It is important that inputs are equal to user needs or intended needs. “Successful design validation can only occur if the user needs and intended use have been well defined at the very beginning of the design and development phase. One of the major reasons for product failures over the years has been the inability of devices to meet the user and market needs.” If everything was planned accordingly at the beginning and throughout the process than the design validation will be successful.

More information can be found at medicaldesignbriefs, design validation and regulatory requirements.

Design Validation is basically, did the project team design the right device? In the medical device industry the design validation used to create device within a specific requirement, like design outputs. The goal is to accomplish all the users needs. I don’t believe compromising is a solution unless the one of the requirements is impossible to achieve. The goal of validation is to make sure all the user’s inputs are met.

Design Validation is a pivotal stage in the product development cycle. I have experience regarding process validation but not design validation. However, user needs need to be met because that is directly coming from the customer who is providing the insight and need for such a device with x functionalities. If a user need is not met then the Engineering teams responsible needs to reevaluate and plan to meet such needs. Just as Parth mentioned, the goal of validation is to make sure all the user's inputs are met. Otherwise, the product may not fulfill the needs of the customer. Potentially make the product sell less or have to be revised which would create more added time.

Hopefully if the user needs are not met as @hc255 mentions above, they would go back to the spec and make sure the output meets the user needs and intended use. I really don't think there is any room for compromising during Design Validation, because if you end up releasing the product without addressing all these user needs, then that may cause issues with sales and customer complaints. Although going back and re-validating could be time consuming or costly, making compromises and releasing a product that isn't meeting all the user needs and intended use will ultimately become more time consuming, costly and detrimental for sales down the line.

I think design validation is to make sure your product does what is suppose to do. Not to define or to verify the output. Design verification is more to set the expectation and to make sure input equal to the output. sometimes we try to be as close as we can help with customer needed but you could face limitation from a different kind, that prevents you from implementing what customer needs 100%. so, I think validation is to check your design vs the expected output of paperwork.

The validation check is a design step that insure that the input meets the user intent, if it does not then the design is incomplete or simply something else. I think that depending on the limitation that is preventing the user intent to be seen in the input, you wont really be compromising but saying your lacking in what’s needed to get the job done.

When most medical device engineers hear the term “Design Verification” they think of one thing: testing. While it is true and very likely that Design Verification will involve testing, there are other acceptable verification activities. Design Verification activities can include tests, inspections, and analyses. The purpose of Design Verification is to confirm your Design Outputs meet your Design Inputs. This is why you have to think about Design Verification when defining Design Inputs.

Design validation in medical devices is that it meets the user needs and intended uses. Design validation involves testing to demonstrate that he medical device functions as expected and meets the user needs. There could be incorporations of inspections and analyses as a part of validation in addition to the testing. Validation is important because the demonstrates that the device has met the user needs or not. Compromising on the validation would not execute the proper testing. Validation is important since the device meets the safety standards, characteristics and requirements.

The whole reason why medical devices, or products in general, are created are to fill a users need, and that need will be heavily researched prior to the initiation of the project, think back to the initiation stage. If you come to the validation stage of product development and your inputs are "abc" and your user needs are "xyz" (very far off) then you would have to reevaluate your methods or your design so that it will meet those user needs in the future. Validation will show you how the product works in the real world situations and if it can actually perform the way it is supposed to. Many things can effect the end product in ways you may have not foreseen, for example minor changes early in the development process may have a domino effect leading up to an unintended compromised device/user interaction, but I don't think compromises will be made intentionally (if that is what the original post was implying).

The way I see it is that the design inputs that you write in must meet the needs of the customer because that is the ultimate purpose of this project. You are doing this project to produce something (e.g. a product or service) that will fulfill the needs of the customer, because he/she is the source of your revenue that your business depends on. There are times when the product may be compromised because there are defects made in the manufacturing process that are not intended. For every 10,000 products, there will always be a certain portion of them that do not fulfill customer needs because there are defects within the device that were caused by an error in actually making the product. Obviously, this was not intended by the businesses but there is always imperfection in producing products and it's impossible for a manufacturing process to produce perfect products continuously. Not every customer's needs are met because some of them will get products that have defects that are not the result of a mistake made within the project but that is caused by the manufacturing process. The actual desired product was produced by mass production will yield defective products, which is why people return products and file complaints with the company. It's possible to produce a product that does meet all of the customer's needs, but it depends on the number of needs that he/she and what those needs are because they could conflict with each other. However, not every customer will be satisfied because of the aforementioned reasons.

One of the most important phases of project management is known as design validation. The process of validation generally occurs as one step or multiple steps of the process, usually in stages and is used to determine if the project is meeting specifications. The specifications of the project are highly detailed, and it is up to the project manger to evaluate the validation process to be sure the project is meeting the requirements. Experience in project management can assist supervisors in evaluating the different phases and steps of validation. Where validation is the technique to evaluate the stages of the project, verification is the proof of compliance made by the project manager. This proof can be in the form of certification, or can be as simple as different area supervisors signing off on the phase of the project. Validation may be a complicated series of tests and controls, where verification is ensuring that those tests produced the expected results. A Project Manager monitors the results through the process and compares them to the stage of the project. The procedure of validation and verification helps advance the project and measures progress.

 Design validation is one of the most important aspects of the design and development process for medical devices. Design Validation is a testing process by which you prove validate that the device works for the end user as intended. official word from the FDA (21 CFR 820.3 ) states that that design validation is establishing by objective evidence by objective evidence that device specifications conform with user needs and intended uses.

Design Validation is one of the important steps in medical devices design and development processes. The goal is to meet the user needs, device to work in the user environment, safety of the equipment for user and the patient. Design validation is needed to check how well the device is designed for customer needs. It is basically the process of meeting intentionally the end-user needs.

Design validation is an important part of the process of completing a project. Shipping a device without properly testing it can cause a number of issues. Without testing, there is no way to determine if the device is safe enough to use or if it is actually effective. It is also important to make sure that you are delivering a device that meets the needs of the customer. I worked on a project to design a cheap and portable way to capture the total number of eye movements in a set period of time. One of the last parts of this project was validating the design, and testing to make sure that it counted the correct number of movements. Whether or not you have to hit the requirements exactly is dependent on the client. Some may want you to get everything they want, but some may be content with just the major needs, and be willing to compromise on some of the smaller needs.