Columns


  • Autism Treatment Options Reach Fever Pitch

    Autism Treatment Options Reach Fever Pitch

    The AVACEN 100 (Advanced VAscular Circulation ENhancement) is an FDA-cleared, over-the-counter, non-invasive heat therapy device indicated for temporary relief of minor muscle and joint pain stiffness, joint pain associated with arthritis, muscle spa…
    Sam Brusco, Associate Editor 01.30.18

  • Cardiovascular | Digital Health
    Feeding the Medtech Innovation Pipeline

    Feeding the Medtech Innovation Pipeline

    MassMEDIC is the largest regional medical device association in the United States, with member companies ranging from the largest to the smallest medical technology innovators. The MassMEDIC Medtech Showcase, held in October every year, is a meeting…
    Maria Shepherd, President and Founder, Medi-Vantage 01.30.18

  • R&D & Design
    Shop Smart: How to Make the Most of the Prototype Phase

    Shop Smart: How to Make the Most of the Prototype Phase

    There are two basic types of people: Those who make sweeping generalizations, and those who don’t. (Actually, there’s a third type—one who opens columns with corny jokes and strains to hear the laugh track over the lonely cricket in…
    Dawn A. Lissy, President & Founder, Empirical 01.30.18

  • The Big Squeeze Is On: An Examination of the Health Insurance Impact

    The Big Squeeze Is On: An Examination of the Health Insurance Impact

    As 2018 begins, there is unprecedented angst among the general population about individual healthcare coverage. MPO readers and I share this angst, though we are probably more likely than most to voice our concerns because of the nature of our jobs&m…
    Chris Oleksy, Founder and CEO, Oleksy Enterprises and Next Life Medical; CEO, Emergent Respiratory 01.30.18

  • Act Now to Prepare for MDSAP Audits

    Act Now to Prepare for MDSAP Audits

    The clock is ticking for medical device manufacturers worldwide. Manufacturers that want to continue selling products in Canada’s $6.7 billion medical device market should be preparing and planning for the international Medical Device Single Au…
    Kim Trautman, Executive Vice President of Medical Device International Services, NSF International 01.29.18

  • Back to Basics: A Regulatory Professional

    Back to Basics: A Regulatory Professional's New Year's To-Do List

    As 2018 begins, it may be tempting to tackle the array of contemporary issues currently facing regulatory professionals, but I like to start the year by getting back to basics. For me, a calendar change is a time for mental tool sharpening and corpor…
    James A. Dunning, Principal, QPC Services, LLC 01.29.18

  • Four Key Takeaways from NAFTA’s Impact on Medtech

    Four Key Takeaways from NAFTA’s Impact on Medtech

    Renegotiations for the North American Free Trade Agreement (NAFTA) kicked off in August 2017, making this an opportune time to discuss the impact the trade agreement has made on the region’s medical goods supply chain. The trade agreement, whic…
    Mihir Torsekar, International Trade Analyst, U.S. International Trade Commission 01.29.18

  • Contract Manufacturing
    Absence Makes the Heart Grow Cold: Ensuring Regular Client/Service Provider Contact

    Absence Makes the Heart Grow Cold: Ensuring Regular Client/Service Provider Contact

    Much of project management (and business management in general) involves understanding human nature and putting practices in place which safeguard against problems—especially expensive problems! Human nature can make it easy to slip into a comf…
    David C. Robson, Principal, Robson Advisors 01.29.18

  • MedTech M&A and Manufacturing Predictions for 2018

    MedTech M&A and Manufacturing Predictions for 2018

    2017 was a year of unprecedented global change, and the impacts were certainly felt in medtech and healthcare. Some of the biggest changes occurred in the United States: Businessman/reality television star Donald Trump took office and the Republican…
    Mark Bonifacio, President, Bonifacio Consulting Services 01.29.18

  • Takeaways from the MPO Summit 2017

    Takeaways from the MPO Summit 2017

    It’s a lot more difficult than it looks. To the untrained (or uneducated) eye, outsourcing can seem like a relatively simple process. But medtech industry executives know the practice requires the right mix of skills, experience, support, an…
    Michael Barbella, Managing Editor 11.07.17

