The medical device industry continues to grow and undergo rapid changes. The global medical device market is estimated to reach over $700 billion by 2027. Medical devices include products of all complexities, ranging from bandage strips and thermometers to in vitro diagnostics, orthopedic and other implants, life-sustaining devices, combination products (including a drug or biologic plus a device), and much more. Project management, including how to apply “Ways of Working” such as Waterfall and Agile development approaches, is a strategic skill for leading teams to develop and manage medical devices throughout their product AND project lifecycles.
• Understand the medical product lifecycle, how medical devices are defined and classified, regulatory pathways to commercialization in the US & EU, the Quality Management System and considerations for combination products.
• Understand how project management can be deployed to product lifecycle projects to achieve product and organizational goals, including considerations for using an Agile approach for iterative development, testing and clinical studies.