ARTICLES BY BOB MARSHALL

3 Pros Keeping Your Device On The Market
3 Pros Keeping Your Device On The Market In the final chapter of this series, we will discuss three key individuals who sustain a device from release until the device is retired.  Continue Reading...
Are You Satisfied With The FDA?
Are You Satisfied With The FDA? More than half of Americans are displeased with President Donald Trump's performance to date, and nearly four-fifths of the nation collectively sighs when evaluating Congress. So what does the medtech industry think of the U.S. Food and Drug Administration as we near the halfway point of 2017? The answer may surprise you.   Continue Reading...
Lights, Camera, Validation! — Preparing For FDA Prime Time
Lights, Camera, Validation! — Preparing For FDA Prime Time 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.  Continue Reading...
Unintended Con$equences Of FDA Form 483s
Unintended Con$equences Of FDA Form 483s 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.  Continue Reading...
To Test Is Human, But Verification Is Divine
To Test Is Human, But Verification Is Divine 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.  Continue Reading...
Routine FDA Inspections: Lower The Boom On The Back Room
Routine FDA Inspections: Lower The Boom On The Back Room 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?  Continue Reading...
3 Design-Related Partners For Medtech Development
3 Design-Related Partners For Medtech Development 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.  Continue Reading...
Killer Experiments Help Coulter Spur Innovation
Killer Experiments Help Coulter Spur Innovation 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...  Continue Reading...
4 Early-Stage Relationships Vital To Medtech Development
4 Early-Stage Relationships Vital To Medtech Development 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.  Continue Reading...
Making A Hard Choice To Thrive
Making A Hard Choice To Thrive If everything has been going so well, why did iuvo BioScience divest the sterilization portion of its business? In a word – focus.  Continue Reading...
More from Bob Marshall
Bob Marshall

Bob Marshall

Bob Marshall brings more than 20 years of experience in medical device product development, manufacturing, quality assurance, and regulatory affairs to Med Device Online. He spent the last seven years with medical device consulting firm Regulatory & Quality Solutions, and previously held leadership positions with Renal Solutions (now Fresenius Medical Care), Siemens Medical Solutions, Medrad (now Bayer HealthCare), and Respironics (now Philips Healthcare). He holds both a BS degree in electrical engineering and an MS degree in organizational leadership from Geneva College.