Applying Agile in MedTech Development
Agile came, saw, and conquered the world of software development. Just two decades ago, it was a new method that only a few startup companies ventured to play around with. Today, Agile (and its extension DevOps) is used with confidence by global enterprises all over the world, and safety-critical companies are forced to jump on the bandwagon to avoid being left behind. FDA's 2013 endorsement of the methodology propelled its adoption in medical device development.
However, having turned from experimental to experiential at lightning speed, maturity in Agile is still notoriously difficult to achieve. Satisfying the stringent requirements of medical regulations in an incremental, iterative, and collaborative development environment is far from trivial. Adopting Agile without jeopardizing compliance is a challenge, and best practices are invaluable for developers looking to accelerate the delivery time of high quality, cutting-edge medical technology products.
To help you realize Agile’s benefits while maintaining compliance with ISO/IEC/FDA standards, we got together a panel of medical experts with years of experience applying Agile in medical device development. Our panelists for this event represent innovative medtech companies and shared their ideas and best practices on implementing Agile in regulated development.
Sarb Singh-Kaur, VP of Software Engineering, Spok (formerly Director of Patient Care Software, Medtronic Neuromodulation)
Sarb has over 18 years of experience driving cutting edge innovation in the Data Storage, Data Protection, Medical Devices, Healthcare and Telecom industries. He’s worked with Fortune 500 companies, and as a senior software engineering leader, he has driven the Agile transformation at Medtronic Neuromodulation. Today, he is the VP of Software Engineering at Spok, a leading company in clinical communication solutions.
Alan Schachtely, Senior Director, SW Engineering, Bigfoot Biomedical
Alan is an experienced software director who has worked with companies like GE before joining Bigfoot Biomedical. The Milpitas, CA-based startup company is developing a connected ecosystem of medical technology to manage diabetes care. Alan has a proven track record of building and leading high performing Agile software development teams, and runs a rigorous lean Agile shop at Bigfoot.
Jared Miller, Co-Founder and CTO, Babyation
With extensive experience in system integration, IT engineering, and software development, Jared is an expert in the implementation of emerging technologies. Running his own software and technology consulting firm for over 10 years, he has supported the implementation of quality systems and change management practices at a number of organizations. Jared started Babyation in 2015 with his wife to bring innovative, tech-driven solutions to parents. He was involved in deve
The discussion will be moderated by Kelly Weyrauch of Agile Quality Systems
With 20+ years of experience, Kelly is the owner and Principal Consultant at Agile Quality Systems, a consulting service focused on helping medical device companies develop effective quality management systems using Agile. After spending more than 15 years at Medtronic first as Software and Systems Engineer, then as Compliance/Audit Specialist, Kelly moved on to becoming a certified Agile trainer and coach. In his consulting practice, Kelly helps medical device companies embrace Agile principles and practices while satisfying regulatory requirements.
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