in the products, whereas Validation is necessary for judging it through end user’s perspective. In my opinion, even if validation is not performed due to reasons listed above, it is always good practice to conduct human factor study to be precisely sure that device, equipment or process fits well to human body.

-Hetal

Like Hetal mentioned above, it is a good idea to conduct a human factor study even if no changes were required after verification. For medical devices, it is crucial to run the human factors/usability engineering process in order to reduce risks and further ensure that a device can be used safely by patients. By performing human factor studies, the risk of recalls, adverse events, and user errors can be reduced. Additionally, the device should be checked to have safe connections with any accessories and also have functional controls and displays. A human factor study will decrease user reliance on manuals for the device and decrease the need for user training/retraining.

In general, validation is an important part of getting a product to market because it verifies that the user needs are met. Even though it may take up to a few years to complete, it can improve the launch success and reduce the chances of product recalls. Also, other benefits can include the reduction of scrap, increase in outputs, eliminate rework that help with the product’s success. In addition to this, the human factors are one of the additional process that can improve the launch success. I agree with the statements above that this testing assist in identifying errors during user interaction that could lead to harming the patient. Similarly, it is used to assess the effectiveness of risk management and confirm that the mitigation for residual risks is acceptable.

http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm484345.pdf
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm259760.pdf

Hi,

It’s very important to do the human factors evaluation. It shows the interactions between the device and the user. It’s performed to make some manipulations to the device and perhaps replace some components. It is crucial when we want to know the interference between the user and medical device. When human factors are considered the device is safer and easier to use. The devices operation is better understood. It also show easier methods of device maintenance and repair. So, even the validation is not required the human factor study should be executed.

Thanks

Even though the FDA does not have hard rules for human factors, only guidelines (as per the link given by Luisa).The FDA expects manufacturers to engage in human factors for risk management and it is very important. The human factors focus for risk management is the use-related errors. Risk management of use-related errors deals with the identification and description of use scenarios that could result in hazards and the assessing of these risks. To asses these risks it is needed user interface design changes that eliminate or mitigate risks. Then by verifying that the design changes do mitigate risk and that no new hazards are introduced they can validate that the final device can be used safely and effectively. Device manufacturers shall definitely perform human factor evaluations to ensure that the device can be used safely and effectively, and that they can justify their level of human factors effort to the FDA if asked.

Human factors/usability engineering focuses on the interactions between people and devices. For medical devices, the most important goal of the human factors/usability engineering process is to minimize use-related hazards and risks and then confirm that these efforts were successful and users can use the device safely and effectively.

In my opinion, I would say that the human factors is not required in the case where validation is not required. If no changes were made to the point where clinical trials are not needed and there are no changes to the user interface as you mentioned, then it should not be a requirement. However, I would have to agree that having it would not hurt, it can only help in the long run.

I do believe that even if there are no changes after the verification the human factors evaluation is needed because it allows you to check the quality of the product. Also, the evaluation can show if the product can be a good use to the human body. Just think about if there is no evaluation is not completed the device can be harmful for patients. The link below is an article that was written by ASME that breaks down Validation and Verification for Medical Devices. One of the things I found interesting was that it gives answers to question that you may have about Validation and Verification.
https://www.asme.org/engineering-topics/articles/manufacturing-design/validation-verification-for-medical-devices

Even though the lecture cited examples, I would sleep easier knowing validations were done to mitigate risk. Even if there were no changes affecting the human factors of the device, you still need to check the product. What if there are no changes but suddenly an outside factor such as out of control bioburden affects your product? The validations are there to help you mitigate these and other factors. Besides, its good business practice as it does build a foundation for new experiments later on or, in the eyes of an auditor, allows you to boast the robustness of your quality plan/risk mitigation.

I agree that is is important to analyze external factors! Once example I know is that IQ's (part of validation) are needed even if the product is moved one foot on the product assembly line because you have to consider things like "Is there any outlet nearby?", "Does the new outlet supply enough power?", etc.

According to the US Food and Drug Administration’s Quality System Regulation (Code of Federal Regulations Title 21 Part 820), 820.3(z) Validation means establishing by objective evidence that the particular requirements for a specific intended use can be consistently fulfilled and 820.3(aa) Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. So, even though it appears to be validation maynot be needed as verification is done, human factor evaluation plays considerable role in detrimining the critical elements.

Design validation ensures that the device conforms to defined user needs and intended use(s). While some design validation can be done through "bench testing" most likely if the device requires user interface it will be essential to perform human factors evaluation in which representative production units are tested under actual or simulated use conditions and will include risk analysis (assessment of use errors).

I agree with previous comments about the need of HF. I came across this interesting situation where it seems like validation could be a bit flexible. There's this article from Arena Solutions giving an example about Band-Aid products as a Class I device.

If the band-aid did not meet the product requirement stated in the document, the company could make design alterations and the validation tests could be repeated. However, because the consequences of band-aid failure are inconsequential, the regulatory board may not need to get all the validation documentation in order to approve the product for sale. In this situation of a product belonging to a low-risk class, the company might be able to present documentation which demonstrates the product and match it with a comparable approved product.
Respectively, I think, when you are in the spot that you don't need a validation, it's all depending on the risks of the product in comparison with the cost of conducting HF evaluation to decide.

(This stated article is from Arena Solutions, I had trouble adding links to comments)

Through my experience I have seen very few cases when a validation is not required. I believe a lot of the requirements come from internal pressure and may not be directly required by the FDA or ISO audits. When in doubt validate. It seems that you are in a way worse situation if a validation was not executed when it was needed than to validate a product that might not have needed to be validated. The validation process can be tedious and often the individuals requiring you to validate are not the ones that need to do the process. It can be annoying to validate a product that seems very unnecessary to validate, but it is always better to be safe than sorry.

Although it may hinder the product a bit in a business sense, I feel as though a medical device meant to work with humans should require validation even if it already passed the verification phase. This is due to the fact that it may not behave consistently across a vast amount of human subjects and these tests need to be in place in order to protect the patients, customers, and the business as well. Even something as simple as a bandage can have adverse effects if it turns out a human can have an allergic reaction to the material. As mentioned above, verification assures that the product works as intended; however, validation demonstrates that the product can work out in the field. With this in mind, it will be prudent to test the product on a wide population before releasing it since not everything may have been caught in the verification phase.