Columns


  • Electronics | Materials | Neurological
    Graphene on My Mind

    Graphene on My Mind

    Scientists are beginning to run out of superlatives for graphene, the two-dimensional wonder material. It’s been hailed as the lightest, strongest, thinnest, and best heat- and electricity-conducting material ever discovered. Similar to the pla…
    Sam Brusco, Associate Editor 05.01.17

  • What’s New in the ED?

    What’s New in the ED?

    Besides wait times that were previously way too long in the emergency department (ED), there is much medtech manufacturers need to know about this section of the hospital. (By the way, wait times are going down for various reasons.) Hospitals recogni…
    Maria Shepherd, President and Founder, Medi-Vantage 05.01.17

  • Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel

    Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel

    For a company navigating a Class III medical device’s path to market, the U.S. Food and Drug Administration (FDA) panel presentation is the make-or-break point. That’s the day to present a case to convince the FDA that the device—fo…
    Dawn A. Lissy, President & Founder, Empirical 05.01.17

  • Four Takeaways from Recent Regulatory Audit Changes

    Four Takeaways from Recent Regulatory Audit Changes

    From medical device production to pharmaceutical manufacturing, the life sciences demand highly regulated operations. In a perfect world, these products would be without defect every time, but the reality is processes can stray from compliance and ca…
    Alexa Sussman, Content Marketing Writer, EtQ 05.01.17

  • Supply Chain Lessons from “TrumpCare 1.0”:  The Good, the Bad and the Ugly

    Supply Chain Lessons from “TrumpCare 1.0”: The Good, the Bad and the Ugly

    I’m going to start this column with some required viewing. The first is Lee Iacocca’s classic Chrysler commercials from the early 1990s in which he offered leadership advice to the auto industry. The second is the acclaimed spaghetti west…
    Chris Oleksy, Founder and CEO, Oleksy Enterprises and Next Life Medical; CEO, Emergent Respiratory 05.01.17

  • R&D & Design | Testing
    The Human Factor

    The Human Factor

    Humans come in all shapes and sizes, ages, and abilities. Sometimes they aren’t logical. Engineers come with logical, rational minds, but sometimes don’t consider emotional behavior. Factoring humans into device design is not always a pre…
    Steve Maylish and Dave Hines, Fusion Biotec 05.01.17

  • Medical Device Funding: Any Signs of Life?

    Medical Device Funding: Any Signs of Life?

    One of the most concerning aspects of the recent financial boom has been the lack of funding for medical device companies. While the implications of this shortage of capital have an immediate impact on anyone involved in the medical device industry,…
    Ben Dunn, Managing Director, Covington Associates 05.01.17

  • Diagnostics | Digital Health | Electronics | Patient Monitoring | Software & IT
    Boldly Entering Healthcare’s Final Frontier

    Boldly Entering Healthcare’s Final Frontier

    Chances are the 21st-century tricorder will look radically different than its fictional 2260s-era counterpart. Foremost, it won’t be as large or bulky as the Hollywood version, nor will it resemble an old-fashioned radio or small portable te…
    Michael Barbella, Managing Editor 04.03.17

  • Diagnostics
    An Update on the In Vitro Diagnostics Sector

    An Update on the In Vitro Diagnostics Sector

    High-profile product launches, resounding clinical data, the U.S. government investment in the Precision Medicine program, and multiple billion-dollar acquisitions are hallmarks of the diagnostics industry. Equally notable was the surprising decision…
    Maria Shepherd, President and Founder, Medi-Vantage 04.03.17

  • Testing
    Peruvian Prospects:  The Medical Device Industry of a Country Founded on Precious Metals

    Peruvian Prospects: The Medical Device Industry of a Country Founded on Precious Metals

    It was a lot to take in running on about five hours of sleep following an international flight complete with a lost luggage cliché. Representatives from multiple agencies—governmental, regulatory, medical device companies, hospital purch…
    Dawn A. Lissy, President & Founder, Empirical 04.03.17

  • Materials | R&D & Design
    Collaborating on Custom Materials Development

    Collaborating on Custom Materials Development

    OEMs and contractors can engage with materials suppliers for custom formulations and product development.
    Deepak Prakash, Vancive Medical Technologies 04.03.17

  • Current Good Manufacturing Practices: Pharma vs. Device

    Current Good Manufacturing Practices: Pharma vs. Device

    After years of working in and consulting for pharmaceutical and medical device companies on quality and regulatory matters, I am still somewhat surprised by the difficulty both industries have in understanding the other’s Current Good Manufactu…
    James A. Dunning, Owner, QPC Services LLC 04.03.17

  • Software & IT
    Integrating Training and Document Control with Automated Solutions

    Integrating Training and Document Control with Automated Solutions

    Companies today use many methods to maintain compliance with safety and quality regulations. Typically, training employees to maintain compliance can easily be reported on a metrics dashboard as “red, yellow, or green” and is the most eff…
    Emily Ysaguirre, Content Marketing Writer, VERSE Solutions 04.03.17

  • Creating Organizational Value in Your Supply Chain: Cost Centered or Growth-Driven?

    Creating Organizational Value in Your Supply Chain: Cost Centered or Growth-Driven?

    “I am fed up seeing all the metrics from my head of Supply Chain on efficiency. I want to hear about what we’re doing to get new customers [and] get to market faster. I don’t want to hear about efficiency. I want to hear about growt…
    Dave Sheppard, Chief Operating Officer and Principal, MedWorld Advisors 04.03.17

  • Testing
    Extractable/Leachable Chemistry Testing Strategies for Medical Devices

    Extractable/Leachable Chemistry Testing Strategies for Medical Devices

    It has become more prevalent and acceptable to use the results of chemistry testing to assess the overall biocompatibility of medical devices. For many devices with prolonged or permanent patient contact, chemistry followed by toxicological assessmen…
    Matthew R Jorgensen, Ph.D., and Thor Rollins, BS, Nelson Laboratories; Allison Komiyama, Ph.D., RAC, AcKnowledge RS 04.03.17

  • R&D & Design
    Why Manage, If You Can Lead?

    Why Manage, If You Can Lead?

    Outsourcing a complex medical design is a complicated process. Once a service provider is chosen, it’s not enough to pass the ball to the development team and follow the usual script of managing deadlines and checking progress. Anyone who&rsquo…
    Steve Maylish and Dave Mock, Fusion Biotec 04.03.17

  • Non-Traditional Buyers Making Waves in Medical Manufacturing M&A

    Non-Traditional Buyers Making Waves in Medical Manufacturing M&A

    Achieving growth through acquisition is a tried-and-true strategy that continues to be a popular expansion mechanism for medical manufacturing companies. Last year was a banner one for medtech M&A (as expertly detailed by medical device industry…
    Brian Gorski, Vice President, P&M Corporate Finance 04.03.17

  • 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