• Login
    • Join
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Manufacturing
    • Markets
    • Top 10
    • Buyers' Guide
    • Events
    • Microsites
    • More
  • Magazine
  • News
  • Exclusives
  • Manufacturing
  • Markets
  • Top 10
  • Buyers' Guide
  • Events
  • Microsites
  • Current & Past Issues
    Features
    Departments
    Columns
    Editorial
    Digital Edition
    Subscribe Now
    Advertise Now
    Editorial Guidelines
    eNewsletter Archive
    eBook
    Top Features
    Orthopedic Implants Are Fit to Print

    Fitting the Mold of Ortho Device Manufacturing

    Artificially Intelligent Design for Orthopedic Devices

    Shoulder Technology Isn't Made 'Off the Cuff'

    Instrument Manufacturing Leads Toward Smarter Surgeries
    Breaking News
    Certifications
    Clinical Trials
    Device Approvals & Patents
    Financial & Deals
    International
    Market Data & Trends
    OEM News
    Orthopedic Innovators
    People
    Product & Service Releases
    Products
    Quality, Recalls & Risk
    Regulatory & Legal
    Supplier & Contract Mfg.
    Live From Shows
    Top News & Features
    Collagen Matrix Rebrands to Regenity Biosciences

    OsteoBoost Study Yields Positive Results

    Conventus Flower Ortho Appoints Jeff Culhane as COO

    Solid Growth Forecast for OTC Braces and Supports Market

    Exactech Boosts AI Expertise with Licensing Deal, Team of Scientists
    3-D Printing/Additive Mfg.
    Assembly & Automation
    Biocompatibility & Testing
    Clean Room
    Coatings/Surface Modification
    Contract Manufacturing
    Design
    Extrusion
    Finishing
    Forging & Casting
    Instruments, Cases & Trays
    International/Offshoring
    Laser Processing
    Materials
    Machining & Tooling
    Molding
    Packaging & Sterilization
    Prototyping
    Research & Developement
    Software & Quality
    Staffing, Training & Prof. Dev.
    Supply Chain

    ODT's Most-Read Stories This Week—March 25

    Switching Sterilization: What Should You Consider When Changing Processes?

    The MDR Delay’s Impact on Regulatory and Testing—An Orthopedic Innovators Q&A

    Navigating the EU MDR UDI Requirements: The Benefits and Challenges

    How 3D Printing is Impacting the Orthopedic Industry
    Biologics
    Bracing/Prosthetics
    Extremities
    Imaging
    Instruments
    Large Joint
    MIS/Robotics
    Spine/Neurology
    Trauma/Sports
    Top Markets
    Enabling Technologies: The Future of Differentiation in Spinal Surgery

    Potential Applications of Continuous Carbon Fiber-Reinforced Additive Manufacturing

    X-Ray Sterilization Considered a 'Game-Changer' for Orthopedic Industry

    Medtech Firms Turning to Rigid Containers Amid Sterilization Wrap Shortage

    7 Ways Design Can Impact Orthopedic Manufacturing Costs
    Companies
    Categories
    Company Capabilities
    White Papers
    Add New Company
    International Buyers Guide Companies
    Life Science Outsourcing Inc.

    AV&R

    Braxton Manufacturing

    Tiodize

    Modern Plastics
    Industry Events
    Webinars
    • Magazine
      • Current & Past Issues
      • Features
      • Editorial
      • Departments
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • eBook
    • Breaking News
    • Buyers' Guide
      • Companies
      • Categories
      • Company Capabilities
      • White Papers
      • Add Your Company
    • Manufacturing
      • 3-D Printing/Additive Mfg.
      • Assembly & Automation
      • Biocompatibility & Testing
      • Clean Room
      • Coatings/Surface Modification
      • Contract Manufacturing
      • Design
      • Extrusion
      • Finishing
      • Forging & Casting
      • Instruments, Cases & Trays
      • International/Offshoring
      • Laser Processing
      • Materials
      • Machining & Tooling
      • Molding
      • Packaging & Sterilization
      • Prototyping
      • Research & Developement
      • Software & Quality
      • Staffing, Training & Prof. Dev.
      • Supply Chain
    • Markets
      • Biologics
      • Bracing/Prosthetics
      • Extremities
      • Imaging
      • Instruments
      • Large Joint
      • MIS/Robotics
      • Spine/Neurology
      • Trauma/Sports
    • Top 10
    • Online Exclusives
    • Slideshows
    • Videos
    • Webinars
    • Events
      • Industry Events
    • Live from Show Event
    • About Us
      • About Us
      • Contact Us
      • Privacy Policy
      • Terms of Use
      • Advertise With Us
    Columns

    How 3D Printing is Impacting the Orthopedic Industry

    Additive manufacturing combats the fragmented supply chain and reverses outsourcing mistakes.

