Featured


  • Adopted Proposal Would Delay MDR One Year

    Adopted Proposal Would Delay MDR One Year

    The proposal would need the full support of the European Parliament and the Council through an accelerated co-decision procedure.
    European Commission 04.03.20

  • Compliance with Medical Product Shortage Reporting Requirements During the COVID-19 Pandemic

    Compliance with Medical Product Shortage Reporting Requirements During the COVID-19 Pandemic

    A reminder of what manufacturers should keep in mind during this turbulent time.
    Online Exclusives Veleka Peeples-Dyer and Khelin Aiken, Baker McKenzie 04.02.20

  • Mike on Medtech: COVID-19, Part 1

    Mike on Medtech: COVID-19, Part 1

    Mike Drues and Sean Fenske discuss Emergency Use Authorization and the potential problems with non-medical device manufacturers producing ventilators.
    Sean Fenske, Editor-in-Chief 04.01.20


  • R&D & Design
    Examining the Usability of Medical Software

    Examining the Usability of Medical Software

    Developers need to consider the ‘human factor’ when it comes to testing medical device software.
    Bruce Johnston, Senior Software Engineering Specialist, MedAcuity Software 04.01.20

  • The Challenge and Opportunity in Corporate Environmental Sustainability Efforts

    The Challenge and Opportunity in Corporate Environmental Sustainability Efforts

    One company shares its experiences and outcomes with ongoing efforts toward a focus on environmental stewardship.
    Neil Peterson, Alisha Jerauld, CPA and Matt Wold, Merit Medical Systems Inc. 04.01.20

  • A Manufacturer’s Secret Weapon: R&D Tax Credits

    A Manufacturer’s Secret Weapon: R&D Tax Credits

    For small and medium-sized medical device manufacturers, qualifying for the tax credits could result in an unexpected windfall.
    Chris Lake, President, R&D Tax Credit Consultant 04.01.20


  • Software & IT
    Validating Your QMS the ‘EZ Way’

    Validating Your QMS the ‘EZ Way’

    Securing approval for an eQMS solution is only the beginning; ensuring it’s properly installed and set up is arguably more significant.
    James Shore and Roxana Rosales 04.01.20

  • Digital Health
    Digital Defenders: COVID-19 Creates a Spotlight on Digital Health Tools

    Digital Defenders: COVID-19 Creates a Spotlight on Digital Health Tools

    Digital health tools like telemedicine, AI algorithms, and connectivity are playing an increasingly important role in helping prevent and manage disease.
    Michael Barbella, Managing Editor 04.01.20

  • Tubing & Extrusion
    Pathways to Care: Tubing Technologies

    Pathways to Care: Tubing Technologies

    Tubing is incorporated into a variety of medical technologies, which is why the demands on manufacturers of the components are increasing substantially.
    Mark Crawford, Contributing Writer 04.01.20


  • The Illusion of Choice in Healthcare

    The Illusion of Choice in Healthcare

    Consolidation hasn’t stopped for healthcare organizations and we can expect the number of decision makers to shrink as healthcare organizations become bigger.
    Maria Shepherd, President and Founder, Medi-Vantage 04.01.20

  • R&D & Design
    Why Outsourcing Is in: Piecing Out Projects Makes Sense

    Why Outsourcing Is in: Piecing Out Projects Makes Sense

    Getting outside help is a trend both large and small medical device companies are following as outsourcing engineering services continues to gain traction.
    Dawn A. Lissy, President & Founder, Empirical 04.01.20

  • Diagnostics
    Gaining a Clearer Picture of Hitachi

    Gaining a Clearer Picture of Hitachi

    Diagnostic imaging is gaining the attention of many in healthcare as the technologies shrink in size and become available to those outside the hospital.
    Sean Fenske, Editor-in-Chief 04.01.20

  • R&D & Design
    Top 10 Considerations for Medtech Inventors

    Top 10 Considerations for Medtech Inventors

    If you or your employer is interested in protecting an invention, then filing a patent application may be the way to go.
    Ryan Connell and Doug Portnow, Schwegman Lundberg & Woessner 04.01.20

  • Medtech Innovation and Adaptation in a Changing Pharmaceutical Landscape

    Medtech Innovation and Adaptation in a Changing Pharmaceutical Landscape

    The two primary industries driving healthcare innovation—pharmaceutical and medtech—are intrinsically intertwined.
    Tom McLean, VP, Development Engineering, R&D Innovation & Technology, West Pharmaceutical Services 04.01.20

  • The Economics of a Sound Regulatory Strategy

    The Economics of a Sound Regulatory Strategy

    While it might be tempting to put off regulatory requirements on a new project, a regulatory assessment should be performed fairly early.
    Christine Scifert and Dawn Norman, M.S., MRC-X LLC 04.01.20

  • The Need for Extraordinary Leadership During a Crisis

    The Need for Extraordinary Leadership During a Crisis

    During these unprecedented times, there have been numerous examples of leadership, both good and bad, from various sources.
    Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 04.01.20

  • COVID-19’s Impact on the Medical Device Supply Chain

    COVID-19’s Impact on the Medical Device Supply Chain

    On March 11, the World Health Organization declared COVID-19 a global pandemic, prompting the shutdown of much of civilized life. Conventional wisdom holds that medtech companies are largely insulated from economic disruption due to the steady demand…
    Tony Freeman, President, A.S. Freeman Advisors LLC 04.01.20

  • R&D & Design
    Supercharge Medical Device Innovation Using Effective User Preference Studies

    Supercharge Medical Device Innovation Using Effective User Preference Studies

    User preference and evaluation studies have been a mainstay design tool for medical device development for decades.
    Philip Remedios, Principal, Director of Design & Development, BlackHägen Design 04.01.20

  • COVID-19’s Lasting Impact on Healthcare’s Supply Chain

    COVID-19’s Lasting Impact on Healthcare’s Supply Chain

    While some have speculated about what will happen after this passes, the one area that most interests me is the medical device and healthcare supply chains.
    Sean Fenske, Editor-in-Chief 04.01.20

  • Industry Events Schedule Disrupted Due to Coronavirus—Full Event List

    Industry Events Schedule Disrupted Due to Coronavirus—Full Event List

    The medical device manufacturing industry has seen the postponement or cancellation of a number of upcoming events.
    Sean Fenske, Editor-in-Chief 03.30.20