• 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
    Transporting Treatment: An Examination of Tubing Technologies

    Outward Appearance: Reviewing Surface Treatment Options

    Face to (Virtual) Face: Telemedicine Now and Post-Pandemic

    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform
    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
    CMS Establishes New Payment for Pelvalon’s Eclipse System

    Varian, Google Cloud Partner to Bring Convenience to Cancer Therapy

    Resonetics Leases New Manufacturing Space in Costa Rica

    Seisa Medical Acquires ProtoQuick and Peridot

    Masimo Device is Useful in Assessing Respiratory Status of Pediatric Tracheostomy Patients
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Transporting Treatment: An Examination of Tubing Technologies

    Outward Appearance: Reviewing Surface Treatment Options

    Face to (Virtual) Face: Telemedicine Now and Post-Pandemic

    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Home Is Where the Heart (Valve) Is

    CGM: Digital Health Meets a Very Large Opportunity

    Biomechanical Engineer, Heal Thyself

    Optimizing MIM in Medical Device Manufacturing

    PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market
    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
    FUTEK Advanced Sensor Technology Inc.

    maxon

    K-Tube Technologies

    MW Life Sciences

    Trademark Plastics Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Three Future Trends and Opportunities in Quality Assurance

    Adopting a Data-Driven Quality Model

    Digital Transformation for Quality and Manufacturing

    Digging into the Cardiac Arrhythmia Monitoring Device Market

    EMS Providers Supplying More Than Electronics to Customers
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Concise Engineering

    K-Tube Technologies

    Creganna Medical, part of TE Connectivity

    Medicoil

    maxon
    • 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
    Online Exclusives

    Partnering with CMOs

    What to expect from a new CMO partner or an existing partnership.

    Partnering with CMOs
    An ideal CMO partner should be adaptable and prepared with advances across manufacturing, regulatory, data and analytics, testing and more.
    Related CONTENT
    • Optimizing MIM in Medical Device Manufacturing
    • PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market
    • A Primer on the Benefits of Metal Injection Molding
    • The FDA Wants to Bring Manufacturing ‘Home’
    • Innovation and Expertise Drive Evolution in Medical Device Manufacturing
    Patrick Malone, Vice President Operations, West Pharmaceutical Services08.24.20
    Original equipment manufacturers (OEMs) are increasingly outsourcing their manufacturing requirements as a strategic approach to streamline operations and remain competitive – minimizing infrastructure and overhead expenses and improving efficiencies. It also allows for greater focus on device development and packaging, providing the flexibility needed to succeed in a fast paced, ever-evolving market.
     
    Such outsourcing helps drive forward critical innovation and presents an increased opportunity for contract manufacturing organizations (CMOs) as partners. It also demands that CMOs as partners be adaptable and prepared with advances across manufacturing, regulatory, data and analytics, testing and more.
     
    Whether understanding what to expect from a new CMO partner or an existing partnership, there are a number of key elements to be aware of that are integral to CMOs offering optimal value to customers while fostering a mutually beneficial partnership:
     
    Regulatory Expertise
    Regulatory hurdles are a challenge many of our customers face, and to be able to rely on their CMO partner to help manage related processes is imperative. CMOs contribute information and data to their customer’s regulatory filings and are responsible for ensuring all quality requirements are met.
     
    In addition, regulatory requirements vary across different markets and countries, so a CMO must understand the required regulatory landscape(s) in order to properly align to their customer’s product distribution strategy.
     
    An agile quality system is a requirement in meeting a broad set of requirements. Timing and uncertainty around regulatory clearance/approval can also present a challenge to CMOs. Clear communication with the customer around this timing is important as CMOs need to effectively plan their capacity to support their customer launch and market expansion needs.
     
    Risk Mitigation and Issues Management
    Risk and challenges must be anticipated and mitigated throughout a product’s lifecycle, in all aspects of development and production. The totality of a product’s quality and safety depends on its various components – from packaging to the delivery of device systems. Through rigorous testing and analysis, CMOs can help ensure that the optimal packaging and delivery systems are selected, and appropriate testing is carried out. Under circumstances where an accelerated timeline must be followed, such as with the current and urgent development of resources to help with management of COVID-19 – safety and quality can become riskier and pose more potential issues. CMOs should be prepared to adapt to differentiated needs, selecting and testing packaging systems faster than usual without compromising any standards, offering both resources and guidance to partners throughout the process.
     
