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Episode 111  |  32:09 min

Importance of Software Requirements in Product Development

Episode 111  |  32:09 min  |  11.07.2019

Importance of Software Requirements in Product Development

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This is a podcast episode titled, Importance of Software Requirements in Product Development. The summary for this episode is: 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.
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.

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