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Class III Med Device Sys

Class III Medical Device Systems

As a Class III Medical Device manufacturer, our OEM partners trust us to custom design, develop and manufacture their implantable pulse generators (IPG) and lead systems. We honor that trust with a focus on accelerating time to market and reducing program risk and commercialization costs. IPGs are an integral part of our history, in the last 40 of our 70+ years, we have designed and developed over 40+ custom IPG systems for customers. Our unique combination of deep expertise, proven technology modules, device platforms and vertically integrated supply chain allow us to deliver complex custom IPG systems, while de-risking program execution and accelerating time to market.

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As a full-service technology partner, we are uniquely equipped to support critical steps across a device’s product lifecycle, from concept to large scale manufacturing. And we strive to become an extension of your team by offering:

  • Hundreds of skilled engineers with expertise in the design, development and manufacturing of active implantable device components and systems.
  • Proven device platforms, such as Integer’s 5cc mSTIM IPG platform, and technology modules that can be customized and leveraged to accelerate and de-risk development.
  • Vertically integrated supply chain for critical IPG and lead components to deliver premium performance cost effectively, including batteries, feedthroughs, enclosures, lead bodies, and precious metal electrodes.
  • Dual site manufacturing for large volume production with capacity for expansion.
  • FDA registered and ISO 13485 certified manufacturing locations.
  • Technology modules that includes charging, communication, stimulation, firmware download, sensing, accelerometer, and real-time-clock
  • Available “off-the-shelf” batteries and feedthroughs with custom development options
  • End-to-end, in-house manufacturing from SMT assembly to sterilization
mSTIM exploded Web

We provide the following capabilities for IPG development and manufacturing.

  • Board & Electronic Design
  • Firmware & Software Development
  • Charging Technologies
  • Communication Technologies
  • Systems Engineering
  • Component Technologies & Design
  • Mechanical Design
  • Process Validation
  • Design Verification & Verification
  • Process Development
  • Manufacturing Transfer
  • Lean Manufacturing

In collaboration, we design, develop and manufacture sensing and stimulation leads for our customers’ implantable device systems. Our design engineers understand the complexity that goes into developing advanced cutting edge lead systems to meet application requirements, from selecting the best materials to utilizing leading industry processes. We have experience in building custom lead systems such as Percutaneous Leads, Paddle Leads and Cuff Leads.

Cuff Lead

Cuff

Paddle Lead

Paddle

Percutaneous Lead

Perc Lead Straight

Our customers leverage Integer’s standard charging platform technologies to accelerate and de-risk development. We design ideal ergonomics for efficiency and comfort in both the patient and clinical environment. Customization is available based on functionality, user interface, size, shape, color, surface type and branding.

We offer fully customizable clinician programmers and patient controllers based on our standard programmer software platform that interfaces with implantable devices to monitor and manage therapy for optimal patient results:

  • Data collection
  • Therapy programs
  • User interface appearance
  • Branding
  • Application functionality

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