• 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
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    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
    MPO's Most Read Stories This Week—June 25

    Magnetic Insight Announces $17 Million in Series B Funding

    BreatheSuite Adds Brad Fluegel to its Board

    Labcorp Launches At-Home Collection Device for Diabetes Risk Testing

    Thirona, Free Flow Medical Partner on COPD Solutions
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Theranos Fraud Trial, Part II: The Blame Game Continues

    An Update on Surgical Robotics

    Letting the Light In: How Failure Analysis is the Cornerstone of Success

    Three Talent Strategies to Attract High-Demand Skills

    The Advantages of Bioburden Screening for Sterilization Validation
    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
    Fusion Biotec Inc.

    BMP Medical

    Concise Engineering

    JBC Technologies

    Cirtec Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    The Power of Leveraging Customer Relationships

    Cost Effective & Efficient Wire EDM Techniques

    How MedTech Professionals Can Help Combat Physician Burnout

    How to Optimize Manufacturing Lines and Choose Which Machines to Buy

    How Are Hypodermic Needles Made?
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Fusion Biotec Inc.

    BMP Medical

    Concise Engineering

    JBC Technologies

    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
    Columns

    Optimizing MIM in Medical Device Manufacturing

    Metal injection molding (MIM) is a good choice for producing medium- to high-volume medtech parts.

    Optimizing MIM in Medical Device Manufacturing
    MIM part with machined slot
    Related CONTENT
    • WESTPAK, Inc.
    • BMP Medical - Delivering Custom Plastics Manufactured Solutions
    • ECA Medical Instruments
    • Nordson MEDICAL
    • C&J Industries Inc.
    Steve Santoro, Executive Vice President, MICRO04.01.21
    Minimally invasive laparoscopic surgical instruments today perform a wide array of essential functions in the operating room—cutting, sealing, stitching, stapling, and insufflating.

    Laparoscopic instruments are much more complex than they were decades ago, allowing surgeons to perform operations faster than in the past. Procedures such as prostatectomies and hysterectomies can now be performed using minimally invasive surgery, which helps reduce complications and improve recovery time and outcomes for patients.

    Medical device manufacturers can use a number of processes for producing parts and instruments for use in surgical applications like laparoscopic minimally invasive surgery. The key is to select the best process for the component being produced. A full-service contract manufacturing organization (CMO) with a range of metal fabricating operations needed for surgical instruments, including critical cleaning operations, should consider several factors, including cost, materials, and volume needed before deciding which process would best meet the customer’s objectives for each project.

    Factors for Consideration
    Cost is usually the biggest factor when deciding on process and technology, and cost of raw materials, process steps, and volumes all need to be factored in. For minimally invasive surgical instruments, metal components often represent a large portion of the costs. Adding process steps will also cause costs to increase, and it’s important to carefully select the optimal process. An experienced CMO will have detailed knowledge of costs and processing, and be able to recommend the best method for each project.

    We conduct extensive cost models along with process capability data before beginning a project so we can recommend and align with our customers. We can typically model a number of scenarios to find the best combination. In general, the more you can simplify, the less costs you will incur.

    Along with cost modeling, we also assess risk prior to each project, which is assessed by looking at factors related to commercial, technical, and compliance factors. Commercial risk is cost-driven and considers a number of factors, including:
    • Over design adds costs
    • Under design not functional/failures
    • Scrap
    • Cycle times
    • Equipment cost
    • Automation
    • Secondary operations

    Reducing technical risk involves an assessment of:
    • Feasibility
    • Timeline
    • Process development
    • Project and tooling cost
    • Process stability

    Compliance risk considers use of known materials and processes that have undergone testing previously, including:
    • Materials of construction
    • Biocompatibility
    • Homogenous
    • Additive manufacturing

    An experienced CMO with prior knowledge can usually assess risk reduction to every unique project, as no two projects are completely the same.

    Metal Injection Molding
    Metal injection molding (MIM) is a good choice for producing medium- to high-volume parts for medical devices for laparoscopic surgery and other high-volume applications. We’ve used MIM successfully for over 20 years to manufacture millions of parts annually for single-use surgical instruments including powered device drive chains, end effectors, connectors, and other applications. MIM is used extensively across industries and markets—it’s a good chance your cell phone has many MIM-produced parts. MIM is a versatile, proven, low-risk manufacturing technology.

    Compared to plastic components, metal as a raw material is very cost-effective to manufacture and there are many more processes available for fabricating metal components. The least expensive component is usually the raw materials. When additional steps are added, costs rise. The key is to pick the best process for each component. Having detailed knowledge of the costs and processing of as many of these technologies as possible makes the job easier.

