Columns


  • Software & IT
    mHealth Not App-ropriate for Some Patients

    mHealth Not App-ropriate for Some Patients

    There it was, in black and white, a bold proclamation of ingenuity and innovation. “Instant Blood Pressure,” blared a banner title in the Health & Fitness section of Apple’s voluminous app store. “Monitor Blood Pressure…
    Michael Barbella, Managing Editor 01.30.17

  • AdvaMed and MassMEDIC: Two Meetings You Should Attend in 2017

    AdvaMed and MassMEDIC: Two Meetings You Should Attend in 2017

    MassMEDIC and the Advanced Medical Technology Association (AdvaMed) are two trade associations that lead the effort to advance medical technology around the world. These organizations act as a common voice for medical device, diagnostics, and health…
    Maria Shepherd, President and Founder, Medi-Vantage 01.30.17

  • Contract Manufacturing | Testing
    Smart Outsourcing: Hiring the Team to Get Your Class III Device to Market

    Smart Outsourcing: Hiring the Team to Get Your Class III Device to Market

    When Cartiva Inc. successfully sped through their Class III device premarket panel in less than half the average time—71 days instead of 159—that caught my attention. For more than 18 years, the Empirical family of companies has partnered…
    Dawn A. Lissy, President & Founder, Empirical 01.30.17

  • Software & IT
    Enthusiastic Leadership at AdvaMed

    Enthusiastic Leadership at AdvaMed

    My first experience at an AdvaMed event years ago found me in Washington, D.C., for the association’s annual meeting. While informative, the feel of the event was a bit “stuffy,” with a heavy focus on regulatory concerns and legisla…
    Sean Fenske, Editor 01.30.17

  • Contract Manufacturing | R&D & Design | Testing
    Don’t Blame ISO for Inefficient Operations

    Don’t Blame ISO for Inefficient Operations

    I’ve heard executives say their small to medium-sized for-profit manufacturing or service company is not operating efficiently because of ISO bureaucracy—specifically, the ISO 9001 Quality Management System or its related standards (ISO 1…
    James A. Dunning, Owner, QPC Services, LLC 01.30.17

  • Contract Manufacturing | Software & IT | Testing
    Strategies for Effective Audits in the Medical Device Industry

    Strategies for Effective Audits in the Medical Device Industry

    Even when they are planned, audits often bring uneasiness to many businesses. People either fear failure or are overwhelmed by the seemingly complicated processes. However, if organizations understand the importance of audits and how to increase thei…
    Alexa Sussman, Content Marketing Writer, EtQ 01.30.17

  • Contract Manufacturing | R&D & Design
    Affordable Care Act 2.0:  Prepare to Redirect the Supply-Value-Care Chain

    Affordable Care Act 2.0: Prepare to Redirect the Supply-Value-Care Chain

    Americans may have been divided last fall on their choice for president, but they were united on one front, at least—the need for healthcare reform. The only polls that were correct were the ones that showed voters’ dissatisfaction with t…
    Chris Oleksy, Founder and CEO, Oleksy Enterprises, Co-Founder, Next Life Medical 01.30.17

  • R&D & Design | Testing
    The Consumerization of Healthcare

    The Consumerization of Healthcare

    In the past (and, to a large degree, today), medical device companies focused on selling products to healthcare providers and payers. However, as healthcare moves away from a reactionary, fee-based care model to health and wellness or value-based mod…
    Steve Maylish and Nick Rakhshani, Chief Commercial Officer, Fusion Biotec; Chief Marketing Officer, Satoba Technology Marketing 01.30.17

  • Contract Manufacturing
    Trump’s 100-Day (Plus) Plan for Medtech M&A

    Trump’s 100-Day (Plus) Plan for Medtech M&A

    Amid much pomp and circumstance, Donald J. Trump has been officially sworn in as the 45th U.S. president, bringing an end to the most inconceivable election cycle in modern history. As Trump’s reign begins, pundits, economists, and ordinary Ame…
    Bryan Hughes, Director, P&M Corporate Finance 01.30.17

  • Numbing the Body Electric

    Numbing the Body Electric

    Why is opioid addiction such a big deal in 2016? It’s not exactly news that prolonged usage of these drugs can lead to a high tolerance for pain medication, addiction, and/or overdose; one needs to look no further than heroin to understand that…
    Sam Brusco, Associate Editor 11.08.16

  • Contract Manufacturing | Testing
    David vs. Goliath:  How a Small Startup Managed to Slingshot the FDA Approval Process

    David vs. Goliath: How a Small Startup Managed to Slingshot the FDA Approval Process

    I chose a career in the medical device industry because I wanted to help people. Specifically, I wanted to help my father, a man who suffered lifelong neck problems because he worked as a mechanic for 40 years. I sought to create a solution to ease h…
    Dawn A. Lissy, President & Founder, Empirical 11.08.16

  • Used Medical Equipment: A Source of Anxiety for the FDA

    Used Medical Equipment: A Source of Anxiety for the FDA

    An eBay search for medical devices (listed under the medical equipment category) is likely to yield various types of used medical equipment—magnetic resonance imaging machines, for example, negative pressure wound therapy systems, X-ray machine…
    James A. Dunning, CEO, QPC Services 11.08.16

  • Contract Manufacturing | Materials | R&D & Design | Software & IT
    How to Effectively Manage Risk in the Supply Chain

    How to Effectively Manage Risk in the Supply Chain

    Today, most life science organizations turn to outsourcing to release products to the market faster. As such, they must be sure that their product meets compliance regulations and is within acceptable specifications. Negative deviations within a prod…
    Emily Ysaguirre, Content Marketing Writer, VERSE Solutions 11.08.16

  • Contract Manufacturing
    Reflections on 2016

    Reflections on 2016

    This year has been fascinating, to say the least. The outcome of the presidential race will have a lasting impact on not only the United States, but also the entire world. Most agree that it’s both shocking and sad that the election was more ab…
    Chris Oleksy, Founder and CEO, Oleksy Enterprises, Co-Founder, Next Life Medical 11.08.16

  • Contract Manufacturing | R&D & Design | Software & IT | Testing
    Creating Value by Design

    Creating Value by Design

    Any development project brings difficulty in understanding what portion of the process adds value, and what just adds time. No one wants to spin their wheels when trying to get to market. Applying research and translating it into a commercial applica…
    Steve Maylish, Chief Commercial Officer, Fusion Biotec; Bruce Sargeant, Founder & CEO, Fusion Biotec 11.08.16