Title:
Contract Manufacturing Strategy: Cultural & Team Alignment
Session Handouts Available at Speaker Approval:
1
Description:
Selecting a Contract Manufacturing partner is an important strategic decision that can impact a Medical Device Manufacturer for many years. Due to the long product lifecycle of regulated medical devices and the FDA regulatory requirements, transferring to a different Contract Manufacturer later can be very time consuming and costly. Selecting the right Medical Contract Manufacturing partner is critical for ensuring quality, reliability, compliance with regulatory standards, and delivery.
Medical Device companies need a Contract Manufacturing partner with a proven commitment to lasting relationships, manufacturing excellence, and regulatory compliance. This presentation will focus on streamlining the Contract Manufacturer selection process to ensure the best manufacturing provider is chosen for a mutually beneficial long-term partnership.
Topics of focus include:
- Why outsource in today’s market? The benefits and challenges of outsourcing.
- An efficient process for evaluating Contract Manufacturers:
- Medical Device Expertise and FDA Experience
- Process Capabilities
- World Class Operations:
- Facilities
- Teams
- Systems and Processes Including NPI & adoption of AI Technologies
- Supply Chain Strength and Supply Chain Resiliency
- Alignment on MSA Terms
- Sustainability
- Transparency and Cultural Alignment
Type:
Theater Session