• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    'Graft-on-a-Chip' Built to Improve Vascular Graft Success

    Abbott Invests €440 in New Irish Facility

    FDA Approves Guardant Health's NGS-Based Companion Diagnostic

    Reflow Medical Completes DEEPER LIMUS Clinical Trial Enrollment

    NanoVibronix Strengthening its Supply Chain to Address Potential Delays
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Cooling and Melting the Pain Away

    What Are the Fundamentals of Go-To-Market Strategy in Medical Devices?

    Minding the Gap: How Harmonizing Quality Systems Pays Off

    Building Strong Partnerships Between Medtech and Surgeon-Learning Platforms

    Four Key Considerations for OEMs Transferring a Product Program
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Trademark Plastics Inc.

    Arthur G. Russell Co. Inc., The

    Concise Engineering

    BMP Medical

    Cirtec Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Medical Computing: COM Express Processes Real-Time Data at the Edge

    The Importance of Building Successful Supplier Relationships

    The Benefits of Outsourcing Innovation in Medtech Manufacturing

    Patching Healthcare Cybersecurity Risks in the Internet of Medical Things

    Leveraging Open Healthcare Data Standards to Improve Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Trademark Plastics Inc.

    Arthur G. Russell Co. Inc., The

    Concise Engineering

    BMP Medical

    Cirtec Medical
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Online Exclusives

    8 Considerations Prior to Nitinol Implant Design

    The nickel and titanium alloy offers advantages for medtech, but questions first need to be answered.

    8 Considerations Prior to Nitinol Implant Design
    Nitinol is an ideal implant material, but with it come a number of manufacturing challenges. Securing the right supply partner is, therefore, a key to success.
    Related CONTENT
    • Nordson MEDICAL
    • Midwest Products & Engineering Acquires MindFlow Design
    • Metal Injection Molding and Metal 3D Printing Examination
    • Contraline Expands Board of Directors
    • MPE Inc. Expands Into EMEA Market
    Norman Noble04.08.16
    The nickel and titanium alloy known as Nitinol is a super-elastic shape-memory alloy responsible for major advances in medical technology over the last 15 years.

    The metal is a highly elastic material that can be processed to maintain a desired geometry. These properties, combined with high fatigue resistance and its ability to provide constant force over a wide range of displacements makes it suitable for use in numerous medical implants and devices including:
    • Vascular stents (e.g., cardio, AAA, peripheral, carotid, venous, and neuro)
    • Transcatheter heart valves
    • Vascular closure implants
    • Neurovascular clot pullers
    • Devices and flow diverters
    • Vena cava filters
    • Orthopedic anchors
    • Atrial fibrillation devices
     
    As well suited as Nitinol is for vascular implant applications, very few manufacturers are able to produce finished goods with it. The major barriers to working with Nitinol are:
    • Material knowledge—Working with the alloy requires extensive knowledge of the metal’s mechanical properties and fatigue characteristics.
    • Low machinability—As a raw material, Nitinol is very difficult to machine with conventional technologies. Multiple proprietary manufacturing processes are required to produce even the most basic Nitinol-based device.
    • Electropolishing and passivation—To protect against the harmful release of nickel into the human body, electropolishing or passivation are required to create a protective titanium oxide layer.
    • Process validation—Nitinol implant manufacturing requires strict process controls and validation to meet the finished material specifications.
     
    When pursuing a manufacturer to produce a new, Nitinol-based implant or device, it is important to evaluate a number of decision factors. The following eight considerations must be addressed before moving ahead with a project.

    1. Raw Material Sourcing
    Before committing to any manufacturer, it’s crucial to know how they will source Nitinol for a given project.
    An original equipment manufacturer’s (OEM) ability to supply the market with product is directly dependent on the contract manufacturer’s ability to source the raw material required to maintain continuity of supply. A sustained disruption in supply is often catastrophic for OEMs. At a minimum, ensure the contract manufacturer will qualify and validate two sources of Nitinol for production. Any disruption in the material quality from the primary source can be quickly resolved by increasing supply from the second.

