Product Verification and Validation…Important Steps to Consider When Bringing Your Medical Device to Market




In a recent blog, Dac Vu of DeviceLab focused on the research and analysis phase of medical product development and how pivotal this first step is. This phase is an accurate way of assessing the marketability and viability of a product, prior to investing time and money in its development. Today, Vu is going to comment on another crucial step in product development: product verification and validation. This step is sometimes overlooked in the planning phase thus can cause budget overrun and launch delays. Vu states, “Basically, your product cannot be placed on the market without FDA approval, certification and validation. This process may take 3 months or longer and can add to the overall cost of product development.

“An example of the validation segment of developing a product is sterilization and packaging. These processes require about 3 months of laboratory work. Essentially, testing is needed to verify that the sterilization process required for the product is effective and all potential bacteria are eliminated. Unfortunately some clients overlook this crucial back-end process and ultimately a release date is not achievable on schedule. It is much more advantageous to account for the back-end tasks in the planning phase so that the duration and budget for these processes are accounted for. Therefore there should be no surprises at the end.

“DeviceLab has expertise in all aspects of product development, including assessing the certification and validation phases. We are a contract medical device design and product development firm and have successfully worked on over 100 products from concept phase to market commercialization. We can help you with all of your design and product development needs, and take into account every crucial step.