Background:

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.

Objectives:

• 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.

Studies have again recently confirmed the correlation between sophisticated knowledge management systems and improved organizational performance. Unfortunately, these studies have again demonstrated that Pharma significantly lags behind other industries in-terms of mature or expert knowledge management standards (38% vs 68% for non-pharma). The lessons learnt part of Pharma knowledge management often simply consists of a lessons learnt review meeting at the end of a project when positive and negative aspects of project performance are reviewed, discussed and documented. Steps are then hopefully taken to capture this knowledge and pass it on, so that it provides a real benefit to the next projects.

There is so much more to lessons learnt and knowledge management than an end of project review meeting and all pharma companies need to up their games in this area in order to achieve better organisational performance. At this meeting pharma and non-pharma industry experts will discuss, amongst other things, how best to conduct and benefit from lessons learnt exercises and provide some additional helpful tools for knowledge management!

Early bird ticket price now available!