• 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
    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability

    Machining & Laser Processing Have Huge Parts to Play in Medtech Manufacturing

    Medtech R&D Teams Must Be Creative & Resilient to Survive

    Struggling Suppliers in Electronics Manufacturing Services (EMS)

    Deep (Brain) Thoughts with Medtronic's Neuromodulation President
    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
    PDC Unveils New Brand Identity

    MD&M West News: Teamvantage Launches New Parent Company

    BD Receives EUA from FDA for COVID-19, Influenza A/B, RSV Combination Test

    Qosina Names Lee Pochter as Executive Vice President

    FDA Okays Early Feasibility Study for Anteris' TAVR Product
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability

    Machining & Laser Processing Have Huge Parts to Play in Medtech Manufacturing

    Medtech R&D Teams Must Be Creative & Resilient to Survive

    Struggling Suppliers in Electronics Manufacturing Services (EMS)

    Deep (Brain) Thoughts with Medtronic's Neuromodulation President
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Deducing the Dual Reality of Elizabeth Holmes

    The Return of the AdvaMed MedTech Conference…Live!

    Material Matters: New Materials Call for New Thinking

    5 Ways to Maintain a Talent-Centric Mindset, Even During Economic Uncertainty

    The Changing Face of UK Medical Device Regulations: Most Recent Update
    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
    Halkey-Roberts Corporation

    NDH Medical Inc.

    Forefront Medical Technology

    JBC Technologies

    Paragon Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Onshoring Medical Device Manufacturing Can Strengthen Supply Chains

    How Artificial Intelligence Can Combat Key Issues Impacting Healthcare

    Why Advanced Sensors Are Crucial Within Medical Pumps

    How Artificial Intelligence Could Help Prevent 80% of Chronic Diseases

    4 Ways to Use Injection Molding in Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Halkey-Roberts Corporation

    NDH Medical Inc.

    Forefront Medical Technology

    JBC Technologies

    Paragon 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

    The State of Supply Chain Risk

    ...

    Related Content
    • PartsSource Unveils New Operations Dashboard
    • Amcor Launches Enhanced Heat Seal Coating Technology
    • BD Names Christopher DelOrefice as EVP and CFO
    • Pandemic has Accelerated Nearshoring Medtech Materials
    • Baxter Begins Collaboration with Amazon Web Services
    James A. Dunning, Principal, QPC Services LLC06.04.18
    Special occasions are usually the perfect time for a stroll down memory lane and a peek into the metaphorical crystal ball. Medical Product Outsourcing’s 15th anniversary is no different, as it has prompted me to pause and reflect on the changes the medtech industry has undergone since 2003 and ponder what further transformations are in store for the sector. The changes are too numerous to itemize, though one in particular served as a guide for my brief jaunt to the past: supply chain controls (and risk). 

    Before I share my insights on supply chain risk, I want to include some general information about supply chain controls for those unfamiliar with this subject. A supply chain is a series of linked activities and organizations to transform natural resources, raw materials, components, services, and information into a finished product that is delivered to end customers. Supply chain controls help minimize risk to a finished product—from its initial creation, to suppliers involved with all stages of development, through final customer distribution. Whether risk stems from an original raw ingredient producer or a storage warehouse, the safety and effectiveness of active pharmaceutical ingredients, foods, drug and biological products, cosmetics, veterinary products, and medical devices are increasingly jeopardized by supply chain challenges. As a result, supply chain controls must continuously evolve to meet rapidly mutating risks.

    Growth of the 21st century globalized economy has allowed these challenges to exceed the 20th century expectations of the U.S. Congress in its creation of the FDA. Consequently, companies and regulators have had to consult a mix of guidance documents written by FDA, international regulatory agencies, and non-governmental organizations to devise a risk reduction strategy for the medtech supply chain.

    Risk management is a key component of any present-day supply chain management program. Supply chain risk management (SCRM) is a discipline of risk management that attempts to identify potential disruptions to continued manufacturing production, and by extension, commercial financial exposure. SCRM attempts to reduce supply chain vulnerability through a coordinated holistic approach involving all supply chain stakeholders; these participants are tasked with identifying and analyzing the risk of failure points within the supply chain. Risk reduction plans can involve logistics, finance, and risk management disciplines. The goal is to ensure supply chain continuity in the event of a scenario that otherwise would interrupt normal business operations and thereby affect profitability. Supply chain risks could potentially include:

    Rapid growth: While considered a primary managerial goal of many commercial organizations, rapid growth can also cause substantial problems and create additional risks. For example, small-scale production processes may not work on a large scale and may require additional development, testing, and validation to ensure they maintain the same level of safety and effectiveness as the approved product(s). Suppliers may not be able to grow at the same pace as the finished product manufacturer, and qualified employees may not be available to meet hiring demands.

    Expanded and new facilities: As new facilities are constructed or brought on-line, or as older facilities are renovated or expanded, potential startup issues may be encountered.
    Increased and/or changing product range: As product portfolios evolve and grow, manufacturing complexity may increase concomitantly. Supply chain professionals must work collaboratively with marketing and finance officials to ensure new products do not disrupt demand for existing products, at least until existing inventory has been depleted and supply chains are modified as necessary.

