Articles by Bob Marshall
Challenges To FDA’s Modernization Of The 510(k) Pathway
The FDA and CDRH need to take a hard look at their plan to revamp the 510(k) pathway -- as well as how that regulatory path has been handled to date.
Fire Your Customers!
In the medical device industry, we are hypersensitive to complaints. Here, we examine complaints from a business satisfaction perspective, rather than the FDA definition, and discuss how to evaluate your customer base.
10x Gets Back To Its Roots
10x for Engineers (10x for Design and Manufacturing), held earlier this month in San Diego, offered prime networking and educational opportunities for MDO's chief editor and other attendees.
Cruising Down The Avenu Until They Turned Onto De Novo Way…
To De Novo, or not to De Novo, that is the question: whether ‘tis nobler in the mind to suffer the slings and arrows of outrageous regulations, or to take arms against them.
FDA: Case For Quality Collaboration
We needed to find out — in the Case For Quality Program in particular — how to get that enforcement fear out of the equation, so we could avoid the front-room/back-room concept and drive improvement.
Helping Burn Victims Feel Comfortable In Their Own Skin
The American Burn Association reported approximately 486,000 fire or burn injuries were seen at emergency departments between 2011 and 2015. AVITA Medical has developed their ReCell skin regeneration platform (currently under FDA PMA review) to improve outcomes for burn victims.
Hospital Care Rounding Third And Heading For Home
In ten years, there will be more patients admitted to the hospital that are actually outside the walls of the hospital, or admitted to home.
Arrhythmia Is Gonna Get You
Existing electrophysiology systems don’t have the fidelity, or noise floors in the hardware and software, to allow doctors to see subtle abnormalities. Doctors believe the ability to see these subtle abnormalities may enable them to provide better, more accurate treatment for arrhythmia.
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.
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.