    Cutting-Edge Innovation
    To keep up with industry advances, CMOs are similarly preparing for advances in manufacturing to meet partner needs. This includes Industry 4.0, which typically refers to the use of data and automation in manufacturing. Simulation, additive manufacturing, data and analytics, and augmented reality are technologies that are currently being used to create “smart factories” where systems, machines and people work together to more rapidly and seamlessly design or create something while improving efficiencies and eliminating errors. A CMOs automated manufacturing environment with real-time access to manufacturing data allows for optimum process control and performance and enables consistency in product performance for their partners. CMOs are currently focused on improvements in infrastructure – including security, systems and data storage – in addition to building and retaining a high-caliber talent pool, to successfully support and drive value through advanced technologies and market growth.
     
    Comprehensive ‘Full Suite’ Solutions
    Strategic partnerships should be not just mutually beneficial but collaborative in nature. Partnering with a CMO that is a leader in its respective market can have myriad benefits, including offering innovative end-to-end strategies and solutions that prioritize quality and safety while minimizing risk, improving time to market, and simplifying processes overall. Further, CMOs with demonstrated leadership have the capacity to support scale up strategies including clinical trials, HF support, regulatory, analytic testing and device manufacturing and live-cycle management.
     
    Due to the cost implications associated with this business and related complex manufacturing requirements, companies may rely even more heavily on CMO partners that can offer an integrated approach to services, across packaging, testing, filing device assembly and final packaging in an effort to help reduce risk and challenges, optimize supply chains and meet time-to-market expectations. For example, the latter – speed-to-market – is becoming even more critical as management of COVID-19 continues. Platform approaches supported by component and system performance data can help position CMOs as better equipped to meet these needs.
     
    High-speed precision automation has become much more common-place because it ensures stability of performance and enables greater levels of productivity and efficiency while providing ability to scale to high volumes. Additionally, as technology continues to revolutionize the health care industry overall, different ways of using data and analytics in manufacturing as well as digital tech and automation will continue to emerge.
     
    Ultimately, strong business practices and processes and the effective use of technology – combined with a long-term strategy – function as important growth drivers and allow CMOs to lead in their sectors. As a result, value and outcomes can be improved for partners while delivering needed therapeutics to patients more effectively and safely.
     

    Patrick Malone, vice president of operations, Contract Manufacturing, West Pharmaceutical Services, Inc., provides strategy, vision, direction and support for West’s six proprietary Contract Manufacturing sites across United States and Ireland. Prior to joining West, Patrick served as the Senior Manufacturing Director and Site Leader of the Medtronic Osteotech Campus, a global leader in the processing of human bone and connective tissue.  Patrick also previously held operations and engineering leadership roles focused on the manufacturing and testing of Medtronic implantable electronic medical devices.
    Related Searches
    • Contract Manufacturing
    Related Knowledge Center
    • Contract Manufacturing
    Suggested For You
    Optimizing MIM in Medical Device Manufacturing Optimizing MIM in Medical Device Manufacturing
    PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market
    A Primer on the Benefits of Metal Injection Molding A Primer on the Benefits of Metal Injection Molding
    The FDA Wants to Bring Manufacturing ‘Home’ The FDA Wants to Bring Manufacturing ‘Home’
    Innovation and Expertise Drive Evolution in Medical Device Manufacturing Innovation and Expertise Drive Evolution in Medical Device Manufacturing
    Freudenberg Buys Merit Medical Freudenberg Buys Merit Medical's Hypotube Manufacturing Biz
    4 Ways the IIoT Improves Medical Manufacturing 4 Ways the IIoT Improves Medical Manufacturing
    Managing Medtech Manufacturing Managing Medtech Manufacturing
    Trends for Medtech Contract R&D and Manufacturing Trends for Medtech Contract R&D and Manufacturing
    Kyocera, Tokyo Medical and Dental University Partner on Vitals Measurement Headset Kyocera, Tokyo Medical and Dental University Partner on Vitals Measurement Headset