    Equally important, the quality, type (sheet or tube), and characteristics of the Nitinol supplied by any given raw material producer is variable. The manufacturer who regularly sources material from many suppliers is able to best match the raw material to your design requirements and product application.
     
    2. Design for Manufacturability and Finite Element Analysis
    It’s important to evaluate product design specifications during the prototyping stage to identify opportunities to reduce cost without compromising the manufactured part’s intended function. Any cost-reducing design changes must be implemented prior to design freeze.

    For any prospective new device design, extensive design and testing services should be available to help the design engineer perform finite element analysis. This ability to model and simulate mechanical behavior reduces the time needed between design iterations—a critical step in the race to bring products to market.
     
    3. Dedicated Process Engineering
    Each manufacturing step requires the contract manufacturer to custom design that operation for any particular product design. This is accomplished by designing, testing, and refining the step using the same model and type of equipment and conditions that will be used in production. The capability to design and manufacture all shape-set tooling and fixturing for each process step in-house is essential to ensure the highest level of quality and process control.

    It is important to understand if the manufacturer does this testing using equipment, experienced engineering personnel, and facilities dedicated solely to process development, so it does not compete for time with products already in the production/manufacturing stream.
     
    4. Manufacturing Parts Complete
    Producing finished Nitinol parts is a complex, multi-phase endeavor, requiring years of experience and numerous manufacturing and finishing process capabilities. It is important to understand upfront if a supplier can completely manufacture a part in-house using special Nitinol processing techniques. Can the supplier handle all manufacturing and finishing required to produce a marketable product without outsourcing any steps?

    By handling all steps in the manufacturing process, the supplier can tune each step based on its knowledge of the upstream or downstream capabilities. This produces the highest level of quality assurance and process control.
     
    5. Finishing by Electropolishing
    A product’s fatigue and corrosion resistance are major factors in its performance. Finishing polishes, passivates, removes micro-cracks, and deburrs the workpiece. There are various finishing methods; electropolishing produces the best results for corrosion resistance and biocompatibility. The electropolishing process can be designed to sharpen or round dimensional features to meet product requirements. Verify that the supplier will use electropolishing and passivation on the finishing of implants.
     
    6. 100% Dimensional Inspection
    Closely regulated, Class III medical implants and devices manufactured to the highest specification are life-saving devices. One of the last steps in producing a device, dimensional inspection is also one of the most critical to verifying a consistent, high quality component that meets design specifications. It is important to know if a supplier has the capability to provide validated, 100% dimensional inspection on each and every implant. Anything less invites risk to the patient and the OEM.
     
    7. Validation and Inspection
    All operational process steps and tooling used to manufacture Nitinol implants must be within established and tested control limits. Validation ensures that the manufacturing process conforms to the control limits. Inspection ensures the manufacturing output does as well. Insist on 100% automated inspection for peak quality.

    Validation must be conducted in accordance to ISO 13485:2012 standards. The contract manufacturer should employ an experienced validation engineering team to provide the strategy and protocols needed to complete all validation activities. Additionally, the contract manufacturer should have in-house verification technologies to support validation, including:
    • Metallography expertise and scanning electron microscopy, which is required to verify removal of heat affected zones
    • Corrosion testing capabilities per ASTM F2129
    • Bend and free recovery and differential scanning colorimeter to verify material Austenite Finish (Af), Mf, Ms, and As transformation temperatures.
     
    8. Athermal Laser Machining
    The demand for smaller devices and entirely new neurovascular applications requires even more innovative manufacturing methods. If the ability to test and produce next-generation implants is a priority, determine if the contract manufacturer has an athermal laser machining capability.
     
    Making the Case
    A medical device startup company approached Norman Noble, a microprecision contract manufacturer of medical implants, with a manufacturing challenge—produce a two-piece, Nitinol-based, heart valve frame implant of the company’s design.
     
    The company’s product engineering team began by visiting Norman Noble to perform a design for manufacturability review. Although the product was in production with another contract manufacturer, ongoing issues with the manufacturing output and quality led the startup to seek another manufacturing source and to potentially rework the design.
     
