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.