Design validation is a stage in product development cycle that makes sure the product does what it's supposed to do. The point of the design validation is not to define outputs or verify outputs, but to set expectations and verify that an input has a distinguishable output. During this stage you are able to identify limitations and what can be fulfilled to customer satisfaction with the product. Overall it is to observe the design and limitations of the product.
Design Validation is actually not always required in the product development process - a product may be sufficient with just Design Verification if it is a product that would not necessitate a clinical trial, i.e. a Class I device. For products like these, there is a low risk associated with not conducting thorough clinical trials, since the device does not pose a significant health danger should the device be defective, and the device's usage is probably self-explanatory. However, for higher-risk devices, proving that the user needs have been met is a must in order to effectively demonstrate that the product can be used properly by the intended user. But again, this still may not require an entire Design Validation stage if all the user needs of your device were tested as outputs during Design Verification. If that is the case then the fact that those were tested during verification may be sufficient.
I believe that the user needs and intended need are not as specific so that when design validation occurs, there is leeway for what is considered passing and failing. They do need to be well defined but not too detailed that when design validation happens, the process might fail and then there is no room to change the process to make the design validation pass. Sometimes there are compromises in user needs when customers want the device or instrument a certain way, for instance what it looks like or what color it is, which can be compromised. What really matters is if the device is being used for the reason it was designed for. If the product is working the way it is, the customers will be okay with the compromised decision of the product. Most user needs are taken into account during the validation but if there is a failure, there needs to be a change made for the good of the patient/client.
After looking at the presentation I came across the topic called Design Validation which says that validation checks that inputs are equal to user needs or intended needs.
So my question is that does this always happens, does this needs are always matched or sometimes somethings are compromised?
Design Validation is the process of ensuring the design outputs meet the user needs. This is an extremely important part of the design process because this is the stage where the design engineers will present the device to the user to ensure the user likes the product. For example, for orthopaedic device companies, the design engineers will meet with the surgeon (user) and show them the product they designed. There will be certain features on the device to highlight and design inputs that need to be validated, i.e. the device must be ergonomically designed, the weight of the device must be low enough for the user to handle, there must not be any sharp edges that could cut the gloves of the surgeon, etc. In order to complete the DIOVV, validation must be completed, or at least addressed. If specific validation activities are not being completed, a rationale must be made an documented in the DIOVV for future reference.
The validation is where the process of evaluating the design/process during or at the end of the product development, meeting intentionally the end-user needs. Successful design validation require thorough understanding of user needs. Validation is a measure of one of the first activities defining user needs. Overall it is to observe the design and limitations of the product.
