Medical Device Design | Research, Design, Development | Integer

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.

Project Management

In collaboration with our partners, Integer’s 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
  • Mitigating risk and managing to estimated project costs and timelines
  • Design verification and control systems
  • Phase gate review process

Technology Department

Our technology department is comprised of a  highly-skilled team of  scientists and engineers who develop breakthrough technologies that can be customized to match the unique requirements of our customers. These cutting edge technologies assure that customers are at the forefront of medical device technology and provide distinct competitive advantages in the form of enhanced patient value.

Examples of Integer-developed technologies include:

  • Greatbatch™ Medical mCONNECT™ – our next generation feedthrough that leverages a proprietary High Temperature Co-Fired Ceramic (HTCC) technology platform.
  • Wet tantalum capacitors – reliable and high energy density customized capacitors for implantable defibrillation.
  • QHR batteries – our hybrid-cathode battery technology, specifically engineered to provide maximum device performance and ensure longevity with minimal size.

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) 

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
  • ISTA and ASTM standards
  • Key performance and validation bench marketing