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NN, Inc. (NNBR)       (%)

Medical Component and Device Manufacturing

Packaged Product, Components, Full DevicesNN, Inc. is your single source engineered solutions provider. For over 40 years, Precision Engineered Products Group’s engineers have been partnering with leaders in the medical and surgical device industry to bring innovation and world-class quality to design, tooling and prototyping, development and assembly of complex components, single-use disposables, surgical and drug delivery devices and instruments, orthopedic and spinal instruments, as well as implants.

The PEP Group is a world class contract manufacturer that provides a broad spectrum of support services to optimize performance and reliability.  As a component manufacturer and finished (assembled, packaged, sterilized) device provider, the PEP Group acts as a single-source partner, streamlining the supply chain and providing value as well as solutions throughout the entire process.

Using a Component Management Process to Scale Up Manufacturing of Drug Delivery DevicesPrecision Engineered Products Group is configured to work with your designers and engineers to provide medical device components, whether your needs be plastic injection molding, metal stamping, metal and/or plastic machining to sub-assemblies or whatever level of assembly services your operation requires. Experienced design-for-manufacture (DFM) engineers lead this effort, working with you to ensure the product can be manufactured using the most efficient processes available.

Core capabilities include:

  • Metal Stamping
  • Electron Beam Welding
  • CNC Milling and Turning of Metal and Plastic
  • Plastic Injection Molding
  • Micro Molding and Stamping
  • Additive Manufacturing/DMLS
  • Automated Assembly
  • FDA Certified Cleanrooms
  • Sterile Barrier Packaging

Managing the manufacturing process from product design to customer distribution location…

The PEP Group controls the entire process of manufacturing a medical, surgical device.   Starting with our customer’s design, we provide guidance on material selection, design-for-manufacture (DFM), efficiencies in tooling, and software-based design recommendations.

Clean Room Assembly

Cleanroom Assembly

Clean room assembly uses PEP Group-designed equipment to provide complex automated, semi-automated and manual assembly under highly controlled conditions. Our four Class 100,000 (ISO Class 8) clean assembly rooms are staffed by dedicated manufacturing engineers and are GMP-trained. Assembly processes include staking, ultrasonic welding and adhesive bonding.

We specialize in the design and supply of product-specific packaging programs. Capabilities include specification rigid blister/Tyvek®, pouch and bulk packaging. We can also provide components and finished devices sterilized through gamma radiation or ethylene oxide, supported by in-house protocol validation including kill rates to 106, accelerated aging and transit testing.

Design

Medical Assemblies Design

Our talented engineers can manage the development process from idea conception to volume production of the final product. From planning to execution, we are ready to completely satisfy your product needs.

Our staff of engineers work in highly-skilled cross functional teams to create innovative product and tooling designs. The teams work to mistake-proof, optimize anticipated performance, reliability, and manufacturability, while driving out unnecessary cost. Fused Deposition Modeling, Additive Manufacturing, Finite Element Analysis (FEA), Moldflow® and other solid modeling tools are used throughout the design process to insure optimized process development and rapid movement to reliable full production. All of this is supported by our dedicated Process Improvement and Technical Service teams utilizing process excellence skills to enhance quality and accelerate cost reduction

Quality

Quality Medical Assembly

Planning for product quality occurs early in the development process. This enables our team to identify critical requirements and define all quality assurance methods for application throughout the entire medical manufacturing process. With a state-of-the-art metrology lab and quality system that is ISO 9001, ISO 13485 and FDA registered, We handle your most technically challenging medical, orthopedic and spinal instruments, drug delivery device and surgical designs with competence to satisfy all of your validation requirements.

Through the use of real-time process monitors, on-line vision systems, and statistical process control, we continuously monitor key process parameters as well as critical component attributes to assure that our processes are repeatable, providing our clients with defect-free components and finished devices. In addition, regulatory compliance technicians and engineers ensure that FDA/GMP and ISO standards are maintained.

Metrology capabilities extend to some of the latest tools to validate complex multi-filleted or featured parts including laser scanning CMM, a process that results in a complete 3D point cloud. Laser scanning enables complete inspection and modeling of complex medical and surgical parts and assemblies.

Prototypes

Medical Assembly Prototypes

Vertical integration – tool build and maintenance, stamping, insert molding, assembly and a dedicated prototype facility provide Precision Engineered Products Group with the means to deliver rapid prototypes of medical and surgical components and devices.

PEP Group’s commitment to a dedicated prototype manufacturing capability is specifically designed to attend to the needs of our customers without having to rely on the equipment and personnel resources in our manufacturing areas. Our ability to complete rapid tool modifications in response to product design changes accelerates product development. This translates into delivery of prototype parts ranging from two days to two weeks. Proof of concept parts and assemblies or small quantity production runs are produced to your specifications backed up by our demonstrated capabilities in engineering, manufacturing and tooling. Ultimately, this up-front design and process qualification ensures out-of-the-box product quality and the delivery of robust products to your customers.

  • Integrated injection molding and precision stamping
  • Plastics and metals machining
  • Fourslide implant wire forming and surgical staple cartridges
  • 3D Printing and additive manufacturing
  • Electron Beam Welding
  • Specification rigid blister, pouch and bulk packaging
  • Sterilization – gamma radiation or ethylene oxide
  • Protocol validation – kill rate 106 accelerated aging, transit testing
  • Automated vision inspection