    MIM integrates injection molding capability with diverse metal selection, and it can replace costly machined components. The process lends itself to automation where high volumes and consistent quality are needed. The process allows for greater design freedom in short development cycles and turnaround time. MIM is ideal for small, complex geometries and intricately-shaped parts. Post MIM, CNC machining can be used to achieve tight tolerances.

    MIM parts have excellent strength, ductility, magnetic response, and can be bent, welded, hardened, and heat treated like any other wrought material. A wide variety of metals can be used for medical device manufacturing using a MIM process, including stainless steel, low alloy steels, carbon steels, Fe-Ni alloys, cobalt alloys, tool steel, and Tungsten alloys. Ceramics can be used for injection molding as well, particularly when furnace furniture is required, though most of our projects typically employ metals.

    A majority of single-use disposable instruments produced through a MIM process use 17-4 grade stainless steel, which can be tempered to various hardness and close to 300-series stainless steel in corrosion resistance. In addition, 316- and 400-series stainless steel can be used in specialty applications, and 316 stainless steel is the gold standard for corrosion resistance when using injection molding. A 440-grade stainless steel can be hardened beyond what is capable with 17-4 grade, however, corrosion resistance is better with 17-4 grade and 440-grade requires tighter control of heat treating and a more robust post-cleaning process.

    Some stainless-steel grades aren’t able to achieve the same degree of strength as other grades, so it’s important to consider what mechanical properties will be needed when choosing materials. Generally speaking, materials that are readily available and widely used will help reduce costs and process time.

    A distinct advantage of an injection molding process is its shorter timelines. For standard components, we can produce 30 to 40 molds a month. Prototype tools will typically require two to three weeks and samples can be produced in one to two weeks. Production tools will take anywhere from four to six weeks. Time frames can be compressed by using reliable vendors to build the molds. Many projects require multiple tools, and bottlenecks can occur at the beginning when deciding on a mold and reviewing designs to ensure functionality will not be compromised. Inefficiencies also may occur at the end of the process if a touchup is needed on a mold or if extensive testing in the metallurgy lab is involved. Be aware of these potential risks and factor them into timelines.

    Batch and continuous processes, both widely available, can be used for medical device manufacturing. We utilize a proprietary feedstock formulation with high quality alloy powders needed for surgical instruments. The green strength of our medical parts is quite high, and the advent of higher quality feedstocks have virtually eliminated failures due to molding and handling defects, including green and brown state cracks.

    A continuous process is especially conducive for high-volume applications and uses raw materials that are readily available. However, all feedstocks and processes are not equivalent. The key to the process is achieving consistent shrinkage and diffusion of organics out of the metal matrix. Furnace furniture is another consideration that can be overlooked. The part datum structures must be married to the furnace furniture to get the most consistent results, especially if secondary machining is used.

    Consistent diffusion of organic binders and surfactants is critical to achieving optimal mechanical properties. High residual carbon content is a disadvantage for components that will be subsequently welded. In addition, poor diffusion increases the voids in the metal matrix by trapping gas and the lower density will dramatically reduce strength. Coring is a common strategy used to help equalize diffusion distances, or material can be removed completely.

    In terms of tolerance, a larger feature will require a larger tolerance, since parts shrink 15-18 percent during sintering. Keep in mind that more shrinkage will occur in a vertical direction due to gravity and less shrinkage will occur in a lengthwise direction due to drag on the furnace furniture.

    Larger, longer parts will require tighter tolerances and machining may be necessary depending on the application. Thickness must withstand the weight of the part in the furnace and complex parts like jaws with cantilevered design features will require custom furnace furniture.

    Design for Manufacturability
    Design and commercial considerations are important factors for medical device manufacturing. A Design for Manufacturability (DFM) approach allows design and development cycles to be shortened so products can be manufactured at a lower cost. Using DFM, an experienced CMO can identify raw materials and methods that will optimize the manufacturing process by reducing steps and ensuring standardization in parts quality. An even thickness, stable base while sintering, and good feedstock flow can all be achieved with good design considerations.

    Conclusion
    CMOs should consult with OEM customers early on in the process to review and align on design and commercial needs of each project. Doing so will ensure that risks are reduced, and products achieve target functionality at cost. Using modern manufacturing techniques, including MIM, combined with engineering expertise and innovation, CMOs can deliver high-quality parts and products for their customers efficiently, cost-effectively, and on time. 


