Design Validation is the testing of a product to ensure that it meets the user's needs along with its expected intended uses by the engineers. Specified operation conditions must also be followed.

1) Slide- This product would benefit clinical trials because it is susceptible to user error. If the slide is not prepared the way it was engineered to be, different results could occur. In the eyes of the FDA, it is seen as a new product, and therefore, falls under the need for trials to occur.
2) Bone plate- since this device would classify as a possible class 3 medical device, it would be a good idea for clinical trials to be performed. There is significant risk to the patient if failure of the device were to occur. This medical device may acts differently in subject due to material, position, or shape/size further warranting the need for trials.
3) Suture- Clinical trials are not required if the material the suture is made of along with the antimicrobial used have previously underwent clinical trials in the past. There is no need to repeat costly trials required by the FDA. once again, this is not a new technology so clinical trials would not be required.
4) Knee brace- clinical trials are not required because similar products have already been on the market for some time. This is not 'new technology' so similar trials have already been done on their predecessors. The device is also non-invasive, posing no direct harm to the individual utilizing the technology.

http://www.mddionline.com/blog/devicetalk/design-validation-just-user-testing
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm

Design Validation means exactly that, verifying that the right device was designed. For example, if a user wanted an ointment to heal burn scars but the final product only caused hair to grow on the scar instead then this product would fail design validation. In these respects, don't all medical devices need clinical evaluation for their design validation? Then determining whether a device needs a clinical trial would mean identifying if it is really, truly a medical device.

1. No. Since stems cell marker presence is more of an accompaniment to a medical decision, they have little risk on the patient and therefore such a device would not need clinical trials. This is nothing like a Pap smear or even a molecular test for cancer biomarkers.

2. Yes. Anything implantable posses a high risk to the patient's health and confirmatory clinical trials as to its safety and effectiveness would be required.

3. Maybe. Sutures are a class II device and would only need a 510(k) as long as it is a doppelganger of any existing sutures. Also the antimicrobial part must not seem like a concern and would have to be shown as safe and effective in its use on any previously approved devices.

4. No. This knee brace would be considered a medical support stocking and could be exempt from any clinical trials. Regardless, clinical trials are not needed for ergonomic chairs and keyboards, then why have them for ergonomic knee braces?

Design Validation is the assurance that the product is able to meet the needs of the customer and is in accordance with expectations set by the engineers responsible for creating the product. It involves acceptance and approval from third parties (e.g. customers, external manufacturers, regulators, stakeholders, etc.).

1) Diagnostic slide: These slides wouldn't really benefit from clinical trials and don't really require them. These slides would be used for research and diagnostic purposes, so the work done on these slides would be completed in vitro. In the simplest scenario, the company designing these slides would attempt to create them using existing products on the market in order to have them classified as a class 1 medical device by the FDA. Unless there is something drastically different about the design of these diagnostic slides, they would not need clinical trials in my opinion.
2) Implantable Bone Plate: Without a doubt, a product as invasive as an implantable bone plate would need clinical trials. Like dag56 said above, this would be classified as a class III medical device and would need significant clinical data before commercialization. Even if its design is similar to another currently in the market, any small differences in mechanical and chemical properties can cause severe harm to the patient if tested improperly.
3) Antimicrobial Suture: Unless this suture is of a very similar design to another on the market, I would argue that it would need clinical trials for design validation. Sutures are neither truly invasive implants nor extracorporeal devices; they would likely be classified as class II medical devices. An antimicrobial suture would be used as a standard in surgery, so clinical data is very important to ensure proper performance of the suture's ability to close a wound and safely assist the wound healing process without exacerbation.
4) Knee Brace: In 9/10 cases, I would say it does not need a clinical trial. An ergonomic knee brace is an extracorporeal device likely classified by the FDA as a class I medical device. The knee brace itself would most likely either be similar or an improvement on an already existing knee brace design. Specific situations may call for clinical trials; for example, to test a new material in the design on whether it causes an allergic reaction.

-Talha Chaudhry

Design validation is required to verify if user needs and intended uses are met; it can improve the launch success and reduce the chances of product recalls. In simple words, Validation is to check that you have made the device that the customer needs.
According to PMBOK, many devices do not require clinical trials; however, all devices must go through clinical evaluation. I do not think that a diagnostic microscope slide that determines the presence of certain stem cell markers require clinical trial as part of design validation, and the reason is that device has little or no risk to human subject since no direct contact with human; it should consider as a class I device. After reading and searching, I think devices implantation bone plate, antimicrobial suture, and ergonomic knee brace would need clinical trials as those devices have direct contact with human which significantly have greater risks. I think it does require human factor testing as a part of design validation and fall into class III medical device category. Those devices do require clinical and animal testing to prove safety and efficacy.

Design validation means that the right device was designed for its intended use, such as users requirements.

1) A diagnostic microscope slide that determines the presence of certain stem cell markers.
With Respect to the diagnostic microscope, it would not need a clinical trial because the microscope itself can not determine the presence of stem cell markers, but methods for prepping slides would enhance the microscopes imaging ability, but in the end the user has the diagnostic responsibility.

2) An implantable bone plate
yes, implantable bone plats are a class III medical device and require clinical trials to evaluate safety and effectiveness.

3) An antimicrobial suture
Yes, antimicrocobial sutures do need clinical trials, since they support wound closure and release a drug that prevent infection, it would be considered a combination device, that needs to be evaluated for effectiveness and safety.

4) An ergonomic knee brace
No because the brace is used as a support and does not have a high nor moderate risk to the user and most importantly they are non-invasive.

