This video from the Navigating Med Tech podcast features the team at Northeast Biomedical discussing the critical role of understanding the customer and defining user needs in medical device development. The speakers explain that successful medical devices must account for a wide range of stakeholders, including patients, physicians, nurses, hospitals, insurers, and purchasing groups, each of whom influences how a product is designed and used. The conversation explores topics such as human factors testing, usability, risk-based development, regulatory considerations, and the importance of gathering feedback from real users early in the process. Through examples from their engineering and product development experience, the team emphasizes that clearly defined user needs help prevent costly redesigns, improve device usability, and create safer, more effective products that can succeed in real clinical environments.