Articles by Bob Marshall

61. Unintended Con$equences Of FDA Form 483s 4/26/2017

    I talked with Sandra Maddock, president and CEO of IMARC Research, about trends in clinical research for medical devices, and she opened my eyes to a few very sticky situations with the FDA.

62. 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.

63. Routine FDA Inspections: Lower The Boom On The Back Room 4/13/2017

    The FDA's Consumer Safety Officers have a tough job to do inspecting medical device facilities. Are you making it harder for them? And, in doing so, are you making routine inspections harder on your company?

64. 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.

65. 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.

66. 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.

67. Making A Hard Choice To Thrive 3/27/2017

    If everything has been going so well, why did iuvo BioScience divest the sterilization portion of its business? In a word – focus.

68. 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. 

69. 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. 

70. Sanmina's Culture A Template For Medtech Growth 3/7/2017

    Having worked for two different device contract manufacturers, and having made decisions to outsource manufacturing to other contract manufacturers, I’ve had both good and bad experiences. Reflecting on one of my best experiences in outsourced medical device manufacturing, I reconnected with Tim McGinnis, VP of quality assurance and regulatory affairs for Sanmina’s medical division, to gain insight from his successes.