• 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
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    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
    Top News
    Optimize EP Launches CaRM Cardiac Device Data Management Platform

    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR

    Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

    Moon Surgical Expands Leadership Team
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    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
    Spectrum Plastics Group

    Unicep

    Concise Engineering

    Medbio LLC

    PTI Engineered Plastics Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    K-Tube Technologies

    Element

    Qosina Corp.

    PTI Engineered Plastics Inc.

    Unicep
    • 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
    • Podcasts
    • Resources
    • eBook
    • 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

    Expanding Quality Beyond the Four Walls of Your Organization

    As suppliers can impact product quality, device manufacturers must oversee them as though they were an extension of the company and not an outside entity.

    Expanding Quality Beyond the Four Walls of Your Organization
    Seth Goldenberg, Ph.D., and Carl Ning, Veeva Systems03.04.20
    Medical device and diagnostics companies have experienced dramatic growth over the last decade that is significantly impacting the supply chain. Gone are the days of single-source procurement. To keep pace with the velocity of innovation, manufacturers have diversified their network of suppliers. They now source from hundreds—even thousands—of vendors to leverage the global supply of parts, active ingredients, and other components to help drive costs down and stay competitive.

    Because each of these suppliers can impact product quality, device manufacturers must oversee them as though they were an extension of the company and not an outside entity. However, this has become challenging as large suppliers establish hundreds of global manufacturing sites to increase capacity and smaller suppliers are being acquired or divested. This adds to supply chain complexity with more suppliers to manage in more locations amid constant change. 

    Additional suppliers are not only more difficult to track, but also increase the potential for supply chain disruption that could have a domino effect on product quality. Any one vendor could suddenly go out of business, encounter manufacturing snags, decrease capacity, or other events. Adding to the challenge, many medical device companies rely on manual processes and systems that limit visibility and make it difficult to comprehensively monitor supplier quality across longer, more complicated supply chains.

    These challenges have taken a major toll on the industry with a surge in product shortages, recalls, and regulatory citations. The FDA issued 49 Class I recalls in 2019—the most in four years.1 Non-routine quality events—such as major observations, recalls, warning letters, and consent decrees, along with associated warranties and lawsuits—cost the industry between $2.5 billion and $5 billion per year on average.2 These figures do not include losses of goodwill and market share. Further, major quality events can mean long-term devaluation for a company. In the past decade, an average of one company per year has seen a 10 percent drop in share price after a single major product recall.2

    Modern, cloud-based systems that have been used to successfully manage complex supply chains in other industries can help device manufacturers collaborate better with vendors and manage quality more effectively and efficiently. The challenge, now, is supplier adoption. The key to improving quality is not just adopting advanced systems and smarter processes within a device company’s four walls, but also ensuring top suppliers do the same. Bringing external suppliers into the device company’s quality management processes can improve quality and reverse quality’s downward trend—as it must. Following are ways to encourage suppliers to adopt best practices.

    Demonstrate Value and ROI to Suppliers
    Some medical device suppliers are hesitant to collaborate within medical device companies’ quality management systems—they are uncertain how this could impact day-to-day operations. However, if a device company demonstrates the value, efficiency, and operational benefits of a collaborative, best-in-class solution, suppliers will recognize the advantage. For example, joint workshops or conference room pilots of a new system between select suppliers and the device manufacturer provide opportunities to demonstrate system value while fostering productive relationships between manufacturers and suppliers.

    “Patient safety and product quality are our top priorities so as our supply chain grew, we adopted a modern solution that allowed us to automate manual quality management tasks,” said Jon Cornell, head of quality at Coloplast. “Soon, we were able to demonstrate ROI—specifically, how the solution increased efficiency and saved us resources so we were in a better position to maintain high quality.”

    Best-in-class technology solutions enable medical device companies to eliminate the manual steps involved with tracking supplier quality, such as transcribing phone calls into the system of record, inputting incident reports, e-mailing back and forth with suppliers, scanning documents, and more. One Class III medical device company found their supplier quality engineers were spending up to four hours per person each day on administrative tasks. With new technology, companies can dramatically improve efficiency and free staff to focus on other tasks.

