From The Editor
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Get Involved In The FDA Process…Or Else!
1/16/2018
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 Armstrong Jazz Award and every time I lay eyes upon it – I think to myself, what a wonderful world!
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Want Better Devices? Send Your Engineers Into The OR
1/10/2018
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.
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2018 – Good For The Device Industry, Good For Patients, Good For FDA
1/1/2018
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.
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Update On The Implantable Bioartificial Kidney
12/15/2017
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 commented on the article.
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Magee Searching For Unsung Heroes In Women’s Health
12/13/2017
I still remember my first “Magee Prize” like it was yesterday.
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Chan-Zuckerberg: Social Media Monarchy Breeds Philanthropy
12/5/2017
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.
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Serial Life Science Entrepreneur On The Road Less-Traveled
11/29/2017
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?
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FDA Registration for CMOs – Still Crazy After All These Years
11/15/2017
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.
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A Q&A With Dr. Brian Pogue, Incoming Editor-in-Chief, SPIE Journal of Biomedical Optics
11/13/2017
Dr. Brian Pogue of Dartmouth College will take the helm as editor-in-chief of SPIE’s Journal of Biomedical Optics (JBO) starting Jan. 1, 2018. Pogue spoke with Photonics Online about his decision to join the JBO as editor-in-chief, his vision for the journal, and how he balances all of his interests in limited time.
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DePuy Synthes Bringing Hip Surgery To The Front
11/10/2017
The modern era of hip replacement started in the 1950s and 1960s, and the traditional approach — the posterior approach — led the way. Then the anterior approach came to the United States