New Product Introduction
New Product Introduction (NPI) is the challenging process that shepherds a medical device from concept to commercialization while ensuring compliance with regulatory, quality, and market requirements.
In this structured, highly regulated environment, the OEM must bring a product to market that is safe, effective, and profitable.
Schivo starts working with its OEM clients early in the concept stage, linking design directly to manufacturing to ensure an efficiently designed and engineered product. Using the Design for Manufacturing (DFM) approach and performing early-run pilot manufacturing builds, our engineers identify discrepancies, prevent mistakes, and optimize product design early in the process. The result is a simplified design that reduces cost, accelerates time to market, assures reliability, and complies with quality standards.
Schivo’s NPI platform includes the following capabilities:
- Deep product knowledge
- Streamlined design analysis
- Proven track record of success ¬ from concept to launch
- Schedule-sensitive project teams
- Dedicated development lab
- Optimized design transfer
- DFM focus that is flexible and scalable
Our expertise supports and guides OEM customers as they journey through NPI’s most critical stages: design and development, regulatory strategy and submission, manufacturing design and transfer, pilot production, and process validation.
