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Webinar Series

Digital Health for All: Next-Generation Software Development for Digital Health Webinar Series

Through this four-course series, we will explore how to architect complex software solutions, balance agile with regulatory constraints, and showcase how low-code development catalyzes dev-ops. Attendees will learn how to reconcile the speed of modern software development with current regulatory frameworks in digital health applications. The end goal is to paint a picture of how companies, big and small, can transform their software offering by getting away from the monolithic status quo.



About our Digital Health Series

The lifesaving gifts of today’s medical solutions are predicated on software in every aspect of the value chain. With all evidence pointing towards a future being exponentially software-driven, it is important for developers of medical device solutions to not only understand but adopt the latest and greatest approaches. The speed of adoption in this realm translates to better outcomes for patients and their families. This series will build off our previous Master Classes on Intelligent Design Control as well as parts of Design Excellence. As a leading global provider and developer of software, Siemens has expertise in sharing how it enables transformation with not only its customers but also in regard to its own journey.

Sessions:

Session 1 - Complex Software System Development

Developing software that is part of complex electro-mechanical systems is not just about adopting an agile framework. In this session, we cover the different methodologies teams in the context of properly integrating (and managing!) common tools found across the medical device industry such as GitHub, TFS, JIRA, Jenkins, PLM, test automation (i.e. Vector Cast).

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Session 2 - Regulatory Integration for Software as a Medical Device

Agile software development doesn't naturally lend itself to design control and regulated environments. Our 2nd session will cover traceability of standards, integrating risk management, and delve into how agile teams can show data in a hierarchical sense as opposed to just what's inherently an agile perspective. What are these complexities and how can design control help manage it?

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Session 3 - The FDA's Digital Health Regulatory Journey

Join us for an interview with Bakul Patel, FDA Director of Digital Health to discuss the FDA's digital health regulatory journey. Larry and Bakul will chat through the FDA's digital health journey, their stance on digital transformation, what logical next steps look like in your digital transformation journey and constraints that the FDA is working on to lower the barrier of entry into digital transformation.

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Session 4 - Low-Code Software Development: Hello Mendix

Our digital health finale drives home the value of low-code with an open demonstration of how to create applications with multiple data sources. We will discuss deployment and how to set up a low-code center of excellence.

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About the master class host:

Larry Sampson

With 20-years of operational experience in Medical Device, Larry Sampson knows firsthand how to balance device development agility and regulatory considerations. As a Sr. Director of Medical Device Processes at Siemens, Larry spends his days educating medical device manufacturers on best practices in all aspects of their product lifecycles. Outside the 9-5, Larry enjoys the great outdoors of Colorado with his family.

Larry Sampson, Senior Director of Medical Device Processes
Siemens Digital Industry Software