    Steve Santoro, executive vice president at MICRO, delivered a keynote address during MIM2021: International Conference on Injection Molding of Metals, Ceramics and Carbides, held virtually Feb. 22-25.
    Related Searches
    • Molding
    • Surgical
    Related Knowledge Center
    • Surgical
    • Molding
    Suggested For You
    WESTPAK, Inc. WESTPAK, Inc.
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    ECA Medical Instruments ECA Medical Instruments
    Nordson MEDICAL Nordson MEDICAL
    C&J Industries Inc. C&J Industries Inc.
    Teleflex Medical OEM Teleflex Medical OEM
    NTK Cutting Tools USA NTK Cutting Tools USA
    Oberg Medical Oberg Medical
    LRE Medical GmbH LRE Medical GmbH
    American Swiss Products Co. Inc. American Swiss Products Co. Inc.
    Simbex Simbex
    SigmaTron International SigmaTron International
    MICRO MICRO
    DDL Inc. DDL Inc.
    RJG RJG

    Related Buyers Guide Companies

    • WESTPAK, Inc.

      WESTPAK, Inc.

      ...
      Tim Eells, WESTPAK, Inc. 03.04.22

    • BMP Medical - Delivering Custom Plastics Manufactured Solutions

      BMP Medical - Delivering Custom Plastics Manufactured Solutions

      Medical Contract Manufacturing, Design, Assembly & Packaging

    • ECA Medical Instruments

      ECA Medical Instruments

      ...
      Jim Schultz, VP Customer Solutions 12.02.21


    • Nordson MEDICAL

      Nordson MEDICAL

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

    • C&J Industries Inc.

      C&J Industries Inc.

      ...
      Christa Schreckengost, Marketing Coordinator 12.02.21


    Trending
    • Intermountain Healthcare & Siemens Healthineers Open 3 Tellica Outpatient Imaging Centers
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Magnetic Insight Announces $17 Million In Series B Funding
    • Thermo Fisher Scientific, Bio-Techne Develop Kidney Rejection Test
    • The Power Of Leveraging Customer Relationships
    Breaking News
    • MPO's Most Read Stories This Week—June 25
    • Magnetic Insight Announces $17 Million in Series B Funding
    • BreatheSuite Adds Brad Fluegel to its Board
    • Labcorp Launches At-Home Collection Device for Diabetes Risk Testing
    • Thirona, Free Flow Medical Partner on COPD Solutions
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • OEMs Seek Molders Offering Timely Techniques
    • Robotic Surgery: Cutting Through to the Latest
    • Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    • 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

    Florida Food Products Acquires Javo
    Roquette Launches Nutralys Rice Protein
    New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy
    Coatings World

    Latest Breaking News From Coatings World

    The Southern Society for Coatings Technology's 84th Annual Technical Conference A Success
    PPG to Showcase Specialty Automotive, Aerospace Adhesives, Sealants at Adhesives & Bonding Expo
    PPG’s New Paint for a New Start Initiative to Transform 25-plus Schools Worldwide
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most Read Stories This Week—June 25
    Magnetic Insight Announces $17 Million in Series B Funding
    BreatheSuite Adds Brad Fluegel to its Board
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Pierre Fabre and Lonza Enter Manufacturing Agreement
    MasterControl and Elemental Machines Form Biomanufacturing Partnership
    Qosina Strengthens Aseptic Capabilities
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Benefit Exec Joins Madison Reed's Board
    Peroni & Ellis Brooklyn Launch Fragrance Collection Inspired by Italian Spritz Cocktails
    Rhode Is Trending for June, Trendalytics Says
    Happi

    Latest Breaking News From Happi

    Spate’s Nose for the Latest Beauty Trends Says The Skunk Stripe, Collagen Serum and Waterproof Eyeshadow are Top of Mind for Consumers this Summer
    A Suitor Emerges for Revlon, SK Capital’s New Dealmaker & P&G’s Indoor Air Quality Efforts
    Wonder Curl Wins GlossWire's GlossPitch Competition
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: INX’s VC Fund, Screen Industry and Ball Top This Week’s News
    British Coatings Federation Posts Online History
    Orion Announces Price Increases, Reduced Payment Terms
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    PCMC teams with IGT, Fujifilm makes big announcement and more
    Loftware recognized as 'AIDC Company of the Year'
    Schreiner MediPharm highlights sustainability of Needle-Trap technology
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: SWM and Neenah Introduce Mativ Inc., Avgol honored for Biotransformation Technology & More
    Tranzonic Names VP of Supply Chain
    Ontex Climate Action Targets Approved by Science-Based Targets Initiative
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—June 25
    3Spine Inc. Receives IDE Approval for U.S. Pivotal Clinical Trial
    Volume-Based Procurement to Reduce Chinese Orthopedic Market Value
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: eMagin, Applied Materials, and Schott Top This Week’s Stories
    NREL Names Jennifer Logan to Leadership Team as CFO
    National Grid Renewables Orders 2 GW of First Solar Modules

    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