Industry Perspectives - Design & Development

  1. Understanding The Impact Of New European MDR And IVDR On Quality And Regulatory System Resources
    5/22/2017

    As a result of the European Union's new Medical Device Regulations (MDR) and In-Vitro Diagnostic Regulations (IVDR) adopted earlier this month, many adjustments will be required in the roles and responsibilities of medical device companies, manufacturers, importers, distributors, and authorized representatives.

  2. Failure Analysis 101
    5/15/2017

    A one percent failure rate should be unacceptable in any industry, especially healthcare. More aggressive and smarter testing will, in essence, cut that current failure rate in half. 

  3. Lights, Camera, Validation! — Preparing For FDA Prime Time
    5/3/2017

    In the “validation/manufacturing transfer” stage, we move beyond lab-queen prototypes, small sample sizes, and controlled bench testing to prove that the product will fully satisfy user needs under actual or simulated operating conditions. This is the dress rehearsal for commercialization.

  4. To Test Is Human, But Verification Is Divine
    4/18/2017

    This article is the third in a series exploring some of the important relationships involved in each phase of medical device development. Here, we'll look at key relationships during the verification phase.

  5. 3 Design-Related Partners For Medtech Development
    4/11/2017

    This article is the second in a series exploring some of the important relationships involved in each phase of medical device development. Here, we'll look at key relationships during the design phase.

  6. Killer Experiments Help Coulter Spur Innovation
    4/4/2017

    I previously wrote about phase one of the Coulter Foundation's Translational Research Partnership Program, which assists universities in developing and commercializing medical technologies by forming working partnerships and promoting translational research. Today, I focus on phase two, going inside the Coulter Foundation for perspective, exploring how the second phase benefited from the experiences of the first, and visiting with program leaders from one of the phase two schools.

  7. 4 Early-Stage Relationships Vital To Medtech Development
    3/30/2017

    This article is the first in a series exploring some of the important relationships involved in each phase of medical device development. We'll begin by looking at key relationships during the concept (or conceptual) development phase.

  8. The Sweet 16 Of Medtech Madness
    3/21/2017

    What do basketball and biomedical engineering have in common? They both are areas where universities compete. 

  9. How Digital Knitting Can Stitch A Better Bottom Line On Medical Wearables
    3/16/2017

    As the need for innovative, wearable medical devices increases, so does the importance of new prototyping methods to expedite development time and reduce the time to market. Within soft goods development, digital knitting allows for intricately detailed 3D shapes, and for multiple materials to be integrated into a single, production-level prototype.

  10. Cybersecurity: FDA Leads While CIA Leaks
    3/14/2017

    Ethical Intruder CEO David Kane shared with me recently his perspective on security challenges for medical devices, health IT, and hospitals - as well as strategies to overcome those challenges.