In most cases I believe validation and verification may be necessary especially in medical devices. Verification and validation together prove that a product is safe and that it meets its requirements, specifications, and is used as intended. The purpose of validation is to make sure the product meets its business needs from which the requirements were formed. Even in cases where validation isn't required to be performed it would be a good idea to do so anyway because it offers another possibility to bring up an issue or defect before release.
Validation is not necessary when there is an update to the design which has no bearing on the usability or function of the product. For example, changing the color of a device from blue to green, where color has no bearing on function, would not be re-validated. However, it is good practice to validate all designs because it is important to function in the intended setting.
Validation may not be necessary for all the reasons listed above but it's still better to perform them as it keeps the team and the design on one page. If something changes then it can definitely be verified in the clinical trials which can be beneficial to the organization. Nowadays people trust the organizations more who have accurate data and I think validation is the key to gain success.
Validation is important to determine if the device meets the user needs and it's intended uses, it helps the company determine if they are designing the right device. The FDA heavily focuses on Validation where technically during the entire design controls process of User Needs, Design Inputs, Design Process, Design Outputs, and the final product; Validation is always revisited to see if it achieve's it's main intention. As form what we learned from the lecture, Validation is not required if no changes were made after verification, it may not be required technically but it would still be helpful to run a validation report to ensure it continues to meet the user needs and that it did not deviate from the original design.
I agree with previous posts like @asimbana mentions that validation is important to determine if device meets user needs and it's intended use. I like @williamzembricki's comment "When in doubt, validate". I agree that it is necessary for most cases especially with medical devices for validation to be done. Validation is key in determining and testing that the device meets the user needs, and you want to make sure your company is putting out a quality product and following the necessary steps to ensure that especially for medical devices. It can be costly if the appropriate validation isn't performed. I came across this interesting article from earlier in October in New York Times about how Replacing Faulty Heart Devices Costs Medicare $1.5 Billion in 10 Years. $1.5 B is very big number, the article goes on to say that in the past five to six years, more than 200 cardiac devices have been recalled. Device makers are required to report problems they learn of, often from doctors and hospitals, to a database run by the Food and Drug Administration. Overall, I think Validation is an important step as everyone has mentioned above and is a useful part in the earlier stages before production. No one wants a faulty heart device, that's costly for everyone involved.
Having trouble adding the link: NY Times October 2, 2017 article Replacing Faulty Heart Devices Costs Medicare $1.5 Billion in 10 Years
Validation is always an important step in the Design Controls. However, it is not necessarily always needed if there are no changes like you mentioned. Although that might be the case, I feel that a human factors evaluation should still be done. The evaluations are necessary to understand the interaction between the person and the medical device. There may not be any changes to the product, so it may seem pointless to do the evaluation. However, this could people’s lives at risk. If the human factors evaluation is not completed, and there is a malfunction in the medical device, this could cause harm to the person using it. As a result, this could backlash on the company and it would become unreliable. It is better to be on the safer side and to do the human factors evaluation.
I believe that even though it is not required, it is important to point out that performing the validation process can do more benefit than harm. Although it may add to the costs, it would be better to do because it makes sure that the product made performs up to its desired results. I also think that it may seem as if it is unnecessary but it should still be performed to have the complete process.
Validation is necessary 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. Validation is an important key in determining and testing that the device meets the user needs. In addition, we want to make sure that our company is putting out a quality product that follows the necessary steps to ensure it's safety especially they are medical devices. So, even though there are no changes required after verification, it does not mean that the human factors evaluation is not needed.
In terms of determining whether to perform validation or not, validation should still be conducted in order to keep better understanding the product, and that human factors evaluation should be completed as well. Even if there were no changes to the product after verification, you still need to make sure that the majority of the population will be able to use and understand the device. A device may be extremely useful, but very difficult to operate, understand the results, or manage on a daily basis for an individual. By conducting a human factors evaluation even with no clinical trial or changes to the device, you are marketing your device better by learning exactly how the user is interacting with the device, and how it can made simplified so that more users will purchase and continue using the device. Validation may cost the company more money, but it will give them the ability to perfect their device and make even more money after sales.
I personally would not skip the validation process. 1) you would want to confidently state what parameters your device will conform to without any doubt. 2) If anything happens, it leaves you open to a law suit. Whether it's required or not, it is best practice in my opinion to still utilize it.
Similar to mentioned already, validation is the process of making sure that the objectives meet the user needs and intended uses have met. certain methods that verify these details are through inspections, clinical trials, and design analysis. After the design verification has completed, the design validation is still must to assure all objective according to the documents. Regardless of no changes results after verification, human factor evaluation is required for any equipment.
Hi Fady: let's, for a second, suppose that the auscultation, acoustic medical device, the stethoscope - known to be in use since 1816 - just got introduced to FDA for approval, what classification would anyone expect to be assigned the device; say, in comparison with the stent, of high invasivity during usage?
Measurements taken by both have to do with some aspect of heart functionality; that the heart is the sustainer of our lives, is nothing new to anyone.
You guessed it; most likely class 1 while the stent may be given a class 111 placement.
FDA categorizes medical into one of three classes: class 1, 11, or 111 based on their risks and the regulation controls necessary to provide reasonable assurance of safety and effectiveness. Class 1 devises generally pose the lowest risk to the patient and/or user whereas class 111 devises pose highest risks.
It might even make sense to say that the FDA's concern is merely a matter of necessity - protect the public against hidden dangers.
Although a stethoscope has been in use since 1816, it has never been reported that anyone has been exposed to some level of danger through its use on them; the stent has.
The FDA's medical device classification is only a precautionary measure set forth as an example for medical device designers and manufacturers to emulate.
However, were inspection of the harmless stethoscope brought in for the FDA's approval be limited to verification and the designer of the devise insisted validation be conducted on the device as well, then that would be up to them. No one gets punished for such an act.
A validation is defined as conformation by examination that the particular requirements for a specific intended use can be fulfilled. Examples of when validations is required are sterile package sealing processes. An example of when a validation is not required is a manual cutting process. The following are examples of products that require validation:
1. Class I: a waterproof band-aid
2. Class III: Aortic cutter
A validation is not required if the product changes did not affect the user interface or clinical trial is not needed. It is necessary only for checking product specifications, interface standards and judging through end user’s perspective view. In my opinion, human factors should also be taken into consideration for a medical device to work effectively and efficiently.
Just like the Human Repeat Insult Patch Test (HRIPT) is carried out in clinical study and on product (mostly OTC) just to see if any allergic reaction might have developed over the years. Also, the Human factor study is needed to ascertain the efficacy, efficiency, and the safety of a device. So if human factors study is considered a part of design validation, I would say, in short, validation is needed even when there are no changes in product. A device working for years with no validation can be risky to humans.
In a nutshell, validation also serves as a risk assessment just to make sure that a device will keep working after years and not have any adverse effect on any patient.
