Title: Embracing Change: Your Connected Medical Device Is Never Finished

Speaker: Aaron Joseph, Principal Consultant, Sunstone Pilot, Inc.

Date: February 5, 2019

Traditional approaches to medical device development focus on tightly controlling a final product design. In the modern healthcare environment of software-intensive, connected medical devices, there is no final design and companies must become adept at frequently updating their products. Only by embracing change can companies address the modern challenges of connecting to complex, evolving software and rapidly changing cybersecurity risks. This presentation will describe how to structure medical device development for rapid design iterations to speed up product development and to ensure devices remain safe and secure after product launch. Learn how to configure design control processes to support efficient software patches to address interoperability, cybersecurity, OS upgrades, and bug fixes. We will discuss techniques medical device companies can leverage to minimize the cost of change during product development and throughout the product life cycle.