Columns


  • Diagnostics | Digital Health | Electronics | Software & IT
    The Formidable Team of Clinical and Artificial Intelligence

    The Formidable Team of Clinical and Artificial Intelligence

    Whenever the topic of artificial intelligence arises in conversations I’ve had, I find the focus of discussion veers in a few predictable directions. The first is the 2001 sci-fi drama of the same name directed by Steven Spielberg, chronicling…
    Sam Brusco, Associate Editor 03.07.17

  • HACs and How Medtech Can Help Reduce Medical Error

    HACs and How Medtech Can Help Reduce Medical Error

    After a 30-year effort, data collected in 2014 and published in 20161 shows there has been a 17 percent decline in hospital-acquired conditions (HACs) since 2010. This data is impressive; it represents a 2.1 million case decline in preventable, hospi…
    Maria Shepherd, President and Founder, Medi-Vantage 03.07.17

  • Testing
    Testing…Testing…Is This Thing On? Should You Outsource Device Testing or Keep it In-House?

    Testing…Testing…Is This Thing On? Should You Outsource Device Testing or Keep it In-House?

    When people ask me what I do, I often reply, “I break things for a living.” Yes, I say it with tongue firmly in cheek. That’s a gross oversimplification of a business I’ve been in for almost 20 years: mechanical testing for…
    Dawn A. Lissy, President & Founder, Empirical 03.07.17

  • Verification Matters

    Verification Matters

    At one time or another, many of us have asked ourselves, “Why verify?” We verify/inspect and routinely find no defects or noncompliances. In my case—and I assume for most others—the feeling is fleeting. Verification serves a d…
    James A. Dunning, Owner, QPC Services, LLC 03.07.17

  • Cheat Sheet for Corrective Actions in the Life Sciences

    Cheat Sheet for Corrective Actions in the Life Sciences

    Corrective actions are an important part of managing the quality of a medical device production. In fact, our most recent survey showed 72 percent of quality professionals name corrective actions as the most critical quality and compliance process in…
    Alexa Sussman, Content Marketing Writer, EtQ 03.07.17

  • Materials
    Medical Device Procurement and Materials Management Outsourcing

    Medical Device Procurement and Materials Management Outsourcing

    There seems to be a marked trend in the medical device industry to reduce supply chain complexity. This is not a new phenomenon. For an industry that jealously protects its intellectual property, the sector has not been precious about outsourcing non…
    Dan O'Mahony, Lifesciences Manager, Exertis Supply Chain Services Limited 03.07.17

  • Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical
    Four Common Misperceptions of Accelerated FDA Approval

    Four Common Misperceptions of Accelerated FDA Approval

    The 21st Century Cures Act addresses a wide range of healthcare issues, from opioid-abuse prevention to the need for interoperability of electronic health records. Some of the biggest criticisms of the law, however, focused on provisions intended to…
    Matthew M. Lowe, Executive Vice President, MasterControl 03.07.17

  • Cardiovascular | Diagnostics | Neurological | Patient Monitoring | R&D & Design | Surgical | Testing
    First in Man

    First in Man

    There are two main paths for clinical studies in the United States for medical devices. The first is the most common, called a traditional study. This approach follows a U.S. Food and Drug Administration (FDA) design process including agency testing,…
    Steve Maylish, Chief Commercial Officer, Fusion Biotec 03.07.17

  • Pace of Medtech M&A Activity Not Likely to Abate in 2017

    Pace of Medtech M&A Activity Not Likely to Abate in 2017

    Predicting the future can be risky and fraught with difficulty, especially in the healthcare sector. A myriad of unforeseen factors can affect outcomes, botching even the most conservative of forecasts. Some prophecies have better odds than others…
    Mark Bonifacio, Founder and President, Bonifacio Consulting Services 03.07.17

  • 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