Although it may hinder the product a bit in a business sense, I feel as though a medical device meant to work with humans should require validation even if it already passed the verification phase. This is due to the fact that it may not behave consistently across a vast amount of human subjects and these tests need to be in place in order to protect the patients, customers, and the business as well. Even something as simple as a bandage can have adverse effects if it turns out a human can have an allergic reaction to the material. As mentioned above, verification assures that the product works as intended; however, validation demonstrates that the product can work out in the field. With this in mind, it will be prudent to test the product on a wide population before releasing it since not everything may have been caught in the verification phase.