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7 min reading time
10x faculty member Aaron Joseph believes agile methods can almost universally be appropriate for medical device software development.
Yet he finds relatively few medical device manufacturers have adopted the methodology. Why?
Aaron says, “There’s a mistaken belief that medical device regulations and standards don’t allow for agile methods. But agile can be defined as iterative development to drive rapid learning (as in the scrum method). When combined with empowered product development teams, agile methods can address common problems including:
Is the main challenge to adopting agile methods a simple resistance to change? Perhaps a company is comfortable doing things the familiar way?
Or are the perceived benefits outweighed by the perceived difficulty changing methodologies?
For the group,
· Has your company adopted agile methods for medical device software development?
Meet Aaron, Maren Nelson, and Kelly Weyrauch at their 10x Medical Device Conference panel in San Diego, May 3: http://medgroup.biz/10x
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Janet Andrews, M.A.
Of course, it is challenging to use Agile in a regulated space and under strict quality systems that demand design controls and extensive documentation. Like many others, we used the AAMI TIR45:2012 to get us rolling. It took a lot of trial and error in the beginning months to streamline the system. At this point, it has become second nature.
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Agile has been the dominant model outside of healthcare, it’s only a matter of time before it is commonplace there as well. The benefits are real, but there is hard work to get system rolling, and a lot of diligence, and sometimes course corrections, that needs to happen to keep the system working as intended.
James (Jim) Dent
What’s worse, is that they start talking scrum but have no user engagement or don’t include the necessary stakeholders in the scrum team. The California company IMPAC did a good job with Agile before they were acquired by Elekta. Great ISO/FDA compliant quality system using without waterfall.
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