Design Validation is a powerful tool to achieve a highly effective product. For medical devices, it is crucial to conduct a human factor study to be precisely making sure that the device, equipment or process fits well to the human body. A company does validation to make sure that the company is putting out a quality product that follows the necessary steps to ensure it’s safety, especially if they are medical devices. In short, Design validation is an important part of getting a product to market because it verifies that the user/customer needs are met. It shows the interactions between the device or equipment and the user.
Design validation ensures that the device meet user needs and its intended uses. It is a design control activity that happens when the design development process is at its last stage. Design validation includes every stage from initial production units to final packaging. Design Validation is important to ensure the devices design are proper for desired and functional outcome. Its not if the device is designed right. It is that the design of device is right.
Design validation is crucial, especially if verification fails during the executing phase. It is important to confirm that each numbered input meets the user's needs, before it is tested in a clinical setting. The stakes are higher in clinical testing, so all the risks and user requirements should be clearly stated before we reach that stage. It will also prevent unnecessary financial and time expenditure on those trials. If validation is not met, then adjustments might be needed to the scope and testing protocols. Safety and effectiveness of the final product should be evaluated, especially for medical devices.
Design validation is incredibly important in the product development process because it is what actually tests to make sure you fulfilled your goals. In the early phases of planning, a list of necessary customer needs, should have been translated into technical requirements to satisfy them. After development of the product has taken place, a design validation needs to occur to ensure that these requirements have been met, that the product is safe, and operational. The validation testing is an important factor in product development because of this.
Design validation is important because this is the step where you have to essentially prove that your project was successful. The fundamental purpose behind your project is to develop a product or service that will fulfill a need to a customer, whether it be management or consumers. In the design validation, you have to show that all of your inputs into the product design are met and that they all ultimately will fulfill the needs of your customer. The customer is the one whom the company depends on for revenue and survival; therefore, fulfilling the need of the customer is the most important reason behind any project. In Design Validation, you basically prove that the device that you are introducing to the market can be used by customers and it will perform as expected. As Dr. Simon mentioned, the validation step may not be required if the medical device you have produced through your project is similar to devices already on the market. Another way to think about Design Validation is that you are trying to prove the integrity of your devices, that it will perform as expected and that it meets all of the requirements of not only the customer, but the company and the government.
Design validation is important in design management. The reason being is that it helps make sure that the product passes all test protocol. The test that that are preform during the validation process, examine shelf life, health protocol, efficiency, etc. There are specific requirement that a product must need to be in order to be ready. The validation process help examine and prevents any defects from entering the world, if there is defect they must go back and examined to see what happen before it causes more harm.
Validation is the process of making sure that you have objective evidence that user needs and intended uses are met.. Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Validation it is the establishment of documented evidence of what a system does or what is purports to do based upon the review and analysis of the existing information.
Design validation is important in project management because if the product meets the verification aspects, if it does not meet user needs, the product will not be sold and time and money spent developing it will be wasted. You can try and create specifications and constraints that make sure the customer needs are met, but some are difficult to quantify and need validation to be sure the inputs equal the customer needs. Therefore as a pm design verification is an important part of any project and requires attention.
Design validation is critical to the life-cycle of a project as it is when you test to make sure that the product or deliverables meet the requirements specified by the client. In any company regardless of the industry it is critical to deliver what the client requested. So it is important to design tests in such a way that they will prove whether or not the client's needs have been met. In the Medical Device world this is especially key as the products we design will have a direct impact on people’s lives. Ensuring that the product is effective is critical as pushing a product to the market without properly testing to make sure that it completes its designed function will hurt people.
Even if the product checks off all the boxes, if it does not meet well with customers it wont have sales. This will reflect really poorly on the project manager. The project manager is supposed to be looking out for things like that on top of their other duties during the duration and development of the project. Further as someone above mentioned some companies use validators because people who work closely to the project can be biased so their validation would be too.
Design Validation is a very important because it tests that the device meets the requirements. It is done by customers. It is done to make sure the customer needs are met. Each customer need it created into a test. This is very important because the device was created to help these customers and if the device does not accomplish that then the device does not work. If the device does not pass these tests then the device will not be sold. These tests can also help the team see if there are any little fixes they can make to make it easier for customers to use. Design validation is very important to the project development team.
Design validation is important in product development because it provides evidence that the user needs are met. The fundamental purpose of any project is to produce a product or process that aligns with the requirements of the user. Therefore, user needs must be fulfilled in order to deem a project as complete. Design validation is so important in medical device development that it is considered a requirement as per U.S. FDA regulation 21 CFR Part 820 as well as ISO 13485:2016.
Validation is the process to test to make sure that the device works for the user's end goals. The process usually takes place towards the end of the project life cycle before the product is released, since the device is fully made and already meets the inputs. Verification and validation are not the same; verification occurs earlier compared to validation, and verification tests to make sure that the device is meeting the inputs given. In terms of project management, validation tests are important because project managers can see where the project is along in the timeline, as well as see what results are coming out of the tests. It provides quantitative and qualitative results for the team to see they designed and produced the right device for use.
Design Verification entails that the product you put out is what was actually requested and what the FDA has said is acceptable.
Let's say that the customer wants a product that addresses issues A, B, C, and D. In addition, the FDA says that it MUST align with Rules 1, 2, and 3. Then, when you create the product but miss issue B and rule 2 because you didn't utilise Design Verification, that will not only leave you with a dissatisfied customer and a product that won't be allowed on the market, it will have meant that you've lost out on millions of dollars and hundreds of hours of work, depending on what the product is.
Therefore, its always best to employ this step.
Design verification is extremely important for making sure medical devices adhere to the FDA regulations and restrictions because if they do not, they will be disapproved or cause risk to the user. In today's post-COVID19 climate, there is an influx of people creating masks for non-clinical workers who work in high-risk areas due to their job. I have seen people create masks, but many people are not accepting them due to the verification not being met in the safety the mask provides, rendering them useless. Face shields that are being made by university students for additional clinical PPE (personal protective equipment) also have to meet FDA regulations before being admitted by the hospital. If not, then the safety of the healthcare workers would be the same if they did not work the shield.
The Validate phase – is critical to the long-term success of the project. The transition from the Optimize phase to the Validate phase signals the end of the product creation process and the beginning of the effort to institutionalize the new product design. A poorly implemented Validate phase could mean the supply chain is not ready to support the product, or the product was not validated.
The purpose of design validation is to prove you designed the right device. Doing so means proving the medical device meets the user needs and intended uses.
Design validation is a design controls activity that happens pretty late in the product development process. Despite that, validation is a measure of defining user needs—one of the first activities in product development.
Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.
