Columns


  • 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

  • Top 10 Tips to Get Your Medical Device to Market

    Top 10 Tips to Get Your Medical Device to Market

    I’m no comedian. I have my moments, but I admire people funnier than myself, particularly David Letterman, whose Top 10 lists kept me in stitches late at night for years. There’s a reason I’m in the business of supporting medical de…
    Dawn A. Lissy, President & Founder, Empirical 10.05.17

  • Comparing cGMP Pharma vs. Device:  Subpart C—Buildings and Facilities and Subpart D—Equipment

    Comparing cGMP Pharma vs. Device: Subpart C—Buildings and Facilities and Subpart D—Equipment

    The medical device and pharmaceutical industries are both very unique markets. Although they share the same goal—improving health—the two are different in obvious ways: mechanical (device) vs. chemical (drugs), internal vs. external, volu…
    James A. Dunning, Owner, QPC Services LLC 10.05.17

  • Digital Health
    The Future of Artificial Intelligence and Quality Management

    The Future of Artificial Intelligence and Quality Management

    Industry leaders are required to keep up with change. In regulated industries like the life sciences, ensuring the safety of all products—and therefore, the public—is a main priority. Change is the necessary component driving continuous i…
    Emily Ysaguirre, Content Marketing Writer, EtQ 10.05.17

  • Sustainable Procurement: What is Your Target?

    Sustainable Procurement: What is Your Target?

    Many medtech industry leaders have focused on driving value through world-class procurement practices, and have elevated procurement and supply chain to a strategic role in their organizations. Many of these companies have also recognized the value o…
    Susanna Harkonen, Supply Chain Consultant, and Dave Sheppard, MedWorld Advisors 10.05.17

  • Packaging & Sterilization | Testing
    Packaging Validations—Looking Beyond ISO 11607

    Packaging Validations—Looking Beyond ISO 11607

    Most discussions on packaging validations for medical devices begin and end with ISO 11607: Packaging for Terminally Sterilized Medical Devices, and are laden with interpretations of how the two parts of this standard apply best to the unique aspects…
    Christopher Scott, Vice President, Eurofins Medical Device Testing 10.05.17

  • Diagnostics | R&D & Design
    Designing Diagnostic Consumables: Custom or Off-the-Shelf?

    Designing Diagnostic Consumables: Custom or Off-the-Shelf?

    Designing point-of-care diagnostic cartridges has always been a custom affair. Specialized designers and engineers use know-how in assay development, microfluidics, and systems engineering to develop a product from top to bottom. The result is a cust…
    Steve Maylish, Fusion Biotec, and Richard Spero, Redbud Labs 10.05.17

  • Industry Caps Third Quarter with Flurry of M&A Deals

    Industry Caps Third Quarter with Flurry of M&A Deals

    There never seems to be a shortage of discussion topics in the medical device industry. U.S. Food and Drug Administration (FDA) regulations and overall medical innovation have always proved to be reliable conversation starters, though M&A/cons…
    Mark Bonifacio, Founder and President, Bonifacio Consulting Services 10.05.17

  • R&D & Design
    Charting a Course in Medical Innovation

    Charting a Course in Medical Innovation

    Something obviously was lost in translation. For more than 60 years, the West has found inspiration in the Chinese symbol for crisis. Conventional wisdom avows that the word’s Mandarin translation consists of two characters—one symboli…
    Michael Barbella, Managing Editor 09.01.17

  • R&D & Design
    Medtech Price Strategies: Who Is Going to Pay for It?

    Medtech Price Strategies: Who Is Going to Pay for It?

    Medical device product innovation and pricing strategy must be closely linked. In medtech product development, the three most important questions are: Is there an unmet need that can be answered with a medical device and what is it? I…
    Maria Shepherd, Medi-Vantage 09.01.17