Importance of Software Requirements in Product Development

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.

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Some highlights of this episode 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.

LINKS:

Chris Dupont

Galen Data

ISO 13485 Medical Devices

The Ultimate Guide To Design Controls for Medical Device Companies (waterfall method)

MedTech True Quality Stories Podcast

Greenlight Guru True Quality Roadshow

Greenlight Guru

Memorable Quotes from this episode:

“The medical device industry tends to lag the technology curve...because of the regulatory burden and overhead.” Chris DuPont

“The most important thing that you can do for any medical device product development effort is have solid requirements.” Jon Speer

“As engineers, we want to build the coolest, most advanced stuff. But you have to take the regulatory pathway into account when making design decisions.” Chris DuPont

“The whole premise of design control...as a means to iterate and evolve. This is not a restriction or impediment to you for making progress.” Jon Speer

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