{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F21d140ed-e33f-4185-94bd-da919ea1c481","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Importance of Software Requirements in Product Development","description":"Software and other requirements are critically important to medical device product development. \n\nIn 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.\n\nSome of the highlights of the show include:\n- The medical device industry is about 5-10 years behind the times with adopting state-of-the-art technology. \n- A successful medical device depends on accommodating requirements and stakeholders; requirements change through communication and collaboration.\n- Be vague and add details about concept, features, and customer use as you go through product design and development.\n- Design controls avoid the all-too-common practice of identifying requirements afterwards.\n- Any type of software development methodology/process can be used for a medical device, including waterfall (iterative), agile, scrum, or sprints.\n- At Galen Data, Chris uses the iterative method to define requirements, build prototypes, and get design into the hands of users. \n- Requirements, development, validation, and human factors are interconnected and related when designing a medical device.\n- Concerns regarding connectivity and cybersecurity are valid; there\u2019s risk in transmitting medical data, but even greater risk when not doing so.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/0ea0d162-b465-4ab5-a62c-5bfdb9c8f189/b632ba92-87ae-4fc7-b277-5d1fe2c8fd0f.jpg"}