How do you go about gathering requirements and testing to see if those requirements passed when you are talking about a medical device? Gathering requirements and testing traditional software seems somewhat straightforward in comparison. With medical devices, we are talking about actual humans who are dependent on that software.
Last month I spoke with software development manager Mace Volzing of IntraPace, who uses Jama Contour to manage requirements for the development of the abiliti device — a medical device implanted in obese patients to help control their eating. The device detects when food is eaten and helps the patient to feel a sense of fullness.
In Embedded software for medical devices: Differences to consider in the SDLC, Volzing says that a traditional methodology was used, although he has had success with using Scrum for his website applications. He is thinking about using a hybrid approach for embedded software development in the future.
In Requirements management with embedded software: Interview with IntraPace, Volzing talks more about the requirements process and the increased importance of traceability when working with embedded software applications on medical devices.
Check out this informative and interesting interview!