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Design validation

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(@aasutosh-purohit)
Posts: 37
Eminent Member
Topic starter
 

Testing aimed at ensuring that a product or system fulfills the defined user needs and specified requirements, under specified operating conditions is called Design Validation. My question is why is design validation an important factor in project management?

 
Posted : 10/03/2018 11:50 am
(@cdj24)
Posts: 40
Eminent Member
 

Design validation is important in project management because even if the product meets the verification aspects, if it does not meet the user needs the product will not be used or sold and the time and money spent on development would have been a waste. Validation is part of why pre-clinical testing is done. For example, a hip implant could be designed and meet the design inputs but until it is surgically implanted and analyzed you won't know if the device meets customer requirements. You try and create specifications and constraint 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.

 
Posted : 10/03/2018 2:08 pm
 zbw2
(@zbw2)
Posts: 47
Eminent Member
 

design verification is ensuring that the product that you just spent an extended period of time does what you intended it to do. without design verification there is no way of proving the efficacy of the device. this ultimately can lead to FDA disapproval and/or get you in trouble with the FCC as the device may not provide the functions marketing is claiming in advertisement for the device. Therefore as a PM Design verification is an integral part of any project and requires adequate attention.

 
Posted : 10/03/2018 6:54 pm
(@ak977)
Posts: 41
Eminent Member
 

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.

 
Posted : 10/03/2018 7:36 pm
(@sahitya-sadineni)
Posts: 69
Trusted Member
 

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.

 
Posted : 11/03/2018 4:44 pm
(@ap962)
Posts: 33
Eminent Member
 

Design Validation is carried out by by examination and provision of objective evidence that ensures that device specifications conform with user needs and intended uses. It includes testing of production units under actual or simulated use conditions, software validation and risk analysis.
It is important in Project Management as design verification is a detailed examination of aspects of a design at various stages in the development but, design validation is a cumulative summation of all efforts to assure that the design will conform with user needs and intended use(s), given expected variations in
components, materials, manufacturing processes, and the use environment.

 
Posted : 11/03/2018 5:44 pm
(@merzkrashed)
Posts: 123
Estimable Member
 

I think validation is the most important process in a design control. As a project manager you need to know what is validation mean and how you validate a product. You need to make sure the device you have created is working in the human body and achieved the required goals. Validation is not only the right thing to do, but also its required by the FDA.Also, Quality System Regulation 21 CFR Part 820 and ISO 13485:2012 requiring the manufacturer to perform tasks associated with IQ’s, OQ’s and PQ’s. According to FDA regulations states "You always need to validate if results of a process cannot be fully verified by subsequent inspection and test".
Validation cost a lot, so be aware that not all the medical devices need to be validated. For example as Dr.Simon mentioned, tongue depressor no need to be validated. If every input in the design control is truly and fully verified, so Validation is not required. Finally, by implementing a successful validation process, medical device manufacturers can improve productivity, reduce recalls and consumer complaints and also reduce the burdensome process of investigations.

 
Posted : 11/03/2018 6:19 pm
(@anmolkaur)
Posts: 38
Eminent Member
 

Design validation is an important factor because 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 against critical-to-success (CTS) factors identified by the customer.

 
Posted : 11/03/2018 6:50 pm
(@mb698)
Posts: 83
Trusted Member
 

Design validation proves that the medical device meets the user needs and intended uses. It assures that the product meets the needs of the customers. It is important to do the design validation earlier in the project because it determines if it effectively demonstrated the medical device meets the user needs. Validation is important in the design, development and production of medical devices. Effective and appropriate validation plays an important role in defining the success of a product. Design validation is important because it provides theoretical assurance that the design is appropriate in regard to the defined design input requirement, is safe and effective.

 
Posted : 22/02/2019 12:41 pm
(@ajm73)
Posts: 81
Trusted Member
 

Design validation is important in Project Management because it basically answers the question "Does this device do what it is supposed to do?". If after testing is done the device is found to not perform at the requested level or even misses requirements, then the device is considered to have failed to met the design requirements. This is critical as the whole point of managing the project/device is to deliver on the initial requirements outlined in the beginning. If design validation is not done or is ignored, it can prove to be harmful to the end user and device maker. For the end user, the device may be used with a certain expected intention, but because it did not fulfill the needs, it can cause unexpected and/or harmful results. For the device maker because such a mistake is an expensive problem to fix and can cause harm to the maker's reputation.

 
Posted : 24/02/2019 6:22 pm
 za84
(@za84njit-edu)
Posts: 76
Trusted Member
 

Design validation is an important factor in project management as it will determine the needed deliverable to ensure that the correct product with the aimed solutions will be delivered to the customers' needs. In the medical devices industry, in particular, ignoring the importance of the validation stage means that a company did not design the right device that a patient would need to use, which means a waste of time, effort, money, etc.
Per the Greenlight website, "Design Validation means the medical devices used for validation have to be built in the production environment, using drawings, specifications, etc. (i.e. Design Outputs) by production personnel. This means that the end-user(s) should be involved and the device should be tested either under simulated use or actual use."
The importance of validation is caused by the consequence that would occur if this step was ignored such as a negative effect on public health.

 
Posted : 24/02/2019 6:54 pm
 pi29
(@patricia)
Posts: 76
Trusted Member
 

The purpose of the design validation is to confirm that the product's intended use is what it's designed to be. Not just the product, but whatever the project is. For example, during my internship there was a project that needed validation of the packaging. The purpose was to make sure that the packaging process did not introduce for example pinholes or tears to the packaging, or damage to the seals, as well as that the final package retained its integrity after x amount of time at the storage temperature. The validation had passing results at the end of the study however in other cases sometimes red flags are raised that alerts the quality team to possible concerns in the future. It's an important process that helps confirm the intended use of the material/s being tested and determine possible product concerns that could affect for example product shelf life.

 
Posted : 24/02/2019 7:08 pm
 Sk90
(@sanam)
Posts: 109
Estimable Member
 

Design Validation is a Design Controls activity that happens late in the product development .This is the stage where you actually build a version of the product and validate against the user requirements. 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 specification.The specifications of the project are highly detailed, and the project manager will evaluate the validation process to be sure the project is meeting the requirements. The validation helps advance the project and measures progress.The key benefit of this process is that it brings objectivity to the acceptance process and increases the chance of final product, service, or result acceptance by validating each deliverable. Design validation provides evidence beyond theoretical that the device you designed is truly safe and effective within the context of those same design input requirements.

 
Posted : 25/02/2019 5:17 pm
(@hariharan-ganeshan-thevar)
Posts: 39
Eminent Member
 

Design validation is first stage for the device development and it's most important stage. As the design of the device is made, the main job was to validate or else to check whether the design is proper or not. So the main issues Design validation face that the design validators should not be within the team, should be a external valditors that because the within team valditors can sometime blind the issues where as the external validators can examine and raise the question against the design which leads to problem sloving of the design.

 
Posted : 03/03/2019 3:51 pm
(@jla33)
Posts: 26
Eminent Member
 

One of the most important phases of project management is known as 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 manager 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.

 
Posted : 03/03/2019 5:55 pm
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