  • Market Pressures Have Squeezed Early-Stage Medtech Innovation

    Market Pressures Have Squeezed Early-Stage Medtech Innovation

    AdvaMed exists to advance medical technology around the world as a representative for medical device, diagnostics, and digital health technology companies. Maintaining both a national and global presence in regions and countries including Europe, Ind…
    Maria Shepherd , President and Founder, Medi-Vantage 11.07.17

  • 3D/Additive Manufacturing | Testing
    The Final Four: My Top Headlines for 2017

    The Final Four: My Top Headlines for 2017

    In a year of political and social discord, international conflict, and natural disasters, the big news in the medical device industry really didn’t make headlines—even within our sector. But as 2017 comes to a close, I consider fee hikes,…
    Dawn A. Lissy, President & Founder, Empirical 11.07.17

  • Employee Feedback Should Be Part of a Product Safety Plan

    Employee Feedback Should Be Part of a Product Safety Plan

    Whistleblower lawsuits in the medtech and pharmaceutical industries are often settled for multiple millions of dollars, but not before they potentially cause harm to patients, caregivers, and quite often, the reputation of manufacturers. How then, ca…
    Chris Harvey, Director, Recall Solutions, Stericycle Expert Solutions 11.07.17

  • Comparing cGMP Pharma vs. Device: Subpart E—Control of Components, Containers and Closures

    Comparing cGMP Pharma vs. Device: Subpart E—Control of Components, Containers and Closures

    Anyone working in the pharmaceutical and/or medical device industries knows that both sectors are very dynamic markets. Each is unique in its own way, but the two share a common goal of bringing safe, effective products to market as quickly and effic…
    James A. Dunning, Owner, QPC Services LLC 11.07.17

  • The Importance of Root Cause Investigation and Effectiveness Checks in Corrective Action

    The Importance of Root Cause Investigation and Effectiveness Checks in Corrective Action

    ISO standards and industry regulations require medical device organizations to have a corrective action process. But it’s not enough to just have one—it must be efficient and effective enough to handle issues in a fast-paced and high-impa…
    Alexa Sussman, Content Marketing Writer, EtQ 11.07.17

  • Left Side...Strong Side: Teachable Moments of 2017

    Left Side...Strong Side: Teachable Moments of 2017

    It’s been a fascinating year for healthcare-related supply/value/care chains. To mark its passage, I’ve pulled together several column topics from the past 11 months and applied them to a prediction I made at the recent MPO Summit 2017 (I…
    Chris Oleksy, Founder and CEO, Oleksy Enterprises and Next Life Medical; CEO, Emergent Respiratory 11.07.17

  • R&D & Design
    Five Steps to Successfully Fail Early, Fast, and Often

    Five Steps to Successfully Fail Early, Fast, and Often

    The most successful innovators throughout history used a process called ideation in order to create products that make our lives better and more enjoyable. Thoughtful ideation shortens the development cycle, improves performance, and reduces cost. It…
    Steve Maylish and Mike White, Fusion Biotec 11.07.17

  • Ghosts in the OR: Assessing the Liability Risk of Medical Device Sales Reps Present During Surgeries

    Ghosts in the OR: Assessing the Liability Risk of Medical Device Sales Reps Present During Surgeries

    Despite being present in the operating room (OR) for many surgical procedures, medical device sales representatives have been fairly insulated from liability arising from the products they promote. These “ghosts” in the OR are legally pro…
    Scott Siegner, Associate, LeClairRyan 11.07.17

  • 3D/Additive Manufacturing
    Loading the Printer with Living Ink

    Loading the Printer with Living Ink

    Star Trek’s replicator isn’t looking so far-fetched these days. For those unfamiliar, the classic sci-fi odyssey’s transporter technology materialized food, spare parts, and clothing for the Enterprise crew at a moment’s notic…
    Sam Brusco, Associate Editor 10.05.17

  • Digital Health
    Medtech Is Dead if It Is Resistant to Change

    Medtech Is Dead if It Is Resistant to Change

    MedtechVision2017 isn’t your average “women in medtech” meeting. The founders (www.medtechwomen.org) demand (and receive) the best content from their all-volunteer team of meeting planners and visionaries. This year’s event&md…
    Maria Shepherd, President and Founder, Medi-Vantage 10.05.17