    Modern systems also automate the ongoing process of managing supplier scorecards. For instance, alerts and workflows can be automatically triggered when any supplier nears an unacceptable quality threshold. Device manufacturers can set pre-determined limits across various quality factors, and if breached, the system demotes that supplier from “approved” to “conditionally approved,” and prevents any further purchases until resolved. If needed, it can auto-generate requests for “for-cause audits,” ensuring all suppliers are closely monitored. This also allows device companies to be more proactive in averting a potential disaster. The same is true for suppliers equally as vested in avoiding the financial and brand damage stemming from a major quality event in one of their customers’ products.

    Historically, medical device companies have only been able to react months after discovering an approved supplier slipped from one incident per quarter to 10. By then, the damage has been done and the costs are significantly higher than if it had been caught early. Modern solutions track suppliers in real time, empowering companies to head off a problem early and affording them more control for creative problem resolution. Suppliers, in turn, will likely reduce their quality infractions, and be rewarded by the manufacturer upgrading them to preferential status. Frequency and intensity of supplier audits may also decrease depending on consistent, positive audit results, scorecard, and risk rating, translating into significant time and resource savings.

    “When companies work collaboratively, it’s a win-win-win,” added Cornell. “Working within the same modern system is ideal. Suppliers increase their business, manufacturers improve quality and reduce costs, and patients’ lives are enhanced with safer products.”

    Help Get Suppliers Up and Running Fast
    Naturally, some suppliers are reluctant to adopt a new system if perceived as difficult to use. As consumers, we expect technology to be intuitive with clear, point-and-click navigation for rapid access to records, auto-populating fields to save time, and simple drop-down menus.

    As important, device companies should help suppliers assess organizational readiness by identifying any requisite change management protocol and evaluating the optimal training approach—both from content development and delivery perspectives—to ease the transition. By giving suppliers expert guidance before a changeover, device companies reduce any potential apprehension.

    “The cost of quality isn’t always part of the financial accounting process, so whatever device companies can do to show value will motivate most suppliers to consider making a change,” said Cornell. “Modern systems allow fast information sharing and improved efficiencies but you must roll-up your sleeves and demonstrate that value.”

    Post-implementation, device companies should provide system support, including virtual and/or in-person user training and educational materials to help onboard the suppliers and provide ongoing training sessions in regular intervals. Likewise, technology vendors should be expected to partner with device companies to support their efforts for greater system adoption among suppliers.

    Increase Supplier Quality, Decrease Post-Market Surveillance Burdens
    Modern technology is the core enabler to improving supplier quality management in the medical device and diagnostics industry. However, for manufacturers to fully leverage the advantages of new technology, collaboration outside their four walls is paramount. Device companies must demonstrate system benefits and incentivize suppliers by passing along these benefits such as preferential status or less frequent audits (when possible). In addition, they should encourage system adoption by providing onboarding assistance and comprehensive, ongoing training.

    The result is increased quality of materials coming in, which increases the quality of finished products going out—ultimately, reducing the heavy post-market surveillance (PMS) burden. The PMS team is one of the highest cost centers at medical device companies as it is burdened with handling all product quality complaints (including adverse event and regulatory reporting for health authorities across the globe), complaint investigation, coordination with the CAPA team, and more—all in a fast-paced, high-volume environment. The EU Medical Device Regulation’s heightened focus on PMS adds further strain. 

    Higher quality products reduce complaints and improve patient safety while freeing resources to be redirected to other strategic initiatives like product innovation. This can lead to additional revenue streams that fuel accelerated development of more life-altering products for patients.

    Conversely, device companies that fail to get ahead of supplier quality in today’s complex supplier landscape will face quality issues. Stuck in a reactionary mode, these organizations risk increases in complaints, warning letters, consent decrees, product recalls, and worst of all, causing patient harm.