    Related Online Exclusives

    • Contract Manufacturing | Machining & Laser Processing
      Taking the First Step with Metal Components

      Taking the First Step with Metal Components

      With a foundation in stamping and machining services, Hobson & Motzer offers a revolutionary approach to new product development.
      Sean Fenske, Editor-in-Chief 02.19.21

    • Contract Manufacturing | Electronics
      Innovation, Miniaturization are Top Priorities for Electronic Components Manufacturers

      Innovation, Miniaturization are Top Priorities for Electronic Components Manufacturers

      But many companies are hesitant to start new development projects while the coronavirus is still rampant.
      Michael Barbella, Managing Editor 10.05.20

    • Contract Manufacturing
      Innovation and Expertise Drive Evolution in Medical Device Manufacturing

      Innovation and Expertise Drive Evolution in Medical Device Manufacturing

      MICRO’s president offers a look at the company his family founded 75 years ago as well as the industry it’s supported.
      Brian Semcer, President, MICRO 09.29.20


    • Contract Manufacturing
      Pivoting to Protect Lives and Livelihoods During the Pandemic

      Pivoting to Protect Lives and Livelihoods During the Pandemic

      How Summit Medical manufactured 1 Million FDA-compliant face shields in just 8 weeks.
      Kevin McIntosh, President of Summit Medical 06.18.20

    • Contract Manufacturing
      Translating Outsourcing into Pandemic-Proof Manufacturing

      Translating Outsourcing into Pandemic-Proof Manufacturing

      Using remote service providers and allowing telecommuting can provide unexpected benefits to medical device manufacturers beyond being prepared for a pandemic.
      Ofer Tirosh, CEO, Tomedes 05.04.20

    • Contract Manufacturing
      COVID-19’s Steep Learning Curve: Retooling to Meet Medtech Manufacturing Requirements

      COVID-19’s Steep Learning Curve: Retooling to Meet Medtech Manufacturing Requirements

      There are challenges to address for non-medical device manufacturers seeking to assist with the effort against COVID-19.
      Deborah Jennings-Conner, Director—Global Life and Health Sciences Regulatory and Testing Assurance, and Stewart Eisenhart, Senior Regulatory Analyst, UL 04.30.20


    • Contract Manufacturing
      Partnering for Success: How CMO Expertise Can Help OEMs Thrive

      Partnering for Success: How CMO Expertise Can Help OEMs Thrive

      Building a successful OEM-CMO partnership.
      Carl Savage, Vice President, Business Management, Micro 01.20.20

    • Contract Manufacturing
      5 Questions for Q Medical Devices at Medica/CompaMed 2019

      5 Questions for Q Medical Devices at Medica/CompaMed 2019

      End-to-end design, manufacturing, and supply chain management services.
      Sean Fenske, Editor-in-Chief 11.15.19

    • Contract Manufacturing | R&D & Design
      5 Questions for Integer at Medica/CompaMed 2019

      5 Questions for Integer at Medica/CompaMed 2019

      Full service medical device outsource manufacturer.
      Sean Fenske, Editor-in-Chief 11.15.19


    • Contract Manufacturing | R&D & Design
      5 Questions for Viant at Medica/CompaMed 2019

      5 Questions for Viant at Medica/CompaMed 2019

      End-to-end capabilities, from design and development through to manufacturing, assembly, and packaging.
      Sean Fenske, Editor-in-Chief 11.15.19

    • Contract Manufacturing | Machining & Laser Processing | Materials | R&D & Design
      5 Questions for Resonetics at Medica/CompaMed 2019

      5 Questions for Resonetics at Medica/CompaMed 2019

      Nitinol processing, precision grinding, thin-wall tubing, and 3D ablation capabilities for medical device manufacturing.
      Sean Fenske, Editor-in-Chief 11.15.19

    • Contract Manufacturing | Machining & Laser Processing
      The Advantages of Predictive Maintenance

      The Advantages of Predictive Maintenance

      Why next-gen maintenance is all about prevention.
      Roger Humphrey, Division President, Industries, JLL 09.13.19


    • Contract Manufacturing | Electronics | Neurological
      Taking Charge of an Illness with Neurostim Technology

