Supply Chain

Columns

  • Contract Manufacturing
    Outsourcing and Trade Policies: Navigating a Complex Issue

    Outsourcing and Trade Policies: Navigating a Complex Issue

    The goals for medical contract manufacturing run the gamut from simply finding a lower cost source for building products to finding a partner capable of supporting entry into markets where a device manufacturer has no physical presence. To best deter…
    Walter Tarca, President, Forefront Medical Technology 06.13.19

  • Software & IT
    Connected Quality Systems Reduce Risks

    Connected Quality Systems Reduce Risks

    For the best outcome in medical design innovation with highly outsourced teams, having a rock-solid approach to quality is a prerequisite. As regulatory standards, market requirements, and device complexities have evolved, so too has the weight of th…
    Scott Reedy, Senior Director of Marketing, Arena Solutions 06.13.19

  • Packaging & Sterilization
    Package Testing and Validation: Interplay Between ISO 11607 Updates and MDR

    Package Testing and Validation: Interplay Between ISO 11607 Updates and MDR

    With recent updates to ISO 11607, Part 1 and Part 2, and the Medical Device Regulation (MDR) on track to replace Europe’s current Medical Device Directive (MDD) in 2020, medical device manufacturers are working hard to ensure their package desi…
    Britt Jones, Manager of Package Testing Services, WuXi AppTec 06.13.19

  • R&D & Design
    Designing for a Seamless UX

    Designing for a Seamless UX

    Everyone has experienced the difference between a product that works the way a user thinks, feels, and behaves and one that is irritating, hard to interpret, and inhibits a positive experience. All medical product and service providers must consid…
    Dr. Bryce Rutter, Founder and CEO, Metaphase Design Group Inc. 06.13.19

  • Packaging & Sterilization
    Sterilization Facility Shutdown Sparks Device Shortage

    Sterilization Facility Shutdown Sparks Device Shortage

    Matt Haller put up a good fight. But he was no match for the cancer that sprouted in his stomach and ravaged his entire body, eventually reducing him to a skeletal 100 pounds. In his final days on Earth, Haller found joy in the simple things: travel…
    Michael Barbella , Managing Editor 05.01.19

  • 3D/Additive Manufacturing
    What’s ‘In’ for Manufacturing? (Hint: It’s Not Neon)

    What’s ‘In’ for Manufacturing? (Hint: It’s Not Neon)

    It seems the only time I catch up on the latest clothing fashions is when I seek inspiration online for columns I write pertaining to trends. Each time I do, I’m reminded why I read magazines like MPO and ODT instead of something in the checkou…
    Dawn A. Lissy , President & Founder, Empirical 05.01.19

  • Contract Manufacturing
    Understanding the Competitive Advantages of Full Service Outsourcing in the Make vs. Buy Decision

    Understanding the Competitive Advantages of Full Service Outsourcing in the Make vs. Buy Decision

    Across industries, managers and leaders often struggle to determine whether handling capabilities in-house or outsourcing them is financially and operationally advantageous for their companies. Put more simply, this struggle can be expressed as: &ldq…
    Tom Williams, General Manager, Millstone Medical Outsourcing 05.01.19

  • Software & IT
    Using Digitization to Get Ahead in Medtech

    Using Digitization to Get Ahead in Medtech

    Companies developing cutting-edge medical devices need cutting-edge technology for their business processes. Whether a company focuses on finding new device materials, designing non-invasive monitors, or tackling the regulatory process, medtech is ad…
    Bryant Headley, Customer Success Executive, MasterControl 05.01.19

  • R&D & Design
    Taking the Waste Out of Product Development

    Taking the Waste Out of Product Development

    We have supported the medical industry for nearly 40 years, both in product development and production of precision sheet metal products. These include sterilization cases and trays, pharmaceutical trays, medical furniture, patient handling products,…
    Ron Estes , VP Operations, Estes Design and Manufacturing 05.01.19