    Changes to the supplier base: Suppliers may come and go as supply chains evolve. As this occurs, the overall performance characteristics of the supplier base changes (e.g., quality, delivery performance, lead times, cost variables), which may ultimately impact product profitability. As product profitability changes, managerial pressure to positively impact financial margins by decreasing costs may occur. Such changes may subsequently introduce substantial additional risk into the supply chain.

    New or larger (and more demanding) customers: Generally, larger customers are more demanding. As dependability on specific customer revenues grow, the incentives to ensure customer satisfaction grow as well. Company manufacturing processes that ebb and flow with customer demand risk adding significant capacity and cost upon losing clients.

    Changes to IT systems: Information technology (IT) systems are often a critical component to the logistics of executing supply chain processes. If planned and executed properly, IT operational improvements can add substantial benefits to the value of a supply chain. If conducted improperly, however, the results can be disastrous and lead to litigation.
    Supply chain professionals incorporate at least three types of activities in mitigating supply chain risks:
    1. Sharing expertise: Although critical to their success, mitigating risk is just one of many roles with which supply chain professionals must be comfortable. Compliance professionals can use their expertise to monitor the supply chain and help prioritize risks based on their potential compliance impact. Compliance professionals have a strong role to play in the supply, production, and distribution areas.
    2. Use the supply chain as an entry point: Supply chain professionals have deep relationships with their third-party partners, critical suppliers, and third-party logistics providers. Compliance professionals should use those relationships to develop stronger mechanisms for both internal supply chain partners and the third-parties themselves to understand, identify, and report misconduct and other compliance risks.
    3. Work within the “flow” of the supply chain: Supply chain professionals think about their roles as they relate to product flow from the ground to the customer. Compliance professionals should avoid attempts to “box in” their support within specific aspects of those flows, understanding that a change in one area (e.g., supply) can have a substantial impact on another area (e.g., planning).
    Some concluding thoughts to consider:
    • A long supply chain, with sourcing, manufacturing, packaging, and distribution occurring in different locations globally, has an increased risk of contamination or substitution of alternative ingredients.
    • Safety hazards posed by complex new technologies may be difficult to anticipate during development, and therefore may not be realized until products are used long-term or outside the clinical study environment.  
    • Changes to the product manufacturer’s IT systems could have a substantial impact on product manufacturing operations and must be monitored closely by the supply chain professional.
    • Supply chain professionals must work closely with sales and marketing professionals to monitor changes in product demand in case the changes require alterations in the product manufacturer’s supply chain.
    • Working with suppliers on environmental issues not only generates significant environmental benefits, including reduction in waste and more efficient use of natural resources, but also affords opportunities for cost containment, improved risk management, and enhanced quality and brand image.
    Supply chain controls, especially supply chain risk management, have evolved significantly over the last 15 years, and will continue to do so over the foreseeable future. One thing is certain, though: These controls will definitely look a lot different when MPO celebrates its 30th anniversary in 2033. 


    James A. “Jim” Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies ranging from Fortune 500 medical device firms to startups. Dunning’s passion, however, lies with startups and small companies, especially those in regulatory distress. He has amassed significant experience in preparing 510(k) applications, developing complete quality management systems, providing quality system training, and advising on quality, business, and leadership issues. Dunning is a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professional Society (RAPS). He can be reached at jdunning@qpcservices.com.
    Related Searches
    • pharmaceutical
    • medical product
    • sales
    • Outsourcing
    Suggested For You
    PartsSource Unveils New Operations Dashboard PartsSource Unveils New Operations Dashboard
    Amcor Launches Enhanced Heat Seal Coating Technology Amcor Launches Enhanced Heat Seal Coating Technology
    BD Names Christopher DelOrefice as EVP and CFO BD Names Christopher DelOrefice as EVP and CFO
    Pandemic has Accelerated Nearshoring Medtech Materials Pandemic has Accelerated Nearshoring Medtech Materials
    Baxter Begins Collaboration with Amazon Web Services Baxter Begins Collaboration with Amazon Web Services
    Smaller Devices Require More Efficient Material Integration Smaller Devices Require More Efficient Material Integration
    Pratip Dastidar Joins Establishment Labs as Head of Global Operations Pratip Dastidar Joins Establishment Labs as Head of Global Operations
    Substantial Growth Predicted for Global Ventilators Market Substantial Growth Predicted for Global Ventilators Market
    EU MDR Preparedness: How Is COVID-19 a Factor? EU MDR Preparedness: How Is COVID-19 a Factor?
    How an MDQMS Can Lead to More Efficient and Sustainable Diagnostic Tests How an MDQMS Can Lead to More Efficient and Sustainable Diagnostic Tests
    AdvaMed Encourages Biden to Prioritize Medical Supplies Transport AdvaMed Encourages Biden to Prioritize Medical Supplies Transport
    How Digitization Enables Safe, Connected Operations in Manufacturing How Digitization Enables Safe, Connected Operations in Manufacturing
    Private Equity Group to Buy Medline for Over $30B Private Equity Group to Buy Medline for Over $30B
    Freudenberg Medical Freudenberg Medical's Dr. Sherry Gray Retires as VP/GM
    Four Considerations for Manufacturers When Applying Digitization Four Considerations for Manufacturers When Applying Digitization