    “When suppliers and medical device manufacturers are on the same page, it naturally creates a more seamless working relationship,” concluded Cornell. “Communication increases and risk decreases. Quality issues can be circumvented early. And, both companies benefit from increased efficiencies.” 

    References
    1. bit.ly/mpo032001
    2. mck.co/2vOXmqA


    Seth Goldenberg is responsible for Veeva Vault strategy in the medical device and diagnostics industry, including customer engagement, market adoption, and product development. Goldenberg has nearly 20 years of experience supporting medical device and diagnostic companies to navigate complex regulations and improve market access. Before joining Veeva, Goldenberg was director of product development strategy at North American Science Associates (NAMSA), where he supported medical device companies from inception through commercialization and post-market activities. Outside of Veeva, Goldenberg is an active member of the Regulatory Affairs Professionals Society (RAPS) and is the “entrepreneur in residence” at the Pennsylvania Pediatric Device Consortium. He holds a doctorate in pharmacology from the University of Washington and a master’s degree from the school of biomedical engineering at Drexel University. He can be reached at seth.goldenberg@veeva.com.

    Carl Ning is responsible for Veeva Vault Quality solutions strategy, with an emphasis on the medical device and diagnostics vertical. With over 20 years of experience delivering transformative solutions in the life sciences, consumer products, discrete manufacturing, and financial services industries, Ning has dedicated 15 of those years to quality management. He has been involved in over 100 quality/regulatory system design and implementation initiatives, and continually seeks ways to evolve solution designs to maximize value without sacrificing efficiency and compliance. He can be reached at carl.ning@veeva.com. 
    Related Searches
    • device
    • Manufacturing
    • supplier
    • recalls
    Related Knowledge Center
    • Software & IT

    Related Columns

    • Software & IT
      The Five Steps Toward Machine Learning

      The Five Steps Toward Machine Learning

      When talking about AI and ML, we’re no longer discussing the theoretical scenarios science fiction is made of. We’re talking about what’s possible.
      Sue Marchant, Machine Learning and Artificial Intelligence, MasterControl 05.01.20

    • Software & IT
      Unlocking Market Doors with Real-World Evidence

      Unlocking Market Doors with Real-World Evidence

      Real-world evidence is becoming increasingly important for manufacturers to demonstrate value beyond efficacy and safety standards.
      Seth Goldenberg, Ph.D., Vice President, Vault Medical Device & Diagnostics, Veeva Systems 11.04.19

    • Contract Manufacturing | Software & IT
      Five Ways Quality 4.0 Is Changing the Face of Medical Device Manufacturing

      Five Ways Quality 4.0 Is Changing the Face of Medical Device Manufacturing

      Industry 4.0 represents the dawn of the digital transformation that began with the third revolution, connecting the physical and natural worlds.
      Scott Reedy, Senior Director of Marketing, Arena Solutions 10.08.19


    • Contract Manufacturing | Digital Health | Software & IT
      Connecting the Dots in Medical Device Outsourcing

      Connecting the Dots in Medical Device Outsourcing

      ...
      MPO Staff 07.30.19

    • Software & IT
      Five Strategies to Navigate Regulatory Challenges in Medical Device Development

      Five Strategies to Navigate Regulatory Challenges in Medical Device Development

      ...
      Seth J. Goldenberg, Ph.D., Vice President, Vault Medical Device & Diagnostics, Veeva Systems 07.30.19

