Columns


  • Diagnostics
    Theranos: Not Long for the Business World?

    Theranos: Not Long for the Business World?

    It won’t be long now. With a skeleton staff, dwindling finances, a sullied reputation, and a disgraced leader under criminal investigation, embattled blood testing firm Theranos Inc. seems veritably destined for a terrible, miserable, no goo…
    Michael Barbella, Managing Editor 05.03.18

  • Pharma Industry’s Growth—What Can Medtech Learn from It?

    Pharma Industry’s Growth—What Can Medtech Learn from It?

    Global revenues for our sister industry—pharmaceuticals—continues to grow (Table 1). By 2022, worldwide pharmaceutical sales are projected to reach an estimated $1.4 trillion at a CAGR of 6.4 percent from 2001 sales of $390 billion.2 That…
    Maria Shepherd, President and Founder, Medi-Vantage 05.03.18

  • The Right Vendors Foster Growth: Why Firms of All Sizes Need to Outsource

    The Right Vendors Foster Growth: Why Firms of All Sizes Need to Outsource

    I  was working as a product development engineer at AcroMed (a spinal implants manufacturer that was acquired by DePuy in 1998), when I noticed a gap in the medical device industry. There were plenty of companies coming up with great ideas for d…
    Dawn A. Lissy, President & Founder, Empirical 05.03.18

  • Software & IT
    Embracing the Digital Evolution for Content Management

    Embracing the Digital Evolution for Content Management

    Digitalization, global expansion, and changing compliance requirements are driving medical device manufacturers to rethink their commercial models with a specific focus on content management. The industry’s move toward digital has caused a prol…
    Terri Howard, Director of Commercial Strategy, Medical Device and Diagnostics, Veeva Systems 05.03.18

  • 13485:2016—Beyond the Risk Management File

    13485:2016—Beyond the Risk Management File

    Many companies currently are transitioning from ISO 13485:2003 to ISO 13485:2016, the updated standard drafted to help medtech firms evolve with the industry and address changes in the underlying ISO 9001 benchmark. Some companies, however, are findi…
    James A. Dunning, Principal, QPC Services LLC 05.03.18

  • Medical Devices and the Political Climate of 2018: An Update from the Swamp

    Medical Devices and the Political Climate of 2018: An Update from the Swamp

    The November midterm elections have the potential to shift the power balance, leadership, and legislative agenda of Congress, which would certainly have a sizable impact on the medical device industry. In addition to what lies ahead, current actions…
    Jeffrey J. Kimbell and David C. Rudloff, Jeffrey J. Kimbell & Associates Inc. 05.03.18

  • ISO 13485:2016—Upgrading to the New Edition (Part 2)

    ISO 13485:2016—Upgrading to the New Edition (Part 2)

    For the first time in 13 years, the International Organization for Standardization (ISO) has updated ISO 13485, the medical device industry’s framework for quality management systems (QMS). With an emphasis on risk management in the quality sys…
    Maria Fagan, President and Co-Founder, Regulatory and Quality Solutions LLC (R&Q) 05.03.18

  • Care Chain Consolidation: Tail Wagging the Dog?

    Care Chain Consolidation: Tail Wagging the Dog?

    For the past 35 years or so, supply chain consolidation has become an integral part of the medtech industry. Far less common but increasing in frequency is the desire by non-healthcare entities like Amazon, Apple, CVS, Google, and most recently, Walm…
    Chris Oleksy, Founder and CEO, Oleksy Enterprises and Next Life Medical; CEO, Emergent Respiratory 05.03.18

  • R&D & Design
    To Clinical or Not to Clinical, That Is the Question

    To Clinical or Not to Clinical, That Is the Question

    For simple or well-characterized medical products, it is risk-appropriate and most cost effective to immediately design and engineer the commercial configuration of the device. In these cases, the design would presumably be sufficiently “locked…
    David C. Robson, Principal, Robson Advisors 05.03.18

  • Medtech M&A Off to a Strong Start in 2018

    Medtech M&A Off to a Strong Start in 2018

    The medical device industry seems to be experiencing a bit of déjà vu this year. Though the start of 2018 was tinged with uncertainty over changes in the global healthcare market and the fate of Obamacare’s medical device tax,…
    Mark Bonifacio, President, Bonifacio Consulting Services 05.03.18

  • Software & IT | Surgical
    Extolling the Virtues of Surgical Simulation

    Extolling the Virtues of Surgical Simulation

    Gaining surgical competence for a new technique has a drastic learning curve. When surgeons are trained to perform a new procedure, however, the curriculum appears remarkably straightforward. Typically, the surgeon will attend a one- or two-day cours…
    Sam Brusco, Associate Editor 04.03.18

  • Will Medtech M&A Mania Continue?

