Supply Chain

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

    Connecting the Dots in Medical Device Outsourcing

    San Francisco is globally renowned for many things: The Golden Gate Bridge (its color, international orange, was actually a primer used to protect the steel during transit), Ghirardelli chocolate, the TransAmerica pyramid building, and the “Pai…
    MPO Staff 07.30.19

  • Materials | Packaging & Sterilization | R&D & Design
    Case in Point: Robust Sintered PTFE Material Helps to Reduce Risk of HAIs

    Case in Point: Robust Sintered PTFE Material Helps to Reduce Risk of HAIs

    In China, concerns are mounting over the life-threatening issue of healthcare-associated infections (HAIs) and how to prevent future incidents from occurring. Recently, researchers investigated increased hospitalization costs due to HAIs,1 which not…
    Jack Chan, Global Marketing Director—Medical, Porex 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

    Medical device products are rapidly evolving to become more personalized and connected, leveraging artificial intelligence (AI), robotics, and mobile technology. Against this backdrop of continual innovation, medical device manufacturers face uniq…
    Seth J. Goldenberg, Ph.D., Vice President, Vault Medical Device & Diagnostics, Veeva Systems 07.30.19

  • R&D & Design
    What Is Human Factors Engineering and Why Is It Important?

    What Is Human Factors Engineering and Why Is It Important?

    It is becoming common knowledge Human Factors Engineering (HFE), also known as Usability Engineering (UE), is required as part of most medical device development. But what exactly does that entail and how does it affect product development? A rece…
    Rich Newman, Usability Engineering Manager, BlackHägen Design 07.30.19

  • 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