Implementing Agile in an FDA-regulated Environment

Neeraj Mainkar, Neuronetics

While many industries have adopted agile, the medical device industry, which develops products for life-critical applications-where quality and reliability are clearly a top-priority, remains largely stuck under the “waterfall.” Medical device firms must comply with FDA regulations that overwhelmingly suggest a controlled, phase-gated approach to software development. Unfortunately, many companies and development organizations interpret FDA regulations to require a steep waterfall. Many industry long-timers incorrectly see agile as an undisciplined style of software development. Neeraj Mainkar demonstrates how those in regulated industries can overcome these and other hurdles. At Neuronetics, he helped implement key elements of agile while fully complying with FDA regulations. Neeraj explains how his group implemented agile best practices to regularly meet key project milestones, and used effective project management tools and communication techniques to overcome organizational challenges. He reports on ways that agile practices have helped improve the quality and reliability of their software, and served their company to produce software that better meets their customers’ needs.

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