    Will Medtech M&A Mania Continue?

    There are many opinions about the scope and scale of future medtech mergers after the M&A boom seen in 2016 and 2017. By June 2017, medical device M&A value rose 178 percent,1 propelled by the strategic imperative for medical device companies…
    Maria Shepherd, President and Founder, Medi-Vantage 04.03.18

  • Learn from My Mistakes: Why You Need a Quality System

    Learn from My Mistakes: Why You Need a Quality System

    I’ve made my share of stupid mistakes. When I was younger, most of them stemmed from just not thinking things through. I still cringe to admit I had some really big hair in the 1980s, one of many reasons I’ll be forever grateful my younge…
    Dawn A. Lissy, President & Founder, Empirical 04.03.18

  • Brexit: D-Day or the Y2K for Global Supply Chains?

    Brexit: D-Day or the Y2K for Global Supply Chains?

    On the same day Britons went to the polls to determine their country’s future with the European Union (EU), the Irish Business & Employers Confederation (IBEC) held a manufacturing conference in Dublin. IBEC represents the policy interests…
    Dan O’Mahony, Lifesciences Manager, Exertis Supply Chain Services Limited 04.03.18

  • Planning for Brexit

    Planning for Brexit

    Are you ISO 13485 certified by a United Kingdom Notified Body? Perhaps you’re a contract manufacturer serving OEM customers who are certified by a U.K. Notified Body. Either way, medical device companies must start preparing now to mollify the…
    James A. Dunning, Principal, QPC Services LLC 04.03.18

  • ISO 13485 2016: Upgrading to the New Edition (Part 1)

    ISO 13485 2016: Upgrading to the New Edition (Part 1)

    For the first time in 13 years, the International Organization for Standardization (ISO) has updated ISO 13485, the medical device industry’s framework for quality management systems (QMS). With an emphasis on risk management in the quality sys…
    Maria Fagan, President and Co-Founder, Regulatory and Quality Solutions LLC (R&Q) 04.03.18

  • Trade Wars—How Are You Impacted?

    Trade Wars—How Are You Impacted?

    Early last month, President Donald J. Trump ignited a firestorm on Twitter by expressing confidence that America would prevail in an international trade war on steel and aluminum. “When a country (USA) is losing many billions of dollars on trad…
    Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 04.03.18

  • Contract Manufacturing
    How Do I Serve Thee? Let Me Count the Ways

    How Do I Serve Thee? Let Me Count the Ways

    Perhaps it is obvious to most readers these days that using outsourced service providers (OSPs) can be a benefit to a client company. Historically, however, it has not been obvious. Back in the 80s and for much of the 90s, the idea of using outside r…
    David C. Robson, Principal, Robson Advisors 04.03.18

  • Funding New Ideas or Innovation

    Funding New Ideas or Innovation

    Everyone has the next big new idea, and in medtech, they don’t come cheap. But companies also don’t have to be valued in the billions of dollars to make an impact or get an idea moving forward.   The funding environment is hi…
    Marissa Fayer, President, Fayer Consulting LLC; CEO, HERHealthEQ; and Partner, LLEX Partners 04.03.18

  • The Not-So-Sweet Road to C-Suite Symmetry

    The Not-So-Sweet Road to C-Suite Symmetry

    Women have made great strides in the past half-century to end workplace gender disparity. They’ve gained legal safeguards (FMLA, Equal Pay Act, Pregnancy Discrimination Act), boosted their earnings potential, and gradually siphoned job market s…
    Michael Barbella, Managing Editor 03.15.18