Guest Columns

  1. 5 Reasons Your Medtech Market Likely Is Smaller Than You Think

    It’s best to be sure you understand the defensible, fact-based market need for your great idea before investing significantly in an intuitive belief of its potential.

  2. 8 Key Changes To Understand In The New European MDR And IVDR

    The new European MDR and IVDR regulations feature several significant changes and, while many medical device manufacturers already have started implementation efforts, this article aims to provide a quick summary of the key changes, aiding organizations in their transition plans.

  3. Managing Risk For Medical Device Clinical Trials

    This article explains the basics of project risk management and how to execute it, and the vital role clinical data play in product risk management, so the clinical trial manager can be better prepared to both manage risks in their trial projects and participate more fully in the device's product risk management effort.

  4. Global Medical Device Development — Trends And Attitudes

    A survey of about 200 medical device professionals examined how challenging it can be to balance innovative product design with compliance and risk management; the survey also looked at time-hungry tasks, technological advancement, and design methodologies.

  5. Automation vs. Artificial Intelligence In Medtech: Where Are We, And Where Are We Going?

    As more stakeholders become involved with automation, AI, and general data management in healthcare applications, the move toward a combination of all three aspects will create healthcare solutions equivalent to sci-fi aspirations.

  6. Using Comic Books To Craft Effective Quick Reference Guides

    Thanks to the huge culture surrounding comic books and Japanese manga, a rich body of work has emerged investigating the comprehension of visual narratives. Here, we explain how some of the cognitive principles and theories resulting from this research can be straightforwardly applied to QRGs.

  7. Examining Medtech’s Booming Heart Valve Market

    Transcatheter mitral valve devices will continue to expand into clinical practice as people age out of open-heart surgical operations, and technology and innovation for mitral valve diseases will continue to improve.

  8. The Science Of Patient Preferences In Med Device Clinical Trial Design

    Can we optimize clinical trial design by considering patients’ urgency for new therapeutic options, as well as their willingness to accept uncertainty? A nearly two-year collaboration — between the FDA Center for Devices and Radiological Health (CDRH), Parkinson’s patients (via The Michael J. Fox Foundation Patient Council), MIT, RTI Health Solutions, and the Medical Device Innovation Consortium (MDIC) — aimed to find out.

  9. A Look At The ISO 14971 And ISO TR 24971 Updates

    How will changes to the ISO 14971, the medical device risk management standard, and its accompanying guidance document, ISO TR 24971, an ISO Technical Report, affect your company? 

  10. Getting Medtech Covered: Payer Strategy Best Practices

    A medtech seeking payer coverage can only really control its own ability to articulate and prove its technology’s market value, while anticipating the myriad variations in coverage requirements. Virtually everything — from stakeholders to priorities to standards for evidence — is subject to change.