Vertically Integrated Contract Manufacturing

Norman Noble, Inc.‘s unique micromachining and finishing capabilities enable manufacturing of the newest medical implant, component and device designs. We specialize in micromachining exotic materials to very complex geometries with dimensional tolerances to +/-.0001”. Our vertically integrated, microprecision manufacturing processes, including dedicated operations for Stent Manufacturing and Orthopedic Implant Manufacturing, make us your single source solution for the most challenging projects. At Norman Noble, Inc., we ensure the highest level of quality for your medical products through our automated, 100% dimensional inspection and complete process validation services per ISO 13485:2003 & EN ISO 13485:2012 (The International Standard For Medical Devices and Implants) and FDA QSR 21 CFR Part 820.

 

Medical Device Manufacturing


Process Validation: Process validation begins at Norman Noble, Inc. (NNI) with a clear understanding of our customers' needs together with ISO standards, Current Good Manufacturing Practices (CGMPs) and the NNI Quality Policy.

During the review process of purchase orders and contracts, our Process Validation team works with customers to develop a validation strategy and a Risk Analysis that incorporates qualified machinery and trained personnel using the most repeatable and reliable test methods. Process development continues with the manufacturing of “pre-qualification” product.

Our engineering team may develop multiple Designs of Experiments to further define the ranges of settings for variable process parameters. The process is then qualified by testing the product at the extremes of these variables, indicating that all products manufactured within the boundaries of these variables produce predictable results. Multiple lots of product are then manufactured and documented over time at the nominal settings of these parameters to challenge various operating conditions, which completes the process validation activities. Additional Product/Process Performance Qualification activities also can be performed as needed.

All validation activities are well documented in our internal Device Master Records, with a statistical approach towards certification of the product meeting each customer‘s requirements. For more information, please dowload our white paper on FDA Compliant Validation of Medtech Implants and Devices.

 

Newest Technologies: Norman Noble, Inc. is the leader in utilizing the newest technologies available for Micromachining, Laser Welding, NiTinol Shape Setting and Specialized Finishing of medical devices and implants. Proprietary Manufacturing technologies are also developed as required and available, including: Athermal Laser Machining, Laser welding of dissimilar materials, Square Corner Electropolishing, Electropolishing of Nitinol, Nitinol Shape Setting and Electrochemical Grinding.
 

7-Axis Contour Milling

Some examples of the many exotic materials we use to manufacture components include: NiTinol, PEEK, Tungsten, Titanium, Platinum, MP35N, Gold, Molybdenum, Bio-absorbable Materials, Cobalt Chrome, Carbide, Kovar, Silver, Implant Grade Stainless, Beryllium Copper, Invar, High Temp Nickel Based Alloys, Platinum Iridium, Tantalum and more.

Design For Manufacturability: Medical Device OEM’s that have applied Norman Noble Inc.’s Design for Manufacturability services have realized substantial benefits. Costs and time-to-market are often cut in half with significant improvements in quality and delivery. These services are most effective when applied to projects that involve tight tolerances and exotic materials, including NiTinol.

By partnering with Norman Noble, Inc. on Design for Manufacturability, our clients have access to:

  • NNI‘s innovative machining and finishing technologies for medical implants and devices
  • DFM expert assistance, which establishes the feature set, how well the features work, and, hence, the marketability of the product
    • Product design determines the bulk of the production cost and has significant influence on quality
  • Dedicated Process Development Centers for prototype manufacturing
  • The most experienced manufacturer of NiTinol-based implants in the world
    • Norman Noble, Inc. is the largest laser contract manufacturer in the medtech industry


For more information, visit our Design For Manufacturability page.

Prototype Manufacturing

Our Process Development Centers support the manufacturing of medical implants, components and devices from initial prototype through FDA approval and full production requirements. Our experienced engineering team develops the manufacturing processes to provide customers with the most cost effective, highest quality medical devices and implants, and our proprietary manufacturing and finishing technologies enable us to bring to market products that might otherwise be considered cost prohibitive or unable to be manufactured using standard available manufacturing methods.

For more information about our prototype manufacturing capabilities, please select from the list of processes below:

 

Engineering and Testing Services: Engineering and testing services are essential to product development, product refinement, manufacturability, verification testing, and FDA approval. At Norman Noble, Inc. these services streamline the product commercialization process for our medtech customers, liberating internal engineering resources and enabling them to bring new products to market quickly and cost effectively.

Norman Noble‘s Engineering and Testing Services offer the following technical services and capabilities to ensure the highest level of quality and yield for medical device original equipment manufacturers (OEMs) worldwide:

  • Finite Element Analysis (FEA)
  • Corrosion Testing per ASTM F2129
  • Design Model Optimization for Radial Force, Design for Manufacturability (DFM), Fatigue Analysis, Raw Material and Process Optimization
  • Test Report Data to support customer requirements for FDA regulatory compliance
  • Scanning Electron Microscopy (SEM) Analysis with EDX
  • Nitinol Austenite finish (Af) analysis using Bend Free Recovery (BFR) per ASTM F2082, and Differential Scanning Calorimetry (DSC) per ASTM F2004

 

Process Validation and Quality Assurance: Norman Noble, Inc. has performed more than 1,700 process validations for Class II and III medical implants and devices. Having experience with 18 of the top medical device OEMs, we’ve distilled our validation process into a fine-tuned, but continually progressing set of best practices.

We believe control and inspection are essential to assuring accuracy in medical device manufacturing, which requires an unwavering commitment to quality. Our quality system is registered to ISO 9001:2008 and IS0 13485:2003 & EN ISO 13485:2012 and our Process Validation Department works to meet your manufacturing objectives and provide IQ/OQ, MSV, PQ/PPQ, TMV, DOE, and risk analysis, etc., to fulfill your product requirements.