Ensuring a Successful New Product Introduction in Manufacturing: Scaling and De-risking the Transition
Sponsored by: Flex
- New Product Introduction
- N P I
Date: 15 May
Time: 3PM London/10AM New York
Scaling and De-risking the Transition
With the increasing number of outsourcing demands, narrow time-to-market windows and growing compliance requirements, New Product Introduction (NPI) in manufacturing can be more challenging than ever. Outsourcing the introduction of production of new medical devices enables medical device companies to focus on next generation product development and commercial launches as opposed to management of the transfer from development to manufacturing to increasing scale. Considerations for smooth NPIs include robust tracking systems, real-time database analysis, proactive view solutioning, and other procedures to avoiding potential launch delays.
On time product launch to the market is essential to achieving business targets, while ensuring product quality and production ramp to meet growing demand. Meeting supply requirements post launch demands flawless execution of the NPI process.
Transfers are multifaceted, complicated and time consuming. Most NPI’s require 2,000 to 7,000 tasks and milestones. Many tasks are sequential and regulatory compliance driven with the need for 3rd party auditing/testing and approvals. These necessary steps have fixed durations and can impact launch timing, including stretching your planned budget. De-risking this set of activities sets the stage for success. Failure to control for those risks can have costly and unplanned consequences.
In this webinar, we’ll start from the beginning, which is concept and continue to full production ramp, regulatory submission support, and conclude with final product release/ramp. We will explore at a high level the systems, techniques, and resources and learn how to weigh, plan and avoid trade-offs that increase transfer risk. You will also see how team skill set selection, defined deliverables, meeting cadence/focus alignment, and clear senior level support and governance are so critical to success.
Flex VP New Product Introduction
Tim Curran has more than 25 years’ experience transferring hundreds of small and large site buildouts, launch/ramps of class I, II and complex PMA medical devices. The NPI team’s unique background of Supply Chain, Automation, Lean, Process Regulatory, Engineering, Quality and Operations ensures Flex covers a wide spectrum of transfer requirements. Tim leads a global team that has successfully launched startup, next generation and transfers of global NPI’s from all possible entry points.
Key Learning Objectives
- Analyze customer/product requirements, scale, scoping the launch
- Understand customer-required effort, data inputs and output requirements
- Learn importance of and possible ways to de-risk product supply continuity
- Explore the five basic launch drivers: Documentation, Resources, Facility/Equipment, Materials, Validation/Regulatory
- Understand importance of dFMEA, pFMEA, Master Validation Plan, Quality Control plans structure
- Learn how to do a robust validation assessment; challenges and possible solutions
- Gain insight into supply chain hurdles, considerations
- Identify startup and ramp considerations, post-launch service needs
- Understand the regulatory path and global timing requirements
- C-Suite levels
- Heads of Research and Development
- Operations Managers
- Operations Directors
- Operations VPs
- Purchasing Directors
- Purchasing VPs
- Quality Directors and Quality VPs