Columns


  • Cardiovascular
    15 Years of Consi-stent Medtech Progress

    15 Years of Consi-stent Medtech Progress

    Though merely 15 years ago, given the breakneck pace of innovation these days, 2003 seems a world away in terms of science and technology. It was the year the Concorde supersonic jet made its final flight; the year Kodak released the first digital ca…
    Sam Brusco, Associate Editor 06.04.18

  • Digital Health
    What a Long, Strange Trip It’s Been…

    What a Long, Strange Trip It’s Been…

    Who could have predicted all the changes we have seen in medtech in the 15 years since 2003? In 2003, pacemakers were only used in cardiology. Since then, modifications of early pacemaker technology have erupted into the neurostimulation market. In M…
    Maria Shepherd, President and Founder, Medi-Vantage 06.04.18

  • 3D/Additive Manufacturing | Surgical
    Top 5 of the Past 15: Moments that Shifted, Shaped, or Shook the Medical Device Industry

    Top 5 of the Past 15: Moments that Shifted, Shaped, or Shook the Medical Device Industry

    You don’t have to be a Greek philosopher to understand the only constant is change; we see it every day in our personal and professional lives. The medical device business is driven by disruptive change fueled by our commitment to continually d…
    Dawn A. Lissy, President & Founder, Empirical 06.04.18

  • Diagnostics | Materials | Patient Monitoring
    Diabetes Management and the Role of Adhesives

    Diabetes Management and the Role of Adhesives

    Diabetes management has come a long way over the past few decades. The disease that used to require patients to visit their doctor’s office on a weekly basis for glucose readings can now be continuously monitored on-the-go in the office or at h…
    Del R. Lawson, Ph.D., R&D manager, Critical and Chronic Care Solutions Division, 3M 06.04.18

  • Digital Health
    Mobile Medical Applications: The Regulatory Framework in the U.S. and the EU

    Mobile Medical Applications: The Regulatory Framework in the U.S. and the EU

    The medical device market is one of the largest industries in the healthcare sector, which has seen significant growth in the last 15 years. Harnessing the benefits of the digital revolution and medical technology, the industry is in a state of conti…
    Sudeep Kolluri, Solutioning Lead, Freyr 06.04.18

  • Packaging & Sterilization
    How the Right Logistics and Repair Vendor Can Drive Supply Chain Value

    How the Right Logistics and Repair Vendor Can Drive Supply Chain Value

    Over 80 percent of medical device companies in the United States have fewer than 50 employees, and the majority of those people are innovators and entrepreneurs, not logisticians or technicians. Once a new product hits the market, the manufacturers a…
    Matthew Riehl, General Manager, Columbus GSC, Flash Global 06.04.18

  • The State of Supply Chain Risk

    The State of Supply Chain Risk

    Special occasions are usually the perfect time for a stroll down memory lane and a peek into the metaphorical crystal ball. Medical Product Outsourcing’s 15th anniversary is no different, as it has prompted me to pause and reflect on the change…
    James A. Dunning, Principal, QPC Services LLC 06.04.18

  • Buyer (and Seller) Beware:  Rate-Setting Commissions and the Future of Healthcare Delivery

    Buyer (and Seller) Beware: Rate-Setting Commissions and the Future of Healthcare Delivery

    As the fierce healthcare debate of repeal-and-replace has tapered off in the nation’s swamp, states are using their authority to craft innovative policy solutions to improve the health and well-being of their populations that reflect the politi…
    Jeffrey J. Kimbell and Caroline P. Tucker, Jeffrey J. Kimbell & Associates Inc. 06.04.18

  • Software & IT
    Digitalization of the QMS: 15 Years of Evolution

    Digitalization of the QMS: 15 Years of Evolution

    Quality management has been a concept from the first time people created goods—higher quality goods represented higher status in society. Since then, the way we create, distribute, and evaluate goods has changed drastically. Factory producti…
    Alexa Sussman, Content Marketing Writer, EtQ 06.04.18

  • What Medtech Issues Keep You Up at Night?

    What Medtech Issues Keep You Up at Night?

    Anniversaries are more than mere milemarkers on life’s highway. They afford us the opportunity to reflect, reminisce, and take stock of our choices, while concurrently inspiring us to envision the future of our willfully-chosen paths. Such is t…
    Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 06.04.18

  • Charting the 15-Year Growth of Medtech and Its Supply Chain

    Charting the 15-Year Growth of Medtech and Its Supply Chain

    With Medical Product Outsourcing marking its 15th anniversary, I thought it would be appropriate to reflect upon the growth of the medical device industry and supply chain since 2003. Although a blizzard of financial statistics does not make for the…
    Tony Freeman, President, A.S. Freeman Advisors LLC 06.04.18

  • R&D & Design
    The Future’s So Bright, You Gotta Wear Shades

    The Future’s So Bright, You Gotta Wear Shades

    Thirty years ago, CAD was not broadly available. Components, assemblies, and mold drawings were drawn on vellum—with a pencil—and printed on paper. The internet as we know it did not exist. Engineers and buyers had to peruse the Thomas Re…
    David C. Robson, Principal, Robson Advisors 06.04.18

  • Cardiovascular | Digital Health | Neurological
    The Human Cyborg, Circa 2033

    The Human Cyborg, Circa 2033

    The world is full of Neil Harbissons. So claims billionaire futurist Elon Musk, dreamer extraordinaire and outspoken doomsayer of artificial intelligence who is helming an effort to colonize Mars. Musk contends the Earth’s dominant species has…
    Michael Barbella, Managing Editor 06.04.18

  • Diagnostics | Digital Health
    A Past Glimpse Into the Future

    A Past Glimpse Into the Future

    Scott Gottlieb, M.D., apparently is a man of many talents. Not only can the U.S. Food and Drug Administration’s (FDA) 23rd commissioner communicate effectively, lead forcibly, invest cleverly, dress stylishly, and rear fowl effortlessly, he als…
    Michael Barbella, Managing Editor 06.04.18

  • 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