• 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
    BD Recalls Intraosseous Products Over Multiple Issues

    Rapid Medical Expands U.S. Portfolio

    MMS Holdings Partners With Lindsay Goldberg

    ENDRA Life Sciences Issued 28th Patent

    Levita Magnetics Closes $26M Series C
    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
    Fusion Biotec Inc.

    Xact Wire EDM Corp.

    Trademark Plastics Inc.

    JBC Technologies

    Arthur G. Russell Co. Inc., The
    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
    Fusion Biotec Inc.

    Xact Wire EDM Corp.

    Trademark Plastics Inc.

    JBC Technologies

    Arthur G. Russell Co. Inc., The
    • 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

    PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market

    With smart onshoring strategies, the medical device industry can collaborate to fix supply chain issues.

    Related CONTENT
    • WESTPAK, Inc.
    • BMP Medical - Delivering Custom Plastics Manufactured Solutions
    • ECA Medical Instruments
    • C&J Industries Inc.
    • Teleflex Medical OEM
    Claudio Hanna and Ralph Tricomi , Web Industries04.01.21
    “It’s time to fix America’s supply shortage problems for good.”

    This statement from President Biden’s 2021 pandemic response plan sums up the sentiments of many U.S. business leaders and everyday Americans. They are not alone. COVID-19 challenges have governments and businesses globally assessing their supply chain resiliency for critical healthcare products, including personal protective equipment (PPE) and diagnostic tests. This has rekindled interest in domestic manufacturing, which in turn, creates valuable jobs and helps the economy.

    While this is good news in many ways, it also poses new challenges. Offshore sourcing has dominated for decades. Converting to onshore production takes commitment and thoughtful planning. Also, big, new opportunities attract opportunists and associated risks for quality problems, intellectual property breaches, and missed deliveries. As medical product original equipment manufacturers (OEM) craft their onshoring strategies, smart leaders proceed with both urgency and caution.

    If you are an OEM of PPE or diagnostic testing devices, you probably are evaluating your onshoring choices, trying to determine how to transfer some portion of production stateside. Whether you acquire or expand in-house production or partner with a contract manufacturing organization (CMO), you need a seamless transfer of processes and expertise to execute your domestic production strategy.

    Onshoring Orders
    In January, President Biden issued a 200-page report, “National Strategy for the COVID-19 Response and Pandemic Preparedness.” The report includes plans for securing the pandemic supply chain and establishing a U.S. manufacturing base for future health emergencies. “To respond more effectively to this crisis and ensure the United States is able to respond more quickly and efficiently to the next pandemic, we need a resilient, domestic public health industrial base,” the report said. “The U.S. government will not only secure supplies for fighting the COVID-19 pandemic but also build toward a future, flexible supply chain and expand an American manufacturing capability where the United States is not dependent on other countries in a crisis.”

    The report refers to the Executive Order, “A Sustainable Public Health Supply Chain.” This order directs development of a Pandemic Supply Chain Resiliency Strategy to design, build, and sustain both short- and long-term U.S. capability to make supplies for this and future pandemics and biological threats. The order instructs the federal government to focus on building a U.S. supply chain in four sectors:
    • Antigen and molecular-based testing
    • PPE and durable medical equipment
    • Vaccine development and manufacturing
    • Therapeutics and key drugs

    The order also invokes the Defense Production Act and other appropriate authorities to fill supply shortfalls in 12 critical supply categories, including:
    1. N95 masks
    2. Isolation gowns
    3. Nitrile gloves
    4. Polymerase chain reaction (PCR) sample collection swabs
    5. Test reagents
    6. Pipette tips
    7. Laboratory analysis machines for PCR tests
    8. High-absorbency foam swabs
    9. Nitrocellulose material for rapid antigen tests
    10. Rapid test kits
    11. Low dead-space needles and syringes
    12. All necessary equipment and material to accelerate the manufacture, delivery, and administration of the COVID-19 vaccine

    As of this writing, President Biden’s $1.9 trillion stimulus plan passed in the House and was pending U.S. Senate consideration. The plan proposes funding for COVID-19 vaccine distribution and testing.