    Related Breaking News

    • PartsSource Unveils New Operations Dashboard

      PartsSource Unveils New Operations Dashboard

      New dashboard gives clients real-time insights across the medical device supply chain.
      Business Wire 08.26.21

    • Packaging & Sterilization
      Amcor Launches Enhanced Heat Seal Coating Technology

      Amcor Launches Enhanced Heat Seal Coating Technology

      New heat seal adhesive helps medical device manufacturers better mitigate risk for greater patient safety.
      Amcor 08.23.21

    • BD Names Christopher DelOrefice as EVP and CFO

      BD Names Christopher DelOrefice as EVP and CFO

      DelOrefice joins the company from Johnson & Johnson.
      BD 08.12.21


    • Materials
      Pandemic has Accelerated Nearshoring Medtech Materials

      Pandemic has Accelerated Nearshoring Medtech Materials

      Buying materials from overseas may be cost-effective, but it can create an environment with less collaboration and less room for innovation.
      Michael Barbella, Managing Editor 08.06.21

    • Digital Health
      Baxter Begins Collaboration with Amazon Web Services

      Baxter Begins Collaboration with Amazon Web Services

      Advancing strategic priorities in digital health, customer experience, and technology modernization.
      Baxter 08.03.21

    Loading, Please Wait..

    Trending
    • The Future Of Biomedical Engineering Advancements
    • MO SCI Acquires Assets Of 3M’s Advanced Materials Business
    • CGM Devices Could Become Main Glucose Monitoring Solution In U.S.
    • Endologix Shares Positive 12-Month Results Of DETOUR-2 Trial
    • FDA Okays Early Feasibility Study For Anteris' TAVR Product
    Breaking News
    • PDC Unveils New Brand Identity
    • MD&M West News: Teamvantage Launches New Parent Company
    • BD Receives EUA from FDA for COVID-19, Influenza A/B, RSV Combination Test
    • Qosina Names Lee Pochter as Executive Vice President
    • FDA Okays Early Feasibility Study for Anteris' TAVR Product
    View Breaking News >
    CURRENT ISSUE

    January/February 2023

    • Struggling Suppliers in Electronics Manufacturing Services (EMS)
    • Machining & Laser Processing Have Huge Parts to Play
    • Medtech R&D Teams Must Be Creative & Resilient to Survive
    • Medtronic Neuromodulation President, Nnamdi Njoku, Interview
    • 6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    • 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

    Tocotrienols May Have Protective Effect on Liver in NAFLD Patients
    Indian Gooseberry Extract Shown to Offer Blood Sugar Management Benefits
    ADM Expands Production to Meet Demand for Probiotics
    Coatings World

    Latest Breaking News From Coatings World

    AkzoNobel Reports Revenue Growth in 2022
    Orion Engineered Carbons Announces New Distribution Partnerships
    Personnel Changes at BASF
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    PDC Unveils New Brand Identity
    MD&M West News: Teamvantage Launches New Parent Company
    BD Receives EUA from FDA for COVID-19, Influenza A/B, RSV Combination Test
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Gerresheimer/Corning Announce Joint Venture to Meet Growing Demand for Velocity Vials
    KORSCH Acquires MEDELPHARM to Strengthen R&D Product Line
    SRI Names Kathlynn Brown Biosciences Division President
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Kiss Colors & Care Taps Rapper JT as Brand Partner
    Revolution Beauty Expands into Walmart in the U.S.
    Macro-Environmental Factors Impacting the Packaging Industry
    Happi

    Latest Breaking News From Happi

    Perfect Corp. Receives MLPS 2.0-Compliant Status to Help Beauty Brands Meet China's National Cybersecurity Standards
    Mary Kay Supports Ocean Conservation at International Marine Protected Area Congress
    Mintel Reveals Macro-Environmental Factors Impacting Household and Personal Care Packaging
    Ink World

    Latest Breaking News From Ink World

    Heidelberg Well on Track after Three Quarters of FY2022/23
    Orion Carbons Announces New Distribution Partnerships
    DuPont Reports 4Q, Full Year 2022 Results
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    'Build Back the Wisconsin Paper Industry' event announced
    Magic Johnson to keynote Dscoop Edge St. Louis World Expo
    Norway's Digital Etikett grows with HP Indigo
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Edgewell’s Sales Increase
    Mitsui Chemicals, Asahi Kasei Combine Nonwovens Businesses
    Hospeco Offers TaskBrand Prep-Paint-Finish Wiping System
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    OssDsign Launches New Product for Additional Surgical Procedures
    OSSIO Introduces Non-Permanent Compression Staple
    Dennis Jones Joins Intelivation Technologies as Manufacturing VP
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Zebra Partners with Fundación Cardiovascular de Colombia
    Emerson Reports 1Q 2023 Results
    Identiv Expands NFC and HF Solutions Portfolio

    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