    The company advised Norman Noble on the challenges they were facing with the current supplier, including:
    • Inconsistent delivery due to sub-optimal Nitinol tubing quality
    • Issues providing consistent laser cut quality and electropolishing finish
    • Lack of welding capability to produce a two-piece implant assembly
    • A deficit of in-house capabilities to perform 100% dimensional inspection or validation
     
    Accordingly, the finished parts had dimensional defects related to the shape-set form that did not meet specifications to the extent they could be seen without the aid of a microscope.
     
    Norman Noble conducted a process review, resulting in the elimination of two manufacturing steps by using an athermal laser, which produces no heat affected zone. This lead to a significant cost reduction that allowed the production pricing to be significantly below the startup company’s target. Electropolishing with minimum material removal would be used to finish the piece and provide a mirror-like, passive biocompatible finish.
     
    Satisfied with the potential for the product design and manufacturing process improvements to make the product viable, the startup company instructed Norman Noble to proceed with prototyping and feasibility analysis. Those steps included:
    • Developing custom shape setting tooling to ensure all finished part specifications were achieved
    • Establishing the best primary tubing supplier for the short term and, at the same time, developing a plan for qualification of a second raw material source to maintain continuity of supply.
     
    Prototype parts were manufactured in 8 days and then shipped to the company for initial design verification testing. A second iteration was required and manufactured in 3 days to complete design verification testing.
     
    The validation strategy was developed by Norman Noble and submitted to the startup company using a parallel path to the prototype manufacturing and functional testing. Upon completion of verification testing, the validation was executed and a full report was provided in 27 days.
     
    Ultimately, a large medical OEM that had worked with Norman Noble previously acquired the startup company. The large OEM confided that the supply chain was a key part of their decision to make the acquisition.
     
    The product is quickly becoming the standard of care for its innovative application and is in clinical use for the treatment of patients around the world.
    Related Searches
    • implant
    • development
    • microscope
    • startup
    Related Knowledge Center
    • Testing
    • Contract Manufacturing
    • R&D & Design
    Suggested For You
    Nordson MEDICAL Nordson MEDICAL
    Midwest Products & Engineering Acquires MindFlow Design Midwest Products & Engineering Acquires MindFlow Design
    Metal Injection Molding and Metal 3D Printing Examination Metal Injection Molding and Metal 3D Printing Examination
    Contraline Expands Board of Directors Contraline Expands Board of Directors
    MPE Inc. Expands Into EMEA Market MPE Inc. Expands Into EMEA Market
    Zeus Acquires CathX Medical Zeus Acquires CathX Medical
    Maintaining Quality in the Fast-Paced Contract Manufacturing Industry Maintaining Quality in the Fast-Paced Contract Manufacturing Industry
    A Contract Manufacturer Selection Handbook A Contract Manufacturer Selection Handbook
    Leveraging Your Outsourcing Relationship for Success—A Medtech Makers Q&A Leveraging Your Outsourcing Relationship for Success—A Medtech Makers Q&A
    SMC Ltd. Expands Costa Rica Facility SMC Ltd. Expands Costa Rica Facility
    Axonics Forges Manufacturing Partnership With Micro Systems Technologies Axonics Forges Manufacturing Partnership With Micro Systems Technologies
    Use Vertical Integration to Increase Productivity, Drive Innovation Use Vertical Integration to Increase Productivity, Drive Innovation
    Cretex Companies CEO Steps Down Cretex Companies CEO Steps Down
    FOREFRONT MEDICAL TECHNOLOGY ANNOUNCES UNIQUELY-DESIGNED COVID-19 TEST SWAB FOREFRONT MEDICAL TECHNOLOGY ANNOUNCES UNIQUELY-DESIGNED COVID-19 TEST SWAB
    Centerpiece to Open New North American ETO Sterilization Facility Centerpiece to Open New North American ETO Sterilization Facility