Design validation means that the right device was designed for its intended use, such as users requirements.

1) A diagnostic microscope slide that determines the presence of certain stem cell markers.
With Respect to the diagnostic microscope, it would not need a clinical trial because the microscope itself can not determine the presence of stem cell markers, but methods for prepping slides would enhance the microscopes imaging ability, but in the end the user has the diagnostic responsibility.

2) An implantable bone plate
yes, implantable bone plats are a class III medical device and require clinical trials to evaluate safety and effectiveness.

3) An antimicrobial suture
Yes, antimicrocobial sutures do need clinical trials, since they support wound closure and release a drug that prevent infection, it would be considered a combination device, that needs to be evaluated for effectiveness and safety.

4) An ergonomic knee brace
No because the brace is used as a support and does not have a high nor moderate risk to the user and most importantly they are non-invasive.

In my opinion, Design Validation (DV) refers to the assurance that a device falls within the requirements that are set forth in the beginning of the project. I believe that DV makes sure that the design of the product fulfills its intended purpose.
Before I comment on whether a product requires clinical trials, I want to first elaborate what clinical trial means to me. Clinical trials are tests at which PARTICIPANTS are involved and are the subjected to different exams while under the intervention of a specific product.
1) Stem cell slides – clinical trials may not be necessary for this type of device. Testing the efficacy of the slide does not rely on the person but on the type of stem cell. Verified stem cells can be used for testing the slides and if it yielded the expected results consistently, it can be classified as a success.
2) Bone plate – this device requires clinical trials because these need to be tested while WITHIN the user. It can be started within different species of models but this devised must be implanted in subjects in order to verify its efficacy as a implant.
3) Suture – since it involves the direct application in the body, it must have clinical trials. From the trials, possible side effects can be discovered through this and other flaws, similar to the implant.
4) Knee brace – clinical trials must be used to assess its effectivity, along with the previous design tests. It may show the effects of the product to the gait of the user. Clinical trials are important because products like this pertain to function that are important to its users. It is important to ensure that they are safe, effective, and do what they are design for.

In my opinion, design validation is the first quality control parameter of a product that ensures that a product not only satisfies all the previously outlined requirements, but also the regulations of the industry. For example, when designing a project you might come up with unique requirements that are outside of the realm of what is currently on the market but it would still need to meet all the regulations that the other products on the market met.

1) A diagnostic microscope slide that determines the presence of certain stem cell markers.

In my opinion this would be under the CBER and would require a trial because it would be a "blood establishment product".

2) An implantable bone plate

In my opinion this would be under the CDRH and be a class 2 and only require a 510(k). As part of the 510(k), it doesn't need a trial but in my opinion a trial should be conducted.

3) An antimicrobial suture

Again, in my opinion this will be under the CDRH and be a class 2 and only require a 510(k). As part of the 510(k), it doesn't need a trial but in my opinion a trail should be conducted.

4) An ergonomic knee brace

This is under the CDRH and is a class 1 so it is exempt from pre-market notification and doesn't need a trial.

Design validation ensures that devices conform to defined user needs and the intended use stated in the design input. I believe a diagnostic microscope has no risk on people therefore there is no need for clinical trial. An implantable bone plate is considered class III medical device meaning highly risk for patients so we must perform clinical trial as part of design validation. An antimicrobial suture will require clinical trial because we don't know how the patient is going to react, also it is considered class II. Lastly, an ergonomic knee brace is a class I with little or no risk, so we do not need a clinical trial.

The initial step to take all together for a mix item to get FDA endorsement is to discover what is the fundamental reason for the item. I simply need to highlight how imperative it is for an item to distinguish its principle useful prerequisite. There were two or three cases from address of how there can be an alternate mix of medications, gadgets, and biologics. To review, there could be a medication that is infused by a syringe. It's fundamental method of reasoning would in all likelihood be the medication in light of its metabolic impact. Another eventual an anti-infection covered hip stem. The principle reason of this would be the hip stem in light of the fact that toward the day's end, it's a physical gadget intended to give basic support.

Any Design Validation procedure comprises of the tests required to demonstrate the functions of the medical device as expected and it should meet the needs of the user. It incorporates inspection and analyses as part of validation in addition to testing.

Any given medical device includes the label, the instructions for use, the packaging, and everything inside your packaging. So you can say Validation includes all of it.

1) Diagnostic slide : In my opinion, since the slide is already present in the market and it will be used in Vitro, it falls under class 1 and so doesn't require any clinical trials for that matter. Whether it is used for diagnosing the stem cells Bio-markers or something else, it can never be classified in any other category. So i guess FDA should be fine with it without it going any clinical trials.

2) Bone plate: From the video lectures what i have understood is, that a bone plate is classified as Class 2 material. And since its not a new innovation so it must be filed under 510(k). And there shouldn't be any requirement for the clinical trials in case of an implantable bone plate as bone plates are always implanted. So it doesn't make a difference whether its a bone plate or an implantable bone plate. But it would be best if the company can just call it a 'bone plate' instead of calling it an 'implantable bone plate'. Because anything that sounds complicated can come in the radar of the class 3 according to FDA.

3)Antimicrobial suture: A suture is usually a class 2 material and needs a 510(k) filing but since this suture claims to have antimicrobial effect when used. So it will have to prove its safety and efficacy, thus will require a clinical trial. Because then it falls under Class 3 as it provides something extra from the usual sutures. But if its already there in the market, then 510(k) form should be good enough.

4) Ergonomic knee brace: A device like that which provides support to the knee cap doesn't even require a Pre-market notification as it is a Class 1 device. So clinical trials is out of question.