Developing a new product that lives up to, or exceeds customers’ expectations, meets any applicable regulatory requirements, and is safe and effective to use needs to be tested, evaluated, verified and validated. New product design verification and validation efforts require a considerable investment in money and time that can cause a bottle neck in successfully commercializing a new product. Regulated products usually cannot be sold until product design verification and validation are successfully completed. If there are complications in the design verification or validation process that delay a new product launch, significant sales revenue losses compared to expectations can be realized. Using the LEAN V&V method can minimize the time and cost required to successfully commercialize a new product alleviating likely bottlenecks. The Lean V&V methodology starts with having a thorough set of product design requirements reflecting VOC’s (Voice of The Customer) and VOB’s (Voice of the Business) to inform the product design. Defining the V&V requirements by determining what is needed to verify and validate each of the product design requirements while the product is still being designed is the first step in the LEAN V&V process. Often product developers conduct a series of standardized tests that may or may not verify or validate if the new product meets the product design requirements. Relying on standardized tests can result in wasted time and money testing the product for characteristics that are not required while not verifying or validating characteristics that are required, resulting in the risk of quality issues, field failures and potential regulatory compliance issues once the product is commercialized. The LEAN V&V method focuses efforts on the minimum effort needed to effectively prove that each product design requirement is satisfied providing a high confidence that there will be no post product launch quality issues, field failures or regulatory compliance issues. Additionally, using the LEAN V&V method assures that there are no wasteful verification or validation activities. This can reduce the V&V cost by as much as 50%, and shave several months off of the time to launch the commercialized product. If you want to beat the competition to the market with a new product or technology, assure the product will meet or exceed customer expectations and any regulatory requirements, and alleviate the testing bottle neck, use the LEAN V&V method.