Guest Columns

  1. 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? 

  2. 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.

  3. 4K Operating Room Technology Advancing, Despite Initial Doubts

    As the minimally invasive approach continues to become standard procedure, demand for surgical visualization equipment will continue to rise. Continued adoption of 4k technology is bolstering growth in the total U.S. video and integrated operating room equipment market, which currently is valued at almost $2.3 billion.

  4. Your Medical Device Software Will Need Updated — Better Plan For It Now

    Medical devices released into the market are part of an evolving software and security ecosystem in which new vulnerabilities are discovered or introduced all the time. The FDA's Medical Device Safety Action Plan outlines evolving expectations for the medical device industry, including expectations for secure updates.

  5. Should You Conduct Your Medical Device Clinical Trial In Latin America?

    Bilingual U.S. board-certified physicians who have a track record of research and publications and and the fact that trial costs are significantly lower in the region, makes Latin America very attractive for U.S. life sciences companies looking to conduct cost-effective and ethical OUS clinical trials.

  6. AI And Psychology In Device Development: Current Roles + What’s Next

    Given the level of regulation in the sector and the significant responsibility of assisting in patient care, it’s important that innovators, providers, and other parties involved have a high-level understanding of both the benefits and the limitations of AI technology. 

  7. Six Principles For Developing A Robust Training Program

    Well-designed training maximizes learner retention and understanding, and focuses on the information needed for safe and successful use. It also is important to understand that training for purposes of risk management cannot prop up a poorly designed device.

  8. Lessons For Medical Device Manufacturers Using 3D Printing

    Advances in the technology that enables production of 3D-printed medical devices continues to outpace development of the regulations, standards, and best practices intended to guide design and delivery of such devices. Learn how to insulate yourself from the resultant legal, regulatory, and business risks.

  9. Writing Compliant IQ/OQ/PQ Protocols — Meeting FDA Expectations

    Writing effective IQ/OQ/PQ protocols is a must for following the regulations required by the FDA for equipment, systems, and utilities to demonstrate suitability for the intended use.

  10. Create A Business Development Plan That Works

    Executives throughout business often misunderstand the meaning of developing business. Business development is about the “long game.” It’s about developing opportunities and collaborations over the longer term, while solidifying and expanding current customer relationships.