Medical Manufacturing Solutions | R&D - Ways Integer Partners

Research, Design & Development

Integer™ has a long history of partnering with leading medical device companies to provide design, engineering and medical manufacturing solutions ranging from complex, finished devices to components that meet stringent quality and regulatory requirements. When it comes to introducing a breakthrough medical technology, speed to market is critical.  Our focus, in co-development, is to help you manage risk throughout the development process and accelerate your time to market in a cost-effective manner.

Integer's Product Lifecycle - Medical Manufacturing Solutions

 

Project Management

In collaboration with our partners, Integer program managers plan, implement and control projects in accordance with critical standards, regulations and quality systems.

Our approach focuses on achieving customer goals through:

  • Collecting requirements, defining scope and developing project plans
  • Mitigate risk and manage to estimated project costs and timelines
  • Design verification and control systems
  • Phase gate review process

Design for Excellence

Integer implements design for excellence (DFx) best practices to ensure repeatable, higher quality and reliable product manufacturing.  Our team of experts use a disciplined design process to identify critical characteristics, simplify designs and optimize production processes to reduce our customers total cost of ownership.

The design process includes:

  • Design evaluation to streamline functional parts
  • Six Sigma methodologies to minimize defect rates
  • Multi-phased manufacturing approach for a smooth transition between development stages
  • Create and provide a Design History File (DHF) 

Prototyping

As a single-source development partner, our experienced team of engineers, materials experts, scientists and skilled technicians extend the capabilities of our customers to bring new products to market quicker. Our prototyping services include:

  • Comprehensive services from early-stage to final design
  • Expertise to evaluate design concept, technical feasibility and performance functionality
  • Rapid prototyping services to accelerate the development process
  • Design assurance testing at any stage

Test Services

Our industry-leading testing labs empower customers with a proven framework to develop and implement design controls to ensure superior quality and reliability. We offer a comprehensive breath of services:

  • Full design verification testing (DVT)
  • Advanced material testing and metallographic evaluation (SEM, FTIR, DMA & DSC)
  • ISO and FDA compliance testing
  • Meet ISTA and ASTM standards
  • Key performance and validation bench marketing