Abstract:
Stage (phase) gate development processes have been widely used in the development of medical devices. A stage gate process is an effective project management technique that divides a complex development process into smaller predefined stages or phases. Each stage generally includes a "gate review" in which a management team or group of stakeholders determine if the project is approved to proceed to the next stage. Although the stage gate methodology is an effective method for managing the development of new products, you must be aware of some potentially costly pitfalls. Because stage gate processes segregate the development process into predefined stages, such as "define", "design" and "manufacture", it can become convenient to treat each stage as an isolated element of the development process. This often leads to a single team member or functional department being assigned sole responsibility to deliver the tasks associated with a particular stage. This type of sequential or "Waterfall" development process often allows deficiencies in the project or product to fester deeper into the development cycle, or even into the commercialization stage.

Xeridiem Medical Devices has developed a stage gate process using concurrent engineering methods to ensure new products are developed using cross functional teams with shared ownership across multiple phases. This concurrent engineering method ensures that the needs of all stakeholders (i.e. users, patients, international regulations, marketing, manufacturing, etc.) are addressed throughout the process. Through the use of real case studies, Xeridiem Medical Devices will demonstrate how a concurrent engineering stage gate process can avoid costly mistakes in the development of medical devices.

We will discuss:

• Stage Gate Background
• Potential Pitfalls of Stage Gate
• Real Life Examples
• Stage Realignment to Concurrent Engineering

Intended audience: Small to mid-size medical device development organizations

About the speaker:
Robert L. Leffler, Technical Director