    How 3D Printing is Impacting the Orthopedic Industry
    An example of an EOS medical hip stem application made with EOS titanium (Ti64).
    Mahemaa Rajasekaran, R&D Engineer, EOS North America03.10.23
    Inflation and supply chain snarls have left medical device makers grasping for solutions, as specialized plastics, metals, and resins needed to make devices are lacking in supply. According to purchasing and consulting organization Premier, the number of medical items in shortage is around five times higher than pre-pandemic levels.1 A partial solution for these shortages is additive manufacturing (AM)—more commonly called 3D printing—which can deliver on-demand, cost-effective, locally produced applications that can be “one of many” (mass production) or “one of one” (mass customization).

    Set to grow to more than $50 billion by 2030,2 3D-printed parts are a convenient and scalable method for manufacturers to build orthopedic implants on an ad hoc basis from digital models. From spinal structures, glenoid replacements, hip implants, implants for oral and maxillofacial surgery, and more, AM combats the fragmented supply chain and reverses outsourcing mistakes that are now negatively impacting U.S.-based healthcare organizations.

    Making Innovative Medical Technology a Reality

    A female stroke patient with damage to her skull and brain was required to undergo complex surgery to repair the affected area. As a result of the stroke, she had a large defect on the left side of her skull, which needed to be filled to protect her brain and restore her cranial shape. Traditional methods of reconstruction simply could not work—it was too costly, and the implant would have arrived months after the patient needed it. By leveraging 3D printing, an additively manufactured implant was created, and her skull was restored to its natural shape, allowing her to recover from her stroke and return to her normal life.

    Since about 2010, most orthopedic companies have been leveraging AM, especially laser powder bed fusion (LPBF). The push into AM was primarily driven by the need to get into new technological breakthroughs that simplify complex medical processes such as osseointegration as early as possible, increasing the probability of patient survival and comfort. Traditional manufacturing methods also often required the production of large quantities of a single design, leading to a one-size-fits-all approach. Similar to how there are standardized shoe or clothing sizes, patients sometimes couldn't find an exact fit and were subject to painful bone-altering procedures to fit the standardization.

    However, at the time, new AM technology allowed for the creation of customized medical devices tailored to the specific needs of each patient based on anatomical data like our female stroke patient. This resulted in a better fit and increased comfort for the patient, which speeds up the healing process and gives people a better post-op quality of life.

    Additionally, AM technology’s potential aimed to improve the performance of orthopedic devices by creating complex internal structures and shapes that may not be possible with traditional manufacturing methods. The ideal result would be medical devices that are stronger, lighter, and more durable.

    The promise of orthopedic AM breakthroughs was that the technology could cut the cost and production of medically compatible materials by an exponential amount. What was originally four months of lead time would be cut to somewhere around a month for products with complex designs.

    Traditionally, organizations would have to order castings that would then go to a different foundry and different third-party vendors to complete individual implants. Depending on the product, additional steps and manufacturing tasks would need to be taken based on factors like relative density and compression strength depending on the product.

    The convenience of having a machine available to print patient-specific, single-use parts like hip shelves or small spinal cage parts right away was too good to ignore. With additive, just being able to model bone structures with computer-aided design files was a huge promise that medical industry players wanted to tap into once the technology became a manufacturing reality.

    The next step would be to allow for the rapid prototyping and testing of new designs, potentially leading to shorter development times and a faster time-to-market for new products. This resulted in cost savings for manufacturers and an increased ability to bring new, innovative products to market faster than ever before. Enabling the production of more affordable medical devices eliminates the need for many of the complex and costly manufacturing steps required for traditional methods, such as tooling and machining. The significant cost savings could then be passed on to patients.

    The ideal scenario for the technology is and will always remain the ability to treat trauma patients as soon as possible by bringing the supply chain closer to hospitals and other medical facilities. Yet, with orthopedic implants, unreliable supply chains potentially cause weeks of product backlogs and availability delays, increasing prices and putting patients in harm’s way due to the inability to get the life-saving items they need in time. Immediately available localized manufacturing would reduce reliance on global supply chains and save lives.

    The goal across the orthopedic industry is to be able to replicate custom medical devices with low to immediate cycle time, especially for complicated medical interventions. If it’s a major additive device or item for a patient, doctors will hopefully cut down on the wait time from more than a month or so to be able to realistically produce a custom 3D-printed bone replacement in as little as three weeks. But, there are complications to this reality.

    The Reality of Innovative Development

    Gradually, the initial activation energy coming off the first AM devices that achieved FDA approval took time because engineers and the industry did not know what standards to test. The FDA generally requires new technology to test for the worst-case scenario and work backward. The primary challenge with this technology was to be strong enough to surpass the strict standards associated with medical applications and work well over time without having to change significant details in the structure of the medical device being printed.

    Any company launching its initial product in a certain material first has to go through the testing and approval cycle with stringent installation qualification, operational qualification, and performance qualifications. In this case, the entire shift in technology hinges on powder.

    LPBF uses powdered material, then prints items on a plate using high temperatures to melt away that powder to create the final item. In a conventional model of components for hip implants, for example, liquid metal is poured into a mold and fuses to create the item. When it comes out of the mold, the liquid cleanly solidifies because the process is done above the melting point.
    A major hurdle for the future of AM in the orthopedic industry is overcoming the risk of powder entrapment in a finished item or within components. It makes obvious sense; doctors don't want to endanger their patients and patients don't want loose powder floating through their bodies. So, there is a need to rethink and revamp cleaning validation processes to ensure safety and replication. For example, while additive has opened up opportunities for new materials, there are biocompatibility studies needed for FDA approval, which are costly and can take a year or longer to play out.