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

    Quality Systems: It’s All Greek to Us

    I admire people who love what they do. There’s a lot of truth to the oft-quoted Mark Twain observation: “Find a job you enjoy doing, and you will never have to work a day in your life.” For the most part, that applies to me. But…
    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

    Medical device developers spend years designing devices that help improve patient outcomes, which leads to millions of dollars invested in product development. If risk and requirements are not managed properly during development, it could result in a…
    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

    Increasing numbers of companies are investing in digital transformation to gain a competitive edge, with digitization set to more than double among manufacturers since 2016 according to Forbes. It’s all part of a rapid technological acceleratio…
    Tony Parise, Product Strategist—Life Sciences, ETQ 04.03.19

  • Testing
    Why Big Companies With Internal Labs Should Outsource Testing

    Why Big Companies With Internal Labs Should Outsource Testing

    Most of us know when we’ve hit that line signaling we’ve left our cutting edge and officially spread ourselves too thin. Pushing to do and be more is often a half-step from maxing out and dropping all those balls we’re juggling.…
    Dawn A. Lissy, President & Founder, Empirical 03.07.19

  • Contract Manufacturing | R&D & Design
    Patent Law: How OEMs and CMs Can Work Together

    Patent Law: How OEMs and CMs Can Work Together

    It is often more cost effective for a medical device company to outsource product development , component manufacturing, or assembly work to a contract manufacturer (CM) since the CM often has the proper equipment, technical expertise, and experience…
    Megha Manjunath and Doug Portnow, Schwegman, Lundberg & Woessner 03.07.19

  • Software & IT
    Three Questions to Master Continual MDSAP Conformity

    Three Questions to Master Continual MDSAP Conformity

    Product recalls frequently make headlines and tarnish brand reputations as a result. In today’s digital world, one bad customer experience with quality can be broadcast in seconds, giving brands little time to react. Not prioritizing quality is…
    Tony Parise, Product Strategist—Life Sciences, ETQ 03.07.19

  • Contract Manufacturing
    Evolving Players in the Medical Device Supply Chain

    Evolving Players in the Medical Device Supply Chain

    Today’s medical device supply chain was shaped by two far-reaching trends: A realization among OEMs over the last 20 years about outsourcing’s ability to reduce manufacturing costs while producing safe, reliable products; and OEMs’…
    Tony Freeman, President, A.S. Freeman Advisors LLC 03.07.19

  • Contract Manufacturing | R&D & Design
    Structuring Successful Outsourced R&D Programs

    Structuring Successful Outsourced R&D Programs

    Have you ever asked a consultant, “We need to outsource regularly but were burned very badly the last time—how will it be any different with your team?” Consider outsourcing as part of your human resource strategy if: You ne…
    Philip Remedios, Principal, Director of Design & Development, BlackHägen Design 03.07.19

  • 3D/Additive Manufacturing | Digital Health
    Discerning Medtech’s Path in 2019

    Discerning Medtech’s Path in 2019

    It’s the dawn of another year, and that means it’s time to engage in the unavoidable pastime of prognostication. Predicting the future isn’t easy, but it can be fun and oftentimes insightful. One of the most rewarding aspects of pro…
    Mark Bonifacio, President, BCS LLC 01.31.19

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

    Disrupting the Outsourcing Model

    The rise and relative success of companies dealing in cloud-based systems has revolutionized how we handle data. This is prompting a shift away from traditional software, hardware, and legacy systems, and enabling companies in new and unexpected ways…
    Steve Maylish and Shannon White, Fusion Biotec 01.31.19

  • Packaging & Sterilization
    Is Your Packaging Provider Prepared If Disaster Strikes?

    Is Your Packaging Provider Prepared If Disaster Strikes?

    The onslaught of devastating hurricanes, wildfires, floods, and other natural disasters the world suffered in 2018 have accentuated the need for business continuity planning (BCP) in medical device manufacturing. Although many companies develop plans…
    Wilfredo Mercado, Vice President of Operations, Latin America, Prent Thermoforming 01.31.19