    These government actions have sparked interest in public-private investment in U.S. manufacturing. No one wants to see a repeat of 2020’s supply chain vulnerability. “It’s not just that we [the U.S.] didn’t have enough masks during the pandemic. This [executive] order is about the future of U.S. competitiveness. Promoting that involves altering global supply chains. It won’t be easy, but there are ways,” said National Public Radio correspondent Sabri Ben-Achour in a Feb. 24 “Marketplace” broadcast.

    Onshoring Options
    Following are several ways to establish a U.S. supply chain.
    • Build or expand a factory.
    • Acquire a business with U.S. manufacturing.
    • Outsource your product’s manufacturing to a U.S. contractor.
    • Do a combination of the above.

    All are viable approaches, but with all paths, OEMs must make their onshore transition without skipping a beat on product quality, consistency, or customer delivery. They need to get up and running rapidly. The United States is still fighting a healthcare emergency.

    Constructing a new factory requires significant investment in bricks and mortar, machinery, and employees. Acquiring a business requires a large upfront investment. Outsourcing to a CMO involves building trust and transferring your product plans to a contractor, ideally one with a strong U.S. manufacturing base and ability to seamlessly integrate with your processes, systems, and people.

    As companies weigh their options, they are running the numbers on U.S. critical medical supplies demand—past, present, and future—and reacting to U.S. government moves. Key variables include:
    • How much PPE and diagnostic test manufacturing capacity is needed to keep up the COVID-19 fight?
    • How much capacity will be required to make products for the Strategic National Stockpile (SNS)?
    • What will be the normalized U.S. demand for PPE and diagnostics in non-pandemic times, and how much of that will be fulfilled from domestic manufacturing?
    • How much U.S. manufacturing capacity is required to meet demand spikes due to future healthcare emergencies?

    Choosing an Onshore Partner
    If outsourcing to a CMO is essential to your onshoring plans, following are qualities to seek in a contracting partner, particularly for PPE and diagnostic test devices.

    Speed and Flexibility: Speed to market is one of the primary advantages of outsourcing to a domestic CMO instead of building your own manufacturing facilities. An established CMO already has a supply chain in place. Ask about available capacity and ability to rapidly scale and commercialize your products. Request a plant tour and look for automation. Highly automated CMOs produce efficiently, control labor costs, and scale to handle spikes and fluctuations in demand.

    Trust: An OEM needs a CMO that shares its commitment to get products to market expediently. Look for a strong track record with reputable customers. Check references and ask about process transparency and proactive communication. Consider the value of experience and number of years in business. Beware of newcomers just diving into the medical products business at the prospect of short-term financial gains. With lives on the line if your product does not perform, you need a trustworthy partner.

    Quality: An OEM and CMO should speak the same quality language. There should be a seamless bridge between OEM and CMO quality assurance and processes. Also seek CMOs with ISO 13485 certification, U.S. Food and Drug Administration site registration, and Current Good Manufacturing Practices compliance. Ask prospective CMOs about how automated equipment, including vision inspection systems, contribute to quality control (QC).

    Expertise: In the medical device industry, specialization matters. Consider whether a CMO is trying to be all things to all people or focusing on deep knowledge in specific product categories. Ask about operational competencies, including converting, laboratory, technology transfer, raw materials sourcing, and packaging capabilities. In addition, delve into the CMO’s information technology strengths and ability to integrate seamlessly with OEM enterprise resource planning, QC, and other solutions.

    Conclusion
    President Biden’s “Sustainable Public Health Supply Chain” executive order prescribes a surge in onshore manufacturing of critical medical products. The president’s 2021 plan states:

    “The Pandemic Supply Chain Resiliency Strategy will address onshoring production of COVID-19 and related pandemic and medical supplies, creating a manufacturing base in the United States that can fill the Strategic National Stockpile, avoiding reliance on other countries for lifesaving medicines and supplies, and allowing the speed and flexibility required to produce needed supplies and medicines for ongoing COVID-19 outbreaks and future biological crises.”

