ARTICLES BY BOB MARSHALL

A Cure For A Broken Heart
A Cure For A Broken Heart A talk with Steven Morris, founding partner, CEO, president, and board member of BIOLIFE4D. His company is leveraging advances in life sciences and tissue engineering to 3D bioprint a viable human heart suitable for transplant.  Continue Reading...
I Said “No.” Management Said “Yes.” FDA Said “Recall.”
I Said “No.” Management Said “Yes.” FDA Said “Recall.” At most medical device companies, mere utterance of the word recall is akin to mentioning the Dark Lord’s name in the Harry Potter series of novels: it’s simply not done, unless one wishes to invite misfortune upon oneself. In Harry Potter’s world, the Dark Lord (Voldemort) is referred to as “He-Who-Must-Not-Be-Named,” a moniker easily coopted by “recall”-averse medical device companies into...  Continue Reading...
Get Involved In The FDA Process…Or Else!
Get Involved In The FDA Process…Or Else! As a child and student, I was mostly an academic. I got report cards with lots of “A’s” on them, but they didn’t hand out trophies for that. I did earn two small trophies for being on the first place team in kickball tournaments (it would have been way cooler if that was dodgeball instead). I did win a “Louie” as the guitar-player in the high school jazz band. I still have the little trophy for my Louis...  Continue Reading...
Want Better Devices? Send Your Engineers Into The OR
Want Better Devices? Send Your Engineers Into The OR Before he was an “Outdoor Man” marketing sporting goods in the Rocky Mountains as the Last Man Standing, Tim (“The Tool Man”) Taylor did most of his work indoors — on a little show called Home Improvement. Fortunately for the often accident-prone know-it-all, he had a competent sidekick in the mild-mannered Al Borland, who often knew a better way to get things done properly.  Continue Reading...
2018 – Good For The Device Industry, Good For Patients, Good For FDA
2018 – Good For The Device Industry, Good For Patients, Good For FDA I recently assembled a forward-looking article for Life Science Leader magazine, blending feedback from seven medical device industry leaders, who discussed industry trends for 2018. Here, I share the full set of responses from Maureen L. Mulvihill, co-founder, owner, and CEO at Actuated Medical, Inc.  Continue Reading...
Update On The Implantable Bioartificial Kidney
Update On The Implantable Bioartificial Kidney In my first year in the Chief Editor’s chair at MDO, one article received more audience comments than any other, by far, but it’s nothing that I can take credit for. It was a news story from early 2016, World’s First Implantable Artificial Kidney Could Enter Human Trials By 2017. As we are poised to enter 2018, it is now obvious that human trials will not begin in 2017, a big disappointment for many of our readers that...  Continue Reading...
Magee Searching For Unsung Heroes In Women’s Health
Magee Searching For Unsung Heroes In Women’s Health I still remember my first “Magee Prize” like it was yesterday.  Continue Reading...
Chan-Zuckerberg: Social Media Monarchy Breeds Philanthropy
Chan-Zuckerberg: Social Media Monarchy Breeds Philanthropy A recent BioBreakfast event welcomed Marc Malandro, VP of operations for science at the Chan Zuckerberg Initiative (CZI), back to the city of Pittsburgh. In his new role, Malandro is part of the CZI team supporting novel advances in the scientific research behind modern medicine.  Continue Reading...
Serial Life Science Entrepreneur On The Road Less-Traveled
Serial Life Science Entrepreneur On The Road Less-Traveled Quick! You’ve just licensed disruptive technology from a university research institution. It holds the promise of improved treatment for a prominent disease around the globe; what do you do first?  Continue Reading...
FDA Registration for CMOs – Still Crazy After All These Years
FDA Registration for CMOs – Still Crazy After All These Years Let’s face it: manufacturing in a regulated environment is more expensive than commercial manufacturing. With all due respect to the venerable prowess of medical device manufacturing professionals, even a lean, mean, 5S, Six Sigma, 8D machine cannot offset the cost created by a plethora of requirements, guidance documents, and standards.  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.