Columns


  • Digital Health | Software & IT | Testing
    Recent Cyber Attack Enough to Make Medtech WannaCry

    Recent Cyber Attack Enough to Make Medtech WannaCry

    It was the U.S. Food and Drug Administration’s (FDA) worst nightmare come true. On May 12, the WannaCry ransomware cryptoworm slithered its way into computers worldwide, infecting as many as 200,000 Microsoft Windows systems in 150 countries…
    Michael Barbella, Managing Editor 06.06.17

  • The Business of Medtech

    The Business of Medtech

    Boston, Mass., was the place to be in the first week of May 2017 for people interested in the business of medtech. The World Medical Innovation Forum kicked off the week for a three-day meeting that maintained a focus on cardiovascular disease and te…
    Maria Shepherd, President and Founder, Medi-Vantage 06.06.17

  • Class III Devices from 10,000 Feet: The Big Picture on Getting Premarket Approval

    Class III Devices from 10,000 Feet: The Big Picture on Getting Premarket Approval

    It takes a certain level of passion and perseverance to break new ground. For the innovator introducing a disruptive technology to improve patient outcomes and lives, the creativity fueling the process of getting a Class III device to market is rival…
    Dawn A. Lissy, President & Founder, Empirical 06.06.17

  • Comparing cGMP Pharma vs. Device: Subpart A – General Provisions

    Comparing cGMP Pharma vs. Device: Subpart A – General Provisions

    Since they are both part of the healthcare industry, you’d think pharmaceutical and medical device companies would have a better understanding of each other’s current Good Manufacturing Practices (cGMP) requirements. Think again. Despite…
    James A. Dunning, Owner, QPC Services LLC 06.06.17

  • Packaging & Sterilization | Software & IT
    Using Automation to Manage Product Serialization and Traceability

    Using Automation to Manage Product Serialization and Traceability

    Serialization and traceability within the life sciences industry have been around since the early 2000s. However, in order to reduce complexities, counterfeiting, and theft, efforts are being made this year to focus on serialization, tracking, and tr…
    Emily Ysaguirre, Content Marketing Writer, VERSE Solutions 06.06.17

  • Diagnostics | Digital Health | Electronics | Patient Monitoring
    The Future of Medical Wearables

    The Future of Medical Wearables

    The wearables market is expected to reach over $4 billion in 2017.1 If that doesn’t paint the picture for a bright future, consider this: one in six consumers currently own and use wearable tech.2 Clearly, the wearables market is exploding and…
    Mike Bolduc, Global Marketing Manager, Industrial and Medical Segments, C&K 06.06.17

  • Contract Manufacturing | Electronics | Machining & Laser Processing | Materials | Molding | Packaging & Sterilization | Tubing & Extrusion
    Medtech’s Golden Opportunity

    Medtech’s Golden Opportunity

    Why supply chain sustainability will benefit the industry and how to achieve it.
    Marissa Fayer, President, Fayer Consulting LLC 06.06.17

  • R&D & Design
    The Buck Starts Here

    The Buck Starts Here

    Commercialization is the confluence of all prior activities, a time of high investment and high anxiety. Here the rubber meets the road—yet for a new device, visibility on that road is often quite poor. A regulatory agency approved your device…
    Steve Maylish, Chief Commercial Officer, Fusion Biotec, and Ben Bobo, CEO, NeuroTemp LLC 06.06.17

  • Midyear Medtech Review

    Midyear Medtech Review

    It’s only been three months since my last assessment of the medical device manufacturing and outsourcing market, but the flurry of deals, activity, and industry news over the last 90 or so days merits an update. As we approach the midpoint o…
    Mark Bonifacio, Founder and President, Bonifacio Consulting Services 06.06.17

  • 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