      Taking Charge of an Illness with Neurostim Technology

      An interview with Heraeus Medical Components' director of product development Steven Scott examining targeted nerve stimulation technologies.
      Sam Brusco, Associate Editor 09.11.19

    • Contract Manufacturing
      The Value of Material Replenishment on the Production Floor

      The Value of Material Replenishment on the Production Floor

      How to keep production moving without stopping work.
      John O’Kelly , CEO/Founder of Newcastle Systems 09.11.19

    • Contract Manufacturing | Electronics | Software & IT
      The Benefits of Software-Powered Electronics Manufacturing

      The Benefits of Software-Powered Electronics Manufacturing

      Enabling medtech innovation and faster time-to-market.
      Sudeep Goswami, VP of Sales for Tempo Automation 09.04.19


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Cheetah Medical Introduces Noninvasive Monitoring System
    • Face Mask Filters 98 Percent Of COVID-19 Particles
    • Diagnosing The IVD Market: An Interview With TEAM Technologies
    • Top 10 Trends In The Medical Device And Equipment Industry
    Breaking News
    • CMS Establishes New Payment for Pelvalon’s Eclipse System
    • Varian, Google Cloud Partner to Bring Convenience to Cancer Therapy
    • Resonetics Leases New Manufacturing Space in Costa Rica
    • Seisa Medical Acquires ProtoQuick and Peridot
    • Masimo Device is Useful in Assessing Respiratory Status of Pediatric Tracheostomy Patients
    View Breaking News >
    CURRENT ISSUE

    April 2021

    • Transporting Treatment: An Examination of Tubing Technologies
    • Face to (Virtual) Face: Telemedicine Now and Post-Pandemic
    • Outward Appearance: Reviewing Surface Treatment Options
    • 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

    Kyowa Hakko Launches Heat-Treated Probiotic Strain for Eye Health
    CGA-7 Green Coffee Extract by Vidya Herbs Achieves Self-Affirmed GRAS Status
    Nutritional Complex Evidenced to Reduce Preterm Birth
    Coatings World

    Latest Breaking News From Coatings World

    Barentz Expands Canadian CASE Team
    Shepherd Color Company Opens Sales Office in China
    Chromaflo Technologies Awarded Gold Status CSR Rating by EcoVadis in EMEA
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    CMS Establishes New Payment for Pelvalon’s Eclipse System
    Varian, Google Cloud Partner to Bring Convenience to Cancer Therapy
    Resonetics Leases New Manufacturing Space in Costa Rica
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Frontage Expands Capabilities at its Clinical Site in Secaucus, NJ
    Ascendia Pharmaceuticals Poised for Expansion
    Bora Pharmaceuticals Adds Roller Compaction Capabilities
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Revlon Unveils New Fragrances Featuring Megan Thee Stallion & Sofia Carson
    Henkel Management Board Welcomes Wolfgang König
    Mielle Organics Gets a Major Investment
    Happi

    Latest Breaking News From Happi

    Nature’s Beauty Debuts Vegan Natural Body Care at Walgreens
    Estée Lauder Expands Beautiful Fragrance Collection
    What You’re Reading on Happi.com
    Ink World

    Latest Breaking News From Ink World

    SE-DA Invests in Kornit Presto S
    Kumon North America Adds Speedmaster XL 106 from Heidelberg
    Iron Oxide Pigments Market to Register 4.7% CAGR from 2021 to 2028: GVR
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Dantex elevates Joseph Sanchez to digital business development manager
    Mactac's Kevin Clunie joins TLMI panel
    MacDermid announces two new global sales roles
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Precision Textiles Offers Biodegradable Medical Fabric
    Northshore Launches Megamax Briefs in New Colors
    Essity Acquires Distribution Rights to Sorbact in Australia and New Zealand
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    New Biosealant Could Stabilize Cartilage, Boost Healing After Injury
    Google Executive Joins SeaSpine's Board of Directors
    HSS and LimaCorporate Open Provider-Based 3D Design and Printing Facility
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Tive Multi-sensor Tracker Solo 5G Relies on Sensirion SHT33
    VTT in 2020: Successful Year Despite Globally Challenging Times
    Lux Research: 3D Printing Market to Reach $51 Billion in 2030

    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