    Related Buyers Guide Companies

    • Nordson MEDICAL

      Nordson MEDICAL

      ...
      Kara Holmstrom, Sr. Marketing & Design Specialist 12.02.21

    • Contract Manufacturing | R&D & Design
      Midwest Products & Engineering Acquires MindFlow Design

      Midwest Products & Engineering Acquires MindFlow Design

      Design firm to enhance MPE's concept to completion model.
      PR Newswire 09.10.21

    • 3D/Additive Manufacturing | Molding
      Metal Injection Molding and Metal 3D Printing Examination

      Metal Injection Molding and Metal 3D Printing Examination

      Both MIM and metal AM serve as alternative options to machining for medtech manufacturers requiring metal components.
      Mark Crawford, Contributing Writer 07.22.21


    • Contraline Expands Board of Directors

      Contraline Expands Board of Directors

      Medical device industry veteran Martin J. Emerson has joined the company's board.
      Business Wire 07.09.21

    • Contract Manufacturing
      MPE Inc. Expands Into EMEA Market

      MPE Inc. Expands Into EMEA Market

      Company has hired a director of International Markets to help lead the expansion.
      PR Newswire 07.06.21

    Loading, Please Wait..

    Breaking News
    • 'Graft-on-a-Chip' Built to Improve Vascular Graft Success
    • Abbott Invests €440 in New Irish Facility
    • FDA Approves Guardant Health's NGS-Based Companion Diagnostic
    • Reflow Medical Completes DEEPER LIMUS Clinical Trial Enrollment
    • NanoVibronix Strengthening its Supply Chain to Address Potential Delays
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • Parylene Coatings for Medical Device Technologies
    • Nearshoring Trends in Medtech Manufacturing
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process
    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market
    Tazo Transitions to Regenerative Organic Agriculture
    Coatings World

    Latest Breaking News From Coatings World

    SONGWON Industrial Group Reports Strong Q2 Financial Results
    PPG Completes COLORFUL COMMUNITIES Project for Boys & Girls Clubs of Greater Houston
    Paul N. Gardner Now Offers Bacharach Sling Psychrometer
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    'Graft-on-a-Chip' Built to Improve Vascular Graft Success
    Abbott Invests €440 in New Irish Facility
    FDA Approves Guardant Health's NGS-Based Companion Diagnostic
    Contract Pharma

    Latest Breaking News From Contract Pharma

    AskBio Appoints Clinical Ops Executives
    SpectrumX Partners With UK Contract Manufacturer
    GL Chemtec Partners with Edgewater Capital to Accelerate Growth
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Arkay Chairman Emeritus Howard Kaneff Has Died
    Nutricosmetics Market to Hit $13.7 Billion by 2030
    Estée Lauder Pledges 100% Electric Fleet of Vehicles by 2030
    Happi

    Latest Breaking News From Happi

    J&J To Stop Global Sales of Talc-Based Products by 2023
    Net Sales Increase 2% for Naples Soap Company in Second Quarter
    Net Revenue Down 12% for Grove Collaborative in Second Quarter
    Ink World

    Latest Breaking News From Ink World

    Heidelberg Enjoys Successful Start to 2022-23 Fiscal Year
    Mimaki Announces New LATAM Website
    Paul N. Gardner Offers Bacharach Sling Psychrometer
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Esko, Constantia Flexibles announce acquisitions and more
    Hybrid Software joins The Flexo Xperience Center
    Flexo Wash LLC and Mike Potter celebrate 20 years
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Focke & Co. to Host Destination: Your Hygiene Hub on August 31
    Exports Dominate Chinese Trade of Tissues, Hygiene Products and Wipes
    Freudenberg to Present Friction Inserts for Wind Energy
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Dental 3D Printing Market is Expanding 20% Annually
    Study Results Released for Abbott's Concussion Blood Test
    Bone Growth Stimulators Market to Top $3B by 2030
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    eMagin Corporation Announces 2Q 2022 Results
    Zebra Technologies’ Emission Reduction Targets Validated by SBTi
    Identiv Delivers Impressive 41% Year-over-Year Growth in RFID Business

    Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login