    How will your business respond? With smart onshoring strategies, the medical device industry, including OEMs, CMOs, and other suppliers, can work together to fix U.S. medical supply chain problems for good.


    Claudio Hanna (channa@webindustries.com) is business development director, Medical, and Ralph Tricomi (rtricomi@webindustries.com) is market development and strategy manager for Web Industries (www.webindustries.com), a precision converting and contract manufacturing organization.
    Related Searches
    • Diagnostics
    Related Knowledge Center
    • Diagnostics
    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
    C&J Industries Inc. C&J Industries Inc.
    Teleflex Medical OEM Teleflex Medical OEM
    Oberg Medical Oberg Medical
    Rootstock Software Rootstock Software
    LRE Medical GmbH LRE Medical GmbH
    Simbex Simbex
    SigmaTron International SigmaTron International
    DDL Inc. DDL Inc.
    High Tech Turning Co. Inc. High Tech Turning Co. Inc.
    Dupaco Inc. Dupaco Inc.
    Nissha Medical Technologies Nissha Medical Technologies
    Northeast Biomedical, Inc. Northeast Biomedical, Inc.

    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


    • C&J Industries Inc.

      C&J Industries Inc.

      ...
      Christa Schreckengost, Marketing Coordinator 12.02.21

    • Teleflex Medical OEM

      Teleflex Medical OEM

      Teleflex Medical OEM is a global business dedicated to transforming ideas into market-ready products.
      Krista Ray, Manager of Global Marketing Communications - OEM 11.30.21

    Loading, Please Wait..

    Trending
    • Cardinal Health CEO Mike Kaufmann Steps Down
    • Medidata Unveils New Tech To Improve Clinical Trial Oversight
    • How To Overcome The Top 6 Medical Device Manufacturing Challenges
    • TruArc Expands Medical Portfolio With Acquisition Of Molded Devices Inc.
    • Chronic, Infectious Disease Prevalence To Benefit Vital Signs Monitoring Market
    Breaking News
    • BD Recalls Intraosseous Products Over Multiple Issues
    • Rapid Medical Expands U.S. Portfolio
    • MMS Holdings Partners With Lindsay Goldberg
    • ENDRA Life Sciences Issued 28th Patent
    • Levita Magnetics Closes $26M Series C
    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

    Valspar Reveals Fresh Lineup of New Shades in 2023 Colors of the Year
    Evonik Grows Strongly in 1H 2022
    PPG Chairman and CEO Joins Disability:IN Effort to Advance Disability Inclusion
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    BD Recalls Intraosseous Products Over Multiple Issues
    Rapid Medical Expands U.S. Portfolio
    MMS Holdings Partners With Lindsay Goldberg
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Almac Invests $65M to Expand North American HQ
    Pace Appoints Nisheet Gupta as EVP and Chief Financial Officer
    West Pharmaceutical Makes Strategic Investment in Latch Medical
    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

    Murad Unveils Supplement Product Lineup to Combat Acne, Aging
    R+Co Launches New Hairstyling Products
    Clinique Launches Pop Plush Creamy Gloss in its Iconic Black Honey Hue
    Ink World

    Latest Breaking News From Ink World

    Evonik Enjoys 31% Growth in 1H 2022
    Sun Chemical Returns to Labelexpo Americas 2022
    DIC Reports Consolidated Financial Results 1H 2022
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Hybrid Software joins The Flexo Xperience Center
    Flexo Wash LLC and Mike Potter celebrate 20 years
    Colordyne hosts open house featuring hybrid print technology
    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

    Study Results Released for Abbott's Concussion Blood Test
    Bone Growth Stimulators Market to Top $3B by 2030
    Surgalign, RTI Settle Lawsuit Over OEM Biz Sale
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Zebra Technologies’ Emission Reduction Targets Validated by SBTi
    Identiv Delivers Impressive 41% Year-over-Year Growth in RFID Business
    Stratasys Signs Agreement to Acquire Covestro’s Additive Manufacturing Materials 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