    Conclusion

    Overall, the impact of 3D printing on the orthopedic industry has the potential to be significant. Customization, improved performance, and cost savings are all potential benefits of additive manufacturing for the production of medical devices in the field of orthopedics. As the technology continues to advance and become more widespread, we will likely see increasing adoption of 3D printing in the production of orthopedic medical devices.

    References
    1. bit.ly/odt230341
    2. bit.ly/odt230342

    Mahemaa Rajasekaran, metals R&D engineer for EOS North America, specializes in metal material and application development, AM design implementation for customers, and customer success throughout the additive minds project lifetime. She previously was an additive manufacturing engineer for Howco Group and a product development engineer, specializing in additive manufacturing at MicroPort Orthopedics Inc. Rajasekaran also held the position of materials engineer with Materials Resources LLC, bringing years of AM and metal material experience to her projects at EOS North America. Rajasekaran holds a bachelor of technology in BTech, metallurgical and materials engineering from the National Institute of Technology, Tiruchirappalli and a master of science in materials science engineering from Carnegie Mellon University.
      Loading, Please Wait..

      Trending
      • Missouri Neurosurgeon Settles Federal Kickback Lawsuit For $825K
      • Enabling Technologies: The Future Of Differentiation In Spinal Surgery
      • Össur Unveils Rebound ACL Brace
      • Spinal Stabilization Technologies Begins LOPAIN2 Trial In South America
      • AAOS News: Mark S. Myerson Receives 2023 Humanitarian Award
      Breaking News
      • Collagen Matrix Rebrands to Regenity Biosciences
      • OsteoBoost Study Yields Positive Results
      • Conventus Flower Ortho Appoints Jeff Culhane as COO
      • Solid Growth Forecast for OTC Braces and Supports Market
      • Exactech Boosts AI Expertise with Licensing Deal, Team of Scientists
      View Breaking News >
      CURRENT ISSUE

      March/April 2023

      • Fitting the Mold of Ortho Device Manufacturing
      • Artificially Intelligent Design for Medical Devices
      • Orthopedic Implants Are Fit to Print
      • 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

      Kemin Human Nutrition & Health Acquires Oral Health Ingredient
      Wiley Eliminates Outer Carton From Packaging to Reduce Waste
      ACG Expands as Vantage Nutrition Acquires ComboCap and its Dual-Chamber Capsule Technology
      Coatings World

      Latest Breaking News From Coatings World

      PPG Names Rodolfo Ramirez GM, Packaging Coatings
      Sherwin-Williams Unveils High Performance Interior Marine Decking Systems
      AkzoNobel Appoints Ricardo Rosso as Pontiac Site Manager
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      Apply Now: Junkosha's Technology Innovator of the Year Awards 2023
      SIS Medical's OPN NC PTCA Dilatation Catheter Released in U.S.
      Digital Transformation Weighs Heavy in Medtech Regulatory Performance
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Thermo Fisher, Arsenal Biosciences Partner to Manufacture Autologous T-Cell Therapies
      Aquestive Therapeutics Expands Libervant License/Supply Agreement with Pharmanovia
      OncoVent, Orient EuroPharma Enter License Agreement for Oregovomab
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Buttah Skin Founder Wins Emerging Brand Partner of the Year Award from Macy’s
      L’Oréal Wins Legal Battle Over “Paris” Product Labels
      Kosé Taps Shohei Ohtani as Global Ambassador
      Happi

      Latest Breaking News From Happi

      Kao Launches Space Shampoo Sheet for Haircare
      Indie Personal Care and Skincare Brand Indigo Wild Mainstreams Geranium-Patchouli Scent
      Procter & Gamble Brings Tide Relief Project to Mississippi Tornado Victims
      Ink World

      Latest Breaking News From Ink World

      INX International Makes Investment in Gooten
      Videojet Launches 1580 C Soft-Pigmented Contrast Printer
      Epson to Showcase Textile, Signage and Aqueous Printers at ISA 2023
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Industrias Omega adds Durst Tau RSC E
      Ahlstrom publishes 2022 sustainability report
      INFOFLEX 2023 to feature 20+ press manufacturers
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      SharpCell Launches Plastic-free Airlaid Material for Premium Napkins
      Suominen Offers Biolace Ultrasoft
      Maxcess Offers More Engineering and Converting Solutions for Iberia
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Collagen Matrix Rebrands to Regenity Biosciences
      OsteoBoost Study Yields Positive Results
      Conventus Flower Ortho Appoints Jeff Culhane as COO
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Universal Display Sponsors, Presents at ICDT 2023
      Miron Washington Joins Impinj Board of Directors
      All-Time High for Global 300MM Semiconductor Capacity in 2026: SEMI

      Copyright © 2023 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