ARTICLES BY BOB MARSHALL

De Novo Working As Intended: A Case Study
De Novo Working As Intended: A Case Study He sat there in the room, looked the FDA reviewers in the eye, and told them there were 10 people who died at his site during the trial, and if he had been allowed to use the data from the new diagnostic, he could have saved at least five of them.  Continue Reading...
Pioneers Recall The “Good Old Days” Of Device Development
Pioneers Recall The “Good Old Days” Of Device Development I love “old school” hardware stores. My best Saturdays, when I’m not out fishing in my little boat, are spent with a pencil behind my ear and a home improvement project to conquer.  Continue Reading...
4 Keys To Choosing The Right Regulatory Consultant
4 Keys To Choosing The Right Regulatory Consultant I spent the first two decades of my medical device career with startups and larger OEMs, working with or hiring consultants, as needed, for support. I then became a consultant for seven years, and I saw outsourced support from the other side. Now, I want to share some perspective on outsourced support. These important relationships can make or break your business.  Continue Reading...
Abracadabra? Nope – Neurostim Is Medicine, Not Magic
Abracadabra? Nope – Neurostim Is Medicine, Not Magic I spoke recently with David Rosen, president and CEO of eNeura, whose  transcranial magnetic stimulation  mini neuromodulation device is the only medical device currently approved in the United States for both the acute and prophylactic treatment of migraine headache.  Continue Reading...
Gore Redefines Inclusion And Occlusion For Stroke Prevention
Gore Redefines Inclusion And Occlusion For Stroke Prevention Most people with a patent foramen ovale (PFO) — a hole occurring in the upper wall between the left and right atria of the heart — do not experience any issues when blood flows from one atrium to the other; however, serious problems can occur...  Continue Reading...
AI Provides Help For The Sandwich Generation
AI Provides Help For The Sandwich Generation Catalia Health's AI-infused personal healthcare companion, Mabu, has conversations with patients every day to manage their treatment and gather data about their progress.  Continue Reading...
Get “Personal” And Go Digital To Secure Medtech Funding
Get “Personal” And Go Digital To Secure Medtech Funding $5.3 billion was invested in the Healthcare sector in Q1 of 2018, including 168 deals, but notice the types of products garnering the attention of venture capitalists...  Continue Reading...
MDTX Was A Cure For The “Regulatory Blues”
MDTX Was A Cure For The “Regulatory Blues” Last week’s MDTX event was a thought leaders' forum for medical device innovators who design, develop, or commercialize devices. There were interesting conversations with speakers and leading-edge knowledge from experts about everything from concept to commercialization, and regulations to reimbursement. My own presentation was on recently-released FDA guidance documents and how these new expectations might influence your next product...  Continue Reading...
Buying More Time For Stroke Victims
Buying More Time For Stroke Victims Fresh regulatory updates and a new generation of medical devices are expanding caregivers’ options for the early management of patients with acute ischemic stroke.  Continue Reading...
What Is The Best Medical Device Job For You?
What Is The Best Medical Device Job For You? A recent look at LinkedIn’s 50 most popular companies not only shows why those companies thrive, but provides insight on how job-seekers can find an employer who shares and supports their priorities and goals.  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.