    • Software & IT
      Connected Quality Systems Reduce Risks

      Connected Quality Systems Reduce Risks

      ...
      Scott Reedy, Senior Director of Marketing, Arena Solutions 06.13.19


    • Software & IT
      Using Digitization to Get Ahead in Medtech

      Using Digitization to Get Ahead in Medtech

      ...
      Bryant Headley, Customer Success Executive, MasterControl 05.01.19

    • Software & IT
      Quality Systems: It’s All Greek to Us

      Quality Systems: It’s All Greek to Us

      ...
      Dawn A. Lissy, President & Founder, Empirical 04.03.19

    • Software & IT
      Five Questions to Improve Your Requirements Management

      Five Questions to Improve Your Requirements Management

      ...
      Kevin Steigerwald, VP of Product & UX, Jama Software 04.03.19


    • Software & IT
      Digital Transformation: Seven Considerations for Your QMS

      Digital Transformation: Seven Considerations for Your QMS

      ...
      Tony Parise, Product Strategist—Life Sciences, ETQ 04.03.19

    • Software & IT
      Three Questions to Master Continual MDSAP Conformity

      Three Questions to Master Continual MDSAP Conformity

      ...
      Tony Parise, Product Strategist—Life Sciences, ETQ 03.07.19

    • R&D & Design | Software & IT
      Disrupting the Outsourcing Model

      Disrupting the Outsourcing Model

      ...
      Steve Maylish and Shannon White, Fusion Biotec 01.31.19


    • Software & IT
      4 Ways to Prepare for the European Medical Device Regulation (MDR)

      4 Ways to Prepare for the European Medical Device Regulation (MDR)

      ...
      Melonie Warfel, Vice President, Medical Device & Diagnostics, Veeva Systems 01.30.19

    • Software & IT
      Organizational and Regulatory Influences on Creating and Sustaining an Effective QMS

      Organizational and Regulatory Influences on Creating and Sustaining an Effective QMS

      ...
      Annette Schaps, Schaps Consulting, and Chuck Cimalore, Arena Solutions 11.26.18

    • Software & IT
      How to Choose the Right Quality Management System

      How to Choose the Right Quality Management System

      ...
      Chuck Cimalore and Rasean Hamilton, Omnify Software and EarLens 09.07.18


    Trending
    • STERIS To Buy Cantel Medical For $4.6B
    • Meeting Critical Ventilator Product Requirements Amid Pandemic
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Abbott To Supply Additional 30M COVID-19 Tests To U.S. Gov't
    Breaking News
    • Optimize EP Launches CaRM Cardiac Device Data Management Platform
    • U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    • FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    • Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation
    • Moon Surgical Expands Leadership Team
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • 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

    NSF Begins New Certification Program
    Eriocitrin Shown to Have Metabolic Benefits in Recent Study
    EverGrain Introduces Sustainable Barley Ingredients
    Coatings World

    Latest Breaking News From Coatings World

    Zeppelin Acquires MTI Mischtechnik
    Ezio Braggio Joins ChemQuest Europe
    IFS Coatings Announce Carbon Offset Program
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Optimize EP Launches CaRM Cardiac Device Data Management Platform
    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Frontage Bolsters Clinical Services Capabilities
    Sanofi Unveils EUROAPI as Name of New European API Company
    Thermo Fisher Buys Novasep's Viral Vector Manufacturing Biz
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Neenah to Host Packaging Webinar for Printers
    W.S. Badger is Named a ‘150 Top Impact Company’
    Mana Products, Meiyume and RPG Form The Vertical Beauty Alliance
    Happi

    Latest Breaking News From Happi

    Amyris Named a Top Social & Environmental Impact Company
    L'Oréal Bans Animal Hair in Brushes
    Ashland Launches Antaron ECo Gel
    Ink World

    Latest Breaking News From Ink World

    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Techkon USA, Konica Minolta Partner
    Alon Bar-Shany Appointed Chairman of Highcon Board
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Exhibitor registration opens for virtual.drupa
    FTA planning in-person Forum & INFOFLEX
    Fortis Solutions Group achieves SGP certification
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Shemesh Adds U.S. Headquarters
    TZMO USA, Special Needs Group Form Partnership
    BAHP Announces 2021 Officers, Board of Directors
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA
    Boston Scientific Releases WaveWriter Alpha Spinal Cord Stimulators in U.S.
    New Chief Clinical Officer on Board at IncludeHealth
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Toppan Announces 2050 Environmental Vision
    SOI Industry Consortium Joins SEMI as Strategic Association Partner

    Copyright © 2021 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