Software and other requirements are critically important to medical device product development. In this episode, Chris DuPont, co-founder and CEO of Galen Data, provides his best practices for listeners to consider with their medical device product development efforts. Some of the highlights of the show include: - The medical device industry is about 5-10 years behind the times with adopting state-of-the-art technology. - A successful medical device depends on accommodating requirements and stakeholders; requirements change through communication and collaboration. - Be vague and add details about concept, features, and customer use as you go through product design and development. - Design controls avoid the all-too-common practice of identifying requirements afterwards. - Any type of software development methodology/process can be used for a medical device, including waterfall (iterative), agile, scrum, or sprints. - At Galen Data, Chris uses the iterative method to define requirements, build prototypes, and get design into the hands of users. - Requirements, development, validation, and human factors are interconnected and related when designing a medical device. - Concerns regarding connectivity and cybersecurity are valid; there’s risk in transmitting medical data, but